- India is the 4th largest Asian medical devices market.*
- 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 1.32% of the country’s GDP. *
- The Indian medical device market share in the global market is estimated to be 1.65%. *
- The current market size of the medical devices sector in India is estimated to be USD 11 Bn and its share in the global medical device market is estimated to be 1.5%.*
- The Indian pharmaceutical industry includes a network of 3,000 drug companies and 10,500 manufacturing units. It is projected to reach a value of US$ 130 billion by 2030.*
- Indian medicines are preferred worldwide, thereby rightly making the country the “Pharmacy of the World”. *
- India is the largest supplier of generic medicines. It manufactures about 60,000 different generic brands across 60 therapeutic categories and accounts for 20% of the global supply of generics.*
- India accounts for about 60% of global vaccine production. *
- Reasons to Invest
- India striving to eliminate TB from the country by 2025, five years ahead of the global Sustainable Development Goal.*
- The size of the Indian medical devices market is expected to grow to USD 50 Bn by 2030 with CAGR of 16.4 %. *
- Healthcare sector in India is expected to reach a size of USD 50 bn by 2025. *
- India’s share in medical tourism is expected to be around USD 10 bn by 2023.*
- Under the ‘Promotion of Bulk Drug Parks’ Scheme, the government has set financial outlay of INR 3000 cr and the tenure id from 2020-2021 to FY 2024-2025. The parks will have common facilities such as a solvent recovery plant, distillation plant, power & steam units, and a common effluent treatment plant. *
- The Government has set a target to increase the number of Jan Aushadhi Kendras to 10,000 by March 2024.*
- India's vaccine market is expected to reach a valuation of INR 252 bn by 2025.*
- Key Achievements
- The number of Kendras have increased to 9000 from 8610 in the last financial year under PMBJP.*
- Dr Jitendra Singh announces India’s first indigenously developed vaccine, “CERVAVAC” for the prevention of cervical cancer.*
- eSanjeevani surpasses records by registering 1 crore consultations in approximately 5 weeks.*
- World’s first intranasal COVID19 vaccine, iNNCOVACC marks a glorious tribute to the call for Atmanirbhar Bharat.*
- Recent Announcements
15th August 2023: Government to open 25000 Jan Aushadhi Kendras to make medicines available at affordable prices.
11th Jul 2023: It is important for MSME Pharma Cos. to be alert to quality of drugs and expeditiously move towards Good Manufacturing Processes through self-regulation.
23rd June 2023: Indian pharma industry should strive to maintain the reputation of India as the ‘Pharmacy of the World’: Dr Mansukh Mandaviya
09th June 2023: Doctors may soon diagnose peptic ulcer & disease stage by recognising breath patterns
22nd May 2023: COVID-19 Update: 1282 vaccine doses administered in last 24 hours, recovery rate stands at 98.80%
- The Average Index of Industrial Production of Manufacturing of pharmaceuticals, medicinal chemicals and botanical products in the FY 2022-23 is 217. *
- The number of medical colleges has been increased from 387 to 596, the number of MBBS seats has been increased from 51,000 to 89,000 and the number of PG seats has been increased from 31,000 to 60,000.*
- 1205 health facilities have registered under incentive scheme under Ayushman Bharat Digital Mission (ABDM) with 567 public and 638 private hospitals/ clinics/ diagnostic labs. Further, out of the 25 digital solution companies registered, 22 are from the private sector.*
- Till June 2023, close to 120 health facilities and 7 health tech companies have received incentives totalling to Rs. 4.84 Cr. The incentive recipients include government hospitals like AIIMS Delhi, AIIMS Raipur, AIIMS Bhopal, Lok Bandhu Rajnarayan Combined Hospital, Lucknow, KC General Hospital Bengaluru and private hospitals like KGMU, Lucknow, KIMS Hubbali Bengaluru among others. Diagnostic labs like Indira Path Labs Delhi and Lucknow, Sahayog Pathology Laboratory Pune and Leo Clinical Lab Kannur and digital solution companies like NIC (Nextgen HMIS), CDAC (eSushrut), Driefcase, Ekacare (Orbi Health), Bajaj Finserv and Paytm are some of the top performing entities under DHIS.*
- Growth Drivers
- NHA under its flagship scheme of Ayushman Bharat Digital Mission (ABDM) announced the launch of a revamped Ayushman Bharat Health Account (ABHA) mobile application. The updated version of the ABHA app has new User Interface (UI) and added functionalities that enable individuals to access their health records anytime and anywhere. *
- PM dedicates to nation seven cancer hospitals across Assam. *
- Revamped CGHS Website and Mobile App “MyCGHS” is launched to provide easy access to healthcare services to more than 40 Lakh beneficiaries. *
- Union Minister Dr Jitendra Singh says, last 9 years have turned India into a cost effective medical destination.*
- 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. *
- BRICS Vaccine R&D Centre is launched to streamline Vaccination Resources and Facilitate Equitable Access to safe and efficacious COVID-19 vaccines. *
