Panel for more trials on fixed-dose drugs

Panel for more trials on fixed-dose drugs

New Delhi: An expert committee on fixed-dose combination (FDC) drugs has recommended that all three-drug combinations be studied against two-drug combinations to prove their efficacy over the latter.

In a June meeting, the minutes of which were reviewed by Mint, the subcommittee of the Drug Technical Advisory Board—India’s highest advisory body on pharmaceuticals—concluded that medications made from a combination of three different drugs would need further clinical trials to prove their safety and efficacy within 6-12 months from the date of final decision on their marketing.

“All three-drug combinations will have to be studied. But the committee has found no problems with the two-drug combinations," said R.K. Sanghvi, chairman of the medical sub committee. “The industry will have to conduct trials on the three-drug combinations against the two-drug ones."

There was a crackdown on the 294 FDCs in 2007 when the drug controller general of India (DCGI) asked for their withdrawal from the market for lack of approval by the central authority. The FDCs in question had received approvals from state licensing authorities but under the Drugs and Cosmetics Act, 1940, any new drug after 1988 requires a licence from DCGI.

Of the 294 FDCs, a decision was taken on 138. The regulator and industry lobby groups agreed last year to set up an expert panel to decide on the remaining 156. While 43 FDCs from the list have been banned, a decision on the rest is still awaited. In the meeting in June, the committee took up FDCs relating to the musculoskeletal system. Of the 28 FDCs in the therapeutic category, 14 will have to be re-examined, all being three-drug combinations.

“In the next meeting, we will discuss FDCs for the gastrointestinal tract. In another four meetings we should have clarity on all the FDCs in our list," added Sanghvi.