- The Pharmaceutical industry in India is the 3rd largest in the world in terms of volume and14th largest in terms of value. The Pharma sector currently contributes to around 1.72% of the country’s GDP. 24
- Major Segments of the Pharmaceutical Industry are Generic drugs, OTC Medicines and API/Bulk Drugs, Vaccines, Contract Research & Manufacturing, Biosimilars & Biologics. 24
- India has the second-highest number of US FDA approved plants outside the US. India is the largest provider of generic drugs globally.24
- Indian medicines are preferred worldwide, thereby rightly making the country the “Pharmacy of the World”.24
- India is 3rd largest market for APIs globally, 8% share in the Global API Industry, 500+ different APIs are manufactured in India and it contributes 57% of APIs to prequalified list of the WHO.24
- Pharmaceuticals industry expected to reach USD 65 bn by 2024, and USD 120-130 bn by 2030
- An overall increase of 7.95% in budget allocation for Health Schemes in 2021-22 as compared to allocation in 2020-21.21
- Pharmaceutical is one of the top ten attractive sectors for foreign investment in India.
- The pharmaceutical exports from India reach more than 200 nations around the world, including highly regulated markets of the USA, West Europe, Japan, and Australia. 1
- About 20% of the global exports in generic drugs are met by India. 1
- The Indian pharmaceutical industry is the third-largest in the world by volume and 14th largest in terms of value. It contributes 3.5% of the total drugs and medicines exported globally.
- India supplied around 45 tons and 400 million tablets of hydroxychloroquine to around 114 countries globally.
- The current market size of the Indian pharmaceutical industry is around USD 50 bn.
- Reasons to Invest
- India's healthcare market may see a threefold jump in value terms to reach USD 372 bn by 2022 with rising income, greater health awareness, increased precedence of lifestyle diseases and improved access to insurance. 2
- Ayushman Bharat is National Health Protection Scheme, which will cover over 100 mn poor and vulnerable families (approximately 500 mn beneficiaries) providing coverage up to INR 5 lakh per family per year for secondary and tertiary care hospitalization.3
- Under the ‘Promotion of Bulk Drug Parks’ Scheme, the Union government aims to develop 3 mega Bulk Drug parks in India in partnership with the States. The parks will have common facilities such as a solvent recovery plant, distillation plant, power & steam units, and a common effluent treatment plant. 7
- The presence of a skilled workforce as well as high managerial and technical competence is a source of attraction for private players. Pharma companies have already increased spending in the country to tap rural markets and develop better infrastructure. 1
- Nearly 11.9 lakh Health IDs have been generated and 3106 doctors and 1490 facilities have registered on the platform.
- GOI plans to manufacture 5 billion vaccines next year and ensure the safety and security of people across the world post-vaccination.
- Key Achievements
- More than 11.74 lakh users are connected with the Jan Aushadhi Sugam App.
- 102 Jan Aushadhi Kendra under PMBJP were opened during June 2021 across the country taking cumulative total to 7867.
- The total size of the drugs & medical device industry is around US$43 billion. Currently, the growth rate is 7-8% in the drug sector and 15- 16% in the medical device sector.12
- Under PLI Scheme for API/KSM/DI received total 215 application and PLI Scheme for Medical Devices received 28 application in November 2020.18
- Number of sanctioned posts in CDSCO have been increased from 111 in 2008 to 492 in January, 2021.
- Government has approved a proposal for strengthening the drug regulatory system in the country, both at the level of Central and the State Governments at a total expenditure of INR 1,750 crores.
- Dr E. Poonguzhali, a woman scientist at the Department of Chemistry, IIT-Madras, Chennai, has been granted a patent for developing a green methodology for producing a medicinally important compound called Benzo[b]thiophene.
- A team of Indian Scientists has identified the next-generation probiotic bacterium Lactobacillus Plantarum JBC5 from a dairy product that showed great promise in promoting healthy aging.
- Indian Scientists have developed a yogurt using a probiotic bacterium which can be consumed to derive all these health benefits.
