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Persisting illness

WHO’s alert on Maiden Pharma’s drugs is yet another instance of quality concerns about Indian pharma products

Persisting illness
The WHO had informed India's drugs regulator, the Drugs Controller General of India of the adverse incidents in late-September, which then initiated the probe along with state authorities.

The World Health Organization has issued an alert saying cough syrups manufactured by an Indian drug maker, Maiden Pharmaceuticals, could potentially be linked to the death of 66 children in The Gambia, a small African nation. The global health body has flagged “unacceptable amounts” of dangerous contaminants in the medicines. This is probably the latest such instance of “substandard” India-made drugs. Concerns over quality have dogged Indian drug-makers for long. Just this year, the US Food and Drugs Administration (FDA) issued a warning letter to an Indian manufacturer—Aurobindo Pharmaceuticals, in January—citing, among other concerns, adulteration of the drugs it makes. Also, there have been eight alerts issued by the American drugs regulator against drug imports from India this year, for a host of reasons including microbial contamination, failure to follow Good Manufacturing Practices, refusal to submit to an FDA inspection, etc.

Indeed, the country has faced the highest number of FDA inspections since 2009. It has been argued by Indian industry and lawmakers in the past that Western regulatory action against Indian drugs and drug-manufacturers is motivated more by a discomfort with India’s growing heft as a manufacturer of affordable drugs than by any meaningful quality issue. But, incidents like the latest one make it difficult to sustain such an argument.

Also Read: WHO warns against Indian cough syrups after 66 children died in Gambia

The government is probing the issue even as it awaits a report from the WHO that establishes a “causal relationship” between the exported drugs and the adverse incidents in The Gambia. The WHO had informed India’s drugs regulator, the Drugs Controller General of India of the adverse incidents in late-September, which then initiated the probe along with state authorities. However, the country can hardly afford a post facto approach if it is to continue nurturing its ambition to be a global drug-exports leader. Its exports (FY22) have doubled from FY14, and the government has attributed this to “price competitiveness and good quality”. The Gambia deaths, the FDA flagging quality and procedural issues at three India production sites of Biocon Biologics in July and August, and the suspension of Covaxin supply through UN procurement agencies in April this year, because of “deficiencies in good manufacturing practices” at the manufacturers facilities are only some instances that offer a reality check on the assertion.

Experts believe whether drug manufacturers make medicines for the Indian market or for export purposes, quality issues emerge from problems with India’s drug regulation regime. Among the many challenges in ensuring high-quality drugs is the fact that the federal structure allows for a drug considered substandard by one state to be marketed or exported out of another that has not caught up with the quality deficiency. Without legally-binding codes on drugs transport, from the manufacturing unit to the point-of-sale/shipping, and on safe drugs storage along the value-chain, quality issues are going to persist. The new Drugs, Medical Devices and Cosmetics Bill has missed addressing this. There is also a need to strengthen the Failure Modes and Effects Analysis-based cleaning procedures and equipment maintenance review to ensure cross-contamination is avoided. A standardised quality benchmark is also a crying need—drug makers today adhere to different quality protocols depending on the market they serve. To that end, India becoming a member of the Pharmacueticals Inspection Convention will help baseline standards, and will give a reasonable and near-universally accepted stamp of quality.

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