Last Updated on December 31, 2023 by The Health Master
Pharma PLI schemes
The government’s production-linked incentive (PLI) schemes aimed at promoting domestic drug manufacturing and pharmaceuticals have made progress, with 32 Micro, Small, and Medium Enterprises (MSMEs) being selected for participation.
The selection data was shared by Bhagwanth Khuba, Minister of State in the Chemicals and Fertilizers Ministry, in a written reply to a question in the Lok Sabha.
1. PLI Scheme for Key Starting Materials (KSMs) and APIs
Under the PLI scheme for the promotion of domestic manufacturing of critical KSMs, Intermediaries (DIs) and Active Pharmaceutical Ingredients (APIs), 12 MSMEs have been chosen for 15 projects.
The scheme has a financial outlay of Rs 6,940 crore and spans from FY21 to FY30.
Active Pharmaceutical Ingredients (APIs) are substances or mixtures that provide biological activity or direct effects in the diagnosis, cure, treatment, or affecting the structure of the body of humans and animals.
2. PLI Scheme for Pharmaceuticals
Another PLI scheme, specifically for pharmaceuticals, has been allocated a financial outlay of Rs 15,000 crore for the period from FY21 to FY29.
Out of the total 55 beneficiary enterprises, 20 MSMEs have been selected to manufacture eligible products falling under three product categories.
The 20 MSMEs are categorized under Group-C, which comprises the following product types:
- Group 1: Manufacturers of complex generic drugs, gene therapy, or patented drugs.
- Group 2: Manufacturers of APIs, DIs, and KSMs.
- Group 3: Manufacturers of repurposed drugs, including autoimmune drugs, anti-cancer drugs, anti-diabetic drugs, cardiovascular drugs, psychotropic drugs, and anti-retroviral drugs.
3. MSME Presence in India’s Pharma Sector
As of August 1, 2023, India’s pharmaceutical sector had a total of 92,499 registered MSMEs on the Udyam platform.
The PLI schemes aim to support and bolster the presence of these MSMEs in the pharmaceutical industry, encouraging domestic manufacturing and reducing dependence on imports.
4. Adoption of ‘Good Manufacturing Practices’ (GMP)
To maintain quality standards and enhance the pharmaceutical manufacturing sector, the health ministry has set a deadline for MSMEs (with an annual turnover of less than Rs 250 crore) to adopt ‘Good Manufacturing Practices‘ (GMP).
A 12-month timeframe has been provided for smaller manufacturers, while larger pharmaceutical companies have been given six months to comply with GMP guidelines.
GMP was first introduced in 1948 and last amended in 2018.
The guidelines prescribe specific measures for premises and materials, covering aspects such as location, surroundings, water system, waste disposal, and warehousing.
Conclusion
The PLI schemes introduced by the government have taken a significant step toward boosting domestic drug manufacturing and pharmaceuticals.
By selecting 32 MSMEs to participate in the schemes, the government aims to reduce reliance on imports and enhance the country’s self-sufficiency in the pharmaceutical sector.
Additionally, the adoption of Good Manufacturing Practices will further improve the quality and standards of pharmaceutical manufacturing in India.
The combined efforts of the government and the pharmaceutical industry are expected to drive growth and innovation in this critical sector, benefiting both the domestic market and global pharmaceutical supply.
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