Ministry issues revised rules to ensure quality in pharma sector Premium

The Ministry of Health and Family Welfare late last week notified revised rules under Schedule M of the Drugs and Cosmetics Rules, 1945. The revision aims to ensure that the pharma sector recommits to the manufacture of safe, effective, and high-quality drugs in compliance with international quality standards, thus benefiting both patients and industry.

The Ministry of Health and Family Welfare late last week notified revised rules under Schedule M of the Drugs and Cosmetics Rules, 1945. The revision aims to ensure that the pharma sector recommits to the manufacture of safe, effective, and high-quality drugs in compliance with international quality standards, thus benefiting both patients and industry. This is a response to the backlash India has been receiving over reports of sub-standard medicine being exported from India.

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Last year, the country felt intense global scrutiny after the World Health Organization (WHO) issued an alert about cough syrups being contaminated with diethylene glycol and ethylene glycol. These are considered 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. QP Pharmachem Ltd’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.

The latest revision includes five new categories of drugs — pharmaceutical products containing hazardous substances such as sex hormones, steroids (anabolic and androgenic), cytotoxic substances, biological products and radiopharmaceuticals. It also has additional sections including — 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.

According to the new notification, the manufacturer must assume responsibility for the quality of pharmaceutical products to ensure that they are fit for use, comply with the requirements of the license, and do not place patients at risk due to inadequate safety, quality or efficacy.

Additionally, companies must market a finished product only after getting “satisfactory results” from tests of the ingredients and retain enough of the samples of intermediate and final products to allow repeated testing or verification of a batch.

Explaining the rationale, a senior Health Ministry official said the pharmaceutical manufacturing and quality domain has evolved significantly in last 15-20 years.