- 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. *
- The cumulative FDI equity inflow in the Drugs and Pharmaceuticals industry is USD 21.46 bn during the period April 2000 to March 2023. This constitutes almost 3% of the total FDI inflow received across sectors. *
- The cumulative FDI equity inflow in the Medical and Surgical Appliances is USD 2.80 bn during the period April 2000 to March 2023. *
- The cumulative FDI equity inflow in the Hospital & Diagnostic Centres is USD 8.73 bn during the period April 2000 to March 2023. This constitutes almost 1.37% 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), Pharmaceuticals Manufacturing
- Production-Linked Incentive (PLI) Scheme for Pharmaceuticals d (PLI 2.0), Pharmaceuticals Manufacturing
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
Targets of National Health Mission (NHM) by 2025 include:
Reduce MMR to 90 from 113
Reduce IMR to 23 from 32
Reduce U5MR to 23 from 36
Sustain TFR to 2.1
Reduce prevalence of Leprosy to <1/10000 population and incidence to zero in all districts
Annual Malaria Incidence to be <1/1000
Prevent and reduce mortality & morbidity from communicable, non- communicable; injuries and emerging diseases
Reduce household out-of-pocket expenditure on total health care expenditure
Ending the TB epidemic by 2025 from the country.
Guidelines of the Scheme "Promotion of Medical Devices Parks"*
- Objective of the scheme is Creation of world class infrastructure facilities in order to make Indian medical device industry a global leader
- Easy access to standard testing and infrastructure facilities through creation of world class Common Infrastructure Facilities for increased competitiveness will result into significant reduction of the cost of production of medical devices leading to better availability and affordability of medical devices in the domestic market.
Scheme for the Establishment of AYUSH Super Specialty Hospitals/ Day Care Centres for Medical Tourism*
- The Champion Services Sector Scheme for Medical Value Travel has been framed by Govt. of India to enhance Medical Tourism in the country especially in the field of Traditional System of Medicine
- Objective of the scheme is to encourage private investors to invest in AYUSH sector through Establishment of World Class, State of the Art Super Specialty Hospitals/ Day Care Centres of the systems recognized under Indian Medicine Central Council (IMCC) Act, 1970 or Homeopathic Central Council (HCC) Act, 1973 for promoting export of medical value travel services including services supplied to foreign consumers in India by providing interest subsidy.
Scheme for Strengthening of Pharmaceuticals Industry (SPI)
- The total financial outlay of the scheme is INR 500 crore for a period of five years from 2021-22 to 2025-26. The scheme has three sub-components Viz, Assistance to Pharmaceuticals Industry for Common Facilities (API-CF), Pharmaceutical Technology Upgradation Assistance Scheme (PTUAS) and Pharmaceutical & Medical Devices Promotion and Development Scheme (PMPDS).
- Strengthen the existing infrastructure facilities in order to make India a global leader in the Pharma Sector by providing financial assistance to pharma clusters for creation of Common Facilities.
- Upgrade the production facilities of SMEs and MSMEs, to meet national and international regulatory standards, by providing interest subvention or capital subsidy on their capital loans.
- Promote knowledge and awareness about the Pharmaceutical and Medical Devices Industry by taking up studies, building databases and brining industry leaders, academia and policy makers together to share their knowledge and experience.
The National Pharmaceutical Pricing Policy, 2012 (NPPP-2012) notified on 07 December 2012, with the following salient features*
- 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 *
- 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) *
- 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 Services *
- 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 date over 332 million unique patient IDs (ABHA IDs), more than 200,000 Health Facility Registries & over 144,000 Health Professional Registries have been created under 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 2023-24
- The total budgetary allocation for FY 2023-24 towards the Department of Pharmaceuticals is INR 3160.06 cr.*
- The total budgetary allocation for FY 2023-24 towards the Department of Health and Family Welfare is INR 86,175 cr.*
- The total budgetary allocation for FY 2023-24 towards the Department of Health Research is INR 2980 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.
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.
- 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.
- 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. *
- 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. *
- 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). *
- 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. *
- Sector Reports
- 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 2022-23 https://pharmaceuticals.gov.in/sites/default/files/Annual%20Report%202022-23%20Final-3_0.pdf
- 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