- Out of the 49 projects approved so far under PLI scheme for Bulk Drugs, 8 projects with investment of INR 335 crore and with an annual production capacity of 16,021 MT have been commissioned as on date. Further, 12 projects with committed investment of INR 504 crore and having annual production capacity of 18,614 MT are in the advanced stage of completion for commercial production and expected to be completed by 31st March 2022.
- As on 31st January, 2022, the number of pharmaceuticals stores has increased to 8,675. Under the PMBJP, all 739 districts of the nation have been covered. The scheme ensures easy reach of affordable medicine to the people in every nook and corner of the country.
- 39 distributors have been appointed across the country to support the supply of medicines to remote and rural areas.
- Indian pharma companies enabled by their price competitiveness and good quality, have made global mark, with 60 percent of the world’s vaccines and 20% of generic medicines coming from India.
- Recent Announcements
25th May 2022: COVID-19 UPDATE- 192.67 crore vaccine doses have been administered so far under Nationwide Vaccination Drive and Recovery Rate is currently at 98.75%.
18th May 2022: Dr Bharati Pravin Pawar launches National Emergency Life Support (NELS) courses for Doctors, Nurses and Paramedics.
11th May 2022: Dr Bharati Pravin Pawar launches Atal Innovation Mission- PRIME Playbook & Start-up showcase to promote science-based deep-technology ideas to market through training and guidance over a period of 9 months.
6th May 2022: Department of Pharmaceuticals releases “Common Guidelines on Pharmaceutical Innovation and Entrepreneurship” for academic institutions.
28th April 2022: PM dedicates to nation seven cancer hospitals across Assam.
- Exports of Drugs & Pharmaceuticals values at USD 2072.26 mn in April 2022 and records positive growth vis-à-vis April 2021 of 9.49%.
- Drugs and Pharmaceuticals shares 5.15% of the total exports of the country in the month of April.
- Exports of Drugs and Pharmaceuticals values at USD 24475.36 mn from Apr21- Mar22.
- Drugs and Pharmaceuticals shares 5.86% of the total exports of the country in the period Apr21- Mar22.
- The medical devices sector to grow from current USD 11 bn to USD 50 bn in next few years
- India has exported more than 65 mn doses of Covid vaccines to nearly 100 countries in 2021.
- Indian pharma exports witnessed a growth of 103% since 2013-14, from INR 90, 415 Crores in 2013-14 to INR 1,83,422 Crores in 2021-22.
- The Average Index of Industrial Production of Manufacturing of pharmaceuticals, medicinal chemicals and botanical products in the FY 2021-22 is 221.6 and has grown by 1.3 percent.
- Growth Drivers
- Ministry of Chemicals and Fertilizers issued guidelines for implementing the provisions of Public Procurement Order (PPO) related to the procurement of goods and services in Medical Devices.16
- On 21st December 2020, MOU was signed between Tata Memorial Centre of India and Vietnam National Cancer Hospital to promote exchanges in the areas of training and scientific research, health care services, collaboration in diagnosis and treatment for cancer patients.17
- The total market size of the Indian Pharma Industry is expected to reach USD 130 bn by 2030.
- Till November 2021, 33 states have set up designated Special Courts for a trial of offenses under the Drugs and Cosmetics Act for speedy disposal.
- CSIR and Institut Pasteur signed an MoU to jointly research and focus on emerging and remerging infectious diseases and inherited disorders and enable delivery of effective and affordable healthcare solutions not only for the people of India and France but for the global good.
- National Regulator approves “Conditional Market Authorization” of two COVID19 Vaccines- Covaxin and Covishield which reflects India’s proactive and agile COVID19 Management.
- Atal Innovation Mission (AIM), NITI Aayog, and USAID are in a partnership under the Sustainable Access to Markets and Resources for Innovative Delivery of Healthcare (SAMRIDH) initiative, which will improve access to affordable and quality healthcare for vulnerable populations in tier-2 and tier-3 cities, and rural and tribal regions.
- The Central Council for Research in Ayurvedic Sciences (CCRAS), the largest Research Council under the Ministry of Ayush, GOI has initiated the use of eOffice for its official purposes in its quest for becoming a paperless organisation.
