Updated: June 2, 2020 5:17:45 am
The Central Information Commission (CIC) has expressed “serious concern” with the Central Drugs Standard Control Organisation’s (CDSCO) inability to maintain records after the drug regulator allegedly misplaced findings of a crucial 2013 investigation into approvals of certain drugs marketed here. The report in question, a Parliamentary committee-mandated review of CDSCO’s procedures and practices to approve four drugs and their related clinical trials, reveals their approvals were “irregular”.
Drafted by a committee chaired by Banaras Hindu University Institute of Medical Sciences former director Dr TM Mohapatra, the report primarily places the onus of these irregularities on those heading the drug regulator at the time of the approvals. It also highlights specific instances where the CDSCO chiefs “overruled” other senior officials within the body who had raised certain concerns related to the approvals of these drugs or had suggested the need for further studies or data.
Yet, the report was never made public and had allegedly gone “missing” when lawyer Prashant Reddy filed an RTI application for a copy in 2018. Reddy, who works closely with public health activist and Ranbaxy whistleblower Dinesh Thakur in researching the state of India’s drug regulations, says he was made to wait two years to access the report following an appeal.
The CIC on May 26 not only advised the CDSCO to “urgently” streamline the process of digitising its records, but also instructed it to suo motu make public its reports and other associated documents “for the benefit of the public at large”.
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.
According to the Mohapatra panel, the Drug Controller Generals of India (DGCI) in charge at the time were either “solely responsible” or, with other drug regulatory officers, “primarily accountable” for irregularities in the approvals.
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 DCGI at the time, Dr Ashwini Kumar, had also overruled observations by the Joint Drugs Controller that the company had not submitted animal studies, it stated.
“The case was a total misuse of the statutory and discretory 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 panel in its report. The Indian Express has viewed the uncertified copy of the report given to Reddy in response to his RTI.
“I retired 14 years ago and am not aware of the contents of this report, so I cannot comment on its findings,” Dr Kumar told this newspaper.
“However, as per my recollection, there was widespread off-label use of letrozole in several countries for female infertility. Possibly it was an issue of such off-label use that had come to our notice. Since the law does not permit advertisement of drugs for any indication without CDSCO approval, the company was mandated to apply for formal approval for the same and refrain from promoting it for this indication otherwise,” he added.
The Mohapatra panel had observed the irregularities were a result of the combination of “several” factors, ranging from the lack of proper control over maintenance of files to a “possible” collusion or nexus between officials, experts and the industry.
“Details (related to the Mohapatra panel’s findings and Health Ministry’s response to it) are not available at the moment, as we are all very occupied with the COVID-19 situation. However, systemic reform has been carried out,” said a senior Health Ministry official on condition of anonymity, adding that “new clinical trial rules have been made in 2019 which address most issues raised by various committees in the past about trials and possibilities of errors have been reduced.”
Queries sent on Friday to current CDSCO chief Dr VG Somani about what action the body had taken on these findings remained unanswered by press time Monday.
In the case of painkiller combination aceclofenac+drotaverine, the Mohapatra committee observed that no clinical trials had been conducted and expert recommendations submitted for the approval were “evidently” prepared by the pharma company seeking the approval.
The approval of antihistamine buclizine as an appetite stimulant for children was granted despite “incomplete” data and a note by the Joint Drugs Controller that it had been withdrawn in the US for use in this indication.
Reddy alleges the document was “malafidely” withheld as it detailed “shocking lapses” by the DCGI’s office in granting drug approvals. “Many of these lapses border on criminal negligence,” he had submitted to the CIC.
Thakur, who has an ongoing case related to the approval of some of these drugs at the Delhi High Court, earlier said that the Mohapatra committee’s report was never published and alleged that the government had been avoiding disclosing the report during his litigation as well.
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