Alarmed over the sweeping powers enjoyed by the drug control officers under the recently amended Drugs and Cosmetics Act, the IDMA has asked the government to clip the wings of these officers, including drug inspectors, by issuing written guidelines to be followed by them while initiating action against the drug companies. The IDMA also asked for an amendment to Rule 51 and 52 to make it mandatory to get written consent from the controlling authority for filing prosecution against the drug companies.

The amendment stipulates stricter penalties, including hefty fine and non-bailable arrest, for manufacturing and marketing of spurious drugs. It gives sweeping powers to the drug officers and the police to initiate action against the erring drug manufacturers and marketers. By amending the Act, while the government is hell bent to clean the drug market of spurious drugs, the industry is wary of the unintended consequences and the resultant harassment to the licensed and bona fide manufacturers.

In a representation made to DCGI Dr Surinder Singh, IDMA president B N Singh said that the manual of guidelines for controlling authority should have elaborate guidelines for taking action on not of standard quality reports and other violations of conditions of licenses and various provisions of Act and Rules with emphasis on administrative action. The guidelines may also include instances which should be regularized instead of taking legal action e.g. failure to obtain license for additional premises, failure to submit renewal application within stipulated period, failure to obtain fresh licenses in view of change in the Constitution within stipulated period etc.

It should also include guidelines for interpretation of results of the Government Analyst Report, examination of evidence adduced under Section 25(3) of the Act, need to act judiciously in accordance with the written guidelines issued by the Central and State Government, necessity of passing speaking order while giving consent to file prosecution under the Act and Rules and consent order to include name of accused and specific charges for which consent is given.

The guidelines for drugs inspectors should elaborate on the circumstances and the manner in which the stock of drugs and cosmetics should be seized and the circumstances in which powers to issue prohibitory orders in form 15 should be exercised for e.g. the guidelines may specify that such power should not be exercised for minor violation such as labelling defects. The guidelines may also include a directive that the action should be finalized within specified time from the date of issue of prohibitory order in Form 15.

It should elaborate on the circumstances and the manner in which police help should be taken. The guidelines may specifically include that the police help should be preferably taken only in cases involving clandestine activities, rackets, cases having interstate ramification etc. The Drugs Inspector may not approach police for violations of minor nature committed by the licensed manufacturer.

The IDMA also demanded that the drugs inspector should record storage conditions of the drugs and cosmetics while drawing the sample, he should carry out enquiries to ascertain the actual manufacturer and give the counterpart of the sample to the manufacturer of such drug and should provide copy of the Government Analyst Report to the manufacturer of drug.

The guidelines should also elaborate on the procedure to be followed by the Drugs Inspector on receipt of intimation under Section 25(3) of the Act about adducing evidence in controversion of the government analyst report, steps to be taken by the Drugs Inspector for sending the sample to Central Drug Laboratory on receipt of specific request from the manufacturer of drug or cosmetic and submission of report on not of standard quality report outlining the gist of investigation, list of responsible person with evidence to the controlling authority along with all documents for obtaining consent to file prosecution in the court.

The IDMA also demanded for the amendment of the Drugs and Cosmetics Rules, 1945 to insert new Rule 50B to provide for duties and procedure to be followed by the controlling authority and framing of Rules to provide for the authority empowered to exercise powers to issue directions under Section 33-P of the Act, the procedure and the manner in which such powers can be exercised. DCGI may be empowered under these rules to issue directions in consultation with the Drugs Consultative Committee.