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International public health hazards: Indian legislative provisions

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WHO Library Cataloguing-in-Publication data World Health Organization, Regional Office for South-East Asia. International public health hazards: Indian legislative provisions 1. Health Legislation 2. Public Health 3. National Health Programs 1. India. (NLM classification: W 32)

ISBN 978-92-9022-476-1 Cover photo: © http://parliamentofindia.nic.in/

© World Health Organization 2014 All rights reserved. Requests for publications, or for permission to reproduce or translate WHO publications – whether for sale or for noncommercial distribution – can be obtained from SEARO Library, World Health Organization, Regional Office for South-East Asia, Indraprastha Estate, Mahatma Gandhi Marg, New Delhi 110 002, India (fax: +91 11 23370197; e-mail: searolibrary@who.int). The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use. This publication does not necessarily represent the decisions or policies of the World Health Organization. Printed in India

Contents Acronyms...................................................................................................... v 1. 2. 3. 4. 5. 6. 7. Introduction......................................................................................... 1 Indian legislative position...................................................................... 5 Current status of IHR implementation in India.................................... 14 The way forward ............................................................................... 19 Conclusion.......................................................................................... 22 List of references................................................................................ 23 Annexes............................................................................................. 24

International public health hazards: Indian legislative provisions ................................................................ iii

Acronyms APHO DM Act IHR MoH&FW NCDC NICD PHEIC PHO RRT SOP UT WHO airport health officers Disaster Management Act International Health Regulations Ministry of Health & Family Welfare, Government of India National Centre for Disease Control, Delhi National Institute of Communicable Diseases, Delhi public health emergency of international concern port health officers rapid response teams standard operating procedure union territory World Health Organization

International public health hazards: Indian legislative provisions ................................................................. v

1 Introduction The International Health Regulations (IHR 2005) came into force in June 2007. They placed a number of obligations on the signatory Member States as well as the World Health Organization (WHO). For this purpose, IHR aims to develop agreed mechanism by (Member States) to rapidly share information on occurrences of public health emergency of international concern. The IHR require Member States to: Article 5: detect and notify WHO about a range of disease-related events occurring within their territory that may constitute a public health emergency of international concern. inform the WHO of public health concerns outside their territory, which WHO in turn will verify through surveillance activities with the respective national IHR focal points.

Article 6:

Article 7: ensure that national health surveillance and response capacities meet certain functional criteria, within a certain time frame, especially at points of entry such as airports, sea-ports and ground crossings.

International public health hazards: Indian legislative provisions ................................................................. 1

Building on the unique experience of WHO in global disease surveillance, alert and response, IHR define the rights and obligations of Member States to report public health events and establish a number of procedures that WHO must follow in its work to uphold global public health security. India is one of 194 countries bound by IHR, which aims to help the international community prevent and respond to public health risks that have the potential to cross borders and are of international public health importance. IHR require the Member States to contribute significantly to national and international health security. This study was taken up for a regional workshop on public health legislations for International Health Regulations held in Yangon, Myanmar, 8–10 April 2013 to outline Indian legislation that may be involved for implementing IHR provisions.

1.1 The regional workshop context The overall objective of the regional workshop was “to augment regional capacity in harmonizing national laws with International Health Regulations (IHR 2005)”. The specific objectives were to: (a) review the current status of the policies, legislation, regulations, administrative requirements and other government instruments available to support IHR implementation; (b) identify key gaps; (c) discuss elements of IHR national policies that need to be developed and adopted to support the implementation of required structures and allocate the needed resource; and (d) define the next steps for the way forward.

1.2 Outcomes of the study The study examines the present position in the Indian legal system which may enable the implementation of IHR to •• establish an early warning system of an outbreak;

2.......................................................... International public health hazards: Indian legislative provisions

•• mobilize the Government to administer health care; and •• contain the outbreak within the country. The relevant Indian legislation has been examined for •• biological hazards including infectious diseases, diseases caused by zoonosis and issues relating to food safety; •• chemical hazards; and •• radio-nuclear hazards. These aspects have been examined for the following points of entry into the jurisdiction of India, namely (i) entry by air through airports; (ii) entry by sea through sea ports; and (iii) ground crossings. The study also involved examining the laws that would apply – regardless of the point of entry – for identification/verification/mitigation/ containment of hazards under the additional heading “(iv) applicable to all” A number of laws “other legislation” were also identified, that would be significant in the containment and mitigation of the hazard after its manifestation in India.

1.3 Methodology used The methodology adopted for the conduct of the study included the following steps: (a) identifying the relevant provisions in the Indian laws that aid and impact the implementation of IHR 2005 in India; (b) identifying the various ministries and departments thereunder which are involved in administering the prevalent laws;

International public health hazards: Indian legislative provisions ................................................................. 3

(c) examining the existence of effective operating procedures that invoke relevant provisions of the identified laws including Acts, Rules, Regulations and Orders; (d) outlining the role of the National Centre for Disease Control, New Delhi, the national focal point for India; (e) identifying the gaps in the existing system, if any; and (f) finding a way forward. For this purpose apart from electronic secondary data collection, visits to various government offices as necessary were also carried out.

1.4 Effective Implementation of IHR In order to effectively implement the IHR 2005, it is imperative that each Member State co-ordinates its various core capacities including surveillance, response systems, preparedness to contain and mitigate the risk, systems for risk communications, mobilization of human resources and laboratory network.

4.......................................................... International public health hazards: Indian legislative provisions

2 Indian legislative position 2.1 The Indian legislative structure India follows a quasi-federal system of governance, where there is a division of power at the federal and the state level. While the federal/ central/union government governs the union of twenty-eight states and seven union territories (UT), the State Governments govern their respective states under the Indian Constitution. The Government of India constitutes three branches namely: 1. the Executive headed by the President of India and the Governor as executive head at the state level; 2. the Parliament for the central government and state legislatures which comprise the Rajya Sabha (the Upper House) and the Lok Sabha (the Lower House) at the centre (Central Government) and Vidhan Sabhas in the state (State Legislatures) 3. the judiciary comprising the Supreme Court at the apex, the high courts in the States and the district courts at the district level (Figure 1). The legal system includes statutory laws as well as the common law, which administer the rights and duties of the citizens as enshrined in the Constitution of India.

International public health hazards: Indian legislative provisions ................................................................. 5

Figure 1: Diagrammatic representation of the legislating powers of the Government of India, as laid down in the Constitution Union State

Legislature Structure Upper House Lower House

Executive

Judiciary

Legislature

Executive

Judiciary

President & Vice President Prime Minister & Council of Ministers

Supreme Court of India High Court of Dlehi District Courts in Delhi

Upper House Lower House

Governor Chief Minister & Council of Ministers

High Courts (Except High Court of Delhi Districts Courts

Power

Union List (List I) & Concurrent list (List III)

Art. 52 to 78 & Art. 239 to 241

Art. 124 to Art. 147

State List (List II) & Concurrent list (List III)

Art. 153 to Art. 167

Art. 213 to Art. 237

Result Law (Acts)

Ordinance Bye-law Rule Regulation Notification

Order Directive Judgement

Law (Acts)

Ordinance Bye-law Rule Regulation Notification

Order Directive Judgement

The structure of governance at the Centre is replicated at the State level – with the Executive headed by the Governor appointed by the President, the high courts and the state legislatures which is bicameral in six States and unicameral in the rest. Legislation on federal matters is enacted by the Central Government (Union List of the Constitution of India) and by the state governments on state matters (State list of subject in the Constitution of India), with both central and state governments empowered by the Constitution to legislate on certain subject matters (the concurrent list in Constitution of India).

2.2 Distribution of powers The Constitution of India defines the distribution of powers between the federal and the state governments and also delineates their respective

6.......................................................... International public health hazards: Indian legislative provisions

legislative and administrative powers. The Seventh Schedule under Article 246 of the Constitution identifies and enumerates various subject matters on governance into three lists, namely the Union list, States list and Concurrent list.

Union list The Union list consists of 99 items which include issues of national importance e.g. arms and ammunition, atomic energy, foreign affairs, citizenship, extradition, railways, shipping and navigation, airways, posts and telegraphs, telephones, wireless and broadcasting, currency, foreign trade, inter-state trade and commerce, banking, insurance, control of industries, regulation and development of mines, mineral and oil resources, constitution and organization of the Supreme Court, high courts and Union Public Service Commission, income tax, custom duties and export duties, duties of excise, corporation tax, taxes on capital value of assets, estate duty, and terminal taxes.

State list The State list consists of 61 items which include matters that require proximate governance for addressal of issues e.g. maintaining law and order, police forces, health care, transport, land policies, electricity in state, and village administration among others.

Concurrent list The Concurrent list consists of 52 items which comprise matters of both regional and national importance. For instance, civil procedure for courts of law, economic and social planning, stamp duties, ports, shipping and navigation on inland waterways, collection of vital statistics such as birth and deaths, lunacy and mental deficiency education, contracts, bankruptcy and insolvency, contempt of court, adulteration of food, drugs and poisons, legal, medical and other professions, trade unions, labour welfare, electricity, newspapers, books and printing press as well as prevention of transmission from one state to another of infectious or contagious diseases or pests affecting men, animals or plants.

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Legislative proposals are presented as a bill by the concerned Ministry before either the Upper or the Lower House of Parliament or at the State level. The bill is enacted into law when passed by both houses and assented to by the President or Governor as the case may be. Public participation is invited when the bill is published in the official media, and amendments, if any, are incorporated before enactment. Entry 14 of the Union list in the Constitution of India empowers Parliament with the exclusive power of entering into and implementing treaties, agreements and conventions with foreign countries as well as with powers to make any law for the implementation of such. It may be noted that matters significant to the study for IHR appear in all the three lists, since a number of legislations both at the Centre as well as at the state level deal with health, medicine and treatment.

2.3 Relevant legislation identified in the study It is found that 20 ministries administer the laws which govern various hazard situations and their entry, control and mitigation in India that are relevant for IHR implementation. This study has identified the points of entry in to the country for the following IHR events. The definition of the various forms of legislation is as follows: ACT – A bill which has passed through various legislative steps required and which has become law. RULE – An established standard, guide, or regulation governing conduct, procedure or action. REGULATION – A rule of order having the force of law, prescribed by a superior or competent authority, relating to the actions of those under its control. POLICY – The general principles by which a government is guided in its management of public affairs, or the legislature in its measures. ORDER – A mandate, precept; a command or direction given with authority .

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NOTIFICATION – Issued by a Government (central/state) to exercise the power of a legislative enactment (Parliament/Assembly). These notifications generally lay down the law, taking care of some procedural aspects of the enactment. Table 1: Governance of hazards Orders/ Notifications/ Guidelines/ Standards/ Handbook 4 1 4

S.no.

Type of hazard

Acts

Rules/ Regulations

International conventions

I 2 3

Biological hazards Chemical hazards Radio/Nuclear hazards

21 18 7

12 20 9

2 – –

2.4 Overview of the annex The Indian legislation that may be taken up for IHR implementation has been captured into two annexes. Annex 1 is a quick reference and Annex 2 (enclosed in a pen drive) gives details of the provisions (Table 3). The annexes can be summarized as follows:

Annex 1: Ministries and corresponding legislation Annex 1 is a quick reference chart, which provides a list of ministries and their respective departments/divisions along with the legislation they govern. These directly impact health issues, especially outbreaks resulting from air, sea or ground crossings. This annex captures the legislation and the provisions as relevant to the three types of hazards. It is expected that this will be very useful in the mobilization of resources under laws governed by different ministries, when a standard operating procedure (SOP) is required for the control, containment and mitigation of outbreaks.

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Table 2: Checklist of ministries from Annex 1 S.no. 1. Ministry Ministry of Health & Family Welfare Relevant Department / Division a. AYUSH b. AIDS Control c. Food Safety & Standards Authority of India d. Health & Family Welfare

2. 3. 4. 5. 6. 7.

Ministry of Civil Aviation Ministry of Shipping Ministry of Railways Ministry of Roads, Transport & Highways Ministry of Environment & Forests Ministry of Chemicals & Fertilizers

8. 9. 10. 11. 12. 13.

Ministry of Science & Technology Ministry of Commerce & Industry Ministry of External Affairs Ministry of Drinking Water & Sanitation Ministry of Mines Ministry of Home Affairs

a. b. c. a. b.

Chemical & Petrochemicals Fertilizers Pharmaceuticals Atomic Energy Biotechnology

a. Commerce b. Industrial Policy & Promotion

a. b. c. d. e. f.

Disaster Management Human Rights Judicial North East Internal Security Police

14. 15. 16. 17. 18. 19. 20.

Ministry of Agriculture Ministry of Finance Ministry of Labour and Employment Ministry of Consumer Affairs, Food & Public Distribution Ministry of Food Processing Ministry of Women & Child Development Ministry of Rural Development

a. Animal Husbandry & Dairying b. Agriculture & Cooperation a. Central Board of Excise & Customs a. Consumer Affairs

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The study identified 124 relevant laws/legislation which comprise 67 Acts, the rest being rules, regulations, administrative orders, notifications etc. The Acts are administered by the concerned ministry. However certain Acts are governed by more than one ministry. These are: •• Drugs and Cosmetics Act 1940 - Ministry of Health & Family Welfare and Ministry of Chemicals & Fertilizers •• Environment (Protection) Act 1986 - Ministry of Environment & Forests and Ministry of Science & Technology •• Infant Milk Substitutes, Feeding Bottles & Infant Foods (Regulation of Production, Supply & Distribution) Act, 1992 - Ministry of Food Processing and Ministry of Women and Child Development •• The Destructive Insects & Pests Act, 1914 – amended in 1992 – Ministry of Agriculture and Ministry of Rural Development The Laws/Legislation also comprise 36 Rules, 8 Regulations, 3 Guidelines, 3 Orders, 1 Notification, 2 International Conventions, 1 Handbook, 2 Standards and 1 Policy (see Table 3). Therefore, to identify the provisions in Indian legislation that may promote IHR implementation, it becomes imperative to review the legislative bodies, the legislation and the authority designated under each of the legislations, before an effective system for coordination can be set up, based on a series of SOP for IHR. Table 3: Checklist of regulations, orders etc. from Annex 2 Baggage (Transit to Customs Stations) Regulations 1967; Courier Imports and Exports (Clearance) Amendment Regulations 2010; Regulations (8) Export Manifest (Air Craft) Regulations 1976; Import Manifest (Air Craft) Regulations 1976; Export Manifest (Vessels) Regulations 1976; Food Safety & Standards (Contaminants, Toxins & Residues); The Civil Defence Regulations 1968; The National Institute of Disaster Management Regularions 2006;

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National Disaster Management Guidelines; Guidelines (3) National Disaster Management Guidelines - Management of Nuclear and Radiological Emergencies 2009; Guidelines for Nuclear Transport (Exports) 2006; Plant Quarantine (Regulation of Import into India) Order 2003; Orders (3) The Pet Food Products of Animal Origin (Import into India) Order 2005; Fertilizers (Movement Control) Order, 1960 Notification on Procedure for Import of Livestock Products into India; Cartagena Protocol on Biosafety to the Convention on Biological Diversity 2003; The WTO Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) 1995; Handbook of Procedures (Vol.I) 27 Aug 2009-31 Mar 2014; IAEA Safety Standards 2007; The Environmental Standards List National Water Policy 2002

Notifications (1)

International Conventions (2) Handbook (1) Standards (2) Policy (1)

Annex 2: Information matrix based on various legislation depending on hazards and point of entry Annex 2 is an exhaustive spread sheet tabulating the relevant laws applicable to the three categories of hazards. The laws relevant to each hazard have been organized as per the mode of entry under “Airports”, “Ports” and “Ground crossing” and “Applicable to all”. For example, it is seen that •• 24 legislations are applicable to all points of entry in the category “Biological hazard”, which includes the Patents Act; Biological Diversity Act; Wildlife Protection Act; Seeds Act and Sanitary and Phytosanitary Measures; •• 27 legislations are applicable to all points of entry under the category “Chemical hazard” including Narcotic Drugs and Psychotropic Substances Act and Rules; Drugs and Cosmetics Act; Public Liability

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and Insurance Act; Explosive Substances Act and Chemical Weapon Convention Act; •• 17 legislations are applicable to all points of entry under the category “Radio/Nuclear Hazard” including Atomic Energy Act and Radiation Protection Rules. “Other legislation” captures legislation important for the mobilization of resources within the country to contain and mitigate an outbreak, once such is confirmed.

