All India Drug Action Network (Aidan) has slammed the decision of the Drugs Technical Advisory Board sub-committee on fixed dose combinations (FDCs) to extend the deadline for data submission, calling the move “a joke”.

The sub-committee was constituted in accordance with the Supreme Court order to re-examine the ban on 300-plus FDC drugs. The panel, headed by Dr Nilima Kshirsagar, the chair in clinical pharmacology at ICMR Mumbai, had asked stakeholders to submit data regarding the FDCs in question by April 7. Aidan, a consortium of non-profits in the health sector, sought more time for submissions as more than 1000 formulations related to the 344 impugned FDCs needed to be scrutinised. The sub-committee held a meeting on April 20 and extended the time limit for submissions to May 2.

“This is a joke. We made our submission by April 7 because by that time there was no extension. Then quietly, in a meeting that took place many days after the expiration of the initial deadline, they granted us an extension. Till date we haven’t received any intimation of the extension. We became aware of it through the media on April 27. So we had no significant time until the May 2 deadline. There was no meaningful extension,” an Aidan spokesperson told Pharmabiz.

“We had to write another letter telling them that we had already made our submissions. We can submit further expert evidence in person,” the spokesperson added.
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 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 also filed a petition in the top court against the Delhi high court order. The DTAB panel was constituted in accordance with the top court’s order to re-examine the issue.

The group also didn’t receive any response regarding the conflict of interest issue it has raised. Aidan 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.