India medical products profile 2019

OVERALL SPENDING ON HEALTH Current per capita spending on health care (current US$)4 Share of government vs out-of-pocket spending on health 4 SPENDING ON MEDICINES Spending on medicines as share of total health-care cost 5 Share of public and out-of-pocket spending on medicines 5 COUNTRY AT A GLANCE 1 366 418 Population (in 000s)1 68.8 Life expectancy at birth (in years)2 2015.6 GDP (per capita in current US$)3 India medical products profile 2019 0 10 20 30 40 50 60 $63 70 2006 2008 2010 2012 2014 2016 C ur re nt U S$ 67% 33% 0 20 40 60 80 100 2006 2008 2010 2012 2014 Pe rc en ta ge ( % ) MEDICAL AND PHARMACY WORKFORCE 7.8 Medical doctors/10 000 population6A,A 6.8 Pharmacists/10 000 population6B,B Yes Pharmacy education accreditation6C Yes Continuing professional development for pharmacists6C Pe rc en ta ge ( % ) 34.7% 0 20 40 60 80 100 2005 2008 2011 2014 sh ar e as p er ce nt ag e % 10% 90% 0 20 40 60 80 100 2005 2008 2011 2014 IndiaMedical products profile 2019 KEY MEDICINES POLICIES AND GUIDANCE Key pharmaceutical legislation14 National Medicine Policy15,16 National Essential Medicines List17 National Standard Treatment Guidelines18,19,C Drugs and Cosmetics Act, 1940 and Rules 1945 as amended up to 31 December 2016 Pharmaceutical Policy 2002 National Vacine Policy 2011 National List of Essential Medicines (NLEM)-2015 Both individual disease and state-level standard treatment guidelines exist INTELLECTUAL PROPERTY RELATED POLICIES & PRODUCTION Number of local pharmaceutical manufacturers 20 Least developed country status21 Member of World Trade Organization since22 TRIPS flexibilities used23 4900 for formulations and 1500 for active pharmaceutical ingredient No 1995 Yes ACCESS TO MEDICINES HIV/AIDS and tuberculosis treatment coverage 9,10,11 Diphtheria-tetanus-pertussis (DTP3) and hepatitis B3 immunization coverage 12 Gaps in diagnosis and management of hypertension and diabetes Levels of consumption of narcotic drugs13 56% 65% 0 20 40 60 80 100 2008 2010 2012 2014 2016 2018 Pe rc en ta ge ( % ) 0 20 40 60 80 100 88% 88% 2007 2010 2014 2017 Pe rc en ta ge ( % ) 0 50 100 150 200 250 2008 2010 2012 2014 2016 S- D D D /m ill io n/ da y# Total Methadone Total methadone* Morphine Data insufficient to analyse #S-DDD; Statistical defined daily dose/million/day; *Total minus methadone shows usage mainly for palliative care, because it excludes methadone treatment for drug dependency. IndiaMedical products profile 2019 Market Authorization/ Licensing/Quality Assurance Medicine Patient Medicine Selection Medicine Procurement Pricing and Reimbursement Distribution National regulatory authority: Central Drugs Standard Control Organization (CDSCO) www.cdsco.nic.in Regulated products24: Medicines: YES Vaccines YES Medical devices: YES Traditional medicines25: YES Medicine quality control laboratory26: Total 8: 1- Indian Pharmacopoiea Commission (IPC) Ghaziabad; 5-central drug testing laboratories and 2-regional drug testing laboratories ISO 17025 certified27: YES WHO prequalified28: YES (IPC, Ghaziabad) Number of registered medicines: Not available Agency responsible for selection17: Core Committee on National List of Essential Medicines, Ministry of Health & Family Welfare Number of products on essential medicines list17,D: By active ingredient: 376 By dosage form: Approximately 1000 Traditional medicines products included in essential medicines list29: YES Medicines availability is indicated by health facility level: YES Number of products in national formulary30: National Formulary 2016, Products – 521 Public sector Agency responsible for public procurement31: Ministry of Health and Family Welfare (Central Medical Services Society) Procurement done at Central State Facility Commonly used procurement methods: Competitive tendering (Two bid system) Public sector Agency responsible for distribution31,33: Centralized/decentralized at central/state or local government level Public sector facilities38: Total hospitals: 210 998 District hospitals: 1251 Sub-district hospitals: 2724 Community health centres: 1146 Primary health centres: 31 824 Sub centres: 164 053 Public sector Price control: YES Agency responsible: National Pharmaceutical Pricing Authority32 Price mechanism31,33: Lowest procurement price considered Patient prices for essential medicines in public sector: Free medicines34: YES Fixed price35: YES (Jan Aushadhi Scheme) Private sector Number of wholesalers: Not available Private sector Number of retail outlets20: 800 000 Licensed retail pharmacies per 10 000 population: Not available Number of traditional medicines outlets: Not available Private sector Agency responsible for price control32: National Pharmaceutical Pricing Authority, Ministry of Chemicals and Fertilizers Pricing mechanism: Market based pricing36 Manufacturer Wholesale RetailerE Mark-ups regulated: YES Fixed or regressive37,F: Fixed. Ceiling of drug prices based upon Market Based Pricing (MBP) Pharmaceutical system flowchart IndiaMedical products profile 2019 References 1. United Nations, Department of Economic and Social Affairs, Population Division. World Population Prospects 2019. https://population.un.org/wpp/Download/Standard/Population/- accessed 28th June 2019. 