As the Union Health Ministry is dragging its feet on the issue of notifying the Guidelines attached to the Spurious Drugs Act, pharmaceutical industry is seriously contemplating to move Supreme Court to curb possible harassment of genuine drug companies by drug inspectors by misinterpreting some provisions in the Act. The industry will pray to the Court for the immediate notification of the Guidelines.

According to sources, the industry has already started the preparation for moving Supreme Court on the issue and the case may be filed at any time now. The industry is roping in a senior and reputed lawyer to argue the case.

The Drugs and Cosmetics (Amendment) Bill, better known as Spurious Drugs Act, was passed by Parliament in October 2008 and it received President's assent in December same year. The Bill, which enhanced the punishment to 10 years imprisonment and a fine of Rs 10 lakh for production and sale of spurious drugs, was notified on August 10, 2009, by the union health ministry.

Ever since, there was outcry from the industry over the sweeping powers given to the drug inspectors in the amended Act. It feared that the genuine drug manufacturers will also be harassed by the drug authorities. The industry feared 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 drug authorities.

As the industry expressed its concern, the union health ministry came up with a set of guidelines and senior health ministry officials gave an assurance to the industry that it will make the guidelines mandatory and legally binding to ensure that genuine manufacturers are not harassed by the drug authorities.

But, even after almost a year since the ministry has notified the Bill, it is yet to notify the guidelines. Legal experts in the pharma field are of the opinion that since the new guidelines issued along with the notification by the ministry are not notified, it is not binding on the drug authorities, just like the 1993 DCC guidelines.

It is not that the ministry did not take any action in the direction of notifying the guidelines. It has already taken the initiative and the files related to the notification of the guidelines attached to the controversial Spurious Drugs Act are shuttling between the DCGI office and the union law ministry for quite some time as the ministry is asking clarification on several issues related to the notification.