India’s Pharmaceutical Revolution: Make in India’s Global Impact

1. Role of Department of Pharmaceuticals:
2. • Established in 2008 under the Ministry of Chemicals and Fertilizers to focus on pricing, availability, research, and international obligations in the pharmaceutical sector.
   • Aims to make India the world’s largest provider of quality medicines at reasonable prices.
2. Key Activities:
3. • Ensures affordable drug availability under the Drug Price Control Order (DPCO) 2013.
   • Implements support and revival schemes for Central Public Sector Undertakings (CPSUs).
   • Manages M.Pharm and Ph.D. programs at National Institutes of Pharmaceutical Education and Research (NIPERs).
   • Develops human resources and infrastructure for pharmaceutical R&D and industry, including public-private partnerships (PPPs).
   • Formulates annual plans, budgets, and monitors expenditure.
3. Industry Overview:
4. • India is the world’s 3rd largest pharmaceutical industry by volume and 11th by value.
   • Total annual turnover for FY 2023-24 reached ₹4,17,345 crore, with an average growth rate of 10.08% over the past five years.
   • Globally, India supplies 20% of generic drugs and is a leading supplier of low-cost vaccines.
4. Vaccine Dominance:
5. • India has been UNICEF’s largest vaccine supplier for 6–7 years, contributing 55–60% of total volume procured.
   • Supplies 99% of WHO’s demand for DPT vaccine, 52% for BCG, and 45% for measles vaccines.
5. Export Performance:
6. • Pharmaceutical exports for FY 2023-24 valued at ₹2,19,439 crore.
   • India exports to over 200 countries, including highly regulated markets like the US, UK, and EU.
6. Medical Devices Sector:
7. • India is the 4th largest medical device market in Asia and among the top 20 globally.
   • Exports include ventilators, PPEs, diagnostic kits, surgical gloves, coronary stents, radio-imaging equipment, and body implants.
   • Key segments: electro-medical equipment, implants, consumables, disposables, surgical instruments, and in-vitro diagnostic reagents.
   • Sector is capital-intensive, with long gestation periods, requiring continuous technology upgrades and training.
7. Foreign Direct Investment (FDI):
8. • FDI inflows from April to December 2024 totaled ₹11,888 crore for pharmaceuticals and medical devices.
   • 13 brownfield FDI proposals worth ₹7,246.40 crore approved in FY 2024-25.
   • FDI Policy 2020 allows 100% FDI under automatic route for meditech and greenfield pharmaceutical projects; up to 74% for brownfield pharmaceutical projects (beyond 74% requires government approval).
   • Pharmaceutical sector is among the top 10 for foreign investment in India.
8. Production Linked Incentive (PLI) Scheme:
9. • Launched in 2020 to boost domestic manufacturing, reduce import reliance, and enhance exports under Atmanirbhar Bharat and Make in India.
   • Administers three PLI schemes: Pharmaceuticals, KSMs/DIs/APIs, and Medical Devices.
9. PLI Scheme for Pharmaceuticals:
10. • Approved on February 24, 2021, with a ₹15,000 crore outlay for FY 2022-23 to FY 2027-28.
    • Supports 55 applicants manufacturing high-value products like biopharmaceuticals, complex generics, patented drugs, gene therapy, orphan drugs, and complex excipients.
    • Covers three categories:
    • • Category 1: Biopharmaceuticals, complex generics, patented drugs, gene therapy, orphan drugs, complex excipients.
      • Category 2: APIs, KSMs, DIs.
      • Category 3: Repurposed drugs, autoimmune, anti-cancer, anti-diabetic, cardiovascular drugs, in-vitro diagnostic devices.
10. PLI Scheme for KSMs, DIs, and APIs:
11. • Launched on March 20, 2020, with a ₹6,940 crore outlay for FY 2020-21 to FY 2029-30.
    • Aims to promote domestic manufacturing of 41 critical bulk drugs to reduce import dependence.
    • Notable projects:
    • • Penicillin G (Kakinada, Andhra Pradesh): ₹1,910 crore investment, expected to save ₹2,700 crore annually in imports.
      • Clavulanic Acid (Nalagarh, Himachal Pradesh): ₹450 crore investment, expected to save ₹600 crore annually.
11. PLI Scheme for Medical Devices:
12. • Launched to support high-end medical equipment manufacturing, with a ₹3,420 crore outlay for FY 2020-21 to FY 2027-28.
    • Targets segments like radiology, imaging, cancer care, and implants.
    • Offers 5% incentive on incremental sales for five years:
    • • Category A: Up to ₹121 crore per applicant (FY 2022-23 to FY 2026-27).
      • Category B: Up to ₹40 crore per applicant (FY 2022-23 to FY 2026-27).
12. Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP):
13. • Aims to provide quality generic medicines at affordable prices to all.
    • Activities include:
    • • Raising awareness about generic medicines’ quality and affordability.
      • Encouraging healthcare professionals, especially in government hospitals, to prescribe generics.
      • Enhancing access to essential generics across therapeutic categories, focusing on underserved communities.
    • As of April 8, 2025, operates 15,479 Jan Aushadi Kendras nationwide.
13. Strengthening of Pharmaceuticals Industry (SPI) Scheme:
14. • A Central Sector Scheme with a ₹500 crore outlay for FY 2021-22 to FY 2025-26.
    • Objectives:
    • • Upgrade pharma units to meet current regulatory standards (Revised Schedule M, WHO-GMP certification).
      • Provide reimbursement-based subsidies to enable compliance.
14. Industry Characteristics:
15. • Dominates in branded generic medicines, competitive pricing, and a robust network of indigenous brands.
    • Supported by cost-effective manufacturing and a skilled workforce.
15. Global and Domestic Impact:
16. • India’s pharmaceutical and medical device sectors showcase advancements in science, innovation, and manufacturing.
    • PLI and PMBJP initiatives enhance domestic production and equitable healthcare access.
    • Positions India as a global hub for affordable, high-quality medicines and medical technologies, contributing to global health outcomes.

Key Terms:

• Department of Pharmaceuticals: Government body overseeing drug pricing, availability, and R&D since 2008.
• Make in India: Initiative to boost domestic manufacturing and global competitiveness.
• Atmanirbhar Bharat: Vision for self-reliant India, reducing import dependence.
• Production Linked Incentive (PLI): Scheme offering financial incentives to enhance manufacturing and exports.
• Generic Drugs: Affordable medicines equivalent to branded drugs, lacking patent protection.
• Jan Aushadi Kendras: Outlets under PMBJP selling quality generic medicines at low prices.
• Foreign Direct Investment (FDI): Overseas investment in Indian pharmaceutical and meditech sectors.
• Key Starting Materials (KSMs): Raw materials used to produce active pharmaceutical ingredients.
• Active Pharmaceutical Ingredients (APIs): Core components of drugs responsible for therapeutic effects.
• Strengthening of Pharmaceuticals Industry (SPI): Scheme to upgrade pharma units to global standards.