The Drugs Technical Advisory Board (DTAB) attached to the Union health ministry, which is examining the safety and rationality of a list of 294 fixed dose combination (FDC) drugs identified by former DCGI Dr M Venkateshwarlu, is learnt to have prima facie found most of them 'illogical'. However, the matter has once again been referred to a group of highly qualified pharmacologists at the All India Institute of Medical Sciences (AIIMS), New Delhi.

This is for the second time that these drugs are being examined by the pharmacologists. Earlier, Dr Venkateshwarlu had engaged the services of around 80 independent pharmacologists across the country for examining these drugs and they have classified these drugs into absurd, banned, rejected and need further examination categories. Though these reports are already there, the DTAB wanted to make it more foolproof before recommending for banning of these drugs. However, no timeframe has been set for a final decision, the sources said.

DTAB is the highest technical advisory body on pharma industry and its permission is necessary for banning drugs under section 26-A of the Drugs & Cosmetic Act. The DTAB refers these matters to its sub-committee which is a body of experts in the field of pharmacology. There are nine members in the sub-committee.

Though the overall opinion of the DTAB is that a large number of these 294 drugs are irrational and needed to be banned, the committee wanted to make it more elaborate by examining these drugs by the pharmacologists. That is why it has once again been referred to the pharmacologists, sources said.

In fact, Dr Venkateshwarlu wanted to remove all these 294 irrational drugs from the market and for the purpose he had asked the state drug authorities to withdraw the drugs as it was they who had given licenses to these drugs. But his attempt in this regard did not bear fruit as the drug companies moved court and obtained stay orders against the DCGI order.

As the case was mired in legal wrangles, Dr Venkateshwarlu turned to the DTAB to ban these drugs under section 26-A of Drugs & Cosmetics Act.

Meanwhile, the new DCGI Dr Surinder Singh is also learnt to be waiting for the DTAB's final word on the issue to make his stand on the issue. Interestingly, he did not so far utter a word about his stand on the vexed FDC issue which has sent shivers down the spine of drug companies, small and big alike as a whopping Rs 3,000 crore was at stake.