Manufacture and sale of spurious drugs has been an organized and nationwide criminal activity in the country posing a major challenge to the drug control administration in the absence of effective provisions in the existing law. A bill amending the Drugs & Cosmetics Act with several provisions to curb this menace was thus passed at last by the Parliament in November 2008. The amended law has been stringent enough with a maximum penalty of life imprisonment and a fine of not less than Rs 10 lakh for those engaged in manufacturing fake drugs. There are similar punishments prescribed for members of the trade also. Earlier, the onus of the spurious drugs was only on manufacturers and the traders were mostly exempted from legal action. Now, the new law has provisions to punish the entire distribution chain from retailer to C&F agents if they are found to possess spurious drugs. The law has a provision making the offences cognizable and non bailable. One of the main hurdles faced by state drug control departments has been the inordinate delays in prosecution of offenders. The provision to have special courts to handle spurious drug cases in the new law should prove to be a major deterrent to the offenders.

Pharmaceutical industry and trade had welcomed the government initiative in bringing such a comprehensive set of rules to curb the spurious drug menace. Unfortunately, the new set of rules is yet to be implemented on account of mutual mistrust between the industry and health ministry officials. Industry and trade had raised the concern that the sweeping powers provided to the drug inspectors in the amended Act could be widely misused. Their worry is that the genuine drug manufacturers and traders could be harassed by the drug inspectors under the new system. They had also complained on the lack of clarity about what is spurious or fake drugs in the new Act. A set of guidelines was thus issued in August last year by the health ministry clarifying this. The guidelines ask the state drug control departments to constitute screening committees comprising of at least three senior officers to examine the investigation reports of the cases where prosecutions are proposed to be launched. The committee will have to submit written comment on the investigation reports regarding their feasibility of taking legal action. The inspectors should launch prosecutions on the basis of written permissions from the drug control authority. These guidelines are quite fair and the ministry have committed to adopt them while implementing the amended Act. Now the hitch seems to be industry's lack of trust on the ministry. Industry representatives want these guidelines to be made mandatory and legally binding. For this, a clearance from the law ministry is required. Now the files are stuck with the law ministry as the guidelines may not be made a part of the amended Act.