Government to audit pharma companies in July to review compliance with GMP norms

As part of the government's guidelines, which were announced in July 2023 and notified in December 2023, pharma companies with annual turnovers of over ₹250 crore and above were to compulsorily follow GMP within six months, while those with a turnover of less than ₹250 crore were supposed to do so over a 12-month period.

The deadline set by the government is scheduled to end this month. The government had amended the Schedule M of the Drugs and Cosmetics Rules, 1945, last year to upgrade, tighten and make GMP norms mandatory, especially for micro, small and medium enterprises (MSMEs). 

Harish Jain, president of Federation of Pharma Entrepreneurs, an industry body of MSMEs pharma companies, said, “In today’s time, nobody is 100% perfect. I believe the first phase of audit would be for bigger companies that have a turnover of more than ₹250 crore and above. Most of these companies are already WHO GMP compliant firms and such companies are very less. As far as MSME firms are concerned, I am sure they will show satisfactory compliance of the Schedule M".

The government's action came after several reports in the past year and a half had alleged that cough syrups manufactured by Indian MSMEs were behind the deaths of children in developing countries, including 66 in Gambia and 68 in Uzbekistan.

What is GMP?

Good Manufacturing Practices, or GMP, is a set of mandatory standards that aims to uphold the quality of products by way of controlling the quality of raw materials, methods, machines, processes, personnel, facility and environment, among other things, used in the manufacture of drugs and medical devices. 

GMP was first incorporated in Schedule M of the Drugs and Cosmetics Rules, 1945, in the year 1988, and the last amendment was done in June 2005. 

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In its present avatar, Schedule M prescribes the requirements of facilities, their maintenance, personnel, manufacture, control and safety testing, storage and transport of material, written procedures, written records, and the traceability of sourced material that go into the production of drugs.

With pharmaceutical manufacturing and quality standards developing significantly over the past couple of decades, the linkage between good manufacturing practice and product quality has become increasingly interdependent. 

Hence, it had become paramount to revisit and revise the principles and concept of GMP mentioned in Schedule M, to keep pace with the fast-changing needs of drug manufacturing and quality standards in the country.

A serious matter

Compliance with GMP norms was made mandatory by the government after its risk-based inspection found serious lapses by pharmaceutical companies.

The companies were found wanting in areas of quality failure investigation, internal product quality review, testing of incoming raw material, infrastructural deficiency leading to cross-contamination, an absence of professionally qualified employees, and faulty design of manufacturing and testing areas, among other aspects.

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“The Schedule M of the drugs and cometic rules has been revised and upgraded to adhere to WHO norms to ensure the quality of the drugs. The government is very serious about it and hence, the plan is to conduct the audit July onwards," said an official aware of the matter, on the condition of anonymity.

“This will be a surprise audit as none of the plants would be aware of when the audit will happen. Based on the audit report, action will be taken against the firm for non-compliance," the official added.

Outsized impact

India is the largest supplier of medicines to low- and middle-income-countries (LMIC). This requires a WHO GMP certification. 

There are around 10,500 manufacturing units in India, out of which around 8,500 fall under the MSME category. According to government figures, only around 2,000 of the 10,500 manufacturing units in the country have a GMP certification.

Hence, increased compliance with GMP standards would bring India’s drug manufacturing capability at par with global standards, especially those issued by the WHO. Moreover, the increased compliance would also ensure the production of globally acceptable quality of drugs.

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In the recent review meeting, health & family welfare and chemicals & fertilizers minister, J.P. Nadda had asked the department of pharmaceuticals to ensure that the quality of drugs produced in the country should receive renewed focus and that all the drugs and medical devices manufacturing plants operating in the country should be upgraded to world class standards over the next three years.

Queries sent to the department of pharmaceutical, which operates under the chemicals and fertilizers ministry, remained unanswered at the time of publishing this story.