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India notifies revised Pharma manufacturing rules to ensure quality control

The Union Health Ministry of India, on 6 January, has officially notified the implementation of the revised rules under Schedule M of the Drugs and Cosmetics Rules, 1945.

• By Pooja Chaturvedi Sah
• New Delhi
• Jan 08, 2024

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The Union Health Ministry of India, on 6 January, has officially notified the implementation of the revised rules under Schedule M of the Drugs and Cosmetics Rules, 1945. The revised guidelines mandate better compliance by the pharmaceutical companies with the Good Manufacturing Practices (GMP) for pharma and biopharmaceutical products manufactured across the country. 

With the revised Schedule M, the Government has stressed on ensuring good manufacturing practices and requirements of premises, plant, and equipment for pharmaceutical products, and for the existing GMP framework of Indian pharmaceuticals to align with international expectations. 

The words ‘Good Manufacturing Practices’ (GMP) has been replaced with ‘Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products’ in the amendment. 

"The manufacturer must assume responsibility for the quality of the pharmaceutical products to ensure that they are fit for their intended use, comply with the requirements of the licence and do not place patients at risk due to inadequate safety, quality or efficacy," said the Ministry’s notification, dated 28 December, 2023.

The notification also adds that companies must market a finished product only after getting “satisfactory results” on tests of the ingredients and retain a sufficient quantity of the samples of intermediate and final products to allow repeated testing or verification of a batch.

The Ministry also stated that the pharmaceutical companies, under the revised guidelines, will now have to inform the licensing authority about recalling a drug and will have to report about product defects or faulty production. Till now there was no provision as such. 

Introduction of a pharmaceutical quality system (PQS), quality risk management (QRM), product quality review (PQR), qualification and validation of equipment, and a computerized storage system for all drug products, are some of the changes that are introduced in the revised Schedule M. 

Schedule M of the Drugs and Cosmetics Act, 1940, prescribes requirements to the pharmaceutical companies’ manufacturing plants for maintenance, manufacturing, control and safety testing, storage and transport of material, written procedures and records, and traceability.

GMP is mandatory standards for materials, methods, machines, processes, personnel, and facilities, and was first incorporated in Schedule M in 1988. The revised rules are the first amendment in the Drugs and Cosmetics Rules since June 2005.

The revised Schedule M has 13 parts providing GMP guidelines for the specific requirements for manufacturing pharmaceutical drugs. The revised rules have incorporated five new categories of drugs. 

These new categories include drugs containing harmful substances such as sex hormones, steroids (anabolic and androgenic), cytotoxic substances, biological products, radiopharmaceuticals, phytopharmaceuticals, and investigational pharmaceutical products for clinical trials for humans.

The revised rules will be implemented on the basis of company turnovers. Medium and small manufacturers with an annual turnover of less than Rs 250 crore will have to implement the revised rules within 12 months from its date of publication, whereas large manufacturers with an annual turnover of over Rs 250 crore will be given six months to do so.

Earlier in August, the Ministry had set a six-month deadline for small manufacturers and 12 months for large units to get their World Health Organization-Good Manufacturing Practices (WHO-GMP) certification.