India's Pharma Sector Struggles to Meet New Manufacturing Standards

India's pharmaceutical industry has sought at least two more years to implement the revised pharma manufacturing rules under Schedule M, saying it is necessary to ensure survival of micro, small and medium enterprises (MSMEs).

Schedule M of the Drugs and Cosmetics Rules, 1945 prescribes the good manufacturing practices (GMP) for pharmaceutical products, such as a prompt product recall system for products known or suspected to be defective. Pharma lobby groups have written to the health minister, seeking an extension of the December 2024 deadline to December 2026, citing lack of resources and challenges faced by the industry in implementing the revised norms.

The health ministry had in January this year notified the revised Schedule M.

Laghu Udyog Bharati (LUB), an affiliate of RSS, and Federation of Pharma Entrepreneurs (FOPE), which represents MSME pharma units, have written to health minister J P Nadda, asking him to defer the implementation of Schedule M.

"Its implementation effective December 2024 would be too soon for MSME pharma units," Laghu Udyog Bharati said in its letter to Nadda. It said these units need more time particularly when the production is running. "Therefore, one year's time period is not enough for such an upgrade," the letter said.

Laghu Udyog Bharati representatives will also meet the minister soon to convey its concerns over the revised norms.

Rajesh Gupta, all India head-pharma at Laghu Udyog Bharati and state president of Himachal Drug Manufacturers Association, said MSME pharma industry owners are under pressure to invest Rs 4 to Rs 10 crore to upgrade their existing units following Schedule M provisions.

"We are with the government and have started awareness seminars. However, we need time up to December 2026 for infrastructure upgradation," he said. Meanwhile, FOPE said equipment procurement and installation needs a longer lead time.