- Revamped CGHS Website and Mobile App “MyCGHS” is launched to provide easy access to healthcare services to more than 40 Lakh beneficiaries.
- Cabinet approves MoUg signed between the ICMR, India and Deutsche Forschungsgemeinschaft e.V. (DFG), Germany for cooperation in the field of medical sciences/health research in areas including Toxicology, Neglected (Tropical) disease, rare diseases and any other areas of mutual interest.
- The Union Cabinet was apprised of MoU signed between the ICMR and the National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Health of Department of Health and Human Services, USA to focus on collaboration on tuberculosis, parasitic infections, HIV/AIDS, Allergic diseases, immune system diseases, other emerging and re-emerging pathogens, and other diseases of shared scientific interest.
- Cabinet approves MoU signed between the ICMR, India and the Oxford University, UK to exchange and share ideas on three vector-borne diseases in the elimination phase (malaria, visceral leishmaniasis, filariasis) & emerging infections, Support and develop best practices for data management, data documentation, data sharing and the development of equitable governance frameworks.
- BRICS Vaccine R&D Centre is launched to streamline Vaccination Resources and Facilitate Equitable Access to safe and efficacious COVID-19 vaccines.
- 15 MoUs worth INR 810 crore were signed with the entrepreneurs for setting up of their units in the upcoming Medical Devices Park at Nalagarh in District Solan.
- 33 Ambulances (13 Advanced Life Support Ambulances and 20 Basic Life Support Ambulances) have been flagged off with the aim to improve health and disaster response capacity of Indian Red Cross Society (IRCS) branches.
- The National Health Authority (NHA) has rolled out the module for nurses on Health Professional Registry under Ayushman Bharat Digital Mission (ABDM). The nurses providing health services across modern and traditional systems of medicine can also enroll on Healthcare Professional Registry.
- PM dedicates to nation seven cancer hospitals across Assam.
- Department of Pharmaceuticals releases “Common Guidelines on Pharmaceutical Innovation and Entrepreneurship” for academic institutions with the aim to transform the academic research into innovative and commercially applicable technologies/products; build strong ecosystem for nurturing creativity and entrepreneurial activities and contribute to self-reliant India mission.
- National Emergency Life Support (NELS) courses for doctors, nurses and paramedics. Apart from the training modules, the program also includes developing training infrastructure in all States/UTs to implement the NELS course and creating a cadre of trainers to train doctors, nurses and paramedics working in emergency departments of the hospitals and ambulance services.
- FDI Policy
- Up to 100%, FDI has been allowed through automatic route for Greenfield pharmaceuticals projects. For Brownfield pharmaceuticals projects, FDI allowed is up to 74% through automatic route and beyond that through government approval. 5
- The cumulative FDI equity inflow in the Drugs and Pharmaceuticals industry is USD 19,197.40 mn during the period April 2000 to December 2021. This constitutes 3.35% of the total FDI inflow received across sectors.4
- The cumulative FDI equity inflow in the Medical and Surgical Appliances is USD 2,357.18 mn during the period from April 2000 to December 2021.
- The cumulative FDI equity inflow in Hospital & Diagnostic Centres is USD 7,728.63 mn during the period April 2000 to December 2021. This constitutes almost 1.35% of the total FDI inflow received across sectors.
- Production Linked Incentive (PLI) Scheme
The sector is supported by the following Production Linked Incentive (PLI) Schemes to boost domestic manufacturing capacity, including high-value products across the global supply chain.
- PLI Scheme for Key Starting Materials (KSMs)/Drug Intermediates (DIs) and Active Pharmaceutical Ingredients (APIs) (PLI 1.0), Read More
- Production-Linked Incentive (PLI) Scheme for Pharmaceuticals d (PLI 2.0), Read More
Financial Outlay- INR 21,940 crore
Category 1: Biopharmaceuticals, Complex generic drugs, Patented drugs or drugs nearing patent expiry, Cell based or gene therapy products, Orphan drugs, Special empty capsules, Complex excipients, Phyto-pharmaceuticals
Category 2: Active Pharma Ingredients (APIs), Key Starting Materials (KSMs), Drug Intermediaries (Dls)
Category 3: Repurposed Drugs, Auto-immune drugs, Anti-cancer drugs, Anti diabetic drugs, Anti Infective drugs, Cardiovascular drugs, Psychotropic drugs, Anti-Retroviral drugs, Fermentation based 4 KSMs /DIs
For more details on PLI Schemes, Click Here
- Sector Policy
The National Pharmaceutical Pricing Policy, 2012 (NPPP-2012) notified on 07 December 2012, with the following salient features: 1
- The regulation of prices of drugs on the basis of the essentiality of drugs as specified under the National List of Essential Medicines (NLEM) – 2011.
