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NO ACTION ON FDCs YET
Wednesday, December 10, 2008, 08:00 Hrs  [IST]

The exercise to eliminate thousands of irrational drug combinations circulating in the market by the office of the Drug Controller General of India started June last year. Although thousands of fixed dose combinations of drugs have been in the market with no therapeutic rationale and safety profile for several years, no serious attempt has been made to identify and weed them out. FDCs are considered to be new drugs under Rule 122 (E) (c) of the Drugs & Cosmetics Rules and they need to be approved by DCGI for marketing in the country after submission of all relevant pre-clinical and clinical trial data. A majority of these FDCs available in the market are approved by State Drug Licensing Authorities and not by DCGI. Submission of such test data was not insisted upon by the state licensing authorities before issuing the product licences. The pharmaceutical companies also found it convenient to obtain product licences from the state authorities without the trial data. By commencing the weeding out operation last year Dr. Venkateshawarlu, the former DCGI, set the ball rolling for the first time in the country. Now, after several meetings with the industry representatives, state drug authorities and technical bodies, not much progress has been made to weed out most of these dangerous combination drugs belonging to 294 categories. It is important that these unsafe drugs are taken out of the market at the earliest in the interest of millions of patients. An early solution to the FDC issue is also crucial for thousands of drug manufacturers, especially the small scale units, as the state drug authorities are refusing to give licences to most of the controversial 294 FDC drugs ever since Dr. Venkateshwarlu started the action in 2007. In fact, there was a consensus among the industry and the government in continuation of as many as 138 FDCs out of the total 294 at a meeting held on July 14 this year. But then what is holding the state drug authorities in issuing licences for these drugs is not very clear. If the DCGI has not issued a directive in these cases even after their rationality is approved by experts, that needs to be expedited. Now, the industry has been asked to submit scientific data of the remaining 156 drugs to take a final decision on them. The second meeting on this issue was scheduled for October 1 but that did not take place. An expert panel headed by the DCGI had been constituted to decide the fate of 49 FDCs out of the remaining 156 FDCs some time back. This meeting, scheduled to take place on November 28, did not also take place. It is unfortunate that DCGI office is not able to decide on a vital issue of eliminating unsafe drugs from the market after several years. The first directive from the DCGI office prohibiting state drug controllers to not to issue any more drug licences for combination drugs was issued as early as November 2001.

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