The Federation of Pharma Entrepreneurs (FOPE), a body of around 500 drug manufacturers in the tax holiday states of Himachal Pradesh and Uttaranchal, has urged the Union health minister Ghulam Nabi Azad to make the guidelines attached to the recently amended Drugs and Cosmetic Bill (Spurious Drugs Bill) mandatory, besides rectifying the drafting errors occurred in the amended Act.

FOPE general secretary Vinod Kalani said that the Federation representatives recently met the minister and sought his intervention in the matter which has been pending for some time. Though the pharma industry is happy that the government has brought guidelines to protect the genuine and legitimate manufacturers and clarifying what should be treated as spurious and adulterated, the guidelines that were cleared by 40th DCC (drugs consultative committee) should be made mandatory and the government should ensure that these guidelines are followed by one and all, the federation said.

Pointing out the drafting errors in the Act, Kalani said that some provisions of different sections are contrary to each other. Offenses under sections 28 and 28A are not related to adulterated or spurious drug and are compoundable offenses as per provisions contained in section 32B(1) of the amended act. The offenses of sections of 28 and 28A are, however, categorized as cognizable in section 36AC(1)(a) bail provisions of which are provided in section 36AC(1)(b) designed primarily for offences relating to adulterated or spurious drugs. The provisions of section 32B(1) are thus contrary to provisions of section 36A(1)(a) and 36AC(1)(b). Such drafting errors in the new act should be rectified, the federation asked the minister.

“Besides, there are other drafting errors in the Act. Under Section 36AC, bail provisions should not apply on licensed manufacturers. We should not be treated at par with the criminals,” FOPE said and added that the bail provisions in the amended Act have now become equivalent to TADA, POTA and NDPS Act.

Expressing concern over the misuse of some provisions in the amended Act, FOPE brought to the minister's notice that since there is no separate definition of a substandard drug, the industry will be subjected to harassment, as one will not have a chance to prove when such a charge is framed, except in the court of law. And by that time, if he is not granted bail then one can understand what one will have to face / go through, without any fault.

The industry's major areas of concerns are abuse of special bail provisions provided for spurious, adulterated drugs (Chapter 36AC), misuse of definition of spurious and adulterated drugs and no demarcation of criminal intent or act from the regulatory issues or problems.