Thousands of genuine drug manufacturers, who were apprehensive about the sweeping powers accorded to the drug inspectors under the newly amended Drugs and Cosmetics Act, can heave a sigh of relief as the Drug Controller General of India (DCGI) has eventually decided to notify the guidelines attached to the spurious Drugs Bill. The guidelines, drafted by the DCGI with the active cooperation of the industry, are designed to clip the wings of the drug inspectors.

According to sources, the DCGI office has almost finalised the formalities in notifying the guidelines and it will soon be sent to the Law ministry for its nod. Once the Law ministry gives its green signal, the guidelines will be notified by the health ministry. “The delay in notifying the guidelines is largely due to the procedural delays,” sources added.

Notification of the guidelines was a long pending demand of the industry as ever since the Drugs and Cosmetics (Amendment) Bill was passed by Parliament in October last year, the industry has been expressing its concern over the misuse of several provisions in the Bill. The Bill, enhancing the punishment to 10 years imprisonment and a fine of Rs 10 lakh for production and sale of spurious drugs, was notified by the union health ministry on August 10 this year. Under the new amendment in the Act, production and sale of spurious drug is a non-bailable offence.

When the industry raised the voice of concern over the Act, the DCGI asked the Drugs Consultative Committee (DCC) to frame some guidelines to safeguard the interests of the genuine drug manufacturers. The DCC in association with the industry drafted the guidelines, but the Health Ministry failed to keep its promise of notifying the guidelines along with the Act which would have made it part of the Drugs and Cosmetics Rules to ensure that it is followed and the provisions are implemented by the drug inspectors uniformly.

With the guidelines non-binding on the drug inspectors, there was fear among the industry 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 authorities. There was apprehension among the industry that this guidelines will also go the same way of the DCC guidelines of 1993 which was not followed by the drug authorities as it was not notified.