Fresh drug MSME guidelines on cards as govt finds lapses

livemint.com:

₹250 crore will have to mandatorily adopt good manufacturing practices certification within six months, while those with turnover of less than ₹250 crore will have to do so in 12 months time period," health minister Mansukh Mandaviya said on Wednesday during a press briefing. Firms that fail to do so will be punished as per the provisions of the law, Mandaviya said. Schedule M (of the Drugs and Cosmetics Act) has not been implemented properly by a lot of drugmakers, he added.

There are around 10,500 pharma manufacturing units in the country out of which around 8,500 are MSMEs. India is also a major exporter of medicines to low and middle income countries which require World Health Organization GMP certification. “We have around 2,000 units in the MSME category in the country having WHO GMP certification.

Our observations from ongoing Risk Based Inspections further reiterated the need to have a relook at the current GMP regulations and Quality Management Systems being followed by pharmaceutical manufacturers. We have inspected 162 units and 14 public testing labs till now," said an official aware of the matter. “Major issues found during inspections are poor documentation, lack of process and analytical validation, absence of self-assessment, absence of quality failure investigation, absence of internal product quality review, absence of testing of incoming raw material, infrastructural deficiency to avoid cross-contamination, absence of professionally qualified employees, faulty design of manufacturing and testing areas etc," said the official.