- The regulation of prices of drugs on the basis of regulating the prices of formulations only.
- The regulation of prices of drugs on the basis of fixing the ceiling price of formulations through Market-Based Pricing.
- The provision of exemptions to drugs manufactured through indigenous R&D from price control for five years.
- A Drug Price Control Order 2013 has been notified in May 2013 to implement the provisions of NPPP-2012.
Umbrella Scheme 1
- The Department of Pharmaceuticals has prepared an Umbrella Scheme namely ‘Scheme for Development of Pharma industry’.
- The said Umbrella Scheme comprises of the following sub-schemes:
- Assistance to Bulk Drug Industry for Common Facilitation Centres
- Assistance to Medical Device Industry for Common Facilitation Centres
- Assistance to Pharmaceutical Industry (CDP-PS)
- Pharmaceutical Promotion and Development Scheme (PPDS)
- Pharmaceutical Technology Upgradation Assistance Scheme (PTUAS)
Pharmaceuticals Promotion Development Scheme (PPDS) 1
- Under the PPDS, the Department of Pharmaceuticals aims to:
- Conduct Training/knowledge improvement programs/activities on issues/subjects relevant to the growth of the pharmaceutical industry.
- Organize Summits, Convention, Exhibitions, Pharmacy week, meetings etc. in India and abroad and produce promotional materials like films, displays etc.
- Conduct research studies, sector reports etc.
- Purchase books, quality standards, pharmacopoeias, magazines, directories, software for developing information data banks, developing e-learning modules etc.
- Give awards to achievers in the pharmaceutical industry.
National Telemedicine Services19
- The National Telemedicine Service "eSanjeevani" is a digital health initiative of the Ministry to implement teleconsultation in all the 1.5 lakh Health and Wellness Centres in a 'Hub and Spoke' model, by December 2022.
- eSanjeevani has crossed another milestone by completing 7 mn consultations. In June it served around 12.5 lakh patients, which is the highest since the services were launched last year in March.
- More than 80 Lakh patients served through Central Government’s eSanjeevani initiative.
- The National Telemedicine Service is facilitating over 60,000 consultations for seeking healthcare on a daily basis.
Promotion of Medical Devices Parks
- Under this Scheme a onetime grant-in-aid will be provided for creation of common infrastructure facilities in selected Medical Device Park proposed by a State Government.
- The total financial outlay of the scheme is INR 400 crore (INR 100 crore for each MD Park). The tenure of the scheme is from FY 2020-2021 to FY 2024- 2025.
- Under the scheme, proposals seeking financial assistance from 16 States/Union Territories have been received. After evaluation of the proposals, the Government vide letter dated 24.09.2021 has in-principally approved financial assistance for common infrastructure facilities for 4 medical device parks i.e. Himachal Pradesh, Tamil Nadu, Madhya Pradesh and Uttar Pradesh.
Ayushman Bharat Digital Mission (ABDM)
- PM has approved the national roll-out of Central Sector Scheme, Ayushman Bharat Digital Mission (ABDM) of Ministry of Health and Family Welfare, GOI, with a budget of INR 1,600 crore for five years.
- Under the ABDM, citizens will be able to create their ABHA (Ayushman Bharat Health Account) numbers, to which their digital health records can be linked. This will enable creation of longitudinal health records for individuals across various healthcare providers, and improve clinical decision making by healthcare providers.
- The pilot of ABDM is completed in the six Union Territories of Ladakh, Chandigarh, Dadra & Nagar Haveli and Daman & Diu, Puducherry, Andaman and Nicobar Islands and Lakshadweep with successful demonstration of technology platform developed by the NHA.
