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 following the implementation of the Drugs and Cosmetics (Amendment) Act of 2008 which had enhanced the penalty provisions.

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.

Industry experts also point out sending of sample portion and original report to the manufacturer of alleged NSQ drug also depended on person to person and from state to state. Depending on his/her whims, drug inspector after complying with provisions of the law may write to the manufacturer of disputed drug to forward copies of records of manufacturing, testing, sale, particulars of expert staff, constitution of the firm/ company etc.

Again depending upon choice of the inspector, he can either drop further proceedings or refer the matter to the FDA of manufacturing state for further needful action or may launch criminal prosecution for contravention.

As per the existing guidelines, in the case of drugs manufactured by a licensed manufacturer under a valid manufacturing licence and found grossly sub-standard and where criminal intent or gross negligence is not established, weapon of prosecution should be used judiciously, where it is felt that administrative measures like suspension or cancellation of licenses or compounding of offences would not meet the ends of justice.