The highest drug regulatory body includes sterile equipment manufacturers in the scope of Good Manufacturing Practices

The Central Drugs Standard Control Organisation (CDSCO) has directed sterile kit manufacturers to comply with Schedule M of the Drugs and Cosmetics Regulations, which mandates companies to follow Good Manufacturing Practices (GMP) on par with World Health Organisation (WHO) standards.

Until now, GMP was mandatory only for drug manufacturers, but compliance is considered equally important for sterile product and vaccine manufacturers. This development assumes significance given the growing size of the Indian sterile equipment market.

“The revised GMP notification that was published last December applies generally to all types of pharmaceutical products. It prescribes general requirements that all pharmaceutical companies must comply with. The notification “The requirements for each type of product are clearly specified, such as sterile products, biological products, ophthalmic solutions and other injectables, etc.,” said an official.

“In addition to the general requirements, WHO periodically publishes its guidelines for various products. Companies have been asked to conduct a self-assessment, take necessary measures to address deficiencies and strengthen compliance with GMPs as per WHO standards,” said the official mentioned above.

These products include surgical equipment, forceps, biopsy equipment, ocular equipment including soft contact lenses, ocular solutions, arthroscopes, laparoscopes, and injectables that enter directly into the patient’s bloodstream.

What is GMP?

Good Manufacturing Practices, or GMP, as required by the WHO, prescribe essential standards for improving product quality through control measures related to materials, methods, machinery, processes, personnel, facilities and the environment.

The government, in December last year, amended or revised Schedule M of the Drugs and Cosmetics Rules, 1945 to update, tighten and make GMP norms mandatory, especially for micro, small and medium enterprises (MSMEs).

As part of the government guidelines, which were announced in July 2023 and notified in December 2023, pharmaceutical companies with an annual turnover of more than ₹250 crore were required to mandatorily comply with GMP within six months, while those with a turnover of less than ₹Rs 250 crore was supposed to be invested within a period of 12 months.

Compliance with GMP norms was made stricter to ensure quality standards of drugs being manufactured in India after the central government’s risk-based inspection of pharmaceutical companies found serious lapses at the manufacturing site such as poor infrastructure, poor documentation, under-qualified employees, lack of testing of raw materials, etc.

This happened against a backdrop where Indian cough syrups were killing children in Gambia and Uzbekistan.

DCGI Guidelines

“This is in regard to the review of Annex M and WHO good manufacturing practices for sterile pharmaceutical products, which are published by WHO from time to time. In this regard, all manufacturers are requested to take necessary measures to comply with the various requirements as per the guidelines after due gap analysis,” the DCGI said in an August 7 communication to all vaccine and sterile product manufacturers, seen by Mint.

Aniket Dani, Research Director, CRISILE Market Intelligence & Analytics stated, “As per the latest available data, the domestic vaccines market size stood at around Rs 1,700 crore for FY24. This segment contributed approximately 1% of the total domestic formulations market.”

Rajiv Nath, forum coordinator of AiMeD (Association of Indian Medical Device Industry), said the sterile medical devices market may exceed $4-5 billion.

Government in action

Meanwhile, the government is continuously conducting risk-based assessments of these pharmaceutical companies.

Health Minister JP Nadda recently told Parliament that over the past year the government had conducted risk-based inspections of 400 pharmaceutical companies to check whether they were following GMP norms.

As part of the inspection, more than 300 cause notices, production stop orders, suspensions and license cancellations have been issued.

Questions sent to the spokesperson of the Ministry of Health remained unanswered by the time this edition went to press.