Spurious drug manufacturing and sale is an organized and nationwide criminal activity in India supported by certain powerful vested interests. The problem has been challenging drug control administration in the country for several years in the absence of effective provisions in the existing law. Finally, a bill amending the Drugs & Cosmetics Act with several key provisions to curb this menace has been passed by the Parliament in November 2008. The amended law contains stringent provisions such as 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 provision of 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 is thus very significant and could prove to be a powerful deterrent.

The amended Act thus seems to be quite comprehensive in tackling the menace. Now, what is important is its effective implementation. Both industry and trade have been expressing concern about the stringent provisions of the new law and the possibility of drug control officials harassing their members once the new Act gets implemented. Their concern cannot be ignored considering the kind of corruption exists in most state government offices today. The drug inspectors have been given adequate powers under the amended Act but that should not lead to misuse of power. It is important that genuine manufacturers and traders are not unfairly subjected to harsh punishment under the new law. One major concern of the industry and trade was the lack of clarity about what is spurious or fake drugs in the new Act. A set of guidelines issued last month by the health ministry clarifies this and seek to ensure fair implementation of the amended act. The new guideline asks 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. The authority in turn shall consider the recommendations of the screening committee while taking final decision in the matter. These guidelines provide sufficient safeguards against any possible misuse of the law by the inspectors and senior officials. Industry and trade should now cooperate with drug control administrations to make the government's mission of eliminating fake and spurious drugs from the market a success.