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3 Current status of IHR implementation in India 3.1 Implementation of IHR 2005 in India Many of the laws that may be invoked for implementation of IHR 2005 in India have been in existence for over 100 years. In order to implement IHR 2005, India has taken multi-level steps i.e. at the national, state and district levels and has furthermore examined activities related to airport, sea ports and ground crossings.

NCDC as national focal point in India for IHR The activities at the national level include the designation of the National IHR Focal Point, initially assigned to the National Institute of Communicable Diseases (NICD) under the Ministry of Health and Family Welfare. In 2009, NICD transformed into the National Centre for Disease Control (NCDC), with a larger mandate for controlling emerging and re-emerging diseases. NCDC, headed by a Director, has the following departments: (a) Centre for AIDS and related diseases (b) Integrated Disease Surveillance Project

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(c) Division of Epidemiology (d) Division of Biochemistry and Biotechnology (e) Centre for Medical Entomology and Vector Management (f) Division of Zoonosis (g) Division of Microbiology (h) Division of Malaria and Coordination (i) Division of Parasitic Diseases (j) Division of Planning, Budget and Administration Apart from conducting training and research using a multidisciplinary integrated approach, NCDC is also expected to provide expertise to the states and UT on rapid health assessment and laboratory-based diagnostic services, surveillance of communicable diseases and outbreak investigation. The mandate of NCDC is also to notify public health emergencies of international concern (PHEIC) to WHO, to respond to requests for verification of information of such events, support field investigations for early diagnosis and technical guidance to the States for the timely and effective response to PHEIC. The notification of an outbreak to WHO is based on the identification of any two of the four point criteria of determination of PHEIC: 1. unusual or unexpected event 2. an event that seriously impacts public health 3. event with a significant risk of international spread and 4. event with a significant risk of international spread requiring travel and trade restrictions.

Role of NCDC at the state and district levels Efforts are ongoing to increase awareness about IHR among health administrators and professionals in the South-East Asia Region. NCDC is also mandated with the following:

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(i) establishing an early warning mechanism; (ii) increasing the presence of laboratories in different states; (iii) establishing a network for surveillance and rapid confirmation of diagnosis; and (iv) instituting appropriate and timely response for the prevention and control of outbreaks. Apart from these overarching responsibilities, NCDC has the responsibility of identifying nodal officers at designated hospitals, laboratories, state health directorates, district health authorities, local municipalities, Cantonment Board, as well as at the ministries of civil aviation, shipping, surface transport, agriculture (veterinary department) home affairs, tourism and railways. Nodal officers are also to be identified in the customs, immigration and Airport Authority of India, Association of Shipping Agents and the Central Industrial Security Force. NCDC also has the responsibility to develop guidelines for establishing and training rapid response teams (RRT), which will be deployed in all states at the district level. These are multidisciplinary teams comprising of an epidemiologist, a microbiologist, a physician and an entomologist. As per 2013 data, 118 State and 251 district RRT members are currently deployed. Currently, there are 19 regional and 88 district laboratories. Additional 21 regional and 101 district laboratories are being established

NCDC at the international entry points in India At present, India has 25 international airports, 12 sea ports and ground entry at three major land borders, namely Bangladesh, China and Pakistan. As per NCDC data, seven of the 25 international airports have functional airport health officers (APHO) i.e. Bengaluru, Chennai, Delhi, Hyderabad, Kolkata, Mumbai and Tiruchi. Three airports are in the pipeline for the establishment of APHO. A proposal to establish APHO in the remaining 15 airports also exists. Similarly, there are 10 sea ports with functional port health officers (PHO), with the remaining two in the pipeline. As regards the ground

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crossings, the Government has identified 15 porous borders with a functional health office at Attari, while the remaining entry points are to have functional health offices in two phases, in the near future. As is evident from the above, there is a gap in the specific objectives outlined by NCDC and the actual implementation of IHR 2005. The expected outcome of successful implementation is as follows: (a) development of communicable disease database (b) prediction and early detection of outbreaks (c) early institution of containment measures (d) improvement of preparedness and response capability at all levels (e) reduction in morbidity and mortality. There are gaps in the establishment of basic surveillance infrastructure, such as the absence of health officers at ground crossings, PHO at sea ports and APHO at the airports, that need to be addressed for effective IHR implementation.

3.2 The National Health Bill 2009 The Ministry of Health and Family Welfare (MoH&FW) presented a draft law called the National Health Bill 2009, presently pending in Parliament. The mandate is to “provide for protection and fulfilment of rights in relation to health and wellbeing, health equity and justice, including those related to all the underlying determinants of health as well as health care; and for achieving the goal of health for all; and for matters connected therewith or incidental thereto”. The Bill has preamble clauses, one of which clearly states that the Bill is to be enacted to give effect to a number of international treaties and declarations under Article 252 of the Constitution of India, with one of the said declarations being the “International Health Regulations, Fiftyeighth World Health Assembly (2005)”. As mentioned above, it is within the constitutional powers of Government of India under Item 14 in List I (Union List) in Schedule VII

International public health hazards: Indian legislative provisions ...............................................................17

of the Indian Constitution, to legislate on matters that require to be legislated upon for implementing its international obligations under the international treaties and declarations. Rather interestingly, Schedule III of the Bill lists about 71 Acts already in force to ensure that the Bill is compatible with these Acts. (Source: http://mohfw.nic.in/NRHM/Draft_Health_Bill/General/Draft_National_Bill. pdf). Of the 71 Acts, 28 are covered in Annexes 1 and 2. However, Births, Deaths and Marriages Registration Act, 1886; Epidemic Diseases Act, 1897; Indian Red Cross Society Act, 1920; Drugs (Control) Act, 1950; Beedi and Cigar Workers (Conditions of Employment) Act, 1966; Consumer Protection Act, 1986 etc. are not specific to any hazard or an entry point - but would be incidental to this study and are expected to be very relevant for the purpose of containment and mitigation of disease outbreaks.

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4 The way forward IHR implementation requires an effective system for mitigation, containment and recovery with a multi-dimensional approach. This includes real-time communication systems, integration of data, capacity-building and more importantly, enforcement of policy and plans. NCDC has been working at capacity-building and integration of data. The periodic collection and analysis of district-wise data from different states is a useful starting point to monitor and report outbreaks. The periodic reporting of occurrences of disease outbreaks are captured, clearly identifying the state/UT, the affected district, disease/illness, number of cases, number of deaths, starting date of outbreak, date of reporting, and current status along with comments/action taken (Source: http://idsp.nic.in/idsp/IDSP/rcntobrk.pdf). There is, however, considerable scope under the existing legislation to mobilize resources to contain and mitigate the damage, in case of a serious outbreak. Once a “disaster” is declared by the Government, the provisions of the Disaster Management Act (DM Act) 2005 apply. “Disaster” is defined as “a catastrophe, mishap, calamity or grave occurrence in any area, arising from natural or man-made causes, or by accident or negligence which results in substantial loss of life or human suffering or damage to, and

International public health hazards: Indian legislative provisions ...............................................................19

destruction of, property, or damage to, or degradation of, environment, and is of such a nature or magnitude as to be beyond the coping capacity of the community of the affected area;” However, there is no clarity in the SOP that would be adopted by NCDC, where the situation is not classified as a “disaster” but as an “outbreak” or “potential outbreak”. It is unclear as to how the different ministries would be mobilized by MoH&FW, in the case of an imminent outbreak that is yet to be declared an emergency. The enabling provisions to take control measures across all relevant ministries, in case of an outbreak to mobilize different authorities under the multiple laws governed by different ministries, need to be identified.

4.1 The Disaster Management Act 2005 and IHR implementation The DM Act clearly lays down a multidimensional strategy to handle pre-disaster and post-disaster situations and mandates certain actions by the officers of different ministries to work in tandem, in mobilizing resources across the ministries and departments thereunder, to control and contain the damage wrought/liable to be wrought by a disaster. This is not the case for NCDC, which reports all matters to the Director-General of Health Services, MOH&FW. There is no legal mandate authorizing MOH&FW to approach the relevant ministries every time there is an imminent outbreak, unless it can invoke certain legal provisions under enacted law and request direction from the other ministries. This can be especially tricky in a situation where there is a separation of powers between the Centre and the State.

4.2 Standard operating procedures to mobilize resources for containment/mitigation as opposed to treatment In such a situation or until such time that the National Health Bill has been enacted and all accompanying teething issues resolved, one viable

20I�� International public health hazards: Indian legislative provisions

approach could be to formulate a series of SOP for every identifiable situation, each SOP being approved before-hand by each of the ministries involved, so that a pre-determined cue can trigger off the implementation of the SOP by all the concerned personnel at ground level, without awaiting directions from the top echelons of the concerned ministry. The SOP can be reviewed periodically to: (a) ensure that they are not out-dated; and (b) one re-framed to absorb new developments including the creation of new departments, enactment of new laws, revocation of old laws etc.

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5 Conclusion The study has identified the laws and the ministries that govern the laws. It is apparent from the study that a number of relevant legal provisions required to control and contain an outbreak have been enacted and are in force. However, there are gaps in harmonizing the actions of the existing systems including the nascent system being developed by NCDC along with all the resources - especially for containment and mitigation of a situation capable of being declared an outbreak as well as an existing outbreak. There is an need to develop SOP invoking relevant legislation and having authorities thereunder in place, by the relevant participating ministries, so that all resources can be mobilized immediately in the event of an imminent or a full blown outbreak. Given the various parameters and the complex collection of legislations, the more probable way of setting up a comprehensive and effective SOP would be by adopting a problem-solution approach for every given circumstance and weaving the SOP into a vast resource-mobilizing machinery that would be equally effective in handling anything, from a regional outbreak to a national emergency.

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6 List of references 1. The Constitution of India 2. IHR 2005 3. The collection of data by NCDC – http://idsp.nic.in/idsp/IDSP/rcntobrk. pdf 4. Draft National Health Bill 2009 – http://mohfw.nic.in/NRHM/Draft_ Health_Bill/General/Draft_National_Bill.pdf 5. Disaster Management Act 2005 6. Gazette notifications of various legislations 7. Official websites of relevant ministries.

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7 Annexes Annex 1 – Annex 2 – Analytical matrix Information matrix based on various legislation, depending on hazards and points of entry and their corresponding Ministries - is part of a pen drive enclosed with this report.

24I�� International public health hazards: Indian legislative provisions

Annex 1

Analytical matrix

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Agriculture S. No. 12 Acts – Rules – Order/Notifications Plant Quarantine (Regulation of Import into India) Order, 2003 (8 relevant provisions) Biological Sec 2: [Sec 2(ii), 2(ix), 2(x), 2(xi), 2(xii), 2(xiv), 2(xvi), 2(xviii), 2(xxi), 2(xxii), 2(xxiv)], Sec 3, 4, 6, 7, 8, 9, 10 Sec 2: [2(11), 2(12), 2(13)], Sec 17, 19 Art 1(1), Art 2 (1, 2), Art 5 (1,2,3), Art 6 Chemical –

20 22

The Seeds Act, 1966 (3 relevant provisions) –

– –

– WTO Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement), 1995 (all provisions are relevant) –

– –

Livestock Importation Act, 1989 (3 relevant provisions) –

–

Sec 2: [2(a), 2(b), 2(c), 2(d)], Sec 3, 4 Clause 1, 3, 4, 5, 6, 7

–

The Prevention and Control of Infectious and Contagious Diseases in Animals Act, 2009 (all provisions are relevant)

–

Notification on Procedure for import of livestock products into India (6 relevant provisions) The Pet Food Products of Animal Origin (Import into India) Order, 2005 (3 relevant provisions) –

–

Clause 2: [2(a), 2(e), 2(h), 2(i), 2(m)], Clause 3, 7;

–

Chapter I - Sec 2: [2(a), 2(d), 2(e), 2(f), 2(i), 2(j), 2(m), 2(n), 2(q)], Chapter II - Sec 4, 5, 7, 8, 12, 14; Chapter III - Sec 20-22; Chapter IV - Sec 23 - 28; Chapter V - Sec 29 -34; Chapter VI - Sec 35

–

26I�� International public health hazards: Indian legislative provisions

Radio/Nuclear –

Schedule/Annexure Source Schedule I, II, IV http://dbtbiosafety.nic.in/act/ Plant%20Quarantine%20_ order_2003.pdf

Ministry of Agriculture

Department of Agriculture and Cooperation

– –

– Annex A and C

http://www.agricoop.nic.in/ seedsact.htm http://www.wto.org/english/ tratop_e/sps_e/spsagr_e.htm

Agriculture Agriculture

Agriculture and Cooperation Animal Husbandry, Dairying and Fisheries

–

http://indiankanoon.org/ doc/1577226/ http://www.dahd.nic.in/dahd/ upload/livestockimport.doc

Agriculture

–

Agriculture

Animal Husbandry, Dairying and Fisheries Animal Husbandry, Dairying and Fisheries Animal Husbandry, Dairying and Fisheries Animal Husbandry, Dairying and Fisheries

–

http://www.pfndai.com/ Gazette%20pdfs/066_1842.pdf

Agriculture

–

Schedule A-L

http://www.dahd.nic.in/dahd/ upload/Gazette_20-03-09.pdf

Agriculture

International public health hazards: Indian legislative provisions ............................................................................... 27

S. No. 30

Acts –

66 67

Insecticide Act, 1968 (6 relevant provisions) –

Rules Order/Notifications Biological – Rule 3, 4, 5 Prevention and Control of Infectious and Contagious Diseases In Animals (Form of Vaccination Certificate, Manner of Post Mortem Examination and Disposal of Carcass) Rules, 2010 (3 relevant provisions) – – – Insecticides Rules, 1971 (4 relevant provisions) – – –

Chemical –

Sec 3: [3(b),3c, 3(e),3(k)], Sec 17, 25, 26, 27, 29 Rule 16, 35, 36, 45. Sec 3: [3(f), 3(i)], Sec 8, Sec 10, Sec 12, Sec 20, Sec 20A, Sec 21, Sec 23 - 25

Tobacco Board Act, 1975 (10 relevant provisions)

–

Sec 3: [3(f), 3(i)], Sec 8, Sec 10, Sec 12, Sec 20, Sec 20A, Sec 21, Sec 23 - 25

Drinking water S. No. Acts – Rules National Water Policy, 2002 Order/Notifications – Biological – Chemical –

Commerce and industry S. No. Acts 15 The Patents Act, 1970 (19 relevant provisions) Rules – Order/Notifications Biological – Sec 3: [3(b), 3(i), 3(j)], Sec 47(4), 83(d) & (e), 92, 92A, 99, 100(4) & (5), 118-122, 157A – – Chemical Sec 2(ta), Sec 3:[3(b), 3(d), 3(e), 3(j), 3(p)], Sec 9(3), 47(4), 84, 92, 92A, 100(4), 100(5), 118, 157(A) Rule 71, 100.

