Pharma PLI schemes for MSMEs: The government’s production-linked incentive (PLI) schemes to boost domestic drug manufacturing and pharmaceuticals has selected 32 MSMEs, according to the data shared by Bhagwanth Khuba, Minister of State in the Chemicals and Fertilizers Ministry in a written reply to a question in the Lok Sabha on Friday.

Under the PLI scheme for the promotion of domestic manufacturing of critical Key Starting Materials (KSMs)/Drug Intermediaries (DIs), and Active Pharmaceutical Ingredients (API), 12 MSMEs were selected for 15 projects. The scheme has a financial outlay of Rs 6,940 crores for the tenure FY21 till FY30.

Active Pharmaceutical Ingredients (APIs) are any substance or a mixture of substances that provide biological activity or other direct effects in the diagnosis, cure, treatment, or to affect the structure of any function of the body of humans and animals.

Under another PLI scheme for pharmaceuticals, which has a financial outlay of Rs 15,000 crore for the tenure FY21 to FY29, has 20 MSMEs out of 55 total beneficiary enterprises for manufacturing of eligible products falling under three product categories. The 20 MSMEs were selected under the Group-C category.

The three categories were based on products. Group 1 manufactures complex generic drugs, gene therapy or patented drugs, Group 2 manufactures APIs, DIs and KSMs and Group 3 manufactures repurposed drugs; autoimmune drugs, anti-cancer drugs, anti-diabetic drugs, cardiovascular drugs, psychotropic drugs and anti-retroviral drugs. 

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India’s pharma sector currently has 92,499 MSMEs registered on the Udyam platform as of August 1, 2023, as per data shared by Khuba.

Meanwhile, the health ministry on Wednesday had allotted a time period of 12 months for pharmaceutical manufacturing MSMEs (with an annual turnover of less than Rs 250 crores) to adopt ‘Good Manufacturing Practices,’ in order to avoid strict action, PTI reported. Similarly, the larger pharmaceutical manufacturers were provided a time period of six months.

Also read: Less than Rs 250 cr turnover pharma units must adopt Good Manufacturing Practices in 12 months: Mandaviya

The GMP was introduced in 1948 for the first time, and the last amendment to it was done in 2018. The schedule prescribes certain GMP measures required for premises and materials, related to location, surroundings, water system, disposal of waste, and warehousing, among others.

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