In the meeting held on October 27 with the industry representatives, Dr. Venkateshwarlu, DCGI, had made it amply clear that his office is serious in eliminating the menace of irrational combinations from the market. And he told the representatives in clear terms that they have to stop manufacturing all products having composition of the listed 294 fixed dose combinations forthwith. His office had classified these 294 combinations into different categories based on their irrationality and absurdity. DCGI with the help of a team of 100 pharmacologists had done an excellent job of examining these combinations and classifying them. Before the meeting with the industry, he had already briefed the state drug controllers about the modus operandi of removing these questionable products from the market. The entire crowd of pharmaceutical representatives in the meeting on October 27 agreed to withdraw products of 125 irrational combinations which are classified as banned, rejected and absurd. As far as the other 150 combinations under examination and 19 approved combinations, industry wanted the DCGI to allow continue production as their rationality is under examination. He told the representatives that his office would come out with a decision on them in 40 days. Industry's plea for continuation of manufacturing of products of 169 combinations until then is not accepted by the DCGI.

The dispute has arisen here. DCGI is quite firm and wanted the production of all 294 combinations to be discontinued. He, however, allowed sales of products of 150 combinations till stocks last in trade channels. Now, the industry is opposing the DCGI's stand and the major associations have come together and sent a letter to the secretary in the Union ministry of health seeking intervention in the issue. The joint memorandum said that after the amendment of the Drugs & Cosmetics Rules in 1988, the State Licensing Authorities were required to obtain NOCs from the DCGI before issuing manufacturing licences for new FDCs. But, the SLAs ignored this stipulation and continued to grant manufacturing licences for combination products. Associations are of the view that the office of the DCGI was fully aware of this practice. Some SLAs had even brought the matter to the notice of the successive DCGIs, but they had all ignored the alerts and did not enforce the new rule. Therefore, industry's stand is that the office of DCGI is also responsible for the current state of affairs and he should not be very harsh in this matter now. Sensing the mood of the industry leaders, it is likely that they may not sit quiet on this issue. And any political interference in this matter can mess up the whole initiative. That should not happen. The need to clean up the pharmaceutical market of irrational and unsafe products is of utmost importance for the patient community and for nation's image. And Dr. Venkateshwarlu is the only DCGI who has taken up the matter quite seriously so far. It will be wrong to demoralize him. Certainly, the whole exercise may lead to withdrawal of several products including those having good sales. That is a price the industry has to pay for the public good.