Exorcising the ghost of corruption from the corridors of the drug regulator

An old ghost came alive in pharmaceutical industry circles last week, as news trickled out on the arrest of a top drug regulatory official, a highly-placed drug company official and others, on allegations of corruption.

According to the Central Bureau of Investigation, it had arrested a Joint Drugs Controller of the Central Drugs Standard Control Organisation (CDSCO) for accepting a bribe of ₹4 lakh from Biocon Biologics. This was to waive Phase III trials on its Insulin Aspart Injection, an allegation the company denies.

As the case is investigated, industry-watchers question whether the more things change, it infact remains the same.

Exactly a decade ago, the functioning of the CDSCO was reviewed by a Parliamentary Standing Committee on Health and Family Welfare. And their report did not mince words. “There is sufficient evidence on record to conclude that there is collusive nexus between drug manufacturers, some functionaries of CDSCO and some medical experts” — the Fifty-ninth house panel report (2012), noted on one instance.

Pharma industry veterans admit the regulatory framework has changed in 10 years to include digital systems and subject experts, for example, to reduce the “discretionary” element that puts much power in the hands of a few regulatory officials. But it’s clear, there are still loopholes that need to be plugged, said a seasoned hand from the industry, who did not want to be named.

Coming at a time when India’s drugs and vaccines are in the limelight, against the backdrop of Covid-19, industry representatives called for a swift clean-up of the bribery case, to prevent it from hurting the image of India and its medical products. There is concern that the incident could take down more people and companies as the truth unravels. And, the controversial waiver on the insulin product could cast a shadow on approvals given to other products too, an industry-hand said.

The decade-old house panel report had sought to prevent such arbitrariness. “The Committee, therefore, strongly recommends that there should be non-discretionary, well laid down, written guidelines on the selection process of outside experts with emphasis on expertise including published research, in the specific therapeutic area or drug or class of drugs. Currently, the experts are arbitrarily chosen mainly based on their hierarchical position which does not necessarily correspond to the area or level of expertise. All experts must be made to file the Conflict of Interest declaration outlining all past and present pecuniary relationships with entities that may benefit from the recommendations given by such experts. The consulted experts should be requested to give hard evidence in support of their recommendations,” the report had said.

Revisit 59th house panel report

S Srinivasan of LOCOST (a producer of less expensive drugs) and representative of Aidan (All India Drug Action Network) says, it was time to revisit the 59th house panel report and fully implement its recommendations.

The regulatory system needs to be more transparent in explaining why it approves drugs or clinical trials or waives study requirements required by a product, says Srinivasan. While the final regulatory outcome on a product (after being reviewed by the Subject Expert Committee) is published online – there is no information on the members clearing the product; no details on the scientific discussion, what were the observations of the experts and the logic behind giving an emergency approval or waiver, he says, adding that the Parliamentary report had called for publication of such detail.

Contrast this with the approval process for Covid-19 products in the United States. Anyone could log-in and follow the presentations and discussion at the US Food and Drug Administration.

The Indian regulatory system needs to mention if members have a conflict of interest; and the discretionary element needs to be reduced through checks, including clarity on the rationale behind taking a particular decision, says Srinivasan.

Presently, the industry and regulator seek to project a “patient-centric” outlook, says a pharma industry veteran. But this approach could lose credibility, if the Centre does not ensure that rules to weed out corruption are implemented. And, a mechanism put in place to help people red-flag unethical practices.

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