The DTAB (Drugs Technical Advisory Board) sub-committee's crucial meeting to decide on the DCGI's proposal to ban some of the irrational fixed dose combination (FDC) drugs will be held in the second week of February. DTAB, the highest body under the union health ministry on technical matters concerning the pharma industry, has already given the go-ahead signal to the DCGI's proposal to ban a majority of the 294 contentious FDC drugs.
"The matter is now pending with the Minister and once he clears the file, it will be put up with the DTAB sub-committee for the final nod. The meeting will be held in the second week of February", DCGI Dr M Venkateshwarlu said. As per the existing provisions, DTAB sub-committee's approval is necessary under section 26-A of the Drugs and Cosmetics Act to ban the drugs.
The DTAB sub-committee is a body of experts in the field of pharmacology under the union health ministry. There are nine members in the committee.
Earlier, the DTAB had green signal to the proposal of the DCGI in this regard on January 16. The Board referred the matter to its technical sub-committee to identify the drugs which should be banned. Now, the file is pending with the union health minister Dr Anbumani Ramadoss. Once the proposal gets the minister's nod, it will go to the sub-committee for its final approval, most probably in the second week of February.
Under this proposal, the DCGI wanted to ban all the contentious 294 FDC drugs falling under the categories of absurd, banned and rejected under section 26-A of the Drugs & Cosmetic Act. DTAB sub-committee's seal is necessary to ban the products under this provision. Apart from the drugs falling under these categories, the DTAB sub-committee will also examine the rationality or otherwise of some of the 'need further examination' category drugs.
According to sources, the DCGI may not face any resistance from either the minister or the sub-committee in getting his proposal approved as all of them are kept posted about the developments on the raging FDC issue in which the DCGI is resolved to remove irrational FDC drugs from the pharmaceutical market of the country.