2. World Health Organization. Global Health Observatory (GHO) data: life expectancy. Geneva. http://apps.who.int/gho/data/view.main.SDG2016LEXv?lang=en - accessed 10th May 2019. 3. The World Bank. World development indicators 2018. Washington DC. https://databank.worldbank.org/data/reports.aspx?source=world-development-indicators- accessed on 10th May 2019. 4. World Health Organization. Global Health Expenditure Database (GHED): total health expenditure. Geneva. http://apps.who.int/nha/database/Select/Indicators/en - accessed on 10th May 2019. 5. World Health Organization. National Health Accounts, India. World Health Organization. Geneva. Internal communication, April 2017. 6. A. Global Health Observatory data repository. Health Workforce. Medical Doctors. http://apps.who.int/gho/data/view.main.HWFMEDv - accessed on 28th June 2019 B. Global Health Observatory data repository. Health Workforce. Pharmaceutical personnel. http://apps.who.int/gho/data/view.main.HWFPHAv - accessed on 28th June 2019 C. Decade for health workforce strengthening in the South-East Asia Region 2015–2024. Second review of progress, 2018. 1-52. https://apps.who.int/iris/bitstream/hand le/10665/274310/9789290226574-eng.pdf?sequence=1&isAllowed=y - accessed on 28th June 2019 7. World Health Organization. Global Health Observatory (GHO) data: health workforce pharmaceutical density. Geneva. https://www.who.int/gho/health_workforce/pharmaceutical_density/ en/ - accessed on 13th May 2019. 8. Data taken from SEAR health workforce survey April 2016. 9. United Nations Programme on HIV/AIDS. Estimates of coverage of people receiving ART. http://aidsinfo.unaids.org/- accessed on 10th May 2019. 10. World Health Organization. World malaria reports. Geneva. https://www.who.int/malaria/publications/world-malaria-report-2018/en/- accessed on 10th May 2019. 11. World Health Organization. Global Health Observatory (GHO) data. Geneva. http://apps.who.int/gho/data/view.main.UHCTBTREATMENTv- accessed on 10th May 2019. 12. WHO vaccine-preventable diseases: monitoring system. 2018 global summary. http://apps.who.int/immunization_monitoring/globalsummary- accessed on 10th May 2019. 13. Pain & Policy Studies Group. Country Profiles: Opioid consumption in Morphine Equivalence (ME) minus Methadone. University of Wisconsin, USA. 2015. http://www.painpolicy.wisc.edu/ countryprofiles -accessed 12 May 2017. 14. Central Drugs Standard Control Organization. Ministry of Health & Family Welfare, India. Acts and Rules. https://cdsco.gov.in/opencms/opencms/en/Acts-Rules/index.html- accessed on 13th May 2019. 15. Department of Pharmaceuticals. Ministry of Chemicals & Fertilizers. Pharmaceutical Policy 2002. India. http://pharmaceuticals.gov.in/policy/pharmaceutical-policy-2002 - accessed on 13th May 2019. 16. Ministry of Health & Family Welfare. India. National vaccine policy 2011. https://www.nhp.gov.in/sites/default/files/pdf/NATIONAL_VACCINE_POLICY.pdf - accessed on 13th May 2019. 17. Central Drugs Standard Control Organization. Ministry of Health & Family Welfare, India. National List of Essential Medicines 2015. India. 2015. http://apps.who.int/medicinedocs/documents/ s23088en/s23088en.pdf - accessed on 13th May 2019. 18. National Institute for Health & Family Welfare, Ministry of Health & Family Welfare. National health Portal. Ministry of Health & Family Welfare. India. https://www.nhp.gov.in/standards-and- protocols_pg -accessed 24 May 2017. 19. Ministry of Health & Family Welfare. The Clinical Establishments Act, 2010: Standard Treatment Guidelines. Ministry of Health & Family Welfare. Delhi. http://www.clinicalestablishments.gov. in/En/1068-standard-treatment-guidelines.aspx - accessed on 13th May 2019. 20. World Health Organization, Regional Office for South East Asia. Promoting Cooperation for regulation in trade of medical products: Report of the regional meeting WHO-SEARO, New Delhi, India. September 2015. http://www.searo.who.int/entity/health_situation_trends/report_regional_meeting_22to24_september_2015.pdf?ua=1 -accessed 24 May 2017. 