After several years of inaction, India has finally come to a stage of serious action towards controlling the menace of fake drugs in the country. The problem has been challenging drug control administration in the country for several years in the absence of an ineffective law. In fact, the government has been working on to bring in a comprehensive legislation in this regard for at least seven years now. Finally, the Drugs & Cosmetics Amendment Bill with several key provisions has been passed by the Parliament in November 2008. The new 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 spurious and fake drugs. There are also punishments prescribed for the trade. 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 could be of great relief for the drug control officials. There are thousands of cases of spurious drugs pending in various state courts. Spurious drug manufacturing and distribution is a well-organized and nationwide criminal operation supported by even politicians in some states. A collective effort, involving all related Central and state ministries, industry and trade bodies and consumer organizations, is required to curb this dangerous activity. Enactment of the new law is a significant step to stamp out this menace.

As the punishments prescribed under the new law are severe, the units engaged in this illegal activity will find it tough to survive in future. That is what is desired out of the new statute. Now, the small drug units are expressing serious concern over the way the new rule will be enforced. They fear that they could be harassed and unfairly booked once the Act gets implemented. The fear they are expressing is not entirely without any basis. Firstly, the definition of spurious drugs is not very clear in the new act and that can quite possibly lead to harassment of genuine units for unintentional lapses. Substandard drugs usually contain active pharmaceutical ingredients but not in right quantities. It is, therefore, unfair to classify these products as spurious or fake drugs. Such manufacturers should not be punished on par with fake drug manufacturers. A distinction has to be made in such cases. Now, the drug inspectors have been given a lot of powers under the amended act and there is enough scope for the misuse of such powers. The issue here is how to ensure genuine manufacturers are not subjected to harsh punishment under the new law. The Union health ministry needs to take note of this aspect and direct state drug control authorities so that provisions of the new law are properly enforced.