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A Report on Drug Regulator CDSCO’s ‘Irregular’ Approvals Has Gone ‘Missing’

A Report on Drug Regulator CDSCO’s ‘Irregular’ Approvals Has Gone ‘Missing’

In November, the WHO recommended a triple-drug therapy to eliminate elephantiasis. Representative image. Credit: Pixabay

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New Delhi: An Indian Express report by Prabha Raghavan has trained focus on the Central Drugs Standard Control Organisation’s selectively shoddy record keeping.

Raghavan’s article noted that the Central Information Commission has expressed serious concern on the above issue, especially in the light of the fact that the drug regulator had misplaced the crucial Parliamentary committee-mandated review of the procedures involved in approving four drugs. The 2013 review report, drafted by a committee headed by Dr T.M. Mohapatra, the former director of the Banaras Hindu University Institute of Medical Sciences, found that the CDSCO’s policies were “irregular”.

The report notes that concerns within the CDSCO over approval procedures had been overruled, chiefly by those in leadership positions at the organisation at around that time. However, when lawyer Prashant Reddy filed a request under the Right to Information, to access the report in 2018, it was reported to have gone “missing”.

Public health activist Dinesh Thakur has tweeted on the process in a thread that can be found below. Thakur and Reddy had to appeal to see the report and were made to wait two years for what turned out to be an “unsigned copy” of it, without annexures.

Both have alleged that the report has been made to go missing with malafide intention.

The CIC has now asked the drug regulator to not only digitise its records fast, but also make its reports and the reports on it public.

“The Mohapatra committee’s report takes forward suspicions raised in 2012 by a Parliamentary Standing Committee over the approval processes related to aceclofenac and drotaverine, buclizine, letrozole and placenta extract, either as new drugs or for additional indications,” notes Raghavan in the Indian Express story.

Thakur, too, has cited examples of how some drugs were approved for particular usage in spite of little legal evidence that spoke for such use. He is involved in cases at the Delhi high court on the approval process to some of these drugs.

“For instance, anti-cancer drug letrozole had been approved for improving female fertility despite “no legal evidence” of such an approval in other nations. The Drug Controller General of India at the time, Dr Ashwini Kumar, had also overruled observations by the Joint Drugs Controller that the company had not submitted animal studies, it [the report] stated.”

This, held the report, was a case of total misuse of power by the DCGI and “disregard for the statutory provisions and the observations and suggestions of the immediate senior most officer of the system,” stated the Mohapatra committee’s report.

However, the DCGI, Dr Kumar, told Express that he was not aware of the contents of the report. To the newspaper, Kumar said there was “widespread off-label use of letrozole in several countries for female infertility” and sought to highlight that the company that sold the drug was told it could not promote the drug without formal approval.

The panel also observed several other irregularities. There was not only “lack of proper control over maintenance of files” but also a “possible” nexus between CDSCO officials, experts in the field and the industry.

Indian Express‘s questions to CDSCO chief Dr V.G. Somani had gone unanswered.

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