As a sub-committee of the Drugs Technical Advisory Board (DTAB) gets ready to examine the ban on 300-plus fixed dose combination (FDC) drugs, All India Drug Action Network (Aidan), a petitioner in the case, has come out against the presence of ‘non-expert’ members in the panel and the tight deadline set by the government to make submissions.

In a letter written on March 15 to DTAB chairman Dr BD Athani, which has been reviewed by Pharmabiz, Aidan sought the removal of ‘non-expert’ industry body representatives and professional association members from the sub-committee citing credibility issues and conflict of interest. The group, a network of NGOs in the health sector, called for the reconstitution of the panel to increase its reliability.

The non-profit organisation also wanted the technical advisory board to extend the deadline for submissions by another month as more than 1,000 formulations related to the 344 impugned FDCs need to be scrutinised.

The health ministry last year had banned these FDCs -- drugs containing two or more active ingredients -- after an expert committee headed by Prof CK Kokate declared them unsafe. Drug makers challenged the ban in high courts across the country. In January this year, the ministry moved the apex court challenging a Delhi high court order that quashed the ban. Aidan had also filed a petition in the top court against the Delhi High Court order.

The DTAB panel, constituted in accordance with the Supreme Court order to re-examine the issue, is headed by Dr Nilima Kshirsagar, the chair in clinical pharmacology at ICMR Mumbai. President of Indian Pharmaceutical Association Telangana Dr Rao VSV Vadlamudi, Maharashtra FDA Joint Commissioner OS Sadhwani, one representative each from Indian Medical Association’s New Delhi and Mumbai chapters and a clinical pharmacologist are the other members. DDC (I) CDSCO (HQ) Sanjeev Kumar Gupta is the convener. The committee, which was given three months to finalise the report, last week directed Aidan and other industry stakeholders to make their submissions regarding the FDCs in question before April 7.

In its letter, Aidan objected to the inclusion of industry representatives in the expert panel. “It is clear from this (Supreme Court) judgment that the task assigned to the DTAB or the sub-committee appointed by it is of the nature of an expert review of the report of the Kokate Committee in order that an analysis of these be made in greater depth. Therefore it has to be an expert review committee, the members of which have to be selected on the basis of their expertise in medicine, pharmacology, rational therapeutics and regulation of health care,” Dr Mira Shiva, co-convener of Aidan, wrote in the letter.  

While welcoming the appointment of Dr Kshirsagar as its chairperson, the NGO expressed its disagreement with the appointment of industry association members to the panel. “Representatives of the Indian Pharmaceutical Association (IPA) are representatives of a professional association and not any expert body. Similarly, representatives of the Indian Medical Association (IMA) represent an association of medical professionals and not any expert body. The appointments of these three members, on the basis of their membership in professional associations, do not meet the criteria of expertise and objectivity required for deciding on the findings of another expert body -- the Kokate Committee,” the letter stated.

“Many members of the IPA are affiliated with the pharma industry. There are thus clear, organic conflicts of interest. Further, the IMA is a body particularly known for its conflict of interest with respect to commercial endorsements and vis-a-vis the pharma industry. The sub-committee report headed by Dr Kshirsagar will therefore lack credibility in a matter of grave public health interest if it includes such members,” Dr Shiva added. Aidan also wants the members of the re-constituted committee to declare their conflicts of interest to boost transparency.