DTAB Panel Recommends Ban on 343 FDCs, Six to be Regulated

A sub-committee of the Drugs Technical Advisory Board (DTAB) reviewing the ban on 349 fixed dose combination (FDC) drugs recommended that 343 of them should be “prohibited” and the remaining six should be “restricted or regulated”.
The health ministry banned these FDCs — drugs containing two or more active pharmaceutical ingredients in a fixed dosage ratio — after a 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. The DTAB panel was constituted in accordance with the top court’s order to re-examine the issue. 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.
According to sources, the expert sub-committee has clearly stated in its report that three FDCs should be restricted for specific indications or diseases and the other three should be restricted to specific quantities of ingredients and for specific indications.
The fate of these combination drugs will now be decided by the government. The report would be sent to the ministry in the coming days. The DTAB panel was headed by Dr Nilima Kshirsagar, the chair in clinical pharmacology at ICMR Mumbai.