–

The Patents Rules, 2003 (2 relevant provisions)

28I�� International public health hazards: Indian legislative provisions

Radio/Nuclear –

Schedule/Annexure Source Form A, B, C http://dahd.nic.in/dahd/actsrules.aspx

Ministry of Agriculture

Department of Animal Husbandry, Dairying and Fisheries

– –

http://cibrc.nic.in/insecticides_ act.htm http://cibrc.nic.in/insecticides_ rules.htm http://indiankanoon.org/ doc/847558/

Agriculture Agriculture

Agriculture and Cooperation Agriculture and Cooperation Agriculture and Cooperation

Sec 3: [3(f), 3(i)], Sec 8, Sec 10, Sec 12, Sec 20, Sec 20A, Sec 21, Sec 23 - 25

–

Agriculture

Radio/Nuclear –

Schedule/Annexure Source – http://indg.in/rural-energy/ policy-support/national-waterpolicy-2002

Ministry of Drinking Water and Sanitation

Department of –

Radio/Nuclear Sec 3(b), Sec 4, 35, 39,40, 65, 66, 118-122, 157A

Schedule/Annexure Sec 3b and 40 not mentioned in annex 2 for radio

Source http://www.ipindia.nic. in/ipr/patent/patent_ Act_1970_28012013_book.pdf

Ministry of Commerce and Industry

Department of Industrial Policy and Promotion

Rule 71 on hard copy of overview but not in annex 2

–

http://ipindia.nic.in/ipr/patent/ patent_Rules_2003_280120_ book.pdf

Commerce and Industry

Industrial Policy and Promotion

International public health hazards: Indian legislative provisions ............................................................................... 29

S. No. 51

Acts –

Rules –

–

Explosive Act, 1884 (2 relevant provisions) Foreign Trade – (Development and Regulation) Act, 1992 Marine Products – Export Development Authority (MPEDA) Act, 1972 – Explosive Rules, 2008 – Ammonium Nitrate Rules, 2012

Agricultural and Processed Food Export and Development (APEDA) Rules (1 relevant provision) 1986 (1 relevant provision) –

Order/Notifications Handbook of Procedures (Vol. I) 27th August 2009 – 31st March 2014 w.e.f. 05.06.2012 (1 relevant provision) –

Biological –

Chemical –

–

Rule 9

– –

Sec 2(d),Sec 9: [9(A),9(B)] –

–

– –

Chemicals and fertilizers S. No. 69 Acts Narcotic Drugs and Psychotropic Substances Act, 1985 (10 relevant provisions) Rules – Order/Notifications – Biological – Chemical Chapter I - Sec 2: [2(ii), 2(iii), 2(iv), 2(v), 2(vi), 2(viiia), 2(ix), 2(xiii), 2(xiv), 2(xxiii)], Chapter III - Sec 8-14, Chapter IV Sec 15, 33 Rule 2(2g), 17, 31, 32, 53, 55 - 67

–

Narcotic Drugs and Psychotropic Substances Rules 1985 (18 relevant provisions)

–

30I�� International public health hazards: Indian legislative provisions

Radio/Nuclear Rule 2.32.1, Rule 2.32.2

Schedule/Annexure –

Source Ministry of dgftcom.nic.in/exim/2000/ Comnmerce and procedures/ftp-hbcontents0910. Industry pdf

Department of –

–

http://apeda.gov.in/ Commerce and apedawebsite/corporate_info/ Industry APEDA_Rules_As_on_date.pdf

Commerce

– –

http://dipp.nic.in/English/acts_ rules/Acts/Explosive_Act_1884. pdf http://www.vakilno1.com/ bareacts/foreigntradeact/ foreigntradeact.html http://www.mpeda.com/ Overview/mpeda%20rules/ contents.htm http://peso.gov.in/PDF/ ExplosiveRules2008.pdf http://peso.gov.in/PDF/ Ammonium_Nitrate_ Rules_2012_English_Version. pdf

Commerce and Industry Commerce and Industry Commerce and Industry Commerce and Industry Commerce and Industry

Industrial Policy and Promotion Commerce

–

Commerce

– –

Industrial Policy and Promotion Industrial Policy and Promotion

Radio/Nuclear –

Schedule/ Annexure –

Source

Ministry of

Department of Pharmaceuticals

http://narcoticsindia.nic.in/ Chemicals and upload/download/document_ Fertilizers id08b2dbdc9ca941d237893bd425af8bfa. pdf

–

Schedule I and II

http://www.srmuniv.ac.in/downloads/ Chemicals and narcotics%20drug%20rules%201985.pdf Fertilizers

Pharmaceuticals

International public health hazards: Indian legislative provisions ............................................................................... 31

S. No. 79

Acts The Chemical Weapons Convention Act, 2000 (14 relevant provisions) Prevention of Illicit Traffic in Narcotic Drugs and Psychotropic Substances Act, 1988 The /fertilizers order seems to be from 1985 not 1960. Also the Ministry seems to be a. Agriculture and b. Rural Development, instead of Chemicals & Fertilizers. Not sure whether this stays here or moves under the tag "2 Ministries"

Rules –

Order/Notifications –

Biological –

Chemical Sec 2: [(2(b),2(e)], Sec 15, 16, 17, 33, 34, 39 - 46 –

–

Fertilizers (Movement Control) Order, 1960

–

Civil aviation S. No. 1 2 3 Acts Aircraft Act, 1934 (4 relevant provisions) – should be transferred to "Applicable to All" in annex 2 instead of appearing under each category – Rules – Aircraft Rules, 1937 (4 relevant provisions) The Aircraft (Carriage of Dangerous Goods) Rules, 2003 (7 relevant provisions) Aircraft (Security) Rules 2011 (6 relevant provisions) Order/Notifications – – – Biological Chemical Section 8, 8A, 8B, 10 Section 8, 8A, 8B, 10 Rule 3: [3(1D), 3(3), 3(38), 3(42)], 18, 24C, 39B Rule 2: 2(5), 2(8), 2(15), 2(16), 2(18), Rule 3, 4A, 8, 9, 10A, 15 Rule 2: [2(b), 2( c), 2(q), 2(t), 2(u), 2(z)], Rule 3, 14, 17, 20, 23 Rule 3: [3(1D), 3(3), 3(38), 3(42)], 18, 24C, 39B Rule 2: 2(5), 2(8), 2(15), 2(16), 2(18), Rule 3, 4A, 8, 9, 10A, 15 Rule 2: [2(b), 2(c), 2(q), 2(t), 2(u), 2(z)], Rule 3, 14, 17, 20, 23

–

32I�� International public health hazards: Indian legislative provisions

Radio/Nuclear –

Schedule/ Annexure –

Source http://chemicals.nic.in/cwc-act2000.pdf

Ministry of Chemicals and Fertilizers

Department of Chemicals and Petrochemicals

–

http://ptlb.in/ecommerce/wp-content/ uploads/2014/03/Prevention-OfIllicit-Traffic-In-Narcotic-Drugs-AndPsychotropic-Substances-Act-1988.pdf

Chemicals and Fertilizers

Pharmaceuticals

–

http://agricoop.nic.in/sublegi/ FertilizerControlOrder.htm

Chemicals and Fertilizers

Fertilizers

Radio/Nuclear – – Rule 2: 2(5), 2(8), 2(15), 2(16), 2(18), Rule 3, 4A, 8, 9, 10A, 15 –

Schedule/ Annexure – – –

Source http://dgca.nic.in/rules/act-ind.htm http://dgca.nic.in/rules/act-ind.htm http://dgca.nic.in/airule2003/air2003. pdf

Ministry of Civil Aviation Civil Aviation Civil Aviation

Department of – – –

–

http://dgca.nic.in/security/ Aircraft(Security)%20Rules,%20 2011.pdf

Civil Aviation

–

International public health hazards: Indian legislative provisions ............................................................................... 33

S. No. 5

Acts –

Rules Indian Air Craft (Public Health) Rules, 1954 (Amended in 1969) (All rules are important)

Order/Notifications –

Biological Part I -Rule2: [2(8), 2(8-A), 2(9), 2(10), 2(15)], Part II -Rules 3-33, Part III-Rules 34-49, Part IV - Rules 70-71

Chemical –

Consumer affairs S. No. 83 Acts Consumer Protection Act, 1986 (4 relevant provisions) Rules – Order/Notifications – Biological Sec 2:[2(1)(c), 2(1) (c) (v), 2(1)(c)(vi), 2(1)(d), 2(1)(f), 2(1) (g)]; Sec 14: [14(1)(g), 14(1)(ha), 14(1)(hb)]; Sec 25; Sec 27 Chemical Sec 2:[2(1)(c), 2(1)(c) (v), 2(1)(c) (vi), 2(1)(d), 2(1) (f), 2(1)(g)]; Sec 14: [14(1)(g), 14(1)(ha), 14(1) (hb)]; Sec 25; Sec 27

Environment and forests S. No. 17 Rules The Manufacture, Use, Import, Export & Storage of Hazardous Micro Organisms Genetically Engineered Organisms or Cells Rules, 1989 (6 relevant provisions) CHECK APPROVAL Cartagena Protocol on Biosafety to IN ANNEX 2 the Convention on Biological Diversity, 2003 (12 relevant provisions) The Indian Wildlife – (Protection) Act, 1972 (5 relevant provision) r/w rules 1975 Water (Prevention on hard copy in and Control of overview and bio. Pollution) Act, Not in chemicals. 1974 r/w rules ?? Don’t know what 1975 (15 relevant provisions) that means Acts – Order/Notifications Biological – Rule 3(v), 6, 7, 9, 11, 16 Chemical –

–

Art 1, 2, 3, 4, 5, 15, 17, 18, 23, 25, 26, 31

–

Sec 2: [2(1), 2(2), 2(16c), 2(18A)], Sec 31, 32, 33A, 49 A-C

–

Sec 2: [2(e), 2(g), Sec 2: [2(e), 2(g), 2(j), 2(k)], Sec 24, 2(j), 2(k)], Sec 25, 32, 41-49, 51-52 24, 25, 32, 41-49, 51-52

34I�� International public health hazards: Indian legislative provisions

Radio/Nuclear –

Schedule/ Annexure –

Source http://nihfw.nic.in/ndc-nihfw/html/ Legislations/IndianAirCraft.htm http://indiankanoon.org/ doc/17873873/

Ministry of Civil Aviation

Department of –

Radio/Nuclear Sec 2:[2(1)(c), 2(1) (c) (v), 2(1)(c)(vi), 2(1)(d), 2(1)(f), 2(1) (g)]; Sec 14: [14(1)(g), 14(1)(ha), 14(1) (hb)]; Sec 25; Sec 27

Schedule/ Annexure –

Source http://www.ncdrc.nic.in/1_1.html#_ Hlk149660945

Ministry of

Department of

Consumer Affairs, Consumer Affairs Food and Public Distribution

Radio/Nuclear –

Schedule/Annexure Source Schedule contains List http://nbaindia.org/uploaded/ of Animal and Human Biodiversityindia/Legal/28.%20 Pathogens. Rules%20for%20the%20 manufacture,%20use%20 import%20export%20and%20 storage%20of%20hazardous%20 microorganism%20genetically%20 engineered%20organisms%20 or%20cells,%201989.pdf – http://bch.cbd.int/protocol/text/

Ministry of Environment and Forests

Department of –

–

Environment and Forests

–

http://envfor.nic.in/legis/wildlife/ wildlife1.html http://www.moef.nic.in/legis/ water/wat1.html

Environment and Forests Environment and Forests

–

International public health hazards: Indian legislative provisions ............................................................................... 35

S. No. 59

Acts –

–

64 65

– The Air (Prevention and Control of Pollution) Act, 1981 (15 relevant provisions) The Public Liability Insurance Act, 1991 (6 relevant provisions) National Environment Tribunal Act, 1995 (4 relevant provisions) The Biological Diversity Act, 2002 (4 relevant provisions)

Rules The Environment (Protection) Rules, 1986 (3 relevant provisions) e-waste (Management and Handling) Rules, 2011 (6 relevant provisions Hazardous Wastes (Management, Handling & Transboundary Movement) Rules, 2008 (2 relevant provisions) Municipal Solid Wastes ( Management and Handling) Rules, 2000 (2 relevant provisions) Manufacture, Storage and Import of Hazardous Chemicals Rules, 1989 (1 relevant provision) The Environmental Standards List (45 standards) –

Order/Notifications –

Biological –

Chemical Rule 2: [2(ee), 2(f), 2(ff)], Rule 5, 13. Rule 3: [3(A), 3(I)], Rule 12, 13, 16, 17, 18. Rule 2: [2(d), 2(e)], Rule 3: [3(h), 3(l), 3(m), 3(za), 3(zb)]

–

Rule 3(xv), Rule 9

–

Rule 18 (2)

– –

45 Standards

–

Sec 2:[2(a), 2(b), 2(f), 2(g), 2(j), 2(o)], Sec 16, 17, 19, 20, 21, 22(a), 25, 37- 43 – Sec 2 [2(a), 2(b), 2(c), 2(d), 2(e), 2(h)ii], Sec 3(2) ii, Sec 4 [4(1), 4(2), 4(2a)], 14, 15, 16 Sec 2: [(2e ),2(f)], Sec 2: [(2e ),2(f)], Sec 3, Sec 4, Sec 25 Sec 3, Sec 4, Sec 25

–

Sec 3, 55, 56, 58

–

36I�� International public health hazards: Indian legislative provisions

Radio/Nuclear –

Schedule/Annexure –

Source Ministry of Department of http://www.moef.nic.in/legis/env/ Environment and Environment, env4.html Forests Forest and Wildlife http://www.moef.nic.in/ downloads/rules-andregulations/1035e_eng.pdf http://www.moef.nic.in/legis/ hsm/HAZMAT_2265_eng.pdf Environment and Forests –

–

Environment and Forests

–

Form V

http://www.moef.nic.in/legis/ hsm/mswmhr.html

Environment and Forests

–

http://www.envfor.nic.in/legis/ hsm/hsm2.html

Environment and Environment, Forests Forest and Wildlife

– –

http://www.moef.nic.in/legis/ env_stand.htm http://www.moef.nic.in/legis/air/ air1.html

Environment and Forests Environment and Forests

– –

–

http://www.moef.nic.in/legis/ public/public1.html

Environment and Forests

–

Sec 2: [(2e ),2(f)], Sec 3, Sec 4, Sec 25

Schedule: Heads under which compensation for damages may be claimed –

http://ahec.org.in/wfw/web%20 Environment and ua%20water%20for%20welfare/ Forests environment/NETA_1995.pdf

–

http://www.ijlt.in/pdffiles/ Biodiversity-Act-2002.pdf

Environment and Forests

–

International public health hazards: Indian legislative provisions ............................................................................... 37

S. No. 93

Acts –

Rules Bio-Medical Waste (Management and Handling) Rules, 1998 (3 relevant provisions)

