“Under a central scheme, which is called Pharmaceutical Technology Upgradation Assistance Scheme, MSMEs can seek financial assistance from the government,” said Arunish Chawla, secretary, Department of Pharmaceuticals. “This will open a new window for MSMEs who have an opportunity to get some assistance and be able to get the quality certifications that are now mandatory.”
The health and family welfare ministry has made good manufacturing practices mandatory for pharma companies. A recent notification by the ministry covered 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, risk management and a quality system.
In July last year, health minister Mansukh Mandaviya said that Schedule M should be made compulsory for the MSMEs in the pharma industry in a phased manner. The health ministry said drug manufacturers with an annual turnover of over ₹250 crore must comply with the standards within six months starting from August 1, 2023. Smaller companies will get one year, he had said.
