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Health ministry to revise guidelines for taking action on drugs declared not of standard quality


The Health Ministry is planning to revise the present guidelines for taking action on samples of drugs declared spurious or not of standard quality (NSQ), in the absence of a uniform pattern. The proposal which is under consideration is mooted following allegations that the actions currently taken by the drug control authorities differ from State to state and person to person and the existing guidelines, approved in 1993, have become virtually obsolete in the wake of new legislation. The industry had also been complaining that even the slightest and minor defects in the time of disintegration test and dissolution test invited stricter punishments, causing damage to the reputation and trade by the manufacturers and marketers of drugs. The defect regarding tablets and capsules failing in disintegration test and dissolution test are mentioned in category B (grossly sub-standard drugs) for which prosecution is recommended. Sometimes the samples fail for minor variations in the time of disintegration test and dissolution test. In the previous guidelines approved in 1993, theses defects were mentioned except for marginal variations to be viewed on case to case basis. The issue was taken up at the Drugs Consultative Committee (DCC) to decide whether the samples failing with marginal variations in the disintegration test and dissolution test required prosecution or administrative action under Rule 85(2) of the Drugs and Cosmetics Rules, 1945. The DCC after deliberations felt that the issue should be taken into consideration while revising the present guidelines for taking action on sample drugs declared spurious or NSQ under the new Act.

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1/29/2014 9:25:47 AM