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 Sigh 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.