A sub-committee of the Drugs Technical Advisory Board (DTAB), constituted in accordance with the Supreme Court order to re-examine the ban on 300-plus fixed dose combination (FDC) drugs, has set May 2 as the new deadline for petitioners and appellants to submit relevant data to substantiate their claims.
The health ministry banned these FDCs -- drugs containing two or more active pharmaceutical ingredients in a fixed dosage ratio -- after an expert committee headed by Prof C K 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. The DTAB panel was constituted in accordance with the top court’s order to re-examine the issue. All India Drug Action Network (Aidan), a consortium of non-profits in the health sector, had also filed a petition in the top court against the Delhi high court order.
The panel, headed by Dr Nilima Kshirsagar, the chair in clinical pharmacology at ICMR Mumbai, had directed stakeholders to submit information regarding the FDCs in question by April 7. Aidan approached the DTAB to extend the deadline for submissions by another month stating that more than 1,000 formulations related to the 344 impugned FDCs needed to be scrutinised.
According to sources, the sub-committee found merit in the demand and decided to extend the time limit for submissions at a meeting held on April 20. However, Aidan’s second demand, reconstitution of the sub-committee over the presence of ‘non-expert’ members, is rejected by the government.
The group, in a letter written on March 15 to DTAB Chairman Dr BD Athani, had sought the removal of ‘non-expert’ industry body representatives and professional association members from the sub-committee citing credibility issues and conflict of interest. Besides Dr Kshirsagar, the sub-committee includes 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.
With the DTAB panel’s decision to extend time limit, the non-profit gets more time to provide FDC composition details and the group’s opinion on the therapeutic justification for each ingredient. They are also expected to state whether the FDC drug needs to be regulated or prohibited. It will be an uphill task for the group as the arguments and opinions should be based on scientific evidence and backed by expert articles published on the subject.
The drug makers or appellants are asked to furnish particulars of the FDC, its therapeutic value such as increased efficacy or reduced cost, pharmacokinetic rationality with half-life details of individual ingredients and published data on its safety and efficacy. The regulatory status of the drug in other countries also should be submitted.