The controversial and the much awaited issue of putting in place a binding Guidelines on the Spurious Drugs Act to safeguard the interests of the genuine drug manufacturers has taken another turn with the drug controller general of India (DCGI) setting up a sub-committee under the Drug Consultative Committee (DCC) to review the lingering issue.

A decision to this effect was taken during the day-long DCC meeting held on October 28 in which senior health ministry officials and state drug controllers were present. The sub-committee consists of state drug controllers of Gujarat, Maharashtra, Rajasthan, etc. The committee has been asked to submit a report before the next DCC meeting which is tentatively scheduled for February next year.

Earlier, on September 7 this year, Union health minister Ghulam Nabi Azad, after meeting the captains of the industry in Mumbai, had announced that the ministry would allay the apprehensions of the industry on the implementation of the Spurious Drugs Act by issuing a directive to the state drug authorities under section 33P of the D&C Act under which it would be mandatory for the state drug authorities to follow the guidelines before executing the various provisions of the Spurious Drugs Act.

But, even after the minister's announcement, the DCGI changed track and decided not to issue a directive to the state drug authorities under section 33P of the D&C Act on the plea that there are still doubts whether the guidelines can be brought under section 33P of the D&C Act. Now, the sub-committee will take a decision on the matter.

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, 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 had come up with a set of guidelines and senior health ministry officials had given 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.