The pharma industry in the country has demanded to the Drugs Controller General of India (DCGI) to urgently make further amendments in the D&C Act to protect the bona fide drug manufacturers from being harassed by the drug authorities under section 36AC of the recently amended Drugs and Cosmetics (Amendment) Act, 2008 (popularly known as Spurious Drugs Act).

According to sources, the industry is alarmed over the increasing instances of denial of bail to the licensed manufacturers by the drug authorities taking recourse to section 36AC of the Act. Under section 36AC of the Spurious Drugs Act, the drug manufacturers involved in manufacture, sale and distribution of spurious and/or adulterated drugs are denied bail.

Even though the industry had expressed its apprehensions over the possible misuse of some of the provisions in the Bill, the controversial Bill was passed by Parliament with a voice vote in November, 2008 without taking into account the concerns expressed by the industry. T    he Bill received President's nod in December, 2008 and it came in force from August 10, 2009.

Even though the DCGI, to address the concerns of the industry, had issued 'Guidelines' and circulated it under 33p of the D&C Act for uniform implementation of the Act by state drug authorities, the instances of denial of bail to the licensed manufacturers under the provision of 36AC of the Act have been on the increase in the country. The industry is alarmed over the fact that in many states, the majority of the cases filed for substandard drugs, charges of adulterated or spurious drugs are being framed while filing prosecution.

There are apprehensions in the industry that due to likely misinterpretation of  definition of spurious drugs under section 17B(d) of the Act, in some states even drugs failing in assay are put under the category of spurious drugs. Moreover, taking recourse to section 17B(e) of the Act, injections are categorised as adulterated drugs by the drug authorities in some states on the basis of the government analysis report which declares them as not of standard quality for failing in sterility and presence of particulate matter.

Apart from section 36AC, the industry has also demanded to the DCGI to amend some other sections like the section 36AB of the Act to address the concerns of the honest drug manufacturers in the country. The industry also wanted section 27 of the Act amended to incorporate the word 'knowingly' in the opening paragraph of Section 27.

Expressing concern about the unintended severe consequences of the amended provisions in the Spurious Drugs Act, the industry informed the DCGI that since there are chances that several honest and licensed companies  and persons have to suffer due to some of the provisions in the Act, most of the MSMEs will gradually withdraw from the drug industry. Besides, looking at the risk of undue harassment, manufacturers are not inclined to involve their next generation in the drug industry.