The Centre had notified the Drugs & Cosmetics (Amendment) Act, also known as Spurious Drugs Act, in 2008 with great expectations of curbing the menace of manufacturing and sales of spurious drugs in the country. This illegal business, an organized and nationwide criminal activity supported by certain powerful vested interests, has been challenging drug control administration in the country for several years in the absence of effective provisions in the D&C Act. Now, after several years of debate, a bill amending the D&C Act with some key provisions to eliminate 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 the manufacturing  of fake drugs. There are similar punishments provided for prosecuting members of the pharmaceuitcal trade also. The amended Act is somewhat comprehensive in tackling the menace and the drug inspectors have been given adequate powers to enforce the Act. It 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 prosecuting the 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. Industry and trade, however, have been objecting to these stringent provisions on fears that drug control officials may misuse them leading to harassment of their members. Their concern cannot be totally ignored considering the kind of corruption exists in most state government offices today.

The fears expressed by the industry and trade about the likely misuse of the provisions of the Spurious Drugs Act by the officials are turning into a reality of late. There are reports of  increasing instances of denial of bail to the licensed manufacturers by the state drug authorities by taking recourse to section 36AC of the amended Act. Under section 36AC, the drug units engaged  in manufacture, sale and distribution of spurious or adulterated drugs can be denied bail. And this section is being largely misinterpreted. This is despite Drug Controller General of India issuing guidelines under 33p of the D&C Act for uniform implementation of the amended Act by the state drug authorities. The industry members are alarmed over the fact that in majority of the cases filed for substandard drugs in states, charges of adulterated or spurious drugs are being framed while filing prosecution. In some states, even drugs failing in assay are put under the category of spurious drugs by wrongly interpreting the definition of spurious drugs under section 17B(d) of the Act. Again, by taking recourse to section 17B(e) of the Act, injections are being categorised as adulterated drugs in some states on the basis of  government analysis report which declares them as not of standard quality for failing in sterility and presence of particulate matter. If this is the state of affairs in implementing the Act, more and more drug manufacturers could be subjected to harassment by the officials in different states. This needs to be stopped and DCGI has to intervene without delay. An Act like this, framed after so much of debate, is to achieve the goal of eliminating the menace of spurious and substandard drugs and providing quality drugs to the people of the country.