Order/Notifications Biological – Sec 3;[3(5),3(6)], Sec5, Sec 12

Chemical Sec 3;[3(5),3(6)], Sec5, Sec 12

External affairs S. No. Acts 42 Weapon of Mass Destruction Act, 2005 (11 relevant provisions) Indian Emigration Act, 1983 Rules – Order/Notifications – Biological – Chemical –

–

Finance S. No. 13 Acts – Rules Order/Notifications Biological – Rule 3 and 4 Baggage (Amendment) Rules, 2006 (Baggage Rule, 1998) (under Customs Act, 1962) (2 relevant provisions) Baggage (Transit to – Reg 2 Customs Stations) Regulations, 1967 (1 relevant provision) Chemical Rule 3 and 4

–

Reg 2

38I�� International public health hazards: Indian legislative provisions

Radio/Nuclear –

Schedule/Annexure SCHEDULE I: CATEGORIES OF BIO-MEDICAL WASTE SCHEDULE V: STANDARDS FOR TREATMENT AND DISPOSAL OF BIOMEDICAL WASTES SCHEDULE VI: SCHEDULE FOR WASTE TREATMENT FACILITIES LIKE INCINERATOR/ AUTOCLAVE/ MICROWAVE SYSTEM

Source http://envfor.nic.in/legis/hsm/ biomed.html

Ministry of Environment and Forests

Department of –

Radio/Nuclear Sec 4(e), 4(p), 5, 6, 8, 9, 10, 11, 12, 14, 15, 16 –

Schedule/Annexure –

–

Source Ministry of http://www.mea.gov.in/Uploads/ External Affairs PublicationDocs/148_TheWeapons-Mass-destructionAnd-Delivery-SystemsAct-2005.pdf http://www.moia.gov.in/pdf/ External Affairs preliminary.pdf

Department of –

–

Radio/Nuclear –

Schedule/Annexure Appendix A - F Annexures I -IV

Authority Ministry of http://www.cbec.gov.in/customs/ Finance cs-act/formatted-htmls/bggerules1998-ason-apl2012.htm

Department of Central Board of Excise and Customs

–

http://www.cbec.gov.in/customs/ Finance cs-act/formatted-htmls/csregulationf-dec11.htm

–

International public health hazards: Indian legislative provisions ............................................................................... 39

S. No. Acts 23 The Customs Act, 1962 (10 chapters with relevant provisions)

Rules –

–

Courier Imports and Exports (Clearance) Amendment Regulations, 2010 (2 relevant provisions) Export Manifest (Aircraft) Regulations, 1976 (1 relevant provision) Import Manifest (Aircraft) Regulations, 1976 (1 relevant provision) Export Manifest (Vessels) Regulations, 1976 (1 relevant provision)

Order/Notifications Biological – Chapter I -Sec 2: [2(3), 2(7), 2(8), 2(9), 2(10), 2(11), 2(12), 2(13), 2(21), 2(33), 2(39); Chapter II -Sec 3; Chapter IV -Sec 11; Chapter VI - Sec 31(3); Chapter VII - Sec 48; Chapter VIII - Sec 54(3); Chapter XI - Sec 77; Chapter XII - Sec 91-99; Chapter XIII - Sec 103; Chapter XVI - Sec 137 – Reg 2, Reg 3: [3(a), 3(c)];

Chemical Sec 2:[2(10), 2(11), 2(12), 2(13), 2(21), 2(33)], Sec11, Sec31, Sec 48, Sec 137.

–

Reg 4

–

Reg 4

–

Reg 3

40I�� International public health hazards: Indian legislative provisions

Radio/Nuclear –

Schedule/Annexure –

Authority Ministry of http://www.cbec.gov.in/customs/ Finance cs-act/cs-act-idx.htm

Department of Central Board of Excise and Customs

–

Reg 3 (a)

http://www.cbec.gov.in/customs/ Finance cs-act/formatted-htmls/ cs-curier-imp-exp-clearancedec11.htm – http://www.cainindia.org/ Finance news/12_2010/customs_ regulations_export_manifest_ aircraft_regulations_1976.html http://www.cbec.gov.in/customs/ Finance cs-act/formatted-htmls/csregulations.htm http://www.eximguru.com/exim/ Finance Indian-Customs/CUSTOMSREGULATIONS/EXPORTMANIFEST-VESSELSREGULATIONS-1976.aspx

–

Commissioner of Customs, Department of Revenue Commissioner of Customs, Department of Revenue Commissioner of Customs, Department of Revenue

International public health hazards: Indian legislative provisions ............................................................................... 41

Health and family welfare S. No. 7 Acts – Rules The Indian Port Health Rules, 1955 (all provisions are relevant) Order/Notifications Biological – Part I- Rule 3: [3(1), 3(2), 3(3), 3(4), 3(5), 3(6), 3(5), 3(6), 3(7), 3(8), 3(9), 3(10), 3(11), 3(13), 3(14), 3(15), 3(18), 3(19), 3(20)] Part II -Rules3-19A, 20-36, 39-40, 45-49 Part III - Rules 5054, Rules 54A-55, Part IV - Rules 57 -59, Part V - Rules 60-68 Part VI - Rules 69-72, Part VIII Rules 91 -92, Part IX - Rules 93 -94 – Sec 3: [3(1)(a), 3(1) (e), 3(1)(g), 3(1)(j), 3(1)(k), 3(1)(n), 3(1) (p), 3(1)(s), 3(1)(u), 3(1)(zf), 3(1)(zm), 3(1)(zz)], Sec 20, 21(1), 22, 25, 48-67 Chemical –

Food Safety and Standards Act, 2006 (27 relevant provisions)

–

37 50

The Lepers Act, 1898 (4 relevant provisions) Pre- Conception and Prenatal Diagonistic Techniques (Prohibition of Sex Selection) Act 1994 (1 relevant provision) Prevention of Food Adulteration Act, 1954 –

– –

Sec 2;[2(1),2(2)], Sec 6, 9(1), 11 –

Sec3: [3(1) (a),3(1)(c),3(1) (e),3(1)(g), 3(1) (j), 3(1)(m),3(1) (u),3(1)(zf), 3(1) (zk), 3(1)(zm), 3(1)(zp), 3(1)(zq), 3(1)(zu), 3(1)(zx), 3(1)(zz)], Sec 25, 33, 34, 48-67 – –

–

Food Safety Standards (Contaminants, Toxins, and Residues) Regulations, 2011 (2 relevant chapters)

–

Chapter I, Chapter II

42I�� International public health hazards: Indian legislative provisions

Radio/Nuclear –

Schedule/Annexure Authority Ministry of Appendix 1- 6 UNABLE TO FIND HYPERLINK Health and Family Welfare

Department of Health and Family Welfare

–

http://fssai.gov.in/Portals/0/Pdf/ FOOD-ACT.pdf

Health and Family Welfare

Food Safety and Standards Authority of India (fssai)

– Chapter III Sec 3 and 4

– –

http://theindianlawyer.in/ Health and statutesnbareacts/acts/l16.html Family Welfare http://www.childlineindia.org.in/ CP-CR-Downloads/PNDT%20 Act.pdf Health and Family Welfare

Health and Family Welfare Health and Family Welfare

–

http://www.vakilno1.com/ bareacts/ prevfood1954/prevfood.html http://www.fssai. gov.in/Portals/0/Pdf/ Food%20safety%20 and%20standards%20 (contaminats,%20toxins%20 and%20residues)%20 regulation,%202011.pdf

Health and Family Welfare Health and Family Welfare

–

Food Safety and Standards Authority of India (fssai) Food Safety and Standards Authority of India (fssai)

International public health hazards: Indian legislative provisions ............................................................................... 43

S. No. Acts 78 The Epidemic Diseases Act, 1897 (1 relevant provision) 81 Indian Red Cross Society Act, 1920 (1 relevant provision under 1st schedule) 86 Drugs Control Act, 1950 (6 relevant provisions) National AIDS Control & Prevention Policy (2002) 88 Medical Termination of Pregnancy Act, 1971 (2 relevant provisions) The Mental Health Act, 1987 (2 relevant provisions) Transplantation of Human Organs Act, 1994 (5 relevant provisions) Cigarettes and other Tobacco Products (Prohibition of advertisement and regulation of trade and Commerce, Production, Supply and Distribution) Act, 2003 (5 relevant provisions)

Rules – –

Order/Notifications Biological – Sec 2A – Sec 7

Chemical – Sec 7

–

Sec 2:[2(1)(b),2(1) (d)], Sec 4, 5, 6, 12, 13 –

–

Sec 2:[2(1) (b),2(1)(d)], Sec 4, 5, 6, 12, 13 –

–

Sec 2(d),Sec 3

89 90

– –

Sec 2:[(2(l),2(m)], Sec 27 Sec 2:[2(h),2(o),2(p)], Sec 7, 11, 18, 19 Sec 3; [3(b),3(n),3(o),3(p)], Sec 4, 5, 6, 7

Sec 2:[(2(l),2(m)], Sec 27 Sec 2:[2(h),2(o),2(p)], Sec 7, 11, 18, 19 Sec 3; [3(b),3(n), 3(o),3(p)], Sec 4, 5, 6, 7

–

Home affairs S. No. Acts 32 Disaster Management Act, 2005 (All provisions are relevant) Rules – Order/Notifications Biological – Chap I - Sec 2: [Sec 2(a), 2(d), 2(e)]; Chap III - Sec 24; Chap IV - Sec 34; Chap X - Sec 51-60 Chemical –

44I�� International public health hazards: Indian legislative provisions

Radio/Nuclear – Sec 7

Schedule/Annexure Authority – http://www.indiankanoon.org/ doc/1005961/ First Schedule

Ministry of Health and Family Welfare

Department of

http://www.theindianlawyer.in/ Health and statutesnbareacts/acts/i40.html Family Welfare http://indiankanoon.org/ doc/1403255/ www.naco.gov.in/.../ NationalAIDS Contyrol&PreventionPolicy2002.pdf www.tcw.nic.in/Acts/MTPAct-1971.pdf http://sadm.maharashtra. gov.in/sadm/GRs/Mental%20 health%20act.pdf http://www.vakilno1.com/ bareacts/trnsplantationho1994/ transplantatnhmanorgns.html http://www.indiacode.nic.in/ fullact1.asp?tfnm=200334 Health and Family Welfare Health and Family Welfare Health and Family Welfare Health and Family Welfare Health and Family Welfare Health and Family Welfare

Health and Family Welfare Ayush

Sec 2:[2(1)(b),2(1) (d)], Sec 4, 5, 6, 12, 13 –

–

AIDS Control

Sec 2(d),Sec 3

–

Health and Family Welfare Health and Family Welfare Health and Family Welfare Health and Family Welfare

Sec 2:[(2(l),2(m)], Sec 27 Sec 2:[2(h),2(o),2(p)], Sec 7, 11, 18, 19 Sec 3;[ 3(b),3(n),3(o),3(p)], Sec 4, 5, 6, 7

– –

–

Radio/Nuclear –

Schedule/Annexure –

Source http://ndma.gov.in/en/disaster. html

Ministry of Home Affairs

Department of Disaster Management Division

International public health hazards: Indian legislative provisions ............................................................................... 45

S. No. 33

Acts –

Rules –

–

The Explosive Substances Act, 1908 (4 relevant provisions) Birth, Death & Marriage Registration Act, 1886 (3 relevant provisions) The Registration of Birth & Deaths Act, 1969 (6 relevant provisions) The Civil Defence Act, 1968 – – –

–

Order/Notifications Biological Chap 1 - 8 National Disaster Management Guidelines: Management of Biological Disasters (all provisions are relevant) – National Disaster Management Guidelines: Management of Nuclear and Radiological Emergencies 2009 (all provisions are relevant) – –

Chemical –

–

Sec 2, 3, 4, 5

–

Sec 19, 21, 24

–

Sec 2:[2(b),2(c)], Sec 2:[2(b),2(c)], Sec 8, 10, 13, 20, 23 Sec 8, 10, 13, 20, 23 – – – – – – – –

– The Civil Defence Rules, 1968 The Civil Defence Regulations, 1968 The National Institute of Disaster Management Regulations, 2006 The Notification of National Disaster Response Force (NDRF) Rules, 2008 – – The Arms Rules, 1962

– – – –

–

The Protection of Human Rights Act, 1993 The Arms Act, 1959 –

– – –

46I�� International public health hazards: Indian legislative provisions

Radio/Nuclear –

Schedule/Annexure Annex A, B, C, G, H

Source http://ndma.gov.in/en/ndmaguidelines.html

Ministry of Home Affairs

Department of Disaster Management Division

Chapters 1-8

–

http://ndma.gov.in/en/ndmaguidelines.html

Home Affairs

–

http://www.vakilno1.com/ bareacts/laws/the-explosivesubstances-act-1908.html http://www.womenstudies.in/ elib/legal_resources/lr_the_ birth.pdf http://delhi.gov.in/DoIT/DES/ Registration/ACT.pdf

Home Affairs

Internal Security Division Internal Security Division

Sec 19, 21, 24

–

Home Affairs

Sec 2:[2(b), 2(c)], Sec 8, 10, 13, 20, 23 – – – –

–

Home Affairs

Internal Security Division

– – – –

www.ndmindia.nic.in/acts-rules/ CDAct1968.pdf www.ndmindia.nic.in/acts-rules/ CDRule1968.pdf www.ndmindia.nic.in/acts-rules/ CDRegulation1968.pdf http://www.ndmindia.nic.in/actsrules/GSR681.pdf http://www.ndmindia.nic.in/ flood-2008/gazette-dm.pdf www.alrc.net/PDF/HRActEng. pdf www.vakilno1.com/bareacts/ armsact/armsact.htm www.lawsindia.com/ Advocate%20Library/C18.htm

Home Affairs Home Affairs Home Affairs Home Affairs

– – – –

–

Home Affairs

–

– – –

Home Affairs Home Affairs Home Affairs

– – –

International public health hazards: Indian legislative provisions ............................................................................... 47

S. No.

Acts The National Security Act, 1980 The Indian Penal Code Act, 1860 The Code of Criminal Procedure (Amendment) Act, 2005 The Armed Forces (Special Powers) Act, 1958 The National Security Guard Act, 1986 –

Rules – – –

Order/Notifications – – –

Biological – – –

Chemical – – –

–

– The National Security Guard Rules, 1987 The Border Security Force Rules, 1969 The Central Industrial Security Rules, 2001 The Central Reserve Police Force Rules, 1955 The Indo Tibetan Border Police Rules, 1994 –

– –

– – –

–

The Sashastra Seema Bal Act, 2007

–

Roads and transport S. No. Acts 34 The Carriage by Road Act, 2007 (5 relevant provisions) 35 – Rules – The Central Motor Vehicles Rules, 1989 (7 relevant provisions) – Order/Notifications Biological – Sec 2: [2(a), 2(e)], Sec 13, 14, 18, 20(j), 20(k) – Sec 131 - 137 Chemical – –

Motor Vehicles Act, 1988

–

48I�� International public health hazards: Indian legislative provisions

Radio/Nuclear – – –

Schedule/Annexure – – –

Source Ministry of www.satp.org/.../document/ Home Affairs actandordinances/ nationalsecurityact.htm www.oecd.org/site/adboecdanti- Home Affairs corruptioninitiative/46814358. pdf www.lawzonline.com/.../ Home Affairs Code-of-criminal-procedureamendment-act.html http://indianarmy.nic.in/Site/ Home Affairs RTI/rti/MML/MML_VOLUME_3/ CHAPTER__03/457.htm www.mha.nic.in/.../upload_files/ Home Affairs mhahindi/files/pdf/NSGAct1986. pdf www.mha.nic.in/.../upload_ Home Affairs files/mhahindi/files/pdf/ NSGRules1987.pdf http://www.mha.nic.in/sites/ upload_files/mha/files/pdf/ bsfAct&Rules.pdf http://www.mha.nic.in/sites/ upload_files/mha/files/ cisfrules2001.pdf http://www.mha.nic.in/sites/ upload_files/mha/files/pdf/ crpf_rules1955.pdf Home Affairs Home Affairs Home Affairs

