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The heart-breaking loss of 66 children’s lives in Gambia due to adulterated cough syrup manufactured by a Haryana-based pharmaceutical company has triggered a much-needed debate on India’s drug regulators. But, will anything change?

History is littered with examples of drug regulatory laws being rewritten after, rather than before, tragedies. Take the US, which saw several tragedies in the first half of the 20th century. Its Biologics Control Act, 1902, was enacted immediately after contaminated anti-sera and vaccines killed Americans. The Federal Food, Drugs & Cosmetics Act, 1938, was enacted after the first mass DEG poisoning event that killed more than 100 Americans. The code of Good Manufacturing Practices (GMP) was brought in by the Food & Drug Administration (FDA) after a manufacturing error at a pharma facility in 1941 led to the sale of contaminated drugs, killing more than 300 Americans. Europe, which was slow to learn from these lessons, faced the brunt of the thalidomide tragedy in 1961, which led to the birth of thousands of deformed babies. The drug was never sold in the US because of Francis Oldham Kelsey, an FDA official who blocked its approval due to lack of adequate safety data. Sometimes, all it takes is one bureaucrat with a sense of duty to prevent a tragedy.

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In what may come as a pleasant surprise to many, in India the Parliamentary Standing Committee on Health and Family Welfare rang the alarm bells on India’s drug regulators long before the tragedy in Gambia or the one in Jammu that killed 12 children a few years ago. In its 59th report tabled in 2012, reviewing the working of India’s national regulator—the Central Drug Standard Control Organisation (CDSCO)—the parliamentary panel excoriated the regulator and Drug Controller General of India (DCGI) who heads it. Its every conclusion was backed by an almost forensic examination of official records. That report all but predicted tragedies such as those in Jammu and Gambia.

Yet, the government has taken only baby steps to fix problems. A book titled Healing the Pharmacy of the World by K.L. Sharma, a bureaucrat who was joint secretary in the ministry of health responsible for drug regulation and found himself transferred to the National Commission of Women after he began pushing reform, is essential reading to understand the rot in our regulatory system.

There have been several cases of bureaucrats who were trying to do the right thing being stymied by the judiciary and invisible forces in the ministry of health. For example, a drug approval flagged in the 59th report was a fixed-dose combination (FDC) of flupentixol and melitracen, used to treat depression. As noted by the parliamentary committee, this FDC is not approved in most developed countries, the approval file was missing from the DCGI’s office when the committee asked for it, and reputed psychiatrists whom it spoke to said they did not prescribe this FDC due to lack of convincing clinical evidence. Yet it is sold in India.

The health ministry, acting on recommendations of expert committees, prohibited the drug on two separate occasions—in 2013 and in 2014—only for the Karnataka high court to set aside the prohibition with directions to the ministry to reconsider its action. In both cases, the law had been misapplied, but the ministry did not file an appeal. In 2019, when an expert committee asked the manufacturers of this FDC to submit Phase 3 trial data (the most important clinical evidence) so that it could decide on its therapeutic significance, the manufacturer again moved the Karnataka high court and got a temporary stay on the grounds that some earlier committee had asked for only Phase 4 data for this drug.

Phase 3 trials are typically double-blind randomized clinical studies and are considered the gold standard for generating high quality clinical evidence. Phase 4 data is mostly observational, and is not useful in making reasoned clinical decisions, and the expert committee was correct in asking for Phase 3 data. This time, one of us intervened by filing a legal brief in support of the expert committee’s action, pointing out how Phase 4 data meant nothing without Phase 3 data. This was shortly before covid. Despite the matter pending in court, the DCGI short-circuited the recommendations of its own expert committee by going with the manufacturer’s demand to conduct only Phase 4 trials. Thereafter, the manufacturer withdrew its lawsuit against the government.

This chaotic approach to drug regulation has continued despite the parliamentary standing committee having noted that, “...[it] has come to the conclusion that when it comes to approving new drugs, too much is left to the absolute discretion of the CDSCO officials. There are no well laid down guidelines for determining whether consultation with experts is required."

We highlight the above example to indicate just how complicated and messy the Indian drug regulatory system has become. If we want to prevent tragic deaths and unsafe drugs in India, let us listen to the sage advice of the Parliamentary Standing Committee on Health. Its 59th report is worth its weight in gold, yet much of it is unimplemented by the ministry of health for more than a decade now. Let us heed the wise words of our parliamentarians who authored that report, instead of waiting for more innocent kids to fall victim.

Dinesh S. Thakur & Prashant Reddy T. are co-authors of ‘The Truth Pill—The Myth of Drug Regulation in India’ .

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