Ministry Of Chemicals And Fertilizers: Department Of Pharmaceuticals,2008

Policy Update
Atharva Salunke

Background:

The Department of Pharmaceuticals was established on July 1, 2008, under the Ministry of Chemicals & Fertilizers with the objective of providing greater focus on the development of the pharmaceutical sector in India. The Department plays a crucial role in ensuring the availability of affordable medicines, regulating pricing, encouraging research and development, protecting intellectual property rights, and fulfilling international commitments in the pharmaceutical domain.

Vision: “To make India the largest global provider of quality medicines at reasonable prices”.

Organizations Under Department of Pharmaceuticals (DoPs):

Attached Offices: National Pharmaceutical Pricing Authority (NPPA)
PSUs:

Bengal Chemicals and Pharmaceuticals Limited (BCPL).
Hindustan Antibiotics Limited (HAL).
Indian Drugs and Pharmaceuticals Limited (IDPL).
Pharmaceuticals & Medical Devices Bureau of India [Jan Aushadhi-Bureau of Pharma PSUs of India (BPPI).

Institutions under Department of Pharmaceuticals:

Karnataka Antibiotics and Pharmaceuticals Limited (KAPL), Bangalore.
National Institute of Pharmaceutical Education and Research (NIPER), Hyderabad.
National Institute of Pharmaceutical Education and Research (NIPER), Ahmedabad .
National Institute of Pharmaceutical Education and Research (NIPER), Kolkata.
National Institute of Pharmaceutical Education and Research (NIPER), Guwahati.
National Institute of Pharmaceutical Education and Research (NIPER), Hajipur.
National Institute of Pharmaceutical Education and Research (NIPER), Rae Bareli.
National Institute of Pharmaceutical Education and Research (NIPER), Mohali

Schemes under Department of Pharmaceuticals (DoPs):

A. Scheme for Strengthening of Medical Device Industry

The Strengthening of Medical Device Industry (SMDI) Scheme was launched on November 8, 2024, with a financial outlay of ₹500 crore to support critical areas of the sector. It has five sub-schemes:

Common Facilities for Medical Device Clusters (₹110 crore): Aims to enhance existing infrastructure by supporting common facilities and testing laboratories. In-principle approval has been granted for 4 proposals to set up common facilities and 6 for testing facilities.
Marginal Investment Scheme for Reducing Import Dependence (₹180 crore): Focuses on promoting domestic production of key components, raw materials, and accessories used in medical devices and in-vitro diagnostics, thereby strengthening local value chains.
Capacity Building and Skill Development (₹100 crore): Seeks to bridge gaps in education and research, ensuring quality training in medical technology. Approvals include 13 proposals under Component-A and 5 under Component-B.
Medical Device Clinical Studies Support Scheme (₹100 crore): Provides assistance for clinical studies to ensure safety, efficacy, and credibility of domestically produced devices.
Medical Device Promotion Scheme (₹10 crore): Promotes industry growth by supporting awareness programs, studies, databases, and collaborations between industry, academia, and policymakers.

B. Scheme for Promotion of Research and Innovation in Pharma MedTech Sector (PRIP)

The Promotion of Research and Innovation in Pharma MedTech (PRIP) scheme worth ₹5,000 crore was launched to make the pharmaceutical and medical technology sectors of India from a cost-based one to an innovation-based one.

Under PRIP, seven Centres of Excellence (CoEs) were created at seven National Institutes of Pharmaceutical Education and Research (NIPERs) with a grant to the tune of ₹700 crore to develop their research infrastructure and to support high-quality projects. These CoEs have approved 104 research projects and filed two patents.

The balance of ₹4,250 crore was earmarked to provide funding for the industry and startups to undertake innovative research projects that would help in promoting self-reliance and place India as a global hub for pharmaceutical and medical technology innovation.

