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Due diligence, unsafe drugs (thehindu)



Goaod intentions alone are not enough to secure the public interest. For governments, the manner in which it is protected is equally vital. The Delhi High Court verdict quashing all notifications banning the manufacture and sale of 344 Fixed Dose Combination (FDC) drugs is a lesson in how not to administer a regulatory law. The ban on combination drugs that have little therapeutic value was undoubtedly done for bona fide reasons. However, the government could not convince the court that the ban was valid despite statutory bodies such as the Drug Testing Advisory Board (DTAB) and the Drugs Consultative Committee (DCC) not being involved in the process. There is little doubt that a number of combination drugs should be taken off the shelf. The government believes, as do many health activists, that some combinations are unsafe and/or promote antibiotic resistance, while others lack particular therapeutic value, justification or advantage. Justice Rajiv Sahai Endlaw has correctly refrained from going into the merits of the ban, and has chosen to subject to scrutiny the process by which the decision was arrived at. While concluding that the ban was invalid because the power under the Drugs and Cosmetics Act was exercised without consulting the DTAB and DCC, he has found that the government went about the process in a haphazard manner.

Initially it was noted that in the case of FDC drugs for which manufacturing licences were granted by State licensing authorities between September 1988 and October 2012, the process was done without any approval from the Drugs Controller. When they applied afresh to the Centre, on being asked to do so, their applications were not considered by the Drugs Controller; instead, the Centre formed 10 committees. When these panels failed to consider all the applications, another one, the Kokate Committee, was formed. However, this panel went into the question whether these drugs posed a risk to consumers or lacked therapeutic value and justification. Based on its report, the Centre issued notifications banning these FDCs. In effect, the Centre seemed to have delegated its power to ban drugs to a non-statutory committee, when the Act itself provided for expert bodies through which technical aspects of administering the law were to be considered. The government ought to have been more mindful of the processes. It is possible that an appeal will be filed on the legal aspects of the judgment, but the real lesson from the episode concerns governance, and not the law alone.G

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