Department of – – –

–

– –

– – –

–

http://www.mha.nic.in/sites/ Home Affairs upload_files/mha/files/pdf/ITBPRule-1994.pdf http://www.mha.nic.in/sites/ Home Affairs upload_files/mha/files/pdf/SSBRule2009.pdf

–

Radio/Nuclear – –

Schedule/Annexure – Table provided under sec 137 –

–

Source http://morth.nic.in/writereaddata/ linkimages/gazette92182554. pdf http://admis.hp.nic.in/transport/ pdf_forms/The%20Central%20 Motor%20Vehicles%20 Rules,1989. www.tn.gov.in/sta/Mvact1988. pdf

Ministry of Roads Transport and Highways Roads Transport and Highways Roads Transport and Highways

Department of – –

–

International public health hazards: Indian legislative provisions ............................................................................... 49

Labour and employment S. No. 43 87 Acts The Factories Act, 1948 (2 relevant provisions) The Beedi & Cigar Workers (Conditions of Employement) Act, 1966 (11 Relevant Provisions) The Child Labour (Prohibition and Regulation) Act, 1986 Rules – – Order/Notifications – – Biological – Sec 2: [2(d), 2(j),2(k), 2(n)], Sec 8, 9, 10, 11, 12, 15, 24, 25, 32, 44 – Chemical – Sec 2: [2(d), 2(j),2(k), 2(n)], Sec 8, 9, 10, 11, 12, 15, 24, 25, 32, 44 –

–

Mines S. No. Acts The Mines and Mineral (Regulation and Development) Act, 1957 Rules – Order/Notifications – Biological – Chemical –

Railways S. No. Acts 36 The Railways Act, 1989 (9 relevant provisions) Rules – Order/Notifications Biological – Sec 2;[2(2),2(7),2(19)], Sec 56, 60, 67, 68, 153, 154, 164, 165 Chemical –

Science and technology S. No. Acts 38 The Atomic Energy Act, 1962 (8 relevant provisions) 39 – Rules – Order/Notifications – Biological – Chemical –

Guideline for Nuclear Transfers (Exports) 2006 (all provisions are relevant)

–

50I�� International public health hazards: Indian legislative provisions

Radio/Nuclear Sec 2(cb), Sec 12 Sec 2: [2(d), 2(j),2(k), 2(n)], Sec 8, 9, 10, 11, 12, 15, 24, 25, 32, 44 –

Schedule/ Annexure Schedule first –

Source http://labour.nic.in/upload/uploadfiles/files/ ActsandRules/Service_and_Employment/ The%20Factories%20Act,%201948.pdf http://indiankanoon.org/doc/1326446/

Ministry of Labour and Employment Labour and Employment

Department of – –

–

http://labour.nic.in/upload/uploadfiles/ Labour and files/ActsandRules/SectionoftheSociety/ Employment TheChildLabourProhibition%26RegulationAct1986. pdf

–

Radio/Nuclear –

Schedule/Annexure –

Source http://www.mines.nic.in/mmrd. html

Ministry of Mines

Department of –

Radio/Nuclear –

Schedule/Annexure –

Source Ministry of http://claims.indianrail.gov.in/rct/ Railways railway_act_1989.pdf

Department of –

Radio/Nuclear Sec2(i): 2(a), 2(h), 2(i), Sec 3(v), 14, 16, 17, 24, 30 (ii(j)) 1. Specific Guidelines 2. General Guidelines

Schedule/Annexure –

Source http://dae.nic.in/?q=node/60

Ministry of Science and Technology Science and Technology

Department of Atomic Energy (DAE) –

–

http://dae.nic.in/?q=node/147

International public health hazards: Indian legislative provisions ............................................................................... 51

S. No. 40

Acts –

Rules Atomic Energy (safe disposal of radioactive wastes) Rules, 1987 (3 relevant provisions)

Order/Notifications –

Biological –

Chemical –

–

Atomic Energy (Radiation Protection) Rules, 2004 (21 relevant provisions) Atomic Energy (Working of the Mines, Minerals and Handling of Prescribed Substances) Rules, 1984 (7 relevant provisions) Atomic Energy (Control of Irradiation of Food) Rules, 1996 (5 relevant provisions)

–

cant verify this. Underlying document has format error. No hyperlink is able to access it –

–

Atomic Energy (Radiation Processing of Food and Allied Products) Rules 2012 (2 relevant provisions)

–

52I�� International public health hazards: Indian legislative provisions

Radio/Nuclear Rule 2(i) ; Rule 2(iii): ; Rule 2(ix); Rule 2(x); Rule 2(xii); Rule 2(xiii); Rule 2(xxi); Rule 2(xxii); Rule 2(xxiv); Rule 2(xxvi); Rule 2(xvii); Rule 2(xxix); Rule 4; Rule 14

Schedule/Annexure Form l (Application for authorisation to dispose of radioactive wastes) Form II (Issuance of authorance) Form III (monthly record) Form IV (Quarterly/half yearly/annual return of radioactive waste Form V (Application for authorisation to dispose of radioactive wastes/decayed/ unused sources (by small installation)) Application for license Rules 2: [2(1)(a), 2(1)(e), 2(1)(h), 2(1) for commisioning/ (n), 2(1)(o), 2(1)(k), operation of medical diagonistice X Ray 2(1)(zb), 2(1)(zf)], equipment 3(2), 3(3), 5, 6, 7, 13, 15, 16, 20 -27, 32-35 Rule2: [2(d), 2(h), – 2(i),2(p), 2(r), 2(t), 2(u)], Rule 4(4), Rule 7, 9, 12,

Source http://dae.nic.in/writereaddata/ AE(SDRW)Rules%201987.pdf

Ministry of Science and Technology

Department of Atomic Energy (DAAE)

http://www.dae.gov.in/rules/ rpr2004.pdf

Science and Technology

Atomic Energy (DAE)

http://dae.nic.in/writereaddata/ AE(WMMPS)%201984.pdf

Science and Technology

Atomic Energy (DAE)

Rule2: [2(vii), 2(viii), 2(x), 2(xi), 2(xii), 2(xvi)], Rule 9, 18, 20, 26

Sec 2: [2(d), 2(f), 2(h)], Sec 6

Schedule I Technological conditions for irradiation Schedule IV. Condition for the operation of irradiation facilities, Schedule V General Conditions for irradiated foods Schedule VII Standards of packaging material Schedule (I) (II) and (III), Form II

http://www.dae.nic. in/?q=node/138

Science and Technology

Atomic Energy (DAE)

http://dae.nic.in/writereaddata/ food_irad_rules_2012.pdf

Science and Technology

Atomic Energy (DAE)

International public health hazards: Indian legislative provisions ............................................................................... 53

S. No. 47

Rules Atomic Energy (Factories) Rules, 1996 (2 relevant provisions) The Civil Liability For – Nuclear Damage Act, 2010 (4 relevant provisions) – The Civil Liability for Nuclear Damage Rules, 2011 (1 relevant provision) –

Acts –

Order/Notifications –

Biological –

Chemical –

–

IAEA Safety Standards 2005 (7 relevant provisions)

–

Shipping S. No. Acts 6 The Indian Ports Act, 1908 (13 relevant provisions) 8 The Sea Customs Act, 1878 (5 relevant provisions) Rules – Order/Notifications Biological – Sec 3: [3(2), 3(3), 3(4), 3(7), 3(8)], Sec 6 (p), Sec 54-61, Sec 68B – Chapter I- Sec 3(a), 3(b), 3(d), 3 (e), 3(f); Chapter IV - Sec 18, 19, 19A Chapter XVI- Sec 167 – Sec 172, 271, 272, 331 Chemical Sec 3: [3(2), 3(3)], Sec 21, Sec 27 Chapter I- Sec 3(a), 3(b), 3(d), 3 (e), 3(f); Chapter IV - Sec 18, 19, 19A Chapter XVI- Sec 167 Sec 3: [3(8), 3(21), 3(37)], Sec 331, 354.

–

The Merchant Shipping Act, 1958 (9 relevant provisions)

–

The Draft Shipping Trade Practices Bill, 2010 (4 relevant provisions) The Multimodal Transportation of Goods Act, 1993 (3 relevant provisions

–

Sec 3(1)(a), Sec 6, Sec 22, Sec 27

–

Sec 2: [2(a), 2(f), 2(i), 2(j), 2(m)], Sec 9, 21

–

54I�� International public health hazards: Indian legislative provisions

Radio/Nuclear Rule 7(3), 10

Schedule/Annexure Scheduled XIII

Source http://dae.nic.in/?q=node/73

Ministry of Science and Technology Science and Technology

Department of Atomic Energy (DAE) Atomic Energy (DAE)

Sec 2: [2(c), 2(g) (i), 2g(iv, 2(i),) 2(k), 2(p)(i), 2p(ii)], Sec 4, 14, 19, 39 Rule 6 (1a) Form C

–

Sec 1 (104-106); Sec 2 - 7

–

http://lawmin.nic.in/ld/ regionallanguages/THE%20 CIVIL%20LIABILITY%20 OF%20NUCLEAR%20 DAMAGE%20ACT,2010.%20 (38%20OF2010).pdf http://www.prsindia.org/uploads/ media/Nuclear%20Rules/ Civil%20Liability%20for%20 Nuclear%20Damage%20 Rules%202011.pdf. www-pub.iaea.org/MTCD/ publications/PDF/Pub1225_ web.pdf

Science and Technology

Atomic Energy (DAE)

Science and Technology

–

Radio/Nuclear –

Schedule/Annexure Schedule I -Part II-XI

Source http://shipping.nic.in/ writereaddata/l892s/22046531TheIndianPortsAct.pdf

Ministry of Shipping

Department of –

–

http://www.iracm.com/wpShipping content/uploads/2013/01/loi-surles-douanes-1878-anglais-941. pdf

–

Sec 3 (22A), Sec 344B(1), 344E(2), 344F (2), 344I(2), 344(G)

Schedule 2 Nuclear ship cargo certificate - only applicable for Radio/ Nuclear –

–

http://shipping.nic.in/ writereaddata/l892s/53583188TheMerchantShippingAct.pdf; http://www.dgshipping.gov.in/ Content/MerchantShippingAct. aspx http://shipping.nic.in/ writereaddata/l892s/ shipping%20trade%20 practices%20bill%20201029489910.pdf http://shipping.nic.in/ writereaddata/l892s/47763766TheMultimodal.pdf

Shipping

–

Shipping

–

Shipping

–

International public health hazards: Indian legislative provisions ............................................................................... 55

S. No. Acts 56 Inland Vessels Act,1917 (5 revelant provisions)

Rules –

Order/Notifications –

Biological –

Chemical Sec 2: [2(a), 2(b)], Sec 49, 50, 51, 62: [62(A), 62(B), 62(C)]

2 Ministries S. No. 11 Acts The Destructive Insects & Pests Act, 1914 -amended in 1992 (4 relevant provisions) The Environmental (Protection) Act, 1986 (8 relevant provisions) Drugs and Cosmetics Act, 1940 Rules – Order/Notifications – Biological Sec 2: [2(a), 2(b), 2(c )], Sec 3: [3(a), 3(b), 3(c)], Sec 4A, 4B, 5A – Chemical –

–

Sec 2: [2(a), 2(b), 2(c), 2(e)], Sec 7, 8, 9, 12, 15, 16, 17 Sec 3: [3(b), 3(h)], Sec 8, Sec 9: [(9(A), 9(B), 9(d)], Sec 10, 11, 13, 17, 17B, 18 Sec 3: [3(a), 3(h)], Sec 10, Sec 33: [33(EE), 33(EEA), 33(EEB), 33(EEC), 33(EED)] Sec 3(aaa), Sec 9: [9(c), 9(d)], Sec 10, 13, Sec 17: [(17(A),17 (C), 17(D)], Sec 18, Sec 27(A) Rule 2: [2 (dd), 2(j)], Rule 21a, 23, 25, 26, 29, 29A, 30: [30(AA), 30(B)], 31, 32, 32 (A), 33

For Drugs (7 relevant provisions)

–

For Alternate System of Medicine (3 relevant provisions)

–

For Cosmetics (6 relevant provisions)

–

Drugs and Cosmetics Rules, 1945 (9 relevant provisions)

–

56I�� International public health hazards: Indian legislative provisions

Radio/Nuclear –

Schedule/Annexure –

Source http://shipping.nic.in/ writereaddata/ l892s/34851426TheInlandVesselsAct.pdf

Ministry of Shipping

Department of –

Radio/Nuclear –

Schedule/ Annexure –

Source http://agricoop.nic.in/dtpact.htm

Ministry of 2 Ministries a. Agriculture b. Rural Development 2 Ministries a. Environment and Forests b. Science and Technology 2 Ministries a. Health and Family Welfare b. Chemicals and Fertilizers Health & Family Welfare

Department of Agriculture and Cooperation

–

http://envfor.nic.in/legis/env/env1. html

Biotechnology (Science)

–

http://indianmedicine.nic.in/ writereaddata/mainlinkFile/ File222.pdf

Pharmaceuicals (Chemicals); Ayush (Health)

–

Schedule A and B

–

IInd Schedule

–

Health & Family Welfare

–

multiple Forms and Schedules

http://indianmedicine.nic.in/ writereaddata/mainlinkFile/ File222.pdf

2 Ministries Pharmaceuicals (Chemicals) a. Health and Family Welfare b. Chemicals and Fertilizers

International public health hazards: Indian legislative provisions ............................................................................... 57

S. No. 92

Acts The Infant Milk Substitutes, Feeding Bottles and Infant Foods (Regulation of Production, Supply and Distribution) Act 1992, as amended in 2003 (IMS Act) (7 relevant provisions)

Rules –

Order/Notifications –

Biological

Chemical

Sec 2:[2(d),2(e ),2(f), Sec 2(g)], Sec 3, 4, 5, 8, 2:[2(d),2(e),2(f), 11, 20 2(g)], Sec 3, 4, 5, 8, 11, 20

Sheet2 National Water Policy, 2002 Prevention of Illicit Traffic in Narcotic Drugs and Psychotropic Substances Act, 1988 The /fertilizers order seems to be from 1985 not 1960. Also the Ministry seems to be a. Agriculture and b. Rural Development, instead of Chemicals & Fertilizers. Not sure whether this stays here or moves under the tag "2 Ministries" Fertilizers (Movement Control) Order, 1960

Indian Emigration Act, 1983 Prevention of Food Adulteration Act, 1954 National AIDS Control & Prevention Policy (2002) The Civil Defence Act, 1968 The Civil Defence Rules, 1968 The Civil Defence Regulations, 1968 The National Institute of Disaster Management Regulations, 2006 The Notification of National Disaster Response Force (NDRF) Rules, 2008