C. Scheme for Strengthening of Pharmaceuticals Industry (SPI):

With an investment level of Rs. 500 crores for the period of FY 2021-22 to FY 2025-26, the Strengthening of Pharmaceutical Industry Scheme aims to impart infrastructure with pharmaceutical industry in India, amplify production capacity, and promote knowledge and development concerning pharmaceuticals and medical devices. The Scheme has three components/sub-schemes, viz.:

Assistance to Pharmaceutical Industry for Common Facilities (APICF)

APICF provides financial support to pharma clusters for creating R&D labs, testing laboratories, effluent treatment plants, logistic centers, and training centers, with an outlay of Rs. 178.40 crore; seven projects have been sanctioned with Rs. 121.46 crore and Rs. 62.47 crore disbursed. Incentives cover up to 70% of project costs (90% for Himalayan and Northeastern states) capped at Rs. 20 crore per cluster.

2. Revamped Pharmaceutical Technology Upgradation Assistance Scheme (RPTUAS)

RPTUAS supports existing pharmaceutical units with turnover below Rs. 500 crore to meet Revised Schedule M/WHO-GMP standards, with an outlay of Rs. 300.10 crore. Incentives range from 10-20% of eligible expenditure on utilities, clean rooms, testing labs, effluent treatment, production equipment, and certification expenses, capped at Rs. 2 crore per unit; Under this, till July 1, 2025, support for upgrades to attain the said standards has been approved for 142 micro, small, and medium pharmaceutical companies, with a total sanctioned amount of ₹135.84 crore.

3. Pharmaceutical & Medical Devices Promotion and Development Scheme (PMPDS)

PMPDS promotes research, knowledge, and awareness through studies, databases, and industry-academia engagement, with an outlay of Rs. 21.50 crore; 11 studies were supported, Rs. 1.16 crore sanctioned, Rs. 0.88 crore disbursed, and five reports finalized.

D. Production Linked Incentive (PLI) scheme for Pharmaceuticals:

The Union Cabinet approved the Production Linked Incentive (PLI) Scheme for Pharmaceuticals on February 24, 2021, with a financial outlay of ₹15,000 crore. The scheme will be implemented over six years from FY 2022-23 to FY 2027-28 and aims to strengthen India as a global hub for high-value pharmaceuticals.

In total, 55 applicants have been selected to receive the incentive for domestic production of identified products under three categories: patented and off-patent drugs, complex generics, biopharmaceuticals, orphan drugs, anti-cancer drugs, and drugs used for autoimmune disorders and other critical treatments. The scheme aims at import substitution and also promotes innovation, capacity building, and diversification of product portfolios.

Key Features of the Scheme:

The scheme supports the manufacturing of pharmaceutical goods under three categories:

Category 1: Biopharmaceuticals, complex generic drugs, patented drugs or those nearing patent expiry, gene therapy drugs, orphan drugs, and complex excipients.
Category 2: Active Pharmaceutical Ingredients (APIs), Key Starting Materials (KSMs), and Drug Intermediates (DIs).
Category 3: Repurposed drugs, autoimmune drugs, anti-cancer drugs, anti-diabetic drugs, cardiovascular drugs, and in-vitro diagnostic (IVD) devices

E. Production Linked Incentive (PLI) Scheme for Promotion of Domestic Manufacturing of critical Key Starting Materials (KSMs)/ Drug Intermediates and Active Pharmaceutical Ingredients (APIs) in the Country:

The Production Linked Incentive (PLI) Scheme for promotion of domestic manufacturing of Key Starting Materials (KSMs), Drug Intermediates (DIs), and Active Pharmaceutical Ingredients (APIs) was launched on March 20, 2020, with a financial outlay of ₹6,940 crore for the period FY 2020-21 to FY 2029-30. The scheme aims to reduce India’s high import dependence by promoting domestic manufacturing of 41 identified bulk drugs.

It provides financial incentives for six years on incremental sales, with fermentation-based products receiving 20% incentive for the first four years, 15% in the fifth year, and 5% in the sixth year, while chemical synthesis products are eligible for a uniform 10% incentive over six years.

Industrial Finance Corporation of India (IFCI) Ltd. is the Project Management Agency for the scheme. Out of 249 applications received, 48 have been approved with a committed investment of ₹3,938.57 crore and projected employment generation of nearly 9,618 persons.

