The Centre had brought in the Spurious Drugs Act with effect from August 2009 with the laudable objective of eliminating the menace of manufacturing and sales of fake and spurious drugs in the country. This illegal business, an organized nationwide criminal activity supported by powerful vested interests, has been flourishing in the country for several years in the absence of stringent provisions in the D&C Act. The matter had caught the attention of the government, industry  and patients groups and a bill amending the D&C Act with some key provisions to check this menace has been passed by the Parliament in November 2008 and notified as an Act in 2009. The Act is somewhat comprehensive in tackling the menace and has empowered the drug inspectors with sufficient powers to enforce the Act. By making the penal provisions under the Act more stringent, the government has made it deterrent for the anti-social elements from indulging in these illegal practices. Certain offences have also been made cognizable and non-bailable. Industry and trade, however, have been objecting to these provisions on fears that drug control officials may misuse them leading to harassment of their members.

Enforcement of the provisions of the amended Act and adjudicating cases charged by the drug control officials remains to be still a contentious issue. In case of enforcement of the Act, there are reports of denial of bail to manufacturers by the state drug authorities by taking recourse to section 36AC of the amended Act. This is despite the 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. There has to be more clarity on this matter and the DCGI needs to ensure that genuine manufacturers and traders are not subjected to harassment by the officials. Inordinate delays in prosecuting the offenders continues to be a major hurdle faced by the state drug control officials . There are instances of cases where the courts had taken several years to grant the verdict. Such delays in deciding the cases has been highly de motivating the drug control officials. 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 to the offenders. Now, three years after the notification of the amended Act, the Union Health Ministry has asked States to set up specially designated courts for speedy trial of offences relating to spurious drugs. Fourteen states have set up the designated courts but the remaining states have assured to set up such courts. The fact that the government had taken three years to decide to set up special courts after the notification of the amended act is highly discouraging. Now the question is how much time the other states will take to set up the special courts and start hearing the cases under the Spurious Drugs Act.