58I�� International public health hazards: Indian legislative provisions

Radio/Nuclear Sec 2:[2(d),2(e),2(f), 2(g)], Sec 3, 4, 5, 8, 11, 20

Schedule/ Annexure –

Source http://www.bpni.org/docments/ IMS-act.pdf

Ministry of 2 Ministries a. Food Processing b. Women and Child Development

Department of –

http://indg.in/rural-energy/policy-support/nationalDrinking Water and Sanitation water-policy-2002 http://ptlb.in/ecommerce/wp-content/uploads/2014/03/ Chemicals and Fertilizers Prevention-Of-Illicit-Traffic-In-Narcotic-Drugs-AndPsychotropic-Substances-Act-1988.pdf http://agricoop.nic.in/sublegi/FertilizerControlOrder. htm Chemicals and Fertilizers

Pharmaceuticals

Fertilizers

http://www.moia.gov.in/pdf/preliminary.pdf http://www.vakilno1.com/bareacts/prevfood1954/ prevfood.html www.naco.gov.in/.../ NationalAIDSContyrol&PreventionPolicy2002.pdf www.ndmindia.nic.in/acts-rules/CDAct1968.pdf www.ndmindia.nic.in/acts-rules/CDRule1968.pdf www.ndmindia.nic.in/acts-rules/CDRegulation1968. pdf http://www.ndmindia.nic.in/acts-rules/GSR681.pdf

External Affairs Health and Family Welfare Health and Family Welfare Home Affairs Home Affairs Home Affairs Home Affairs

Food Safety and Standards Authority of India (fssai) AIDS Control

http://www.ndmindia.nic.in/flood-2008/gazette-dm.pdf Home Affairs

International public health hazards: Indian legislative provisions ............................................................................... 59

The Protection of Human Rights Act, 1993 The Arms Act, 1959 The Arms Rules, 1962 The National Security Act, 1980 The Indian Penal Code Act, 1860 The Code of Criminal Procedure (Amendment) Act,2005 The Armed Forces (Special Powers) Act, 1958 The National Security Guard Act, 1986 The National Security Guard Rules, 1987 The Border Security Force Rules, 1969 The Central Industrial Security Rules, 2001 The Central Reserve Police Force Rules, 1955 The Indo Tibetan Border Police Rules, 1994

The Sashastra Seema Bal Act, 2007 Motor Vehicles Act, 1988 The Child Labour (Prohibition and Regulation) Act, 1986 The Mines and Mineral (Regulation and Development) Act, 1957 Foreign Trade (Development and Regulation) Act, 1992 Marine Products Export Development Authority (MPEDA) Act, 1972

Explosive Rules, 2008 Ammonium Nitrate Rules, 2012

60I�� International public health hazards: Indian legislative provisions

www.alrc.net/PDF/HRActEng.pdf www.vakilno1.com/bareacts/armsact/armsact.htm www.lawsindia.com/Advocate%20Library/C18.htm www.satp.org/.../document/actandordinances/ nationalsecurityact.htm www.oecd.org/site/adboecdanticorruptioninitiative/46814358.pdf www.lawzonline.com/.../Code-of-criminal-procedureamendment-act.html http://indianarmy.nic.in/Site/RTI/rti/MML/MML_ VOLUME_3/CHAPTER__03/457.htm www.mha.nic.in/.../upload_files/mhahindi/files/pdf/ NSGAct1986.pdf www.mha.nic.in/.../upload_files/mhahindi/files/pdf/ NSGRules1987.pdf http://www.mha.nic.in/sites/upload_files/mha/files/pdf/ bsfAct&Rules.pdf http://www.mha.nic.in/sites/upload_files/mha/files/ cisfrules2001.pdf http://www.mha.nic.in/sites/upload_files/mha/files/pdf/ crpf_rules1955.pdf http://www.mha.nic.in/sites/upload_files/mha/files/pdf/ ITBP-Rule-1994.pdf http://www.mha.nic.in/sites/upload_files/mha/files/pdf/ SSB-Rule2009.pdf www.tn.gov.in/sta/Mvact1988.pdf http://labour.nic.in/upload/uploadfiles/ files/ActsandRules/SectionoftheSociety/ TheChildLabourProhibition%26RegulationAct1986. pdf http://www.mines.nic.in/mmrd.html

Home Affairs Home Affairs Home Affairs Home Affairs Home Affairs Home Affairs

Home Affairs Home Affairs Home Affairs Home Affairs Home Affairs Home Affairs Home Affairs Home Affairs Roads Transport and Highways Labour and Employment

Mines

http://www.vakilno1.com/bareacts/foreigntradeact/ foreigntradeact.html http://www.mpeda.com/Overview/mpeda%20rules/ contents.htm http://peso.gov.in/PDF/ExplosiveRules2008.pdf http://peso.gov.in/PDF/Ammonium_Nitrate_ Rules_2012_English_Version.pdf

Commerce and Industry Commerce and Industry

International public health hazards: Indian legislative provisions ............................................................................... 61

“International public health hazards: Indian legislative provisions” presents an outline of the provisions in the Indian legal system which may enable the implementation of IHR in the country. International Health Regulations (2005) are the international legal instrument designed to help protect all countries from the international spread of disease, including public health risks and public health emergencies. The present document is the result of a study taken up for the regional workshop on public health legislation for International Health Regulations, Yangon, Myanmar,” 8–10 April 2013. The relevant Indian legislation in the various Acts and rules that may assist in putting early warning systems in place has been outlined. The document intends to provide a ready reference on Indian legislation to enable establishing an early warning system that could assist the Government to provide health care.

ISBN 978-92-9022-476-1

World Health House Indraprastha Estate Mahatma Gandhi Marg New Delhi-110002, India

9 789290 224761

International public health hazards: Indian legislative provisions

ISBN 978-92-9022-476-1 Cover photo: © http://parliamentofindia.nic.in/

© World Health Organization 2015 All rights reserved. Requests for publications, or for permission to reproduce or translate WHO publications – whether for sale or for noncommercial distribution – can be obtained from SEARO Library, World Health Organization, Regional Office for South-East Asia, Indraprastha Estate, Mahatma Gandhi Marg, New Delhi 110 002, India (fax: +91 11 23370197; e-mail: searolibrary@who.int). The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use. This publication does not necessarily represent the decisions or policies of the World Health Organization. Printed in India

Contents Acronyms ..................................................................................................... v 1. 2. 3. 4. 5. 6. 7. Introduction ........................................................................................ 1 Indian legislative position ..................................................................... 5 Current status of IHR implementation in India ................................... 14 The way forward .............................................................................. 19 Conclusion......................................................................................... 22 List of references ............................................................................... 23 Annexes ............................................................................................ 24

International public health hazards: Indian legislative provisions ............................................................... iii

International public health hazards: Indian legislative provisions ................................................................ v

Article 6:

Article 7:

International public health hazards: Indian legislative provisions ................................................................ 1

1.1

The regional workshop context

The overall objective of the regional workshop was “to augment regional capacity in harmonizing national laws with International Health Regulations (IHR 2005)”. The specific objectives were to: (a) review the current status of the policies, legislation, regulations, administrative requirements and other government instruments available to support IHR implementation; (b) identify key gaps; (c) discuss elements of IHR national policies that need to be developed and adopted to support the implementation of required structures and allocate the needed resource; and (d) define the next steps for the way forward.

1.2

Outcomes of the study

The study examines the present position in the Indian legal system which may enable the implementation of IHR to • establish an early warning system of an outbreak;

2.......................................................... International public health hazards: Indian legislative provisions

• •

mobilize the Government to administer health care; and contain the outbreak within the country.

The relevant Indian legislation has been examined for • • • biological hazards including infectious diseases, diseases caused by zoonosis and issues relating to food safety; chemical hazards; and radio-nuclear hazards.

These aspects have been examined for the following points of entry into the jurisdiction of India, namely (i) entry by air through airports; (ii) entry by sea through sea ports; and (iii) ground crossings. The study also involved examining the laws that would apply – regardless of the point of entry – for identification/verification/mitigation/ containment of hazards under the additional heading “(iv) applicable to all” A number of laws “other legislation” were also identified, that would be significant in the containment and mitigation of the hazard after its manifestation in India.

1.3

Methodology used

The methodology adopted for the conduct of the study included the following steps: (a) identifying the relevant provisions in the Indian laws that aid and impact the implementation of IHR 2005 in India; (b) identifying the various ministries and departments thereunder which are involved in administering the prevalent laws;

International public health hazards: Indian legislative provisions ................................................................ 3

1.4

Effective Implementation of IHR

In order to effectively implement the IHR 2005, it is imperative that each Member State co-ordinates its various core capacities including surveillance, response systems, preparedness to contain and mitigate the risk, systems for risk communications, mobilization of human resources and laboratory network.

4.......................................................... International public health hazards: Indian legislative provisions

2 Indian legislative position 2.1 The Indian legislative structure

India follows a quasi-federal system of governance, where there is a division of power at the federal and the state level. While the federal/ central/union government governs the union of twenty-eight states and seven union territories (UT), the State Governments govern their respective states under the Indian Constitution. The Government of India constitutes three branches namely: 1. the Executive headed by the President of India and the Governor as executive head at the state level; 2. the Parliament for the central government and state legislatures which comprise the Rajya Sabha (the Upper House) and the Lok Sabha (the Lower House) at the centre (Central Government) and Vidhan Sabhas in the state (State Legislatures) 3. the judiciary comprising the Supreme Court at the apex, the high courts in the States and the district courts at the district level (Figure 1). The legal system includes statutory laws as well as the common law, which administer the rights and duties of the citizens as enshrined in the Constitution of India.

International public health hazards: Indian legislative provisions ................................................................ 5

Figure 1: Diagrammatic representation of the legislating powers of the Government of India, as laid down in the Constitution Union State

Legislature Structure Upper House Lower House

Executive

Judiciary

Legislature

Executive

Judiciary

President & Vice President Prime Minister & Council of Ministers

Supreme Court of India High Court of Dlehi District Courts in Delhi

Upper House Lower House

Governor Chief Minister & Council of Ministers

High Courts (Except High Court of Delhi Districts Courts

Power

Union List (List I) & Concurrent list (List III)

Art. 52 to 78 & Art. 239 to 241

Art. 124 to Art. 147

State List (List II) & Concurrent list (List III)

Art. 153 to Art. 167

Art. 213 to Art. 237

Result Law (Acts)

Ordinance Bye-law Rule Regulation Notification

Order Directive Judgement

Law (Acts)

Ordinance Bye-law Rule Regulation Notification

Order Directive Judgement

2.2

Distribution of powers

The Constitution of India defines the distribution of powers between the federal and the state governments and also delineates their respective

6.......................................................... International public health hazards: Indian legislative provisions

International public health hazards: Indian legislative provisions ................................................................ 7

2.3

Relevant legislation identified in the study

It is found that 20 ministries administer the laws which govern various hazard situations and their entry, control and mitigation in India that are relevant for IHR implementation. This study has identified the points of entry in to the country for the following IHR events. The definition of the various forms of legislation is as follows: ACT – A bill which has passed through various legislative steps required and which has become law. RULE – An established standard, guide, or regulation governing conduct, procedure or action. REGULATION – A rule of order having the force of law, prescribed by a superior or competent authority, relating to the actions of those under its control. POLICY – The general principles by which a government is guided in its management of public affairs, or the legislature in its measures. ORDER – A mandate, precept; a command or direction given with authority .

8.......................................................... International public health hazards: Indian legislative provisions

S.no.

Type of hazard

Acts

Rules/ Regulations

International conventions

I 2 3

Biological hazards Chemical hazards Radio/Nuclear hazards

21 18 7

12 20 9

2 – –

2.4

Overview of the annex

The Indian legislation that may be taken up for IHR implementation has been captured into two annexes. Annex 1 is a quick reference and Annex 2 (enclosed in a pen drive) gives details of the provisions (Table 3). The annexes can be summarized as follows:

International public health hazards: Indian legislative provisions ................................................................ 9

2. 3. 4. 5. 6. 7.

Ministry of Civil Aviation Ministry of Shipping Ministry of Railways Ministry of Roads, Transport & Highways Ministry of Environment & Forests Ministry of Chemicals & Fertilizers

8. 9. 10. 11. 12. 13.

Ministry of Science & Technology Ministry of Commerce & Industry Ministry of External Affairs Ministry of Drinking Water & Sanitation Ministry of Mines Ministry of Home Affairs

a. b. c. a. b.

Chemical & Petrochemicals Fertilizers Pharmaceuticals Atomic Energy Biotechnology

a. Commerce b. Industrial Policy & Promotion

a. b. c. d. e. f.

Disaster Management Human Rights Judicial North East Internal Security Police

14. 15. 16. 17. 18. 19. 20.

a. Animal Husbandry & Dairying b. Agriculture & Cooperation a. Central Board of Excise & Customs a. Consumer Affairs

10........................................................ International public health hazards: Indian legislative provisions

•

The Laws/Legislation also comprise 36 Rules, 8 Regulations, 3 Guidelines, 3 Orders, 1 Notification, 2 International Conventions, 1 Handbook, 2 Standards and 1 Policy (see Table 3). Therefore, to identify the provisions in Indian legislation that may promote IHR implementation, it becomes imperative to review the legislative bodies, the legislation and the authority designated under each of the legislations, before an effective system for coordination can be set up, based on a series of SOP for IHR. Table 3: Checklist of regulations, orders etc. from Annex 2 Baggage (Transit to Customs Stations) Regulations 1967; Courier Imports and Exports (Clearance) Amendment Regulations 2010; Regulations (8) Export Manifest (Air Craft) Regulations 1976; Import Manifest (Air Craft) Regulations 1976; Export Manifest (Vessels) Regulations 1976; Food Safety & Standards (Contaminants, Toxins & Residues); The Civil Defence Regulations 1968; The National Institute of Disaster Management Regularions 2006;

International public health hazards: Indian legislative provisions ..............................................................11

Notifications (1)

International Conventions (2) Handbook (1) Standards (2) Policy (1)

Annex 2: Information matrix based on various legislation depending on hazards and point of entry Annex 2 is an exhaustive spread sheet tabulating the relevant laws applicable to the three categories of hazards. The laws relevant to each hazard have been organized as per the mode of entry under “Airports”, “Ports” and “Ground crossing” and “Applicable to all”. For example, it is seen that • 24 legislations are applicable to all points of entry in the category “Biological hazard”, which includes the Patents Act; Biological Diversity Act; Wildlife Protection Act; Seeds Act and Sanitary and Phytosanitary Measures; 27 legislations are applicable to all points of entry under the category “Chemical hazard” including Narcotic Drugs and Psychotropic Substances Act and Rules; Drugs and Cosmetics Act; Public Liability

•

12........................................................ International public health hazards: Indian legislative provisions

and Insurance Act; Explosive Substances Act and Chemical Weapon Convention Act; • 17 legislations are applicable to all points of entry under the category “Radio/Nuclear Hazard” including Atomic Energy Act and Radiation Protection Rules.

“Other legislation” captures legislation important for the mobilization of resources within the country to contain and mitigate an outbreak, once such is confirmed.

International public health hazards: Indian legislative provisions ..............................................................13

3 Current status of IHR implementation in India 3.1 Implementation of IHR 2005 in India

Many of the laws that may be invoked for implementation of IHR 2005 in India have been in existence for over 100 years. In order to implement IHR 2005, India has taken multi-level steps i.e. at the national, state and district levels and has furthermore examined activities related to airport, sea ports and ground crossings.

