The Spurious Drugs Act came into effect from August 2009 with the objective of eliminating the menace of manufacturing and sales of spurious drugs in the country. Large number of spurious tablets, capsules and syrups are being sold in the market especially in states where drug control machinery is weak. 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 attracted the attention of the government, industry  and patients groups some time ago 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 quite comprehensive in tackling the menace with the drug inspectors having excessive powers to enforce the Act. The Act contains several 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. A key provision in the Act also makes 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 intended to be a strong deterrent.

Although pharmaceutical industry and trade welcomed the government initiative, there has been apprehension that drug control officials may misuse some of the provisions leading to harassment of their members.  Now that fears have turned into a reality with increasing cases of harassment by the officials reported from various parts of the country. 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. 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. Some officials are reported to be taking recourse to section 17B(e) of the Act and categorizing injections as adulterated drugs on the basis of state governments’ analyst report declaring them as not of standard quality for failing in sterility. Such whimsical and malafide interpretations of the Act by some of the drug control officials is not in the interest of the industry and patient community. Members from the industry have already brought the matter to the notice of the DCGI. It is high time the DCGI intervened in this matter and made necessary amendments to the Act so that genuine drug manufacturers are spared from the harassment and not subjected to unfair punishment.