F. Production Linked Incentive (PLI) Scheme for Promoting Domestic Manufacturing of Medical Devices:

The Production Linked Incentive (PLI) Scheme for Medical Devices was approved by the Government of India on March 20, 2020, with an aim to promote local manufacture of advanced medical devices and reduce dependence on imports. The scheme, which will be only for greenfield projects, has a total budgetary outlay of ₹3,420 crore and is being rolled out during FY 2020-21 to FY 2027-28.

Selected manufacturers receive financial incentives at 5% of incremental sales of eligible devices for a period of five years, with caps of ₹121 crore per applicant in Category A and ₹40 crore in Category B. By September 2024, cumulative sales under the scheme reached ₹8,039.63 crore, including exports of ₹3,844.01 crore, significantly boosting India’s medical device industry and investment.

The scheme targets four segments:

Cancer care / Radiotherapy medical devices
Radiology & imaging medical devices (both ionizing & non -ionizing radiation products) and nuclear imaging devices
Anaesthetics & cardio-respiratory medical devices including catheters of cardio respiratory category & renal care medical devices
All implants including implantable electronic devices

G. Scheme for Promotion of Bulk Drug Parks:

The Promotion of Bulk Drug Parks scheme was approved by the Government of India on March 20, 2020, and notified on July 21, 2020, with a tenure from FY 2020-21 to FY 2025-26. The scheme aims to establish bulk drug parks equipped with world-class common infrastructure to reduce manufacturing costs, enhance competitiveness, and promote self-reliance in bulk drug production.

Financial assistance under the scheme is capped at ₹1,000 crore per park or 70% of the project cost, with a higher support of 90% for projects in Northeastern and hilly states. Proposals from Gujarat, Himachal Pradesh, and Andhra Pradesh have been approved so far. By providing easy access to modern infrastructure for bulk drug units within these parks, the scheme seeks to lower production costs, boost domestic manufacturing, and reduce import dependence.

H. Scheme for Promotion of Medical Device Parks:

The Scheme for Promotion of Medical Devices Parks, approved on March 20, 2020, facilitated world-class common infrastructure facilities to medical device units and strengthened India’s medical devices industry. The total financial outlay of ₹400 crore is being implemented during FY 2020-21 to FY 2024-25.

The Department had received 16 proposals of which Uttar Pradesh, Tamil Nadu, Madhya Pradesh, and Himachal Pradesh have been approved to set up medical device parks. These parks will reduce the cost of production, make it more competitive, and attract investment into the sector.

I. Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP):

The Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP), launched by the Department of Pharmaceuticals in collaboration with Central Pharma PSUs, aims to make quality generic medicines affordable and accessible to all. As of April 8, 2025, there are 15,479 Jan Aushadhi Kendras (PMBJKs) across India.

Key initiatives include the Suvidha Oxo-biodegradable Sanitary Napkins, available at Rs. 1 per pad with cumulative sales of 72 crore as of January 31, 2025, and the Jan Aushadhi SUGAM mobile app for locating Kendras, comparing prices, and checking medicines. PMBJP medicines are 50-80% cheaper than branded equivalents, procured only from WHO-GMP certified manufacturers, and tested in NABL-accredited labs. Kendras receive incentives up to Rs. 20,000/month, and one-time incentives of Rs. 2 lakh for locations in North-East, Himalayan, Island, aspirational districts, or for women, SC/ST, Ex-servicemen, and Divyang entrepreneurs.

Financial Year	Number of PMBJP Kendras Opened
Financial Year	Yearly Addition	Cumulative Kendras	Sales at MRP (Rs. Cr.)
2014-15	8	80	7.29
2021-22	1,053	8,610	893.56
2022-23	694	9,304	1,235.95
2023-24	1,957	11,261	1,470
2024-25 (As on 28.02.2025)	3,796	15,057	1,767

Table 1: Number of PMBJP Kendras Opened and Sales at MRP (Rs. Cr.)