14........................................................ International public health hazards: Indian legislative provisions

International public health hazards: Indian legislative provisions ..............................................................15

16........................................................ International public health hazards: Indian legislative provisions

3.2

The National Health Bill 2009

The Ministry of Health and Family Welfare (MoH&FW) presented a draft law called the National Health Bill 2009, presently pending in Parliament. The mandate is to “provide for protection and fulfilment of rights in relation to health and wellbeing, health equity and justice, including those related to all the underlying determinants of health as well as health care; and for achieving the goal of health for all; and for matters connected therewith or incidental thereto”. The Bill has preamble clauses, one of which clearly states that the Bill is to be enacted to give effect to a number of international treaties and declarations under Article 252 of the Constitution of India, with one of the said declarations being the “International Health Regulations, Fiftyeighth World Health Assembly (2005)”. As mentioned above, it is within the constitutional powers of Government of India under Item 14 in List I (Union List) in Schedule VII

International public health hazards: Indian legislative provisions ..............................................................17

18........................................................ International public health hazards: Indian legislative provisions

International public health hazards: Indian legislative provisions ..............................................................19

4.1

The Disaster Management Act 2005 and IHR implementation

The DM Act clearly lays down a multidimensional strategy to handle pre-disaster and post-disaster situations and mandates certain actions by the officers of different ministries to work in tandem, in mobilizing resources across the ministries and departments thereunder, to control and contain the damage wrought/liable to be wrought by a disaster. This is not the case for NCDC, which reports all matters to the Director-General of Health Services, MOH&FW. There is no legal mandate authorizing MOH&FW to approach the relevant ministries every time there is an imminent outbreak, unless it can invoke certain legal provisions under enacted law and request direction from the other ministries. This can be especially tricky in a situation where there is a separation of powers between the Centre and the State.

4.2

Standard operating procedures to mobilize resources for containment/mitigation as opposed to treatment

In such a situation or until such time that the National Health Bill has been enacted and all accompanying teething issues resolved, one viable

20........................................................ International public health hazards: Indian legislative provisions

International public health hazards: Indian legislative provisions ..............................................................21

22........................................................ International public health hazards: Indian legislative provisions

International public health hazards: Indian legislative provisions ..............................................................23

24........................................................ International public health hazards: Indian legislative provisions

Annex 1

Analytical matrix

International public health hazards: Indian legislative provisions .............................................................................. 25

20 22

The Seeds Act, 1966 (3 relevant provisions) –

– –

– WTO Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement), 1995 (all provisions are relevant) –

– –

Livestock Importation Act, 1989 (3 relevant provisions) –

–

Sec 2: [2(a), 2(b), 2(c), 2(d)], Sec 3, 4 Clause 1, 3, 4, 5, 6, 7

–

The Prevention and Control of Infectious and Contagious Diseases in Animals Act, 2009 (all provisions are relevant)

–

Notification on Procedure for import of livestock products into India (6 relevant provisions) The Pet Food Products of Animal Origin (Import into India) Order, 2005 (3 relevant provisions) –

–

Clause 2: [2(a), 2(e), 2(h), 2(i), 2(m)], Clause 3, 7;

–

26....................................................................... International public health hazards: Indian legislative provisions

Radio/Nuclear –

Schedule/Annexure Source Schedule I, II, IV http://dbtbiosafety.nic.in/act/ Plant%20Quarantine%20_ order_2003.pdf

Ministry of Agriculture

Department of Agriculture and Cooperation

– –

– Annex A and C

http://www.agricoop.nic.in/ seedsact.htm http://www.wto.org/english/ tratop_e/sps_e/spsagr_e.htm

Agriculture Agriculture

Agriculture and Cooperation Animal Husbandry, Dairying and Fisheries

–

http://indiankanoon.org/ doc/1577226/ http://www.dahd.nic.in/dahd/ upload/livestockimport.doc

Agriculture

–

Agriculture

Animal Husbandry, Dairying and Fisheries Animal Husbandry, Dairying and Fisheries Animal Husbandry, Dairying and Fisheries Animal Husbandry, Dairying and Fisheries

–

http://www.pfndai.com/ Gazette%20pdfs/066_1842.pdf

Agriculture

–

Schedule A-L

http://www.dahd.nic.in/dahd/ upload/Gazette_20-03-09.pdf

Agriculture

International public health hazards: Indian legislative provisions .............................................................................. 27

S. No. 30

Acts –

66 67

Insecticide Act, 1968 (6 relevant provisions) –

Chemical –

Sec 3: [3(b),3c, 3(e),3(k)], Sec 17, 25, 26, 27, 29 Rule 16, 35, 36, 45. Sec 3: [3(f), 3(i)], Sec 8, Sec 10, Sec 12, Sec 20, Sec 20A, Sec 21, Sec 23 - 25

Tobacco Board Act, 1975 (10 relevant provisions)

–

Sec 3: [3(f), 3(i)], Sec 8, Sec 10, Sec 12, Sec 20, Sec 20A, Sec 21, Sec 23 - 25

Drinking water S. No. Acts – Rules National Water Policy, 2002 Order/Notifications – Biological – Chemical –

–

The Patents Rules, 2003 (2 relevant provisions)

28....................................................................... International public health hazards: Indian legislative provisions

Radio/Nuclear –

Schedule/Annexure Source Form A, B, C http://dahd.nic.in/dahd/actsrules.aspx

Ministry of Agriculture

Department of Animal Husbandry, Dairying and Fisheries

– –

http://cibrc.nic.in/insecticides_ act.htm http://cibrc.nic.in/insecticides_ rules.htm http://indiankanoon.org/ doc/847558/

Agriculture Agriculture

Agriculture and Cooperation Agriculture and Cooperation Agriculture and Cooperation

Sec 3: [3(f), 3(i)], Sec 8, Sec 10, Sec 12, Sec 20, Sec 20A, Sec 21, Sec 23 - 25

–

Agriculture

Radio/Nuclear –

Schedule/Annexure Source – http://indg.in/rural-energy/ policy-support/national-waterpolicy-2002

Ministry of Drinking Water and Sanitation

Department of –

Radio/Nuclear Sec 3(b), Sec 4, 35, 39,40, 65, 66, 118-122, 157A

Schedule/Annexure Sec 3b and 40 not mentioned in annex 2 for radio

Source http://www.ipindia.nic. in/ipr/patent/patent_ Act_1970_28012013_book.pdf

Ministry of Commerce and Industry

Department of Industrial Policy and Promotion

Rule 71 on hard copy of overview but not in annex 2

–

http://ipindia.nic.in/ipr/patent/ patent_Rules_2003_280120_ book.pdf

Commerce and Industry

Industrial Policy and Promotion

International public health hazards: Indian legislative provisions .............................................................................. 29

S. No. 51

Acts –

Rules –

–

Agricultural and Processed Food Export and Development (APEDA) Rules (1 relevant provision) 1986 (1 relevant provision) –

Order/Notifications Handbook of Procedures (Vol. I) 27th August 2009 – 31st March 2014 w.e.f. 05.06.2012 (1 relevant provision) –

Biological –

Chemical –

–

Rule 9

– –

Sec 2(d),Sec 9: [9(A),9(B)] –

–

– –

–

Narcotic Drugs and Psychotropic Substances Rules 1985 (18 relevant provisions)

–

30....................................................................... International public health hazards: Indian legislative provisions

Radio/Nuclear Rule 2.32.1, Rule 2.32.2

Schedule/Annexure –

Source Ministry of dgftcom.nic.in/exim/2000/ Comnmerce and procedures/ftp-hbcontents0910. Industry pdf

Department of –

–

http://apeda.gov.in/ Commerce and apedawebsite/corporate_info/ Industry APEDA_Rules_As_on_date.pdf

Commerce

– –

Commerce and Industry Commerce and Industry Commerce and Industry Commerce and Industry Commerce and Industry

Industrial Policy and Promotion Commerce

–

Commerce

– –

Industrial Policy and Promotion Industrial Policy and Promotion

Radio/Nuclear –

Schedule/ Annexure –

Source

Ministry of

Department of Pharmaceuticals

http://narcoticsindia.nic.in/ Chemicals and upload/download/document_ Fertilizers id08b2dbdc9ca941d237893bd425af8bfa. pdf

–

Schedule I and II

http://www.srmuniv.ac.in/downloads/ Chemicals and narcotics%20drug%20rules%201985.pdf Fertilizers

Pharmaceuticals

International public health hazards: Indian legislative provisions .............................................................................. 31

S. No. 79

Rules –

Order/Notifications –

Biological –

Chemical Sec 2: [(2(b),2(e)], Sec 15, 16, 17, 33, 34, 39 - 46 –

–

Fertilizers (Movement Control) Order, 1960

–

32....................................................................... International public health hazards: Indian legislative provisions

Radio/Nuclear –

Schedule/ Annexure –

Source http://chemicals.nic.in/cwc-act2000.pdf

Ministry of Chemicals and Fertilizers

Department of Chemicals and Petrochemicals

–

http://ptlb.in/ecommerce/wp-content/ uploads/2014/03/Prevention-OfIllicit-Traffic-In-Narcotic-Drugs-AndPsychotropic-Substances-Act-1988.pdf

Chemicals and Fertilizers

Pharmaceuticals

–

http://agricoop.nic.in/sublegi/ FertilizerControlOrder.htm

Chemicals and Fertilizers

Fertilizers

Radio/Nuclear – – Rule 2: 2(5), 2(8), 2(15), 2(16), 2(18), Rule 3, 4A, 8, 9, 10A, 15 –

Schedule/ Annexure – – –

Source http://dgca.nic.in/rules/act-ind.htm http://dgca.nic.in/rules/act-ind.htm http://dgca.nic.in/airule2003/air2003. pdf

Ministry of Civil Aviation Civil Aviation Civil Aviation

Department of – – –

–

http://dgca.nic.in/security/ Aircraft(Security)%20Rules,%20 2011.pdf

Civil Aviation

–

International public health hazards: Indian legislative provisions .............................................................................. 33

S. No. 5

Acts –

Rules Indian Air Craft (Public Health) Rules, 1954 (Amended in 1969) (All rules are important)

Order/Notifications –

Biological Part I -Rule2: [2(8), 2(8-A), 2(9), 2(10), 2(15)], Part II -Rules 3-33, Part III-Rules 34-49, Part IV - Rules 70-71

Chemical –

–

Art 1, 2, 3, 4, 5, 15, 17, 18, 23, 25, 26, 31

–

Sec 2: [2(1), 2(2), 2(16c), 2(18A)], Sec 31, 32, 33A, 49 A-C

–

Sec 2: [2(e), 2(g), Sec 2: [2(e), 2(g), 2(j), 2(k)], Sec 24, 2(j), 2(k)], Sec 25, 32, 41-49, 51-52 24, 25, 32, 41-49, 51-52

34....................................................................... International public health hazards: Indian legislative provisions

Radio/Nuclear –

Schedule/ Annexure –

Source http://nihfw.nic.in/ndc-nihfw/html/ Legislations/IndianAirCraft.htm http://indiankanoon.org/ doc/17873873/

Ministry of Civil Aviation

Department of –

Radio/Nuclear Sec 2:[2(1)(c), 2(1) (c) (v), 2(1)(c)(vi), 2(1)(d), 2(1)(f), 2(1) (g)]; Sec 14: [14(1)(g), 14(1)(ha), 14(1) (hb)]; Sec 25; Sec 27

Schedule/ Annexure –

Source http://www.ncdrc.nic.in/1_1.html#_ Hlk149660945

Ministry of

Department of

Consumer Affairs, Consumer Affairs Food and Public Distribution

Radio/Nuclear –

Ministry of Environment and Forests

Department of –

–

Environment and Forests

–

http://envfor.nic.in/legis/wildlife/ wildlife1.html http://www.moef.nic.in/legis/ water/wat1.html

Environment and Forests Environment and Forests

–

International public health hazards: Indian legislative provisions .............................................................................. 35

S. No. 59

Acts –

–

64 65

Order/Notifications –

Biological –

Chemical Rule 2: [2(ee), 2(f), 2(ff)], Rule 5, 13. Rule 3: [3(A), 3(I)], Rule 12, 13, 16, 17, 18. Rule 2: [2(d), 2(e)], Rule 3: [3(h), 3(l), 3(m), 3(za), 3(zb)]

–

Rule 3(xv), Rule 9

–

Rule 18 (2)

– –

45 Standards

–

Sec 3, 55, 56, 58

–

36....................................................................... International public health hazards: Indian legislative provisions

Radio/Nuclear –

Schedule/Annexure –

–

Environment and Forests

–

Form V

http://www.moef.nic.in/legis/ hsm/mswmhr.html

Environment and Forests

–

http://www.envfor.nic.in/legis/ hsm/hsm2.html

Environment and Environment, Forests Forest and Wildlife

– –

http://www.moef.nic.in/legis/ env_stand.htm http://www.moef.nic.in/legis/air/ air1.html

Environment and Forests Environment and Forests

– –

–

http://www.moef.nic.in/legis/ public/public1.html

Environment and Forests

–

Sec 2: [(2e ),2(f)], Sec 3, Sec 4, Sec 25

Schedule: Heads under which compensation for damages may be claimed –

http://ahec.org.in/wfw/web%20 Environment and ua%20water%20for%20welfare/ Forests environment/NETA_1995.pdf

–

http://www.ijlt.in/pdffiles/ Biodiversity-Act-2002.pdf

Environment and Forests

–

International public health hazards: Indian legislative provisions .............................................................................. 37

S. No. 93

Acts –

Rules Bio-Medical Waste (Management and Handling) Rules, 1998 (3 relevant provisions)

Order/Notifications Biological – Sec 3;[3(5),3(6)], Sec5, Sec 12

Chemical Sec 3;[3(5),3(6)], Sec5, Sec 12

External affairs S. No. Acts 42 Weapon of Mass Destruction Act, 2005 (11 relevant provisions) Indian Emigration Act, 1983 Rules – Order/Notifications – Biological – Chemical –

–

Reg 2

38....................................................................... International public health hazards: Indian legislative provisions

Radio/Nuclear –

Source http://envfor.nic.in/legis/hsm/ biomed.html

Ministry of Environment and Forests

Department of –

Radio/Nuclear Sec 4(e), 4(p), 5, 6, 8, 9, 10, 11, 12, 14, 15, 16 –

Schedule/Annexure –

–

Department of –

–

Radio/Nuclear –

Schedule/Annexure Appendix A - F Annexures I -IV

Authority Ministry of http://www.cbec.gov.in/customs/ Finance cs-act/formatted-htmls/bggerules1998-ason-apl2012.htm

Department of Central Board of Excise and Customs

–

http://www.cbec.gov.in/customs/ Finance cs-act/formatted-htmls/csregulationf-dec11.htm

–

International public health hazards: Indian legislative provisions .............................................................................. 39

S. No. Acts 23 The Customs Act, 1962 (10 chapters with relevant provisions)

Rules –

–

Chemical Sec 2:[2(10), 2(11), 2(12), 2(13), 2(21), 2(33)], Sec11, Sec31, Sec 48, Sec 137.