- During the pilot, digital sandbox was created in which more than 774 partner solutions are undergoing integration. As on 24th February 2022, 17,33,69,087 Ayushman Bharat Health Accounts have been created and 10,114 doctors and 17,319 health facilities have been registered in ABDM.
Strengthening of Pharmaceutical Industry (SPI)
- The Ministry's scheme “Strengthening of Pharmaceutical Industry (SPI)" with a total financial outlay of INR 500 crores extends support required to existing pharma clusters and MSMEs across the country to improve their productivity, quality and sustainability.
Mantri Bhartiya Jan Aushadhi Kendras (PMBJKs)
- The Government has set a target to increase the number of PMBJKs to 10,500 by the end of March 2025. Product basket of PMBJP comprises of 1451 drugs and 240 surgical instruments.
- Pharmaceuticals & Medical Devices Bureau of India (PMBI), has completed the target of opening of 8,300 PMBJKs for the FY 2021-22 before end of September, 2021 and set a target to increase the number of PMBJKs to 10,000 by March 2024.
- As on 28th February 2022, about 8689 PMBJKs have been opened up in the country covering all districts of the country.
- Financial Support
Union Budget 2022-23
- The total budgetary allocation for FY 2022-23 towards the Department of Pharmaceuticals is INR 2,244.15 cr.
- The total budgetary allocation for FY 2022-23 towards the Department of Health and Family Welfare is INR 83,000 cr.
- The total budgetary allocation for FY 2022-23 towards the Department of Health Research is INR 3,200.65 cr.
Scheme for Promotion of Bulk Drug Parks
- Under the scheme, the Government of India has approved a sum of INR 3,000 cr for setting up 3 mega Bulk Drug Parks in the country. Grants-in-Aid will be provided to States with a maximum limit of INR 1000 cr per Bulk Drug Park. 7
Production Linked Incentive (PLI) Scheme
- Under PLI Scheme in High-Efficiency Manufacturing of Medical Devices was proposed by the Department of Pharmaceuticals with a financial outlay of INR 15,000 cr.15
- Under the scheme, the Government of India will provide up to 20% incentives on incremental sales of 41 products stipulated in the scheme guidelines. The total financial support approved by the government under this scheme is INR 6,940 cr. 8
- Key products are:- Biopharmaceuticals, Complex generic drugs, Patented drugs or drugs nearing patent expiry, Cell-based or gene therapy products, Orphan drugs, Special empty capsules
Complex excipients, Active Pharma Ingredients (APIs) /Key Starting Materials (KSMs) and /Drug Intermediaries (Dls), Repurposed Drugs, Auto-immune drugs, Anti-cancer drugs, Antidiabetic drugs, Anti Infective drugs, Cardiovascular drugs, Psychotropic drugs and Anti-Retroviral drugs
In-vitro Diagnostic Devices (IVDs) - Medical Devices, Phytopharmaceuticals, Other drugs not manufactured in India
- Investment Opportunities
- The Indian Drugs & Pharmaceuticals Limited (IDPL), a public limited company, aims to encourage indigenous production of pharmaceuticals and to support various health programmes of the Central Government. It is currently manufacturing 86 products, under Public-Private Partnership, and 25 products, under non-Public Private Partnership mode. 1
- Japanese companies have been invited to invest in Indian Pharmaceutical and Medical Device Industry. Pharmaceutical Traders Association and Japan Federation of Medical Devices Associations have come to the mutual understanding that cooperation between the two countries can contribute to stabilize the global supply-chain especially of APIs and Medical Devices. 9
