Concerned over the possible harassment to the genuine drug manufacturers under the newly notified Drugs and Cosmetics (Amendment) Act, under which manufacturing and marketing of spurious drugs has been made a cognizable and non-bailable offence, the industry may soon move court.
According to sources, the Indian Drug Manufacturers Association (IDMA) is seriously contemplating to move court on this issue to save the genuine drug manufacturers from the serious implications of the law which a section of the industry described as more stringent than POTA and TADA. Since the IDMA cannot move on its own, it may provide support to a company or a group of companies who move court on the issue which was notified by the union health ministry recently along with some guidelines.
The issue will be discussed threadbare in the executive committee of the IDMA which is meeting on August 28 in Mumbai. There is a predominant view in the IDMA that the industry is left with no other option but to move court as the guidelines attached to the new Law is not legally binding on the authorities, sources said. But before taking a final decision, the IDMA will discuss the entire gamut of pros and cons of dragging the government to court, sources added.
What has annoyed the industry more is the fact that contrary to the health ministry's earlier assurance to the industry to make the guidelines mandatory and legally binding, the ministry did not keep its words as legal experts in the pharma field are of the opinion that the new guidelines issued along with the notification by the ministry is not binding on the drug authorities, just like the 1993 DCC guidelines.
Genuine drug manufacturers fear that if the Act is implemented in its present form, it will have far reaching consequences as there are several provisions in the Act which can be misinterpreted and misused by the authorities, especially the drug inspectors who have been given sweeping powers in the Act. The industry fears that some of the provisions in the Act are so anti-industry that there will be no option for the genuine drug manufacturers but to leave the industry.
Since getting bail is almost impossible and guidelines not legally binding, the fear of prosecution will always hang as the proverbial Sword of Damocles over the head of the drug manufacturers. Major producers of spurious drugs are clandestine operators who ought to use labels of licensed manufacturers. When such drugs enter the chain, the manufacturer whose labels are misused shall face prosecution despite being innocent.
The Drugs and Cosmetics (Amendment) Bill was passed by Parliament in October last year and it received president Pratibha Patil's assent in December last year. The union health ministry on August 10 this year had notified the Drugs Act Amendment Bill along with guidelines, enhancing the punishment to 10 years imprisonment and a fine of Rs 10 lakh for production and sale of spurious drugs.