–

Reg 4

–

Reg 4

–

Reg 3

40....................................................................... International public health hazards: Indian legislative provisions

Radio/Nuclear –

Schedule/Annexure –

Authority Ministry of http://www.cbec.gov.in/customs/ Finance cs-act/cs-act-idx.htm

Department of Central Board of Excise and Customs

–

Reg 3 (a)

–

Commissioner of Customs, Department of Revenue Commissioner of Customs, Department of Revenue Commissioner of Customs, Department of Revenue

International public health hazards: Indian legislative provisions .............................................................................. 41

Food Safety and Standards Act, 2006 (27 relevant provisions)

–

37 50

– –

Sec 2;[2(1),2(2)], Sec 6, 9(1), 11 –

Sec3: [3(1) (a),3(1)(c),3(1) (e),3(1)(g), 3(1) (j), 3(1)(m),3(1) (u),3(1)(zf), 3(1) (zk), 3(1)(zm), 3(1)(zp), 3(1)(zq), 3(1)(zu), 3(1)(zx), 3(1)(zz)], Sec 25, 33, 34, 48-67 – –

–

Food Safety Standards (Contaminants, Toxins, and Residues) Regulations, 2011 (2 relevant chapters)

–

Chapter I, Chapter II

42....................................................................... International public health hazards: Indian legislative provisions

Radio/Nuclear –

Schedule/Annexure Authority Ministry of Appendix 1- 6 UNABLE TO FIND HYPERLINK Health and Family Welfare

Department of Health and Family Welfare

–

http://fssai.gov.in/Portals/0/Pdf/ FOOD-ACT.pdf

Health and Family Welfare

Food Safety and Standards Authority of India (fssai)

– Chapter III Sec 3 and 4

– –

http://theindianlawyer.in/ Health and statutesnbareacts/acts/l16.html Family Welfare http://www.childlineindia.org.in/ CP-CR-Downloads/PNDT%20 Act.pdf Health and Family Welfare

Health and Family Welfare Health and Family Welfare

–

Health and Family Welfare Health and Family Welfare

–

Food Safety and Standards Authority of India (fssai) Food Safety and Standards Authority of India (fssai)

International public health hazards: Indian legislative provisions .............................................................................. 43

Rules – –

Order/Notifications Biological – Sec 2A – Sec 7

Chemical – Sec 7

–

Sec 2:[2(1)(b),2(1) (d)], Sec 4, 5, 6, 12, 13 –

–

Sec 2:[2(1) (b),2(1)(d)], Sec 4, 5, 6, 12, 13 –

–

Sec 2(d),Sec 3

89 90

– –

Sec 2:[(2(l),2(m)], Sec 27 Sec 2:[2(h),2(o),2(p)], Sec 7, 11, 18, 19 Sec 3; [3(b),3(n),3(o),3(p)], Sec 4, 5, 6, 7

Sec 2:[(2(l),2(m)], Sec 27 Sec 2:[2(h),2(o),2(p)], Sec 7, 11, 18, 19 Sec 3; [3(b),3(n), 3(o),3(p)], Sec 4, 5, 6, 7

–

44....................................................................... International public health hazards: Indian legislative provisions

Radio/Nuclear – Sec 7

Schedule/Annexure Authority – http://www.indiankanoon.org/ doc/1005961/ First Schedule

Ministry of Health and Family Welfare

Department of

Health and Family Welfare Ayush

Sec 2:[2(1)(b),2(1) (d)], Sec 4, 5, 6, 12, 13 –

–

AIDS Control

Sec 2(d),Sec 3

–

Health and Family Welfare Health and Family Welfare Health and Family Welfare Health and Family Welfare

Sec 2:[(2(l),2(m)], Sec 27 Sec 2:[2(h),2(o),2(p)], Sec 7, 11, 18, 19 Sec 3;[ 3(b),3(n),3(o),3(p)], Sec 4, 5, 6, 7

– –

–

Radio/Nuclear –

Schedule/Annexure –

Source http://ndma.gov.in/en/disaster. html

Ministry of Home Affairs

Department of Disaster Management Division

International public health hazards: Indian legislative provisions .............................................................................. 45

S. No. 33

Acts –

Rules –

–

Chemical –

–

Sec 2, 3, 4, 5

–

Sec 19, 21, 24

–

Sec 2:[2(b),2(c)], Sec 2:[2(b),2(c)], Sec 8, 10, 13, 20, 23 Sec 8, 10, 13, 20, 23 – – – – – – – –

– – – –

–

The Protection of Human Rights Act, 1993 The Arms Act, 1959 –

– – –

46....................................................................... International public health hazards: Indian legislative provisions

Radio/Nuclear –

Schedule/Annexure Annex A, B, C, G, H

Source http://ndma.gov.in/en/ndmaguidelines.html

Ministry of Home Affairs

Department of Disaster Management Division

Chapters 1-8

–

http://ndma.gov.in/en/ndmaguidelines.html

Home Affairs

–

http://www.vakilno1.com/ bareacts/laws/the-explosivesubstances-act-1908.html http://www.womenstudies.in/ elib/legal_resources/lr_the_ birth.pdf http://delhi.gov.in/DoIT/DES/ Registration/ACT.pdf

Home Affairs

Internal Security Division Internal Security Division

Sec 19, 21, 24

–

Home Affairs

Sec 2:[2(b), 2(c)], Sec 8, 10, 13, 20, 23 – – – –

–

Home Affairs

Internal Security Division

– – – –

Home Affairs Home Affairs Home Affairs Home Affairs

– – – –

–

Home Affairs

–

– – –

Home Affairs Home Affairs Home Affairs

– – –

International public health hazards: Indian legislative provisions .............................................................................. 47

S. No.

Rules – – –

Order/Notifications – – –

Biological – – –

Chemical – – –

–

– –

– – –

–

The Sashastra Seema Bal Act, 2007

–

Motor Vehicles Act, 1988

–

48....................................................................... International public health hazards: Indian legislative provisions

Radio/Nuclear – – –

Schedule/Annexure – – –

Department of – – –

–

– –

– – –

–

http://www.mha.nic.in/sites/ Home Affairs upload_files/mha/files/pdf/ITBPRule-1994.pdf http://www.mha.nic.in/sites/ Home Affairs upload_files/mha/files/pdf/SSBRule2009.pdf

–

Radio/Nuclear – –

Schedule/Annexure – Table provided under sec 137 –

–

Source http://morth.nic.in/writereaddata/ linkimages/gazette92182554. pdf http://admis.hp.nic.in/transport/ pdf_forms/The%20Central%20 Motor%20Vehicles%20 Rules,1989. www.tn.gov.in/sta/Mvact1988. pdf

Ministry of Roads Transport and Highways Roads Transport and Highways Roads Transport and Highways

Department of – –

–

International public health hazards: Indian legislative provisions .............................................................................. 49

–

Mines S. No. Acts The Mines and Mineral (Regulation and Development) Act, 1957 Rules – Order/Notifications – Biological – Chemical –

Railways S. No. Acts 36 The Railways Act, 1989 (9 relevant provisions) Rules – Order/Notifications Biological – Sec 2;[2(2),2(7),2(19)], Sec 56, 60, 67, 68, 153, 154, 164, 165 Chemical –

Science and technology S. No. Acts 38 The Atomic Energy Act, 1962 (8 relevant provisions) 39 – Rules – Order/Notifications – Biological – Chemical –

Guideline for Nuclear Transfers (Exports) 2006 (all provisions are relevant)

–

50....................................................................... International public health hazards: Indian legislative provisions

Radio/Nuclear Sec 2(cb), Sec 12 Sec 2: [2(d), 2(j),2(k), 2(n)], Sec 8, 9, 10, 11, 12, 15, 24, 25, 32, 44 –

Schedule/ Annexure Schedule first –

Source http://labour.nic.in/upload/uploadfiles/files/ ActsandRules/Service_and_Employment/ The%20Factories%20Act,%201948.pdf http://indiankanoon.org/doc/1326446/

Ministry of Labour and Employment Labour and Employment

Department of – –

–

http://labour.nic.in/upload/uploadfiles/ Labour and files/ActsandRules/SectionoftheSociety/ Employment TheChildLabourProhibition%26RegulationAct1986. pdf

–

Radio/Nuclear –

Schedule/Annexure –

Source http://www.mines.nic.in/mmrd. html

Ministry of Mines

Department of –

Radio/Nuclear –

Schedule/Annexure –

Source Ministry of http://claims.indianrail.gov.in/rct/ Railways railway_act_1989.pdf

Department of –

Radio/Nuclear Sec2(i): 2(a), 2(h), 2(i), Sec 3(v), 14, 16, 17, 24, 30 (ii(j)) 1. Specific Guidelines 2. General Guidelines

Schedule/Annexure –

Source http://dae.nic.in/?q=node/60

Ministry of Science and Technology Science and Technology

Department of Atomic Energy (DAE) –

–

http://dae.nic.in/?q=node/147

International public health hazards: Indian legislative provisions .............................................................................. 51

S. No. 40

Acts –

Rules Atomic Energy (safe disposal of radioactive wastes) Rules, 1987 (3 relevant provisions)

Order/Notifications –

Biological –

Chemical –

–

cant verify this. Underlying document has format error. No hyperlink is able to access it –

–

Atomic Energy (Radiation Processing of Food and Allied Products) Rules 2012 (2 relevant provisions)

–

52....................................................................... International public health hazards: Indian legislative provisions

Radio/Nuclear Rule 2(i) ; Rule 2(iii): ; Rule 2(ix); Rule 2(x); Rule 2(xii); Rule 2(xiii); Rule 2(xxi); Rule 2(xxii); Rule 2(xxiv); Rule 2(xxvi); Rule 2(xvii); Rule 2(xxix); Rule 4; Rule 14

Source http://dae.nic.in/writereaddata/ AE(SDRW)Rules%201987.pdf

Ministry of Science and Technology

Department of Atomic Energy (DAAE)

http://www.dae.gov.in/rules/ rpr2004.pdf

Science and Technology

Atomic Energy (DAE)

http://dae.nic.in/writereaddata/ AE(WMMPS)%201984.pdf

Science and Technology

Atomic Energy (DAE)

Rule2: [2(vii), 2(viii), 2(x), 2(xi), 2(xii), 2(xvi)], Rule 9, 18, 20, 26

Sec 2: [2(d), 2(f), 2(h)], Sec 6

http://www.dae.nic. in/?q=node/138

Science and Technology

Atomic Energy (DAE)

http://dae.nic.in/writereaddata/ food_irad_rules_2012.pdf

Science and Technology

Atomic Energy (DAE)

International public health hazards: Indian legislative provisions .............................................................................. 53

S. No. 47

Acts –

Order/Notifications –

Biological –

Chemical –

–

IAEA Safety Standards 2005 (7 relevant provisions)

–

The Merchant Shipping Act, 1958 (9 relevant provisions)

–

The Draft Shipping Trade Practices Bill, 2010 (4 relevant provisions) The Multimodal Transportation of Goods Act, 1993 (3 relevant provisions

–

Sec 3(1)(a), Sec 6, Sec 22, Sec 27

–

Sec 2: [2(a), 2(f), 2(i), 2(j), 2(m)], Sec 9, 21

–

54....................................................................... International public health hazards: Indian legislative provisions

Radio/Nuclear Rule 7(3), 10

Schedule/Annexure Scheduled XIII

Source http://dae.nic.in/?q=node/73

Ministry of Science and Technology Science and Technology

Department of Atomic Energy (DAE) Atomic Energy (DAE)

Sec 2: [2(c), 2(g) (i), 2g(iv, 2(i),) 2(k), 2(p)(i), 2p(ii)], Sec 4, 14, 19, 39 Rule 6 (1a) Form C

–

Sec 1 (104-106); Sec 2 - 7

–

Science and Technology

Atomic Energy (DAE)

Science and Technology

–

Radio/Nuclear –

Schedule/Annexure Schedule I -Part II-XI

Source http://shipping.nic.in/ writereaddata/l892s/22046531TheIndianPortsAct.pdf

Ministry of Shipping

Department of –

–

http://www.iracm.com/wpShipping content/uploads/2013/01/loi-surles-douanes-1878-anglais-941. pdf

–

Sec 3 (22A), Sec 344B(1), 344E(2), 344F (2), 344I(2), 344(G)

Schedule 2 Nuclear ship cargo certificate - only applicable for Radio/ Nuclear –

–

Shipping

–

Shipping

–

Shipping

–

International public health hazards: Indian legislative provisions .............................................................................. 55

S. No. Acts 56 Inland Vessels Act,1917 (5 revelant provisions)

Rules –

Order/Notifications –

Biological –

Chemical Sec 2: [2(a), 2(b)], Sec 49, 50, 51, 62: [62(A), 62(B), 62(C)]

–

For Drugs (7 relevant provisions)

–

For Alternate System of Medicine (3 relevant provisions)

–

For Cosmetics (6 relevant provisions)

–

Drugs and Cosmetics Rules, 1945 (9 relevant provisions)

–

56....................................................................... International public health hazards: Indian legislative provisions

Radio/Nuclear –

Schedule/Annexure –

Source http://shipping.nic.in/ writereaddata/ l892s/34851426TheInlandVesselsAct.pdf

Ministry of Shipping

Department of –

Radio/Nuclear –

Schedule/ Annexure –

Source http://agricoop.nic.in/dtpact.htm

Department of Agriculture and Cooperation

–

http://envfor.nic.in/legis/env/env1. html

Biotechnology (Science)

–

http://indianmedicine.nic.in/ writereaddata/mainlinkFile/ File222.pdf

Pharmaceuicals (Chemicals); Ayush (Health)

–

Schedule A and B

–

IInd Schedule

–

Health & Family Welfare

–

multiple Forms and Schedules

http://indianmedicine.nic.in/ writereaddata/mainlinkFile/ File222.pdf

2 Ministries Pharmaceuicals (Chemicals) a. Health and Family Welfare b. Chemicals and Fertilizers

International public health hazards: Indian legislative provisions .............................................................................. 57

S. No. 92

Acts The Infant Milk Substitutes, Feeding Bottles and Infant Foods (Regulation of Production, Supply and Distribution) Act 1992, as amended in 2003 (IMS Act) (7 relevant provisions)

Rules –

Order/Notifications –

Biological

Chemical

Sec 2:[2(d),2(e ),2(f), Sec 2(g)], Sec 3, 4, 5, 8, 2:[2(d),2(e),2(f), 11, 20 2(g)], Sec 3, 4, 5, 8, 11, 20

58....................................................................... International public health hazards: Indian legislative provisions

Radio/Nuclear Sec 2:[2(d),2(e),2(f), 2(g)], Sec 3, 4, 5, 8, 11, 20

Schedule/ Annexure –

Source http://www.bpni.org/docments/ IMS-act.pdf

Ministry of 2 Ministries a. Food Processing b. Women and Child Development

Department of –

Pharmaceuticals

Fertilizers

External Affairs Health and Family Welfare Health and Family Welfare Home Affairs Home Affairs Home Affairs Home Affairs

Food Safety and Standards Authority of India (fssai) AIDS Control

http://www.ndmindia.nic.in/flood-2008/gazette-dm.pdf Home Affairs

International public health hazards: Indian legislative provisions .............................................................................. 59

Explosive Rules, 2008 Ammonium Nitrate Rules, 2012

60....................................................................... International public health hazards: Indian legislative provisions

Home Affairs Home Affairs Home Affairs Home Affairs Home Affairs Home Affairs

Home Affairs Home Affairs Home Affairs Home Affairs Home Affairs Home Affairs Home Affairs Home Affairs Roads Transport and Highways Labour and Employment

Mines

Commerce and Industry Commerce and Industry

International public health hazards: Indian legislative provisions .............................................................................. 61

ISBN 978-92-9022-476-1

World Health House Indraprastha Estate Mahatma Gandhi Marg New Delhi-110002, India

9 789290 224761

Informations clés

Organisation Organisation mondiale de la santé (OMS)

Type de document Publications

Date d'adoption 1 mars 2015

Source Organisation mondiale de la santé