- A Bulk Drug Pharma Park has been proposed in Solan, Himachal Pradesh to give impetus to the Pharmaceutical industry. An amount of INR 200 cr has been sanctioned for the Bulk Drug Pharma Park and a Satellite extension centre of National Institute of Pharmaceutical Education and Research (NIPER). 10
- The Government of Assam has proposed a Pharmaceutical Park in Chaygaon, Kamrup Rural on a land area of 100 acres. The estimated project cost is INR 153.64 cr. 11
- Foreign Investors
- Teva Pharmaceuticals (Israel)
- Nipro Corporation (Japan)
- Procter & Gamble (USA)
- Pfizer (USA)
- Glaxo Smith Kline (UK)
- Johnson & Johnson (USA)
- Otsuka Pharmaceutical (Japan)
- AstraZeneca (Sweden-UK)
- Annual Report 2019-20, Department of Pharmaceuticals, https://pharmaceuticals.gov.in/sites/default/files/Annual%20Report%202019-20_0.pdf
- Year End Review 2019: Ministry of Chemicals & Fertilizers, PIB, https://www.pib.gov.in/PressReleasePage.aspx?PRID=1598394
- Ayushman Bharat - National Health Protection Mission, National Portal of India, https://www.india.gov.in/spotlight/ayushman-bharat-national-health-protection-mission
- Factsheet on FDI - April 2000 to December 2021, Department for Promotion of Industry and Internal Trade, https://dpiit.gov.in/sites/default/files/FDI%20Factsheet%20December%2C%202021.pdf
- Consolidated FDI Policy, https://invest-india-revamp-static-files.s3.ap-south-1.amazonaws.com/2020-04/FDI%20Policy%202019%20revised_19%20April%202020.pdf
- Union Budget, Government of India, https://www.indiabudget.gov.in/doc/eb/sbe7.pdf
- Guidelines of the Scheme "Promotion of Bulk Drug Parks", Ministry of Chemicals and Fertilizers, https://pharmaceuticals.gov.in/sites/default/files/Guidelines%20of%20the%20Scheme%20Promotion%20of%20Bulk%20Drug%20Parks_1.pdf
- Guidelines for Production Linked Incentive (PLI) Scheme, Ministry of Chemicals and Fertilizers, https://pharmaceuticals.gov.in/sites/default/files/Guidelines%20for%20the%20Production%20Linked%20Incentive%20%28PLI%29%20Scheme%20for%20promotion%20of_0.pdf
- Japanese companies invited to invest in Indian Pharmaceutical and Medical Devices industry, Ministry of Chemicals and Fertilizers, https://pib.gov.in/PressReleseDetailm.aspx?PRID=1626121
- NCAER DIPP District Driven Growth Pilot Study Solan, https://eaindustry.nic.in/ddp/Solan_FINAL_Report.pdf
- Pharmaceutical Park at Chaygaon, Kamrup Rural, https://advantageassam.com/assets/front/pdf/shelf-of-projects/Pharmaceuticals/Pharmaceutical-Park-at-Chaygaon-Kamrup-Rural.pdf
- Annual Report 2019-20, Department of Pharmaceuticals, https://pharmaceuticals.gov.in/sites/default/files/Annual%20Report%202019-20_0.pdf
- Monthly Report, Department of Pharmaceuticals, https://pharmaceuticals.gov.in/sites/default/files/Monthly%20Summary%20.pdf
- PIB Release, https://www.pib.gov.in/PressReleasePage.aspx?PRID=1671912
- PIB Release, https://pib.gov.in/PressReleasePage.aspx?PRID=1671912
- Department of Pharmaceuticals, https://pharmaceuticals.gov.in/sites/default/files/ppo%20signed.pdf
- PIB Release, https://www.pib.gov.in/PressReleasePage.aspx?PRID=1682468
- Monthly Report, Department of Pharmaceuticals, https://pharmaceuticals.gov.in/sites/default/files/Monthly%20Report%20November%202020.pdf
- PIB Release, https://www.pib.gov.in/PressReleasePage.aspx?PRID=1684546
- PIB Release, https://www.pib.gov.in/PressReleasePage.aspx?PRID=1688524
- PIB Release, https://www.pib.gov.in/PressReleasePage.aspx?PRID=1703447
- PIB Release, https://www.pib.gov.in/PressReleasePage.aspx?PRID=1705358
- PIB Release, https://www.pib.gov.in/PressReleasePage.aspx?PRID=1725993
- Annual Report 2020-21 https://pharmaceuticals.gov.in/sites/default/files/english%20Annual%20Report%202020-21.pdf