21. United Nations, Department of Economics and Social Affairs, Development Policy and Analysis Division. LDC list. 2016. https://www.un.org/development/desa/dpad/wp-content/uploads/ sites/45/publication/ldc_list.pdf- accessed on 10th May 2019. 22. World Trade Organization (WTO). Members and Observers. World Trade Organization. Geneva. 2016. https://www.wto.org/english/thewto_e/whatis_e/tif_e/org6_e.htm - accessed on 10th May 2019. 23. World Intellectual Property Organization. Statistical Country profiles. World Intellectual Property Organization. Geneva. http://www.wipo.int/ipstats/en/statistics/country_profile/ –accessed 21 June 2017. 24. Central Drugs Standard Control Organization. Ministry of Health & Family Welfare, India. http://www.cdsco.nic.in/forms/Default.aspx -accessed 24 May 2017. 25. Ministry of AYUSH. Government of India. http://ayush.gov.in/ -accessed 24 May 2017. 26. Central Drugs Standard Control Organization. Ministry of Health & Family Welfare, India. https://cdsco.gov.in/opencms/opencms/en/About-us/Laboratories/ - accessed on 13th May 2019. 27. National Accreditation Board for Testing and Calibration Laboratories. Quality Council of India. http://cercenvis.nic.in/PDF/NABL-2016.pdf -accessed 24 May 2017. 28. World Health Organization. List of Medicine quality control laboratories. Geneva. 2016. https://extranet.who.int/prequal/sites/default/files/documents/PQ_QCLabsList_26.pdf - accessed on 13th May 2019. 29. Ministry of AYUSH. Government of India. Essential Drug Lists of AYUSH. http://ayush.gov.in/tenders-vacancies-and-announcements/publications/essential-drugs-list-ayurveda-siddha-unani- and-homeopathy -accessed 24 May 2017. 30. Indian Pharamcopoeia Commission, Ministry of Health & Family Welfare. India. 2016. https://www.ipc.gov.in/images/news/NFI-0414979118.pdf - accessed on 13th May 2019. 31. Central Medical Services Societies, Ministry of Health & Family Welfare. Government of India. http://www.cmss.gov.in/ -accessed 24 May 2017. 32. National Pharmaceutical Pricing Authority, Ministry of Chemicals & Fertilizers. Government of India. http://nppaindia.nic.in/ -accessed 24 May 2017. 33. Singh PV, Tatambhotla A, Kalvakuntla R, et al. Understanding public drug procurement in India: a comparative qualitative study of five Indian states. BMJ Open 2013;3:e001987. doi:10.1136/ bmjopen-2012- 00198. http://apps.who.int/medicinedocs/documents/s20032en/s20032en.pdf -accessed 24 May 2017. 34. Ministry of Health & Family Welfare. Government of India. Operational Guidelines for Free Drugs Service Initiatives. Ministry of Health & Family Welfare. India. https://www.mpphscl.in/Files/ PDF/b731acad-eded-43b6-b286-99aea308b1fb_0_Free_Drugs_Service_Intitiative.pdf -accessed 24 May 2017. 35. National Pharmaceutical Pricing Authority, Ministry of Chemicals & Fertilizers. Government of India. http://nppaindia.nic.in/nppaprice/newmedicinepricesearch.aspx -accessed 24 May 2017. 36. National Pharmaceutical Pricing Authority, Ministry of Chemicals & Fertilizers. Government of India. Drug Price Control Order 2013. http://www.nppaindia.nic.in/wp-content/uploads/2018/12/ DPCO2013_03082016.pdf -accessed on 13th May 2019. 37. National Pharmaceutical Pricing Authority, Ministry of Chemicals & Fertilizers. Government of India. http://www.nppaindia.nic.in/frequent.html#4 -accessed 24 May 2017. 38. Ministry of Health & Family Welfare. Health Management Information System, National health Mission. Ministry of Health & Family Welfare. Government of India. https://nrhm-mis.nic.in/ hmisreports/frmstandard_reports.aspx -accessed 24 June 2017. Notes: A. 0.78 physicians per 1000 population. B. Less than 1 pharmaceutical personnel per 1000 population. C. Other sources: 1) http://pbhealth.gov.in/AMR_guideline7001495889.pdf 2) http://icmr.nic.in/guidelines/treatment%20guidelines%20for%20antimicrobial.pdf 3) http://www.tbcindia.nic.in/index1.php?lang=1&level=1&sublinkid=4571&lid=3176 4) http://clinicalestablishments.nic.in/WriteReadData/93.pdf 5) http://clinicalestablishments.nic.in/WriteReadData/448.pdf 6) http://nvbdcp.gov.in/iec.html D. By self-calculating all the strengths listed. E. P(c) = P(s).(1+M/100), where P(s) = Average Price to Retailer for the same strength and dosage of the medicine ; M = % Margin to retailer and its value =16. F. A Manufacturer, distributor or wholesaler shall sell a formulation to a retailer, unless otherwise permitted under the provisions of this order or any order made thereunder, at a price equal to the retail price, as specified by an order or notified by the Government, (excluding excise duty, if any) minus sixteen per cent thereof in the case of Scheduled drugs. IndiaMedical products profile 2019