12 March 2024
The Indian pharmaceutical industry, which is one of the world's largest exporters of generic drugs, has been criticised for producing medicines that do not always meet quality standards. Now the Ministry of Health has published revised regulations in accordance with Annex M of the Drugs and Cosmetics Rules.
The revised rules, which were published on January 6, 2024, aim to bring India's GMP recommendations at par with global standards, especially those of the World Health Organization (WHO), and ensure production of high quality, globally acceptable drugs. The revision was also necessitated by the fast-changing manufacturing and quality domain, and the need to keep pace with the latest technological advancements.
With the amendment, the term 'Good Manufacturing Practices' (GMP) has been replaced with 'Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products'.
The changes introduced in the revised Schedule M include the introduction of a pharmaceutical quality system (PQS), quality risk management (QRM), product quality review (PQR), qualification and validation of equipment, and a computerised storage system for all drug products. The revised rules also have five new categories of drugs, such as pharmaceutical products containing hazardous substances, biological products, and radiopharmaceuticals.
According to the article in The Hindu, the manufacturer must assume responsibility for the quality of 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. The manufacturer must also market a finished product only after getting satisfactory results from tests of the ingredients and retain enough samples of intermediate and final products to allow repeated testing or verification of a batch.
The revision comes in the wake of several incidents of contamination and substandard drugs being exported from India. Last year, the WHO issued an alert about cough syrups being contaminated with diethylene glycol and ethylene glycol, which are toxic to humans and can prove fatal. The contamination was allegedly found in samples taken from a batch of cough syrup made by QP Pharmachem Ltd, based in Punjab. The company's manufacturing licence was suspended after cough syrup linked to child deaths in Gambia and Uzbekistan were found to be contaminated. Other cases of alleged contamination have also been reported from cough syrups made in India.