A recent notification by the health ministry covers the revised Schedule M rules for good manufacturing practices and requirements of premises, plant and equipment for pharmaceutical products, with provisions for an annual product quality review as well as quality risk management and a pharmaceutical quality system.
In July last year, health minister Mansukh Mandaviya had said that Schedule M should be made compulsory for the micro, small and medium enterprises (MSMEs) in the pharma industry in a phased manner. The health ministry said drug manufacturers with annual turnover of more than ₹250 crore must comply with the standards within six months starting from August 1, 2023. Smaller companies will get one year to meet the requirements, he had said.
However, the implementation of revised Schedule M for the small and medium sectors would be challenging, said Sanjay Singla, a representative of Laghu Udyog Bharti (LUB), an association of small businesses which is an affiliate of the Rashtriya Swayamsevak Sangh (RSS). He said they are all for quality but the upgrade will come at a cost.
“In the process many units will see closures, resulting in drug prices going up and shortages,” Singla said.
He said the time frame is too short for small and medium enterprises. “The implementation of the new norms would be challenging for smaller firms, which may lead to a rise in near term capex and a permanent increase in operating costs,” he said.According to Punjab Drug Manufacturers’ Association (PDMA), the manufacturing of National List of Essential Medicines (NLEM) drugs, which are under price control, will become unviable as the cost of producing them will exceed the ceiling price due to the new norms.