Financial Year	Number of Medicines	Number of Surgical	Total
2020-21	1,450	204	1,654
2021-22	1,616	250	1,866
2022-23	1,759	280	2,039
2023-24	2,047	400	2,347

Table 2: Number of Medicines and Surgical Products at PMBJP Kendras

J. Scheme of Consumer Awareness, Publicity and Price Monitoring (CAPPM)

Consumer Awareness, Publicity and Price Monitoring (CAPPM) Scheme, which was launched by the National Pharmaceutical Pricing Authority (NPPA), Department of Pharmaceuticals, was approved by the Standing Finance Committee (SFC) on October 29, 2015. It has two components, National Component and State Component.

The national component covers expenditure on publicity through print and electronic media, seminars for consumer awareness, and purchase of medicine samples, while the state component focuses on establishing Price Monitoring and Resource Units (PMRUs). PMRUs, registered societies under the State Drug Controllers, include representatives from NPPA, state health departments, and civil society to strengthen outreach.

Conclusion:

The Department of Pharmaceuticals is on the cutting edge of India’s industrial and healthcare policy, closing imbalances between affordability, accessibility, and innovation. In its efforts through research promotion, self-reliance, and proper availability of quality drugs, the department not only secures the safety of public health but also positions India more strongly as a world pharmaceutical hub. Its policies continue to build a stronger and healthier nation.

References:

Ministry of Chemicals and Fertilizers, Department of Pharmaceuticals. (n.d.). About the Department. Government of India. https://pharma-dept.gov.in/about-department
Pharmaceuticals & Medical Devices Bureau of India. (n.d.). https://pharma-dept.gov.in/bureau-pharma-psus-india-0
Press Information Bureau, Government of India. (2025, July 22). Number of schemes being implemented to realise the vision of Atmanirbhar Bharat in the pharmaceutical sector and to support domestic innovation. PIB Delhi. https://www.pib.gov.in/PressReleasePage.aspx?PRID=2146918
Government of India, Ministry of Chemicals and Fertilizers, Department of Pharmaceuticals. (2024, December 6). Lok Sabha unstarred question No. 1892. https://sansad.in/getFile/loksabhaquestions/annex/183/AU1892_zKyymK.pdf?source=pqals
Press Information Bureau, Government of India. (2021, November 26). Production Linked Incentive (PLI) scheme for the pharmaceutical sector: 55 manufacturers so far to be benefitted. PIB Delhi.https://www.pib.gov.in/PressReleaseIframePage.aspx?PRID=1775321
Ministry of Chemicals and Fertilizers, Department of Pharmaceuticals. (2024). Annual report 2023–24. Government of India. https://pharma-dept.gov.in/sites/default/files/English%20version%20of%20Annual%20Report%202023-24.pdf
Press Information Bureau, Government of India. (2025, April 13). A dose of Atmanirbhar Bharat: How Make in India is transforming India’s global pharmaceutical footprint. PIB Delhi. https://www.pib.gov.in/PressReleasePage.aspx?PRID=2121425
Government of India, Ministry of Chemicals and Fertilizers, Department of Pharmaceuticals. (2024, December 10). Rajya Sabha unstarred question No. 1617. https://sansad.in/getFile/annex/266/AU1617_u1r6TL.pdf?source=pqars
Press Information Bureau, Government of India. (2025, March 6). Jan Aushadhi Diwas 2025: Affordable quality medicines for a healthier future. PIB Delhi. https://www.pib.gov.in/PressReleasePage.aspx?PRID=2108862
10. Press Information Bureau, Government of India. (2025, July 22). Number of schemes being implemented to realise the vision of Atmanirbhar Bharat in the pharmaceutical sector and to support domestic innovation. PIB Delhi. https://www.pib.gov.in/PressReleasePage.aspx?PRID=2146918

About the contributor:

Atharva Salunke is a Policy Research Associate at NITI TANTRA and a Research Intern at IMPRI. He has recently graduated with a bachelor’s degree in political science from Sir Parashurambhau College, Pune.