Over the past three years, 1683 drugs failed quality tests, the health minister of Himachal Pradesh said in a reply to two members of the state legislative assembly in February.

Experts say the disclosure highlights the need for a more effective drug recall mechanism across the country. Ideally, they add, the government should have followed up with a nationwide recall of each of the 1683 drugs that failed the quality tests.

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In 2017, India’s drugs regulator came up with guidelines on recalls. Last year, the Union health ministry notified changes in the Drugs and Cosmetics Rules, 1945, that required pharmaceutical companies to mandatorily follow good manufacturing practices (GMP) . However, there is no drug recall law in the country, and drug recalls largely remain voluntary.

According to the national drugs regulator—Central Drugs Standard Control Organization (CDSCO)— a recall is an action taken to withdraw or remove the drugs from distribution or use including corrective action for which deficiencies are reported in quality, efficacy or safety.

Dinesh S Thakur, pharma expert and co-author of The Truth Pill: The Myth of Drug Regulation in India, recently wrote an elaborate thread on micro-blogging platform X (formerly twitter), that focused on the recall mechanism for drugs that fail quality test.

“…From a public health perspective, each of these quality failures should have been accompanied by a nation wide recall of the batch in question – the recall should have been publicly announced so that nobody else consumed the substandard medicine… how many of you remember hearing about 1683 recall notices over the last 3 years. This is the @MoHFW_INDIA’s fault – a recall system has been on their agenda for the last 46 years – we are yet to see one put in place,” he wrote in the thread.

In their book, Thakur and co-author, Prashant Reddy, talk about fixing accountability for complex inter-state recalls, need for better sharing of information about NSQ (not of standard quality) drugs, or follow-up with patients. Also, how India still lacks a robust law on recalling NSQ drugs.

“This, despite thousands of NSQ drugs being detected every year by government laboratories across India… of what use is this costly exercise of market surveillance which involves funding laboratories and drug inspectors in every state, if it does not result in rapid recalls of NSQ drugs from across the market,” they wrote in the book.

The Himachal Pradesh drugs regulator did not respond to HT’s queries on action taken by the department; the state is a major pharma manufacturing hub.

Any batch of a product not meeting the defined quality standards has to be recalled from the market.

As part of government’s recall and rapid alert system, defective products related to quality include not of standard quality (NSQ), adulterated or spurious drugs. Drugs are recalled from distribution or use, including for the purposes of corrective action, after quality, efficacy, or safety deficiencies are reported. Safety and efficacy-related recalls involve adverse reactions and death due to drug consumption. Recalls also include medications prohibited under the Drugs and Cosmetics Act and those products for which product licenses are suspended or cancelled.

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“Statutory recall wherein the drugs regulator identifies the faulty product after testing, and the concerned licensing authority may order a recall based on the testing results, is always more effective because the regulatory authorities can destroy the seized batches after the court proceedings are over. In case of a voluntary recall, the product stays with the manufacturer and there is always a possibility that the recalled drugs later will find its way back into the market,” said Subhash Mandal, chairman, regulatory affairs, Indian Pharmaceutical Association (IPA).