Fresh drug MSME guidelines on cards as govt finds lapses

August 2, 2023,

New Delhi: The Centre is all set to revise its good practice guidelines for medium, small, and micro enterprises (MSMEs) engaged in making drugs after an inspection of scores of manufacturing sites and labs revealed glaring lapses.

Government officials who inspected 162 units and 14 public testing labs found them riddled with poor documentation, lack of process and analytical validation, infrastructural deficiencies, unqualified employees, and faulty design of manufacturing and testing areas.

The matter of regulating quality is of considerable importance to India, which is the world’s largest exporter of generic drugs and was able to showcase its vaccine manufacturing capacities during the covid-19 epidemic.

At the same time, the government has been tightening its regulations for pharma companies, especially MSMEs, in recent months after some Indian cough syrups made by MSMEs were linked to children’s deaths in several developing countries, including 66 in Gambia.

Authorities recently shut down 31 pharma firms in Himachal Pradesh after finding poor manufacturing practices.

Now, the government is set to re-evaluate what is known as the ‘Schedule M’, which regulates the good manufacturing practices (GMP) and quality management systems followed by pharmaceutical manufacturers.

“Pharma companies having annual turnover of over ₹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.

“To keep pace with fast-changing manufacturing and quality practices, there is a need to revisit and revise the principles and concept of GMP mentioned in current Schedule M. This would bring our GMP recommendations and compliance expectation at par with global standards, specially those of the WHO, and ensure production of globally acceptable quality of drug,” said a second official.

BHARAT TIMES