Even as the pharmaceutical industry in the country is running from pillar to post to get the guidelines attached to the Spurious Drugs Act notified for curbing harassment of genuine drug manufacturers by the drug inspectors by misusing the provisions in the Act, the files regarding the notification of guidelines is still stuck with the Union Law Ministry.

According to sources, the files related to the notification of the guidelines attached to the controversial Spurious Drugs Act have been shuttling between the DCGI office and the union law ministry for quite some as the ministry is asking clarification on several issues related to the notification. “We are not sure the guidelines can be notified or not. It will be decided by the law ministry which is presently examining the files,” a senior official dealing with the issue said.

Earlier, the DCGI office had identified the appropriate provisions under the Drugs and Cosmetics Act under which the guidelines can be made binding on the drug inspectors. Aiming to clip the wings of the drug inspectors, who have been given extensive powers under the amended Act, the DCGI had started initiatives to notify the guidelines attached to the Bill to avoid the unnecessary harassment to the genuine drug manufacturers by the drug inspectors by misusing the provisions in the Act.

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 union health ministry on August 10, 2009 had notified the Drugs Act Amendment Bill, enhancing the punishment to 10 years imprisonment and a fine of Rs 10 lakh for production and sale of spurious drugs. Under the new amendment in the Act, production and sale of spurious drug was made a non-bailable offence.

Ever since the Bill was passed by the government, the sweeping powers given to the drug inspectors in the amended Act was a major contention of the industry. It feared that the genuine drug manufacturers will also be harassed by the drug authorities. The industry fears 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 officials.

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.