Concerned about the inordinate delay in notifying the guidelines attached to the Drugs and Cosmetics Act (Spurious Drugs Act), which was amended last year to provide stringent punishment to manufacturing and marketing of spurious drugs, the industry will soon approach the parliamentary committee attached to the Union Health Ministry to put further pressure on the government.
Industry sources said that the industry is exploring all options to plug the loopholes in the Act which has several features that can be misinterpreted and misused by the drug authorities, especially the drug inspectors who have been given sweeping powers in the Act. One of the options before the industry is to apprise the 31-member parliamentary committee headed by Amar Singh about the concerns of the genuine drug manufacturers arising out of the amendments in the Act, which was passed by the Parliament without any discussion on it.
The notification of the guidelines is important as without notifying the guidelines has no legal standing. Without notifying, the guidelines can at best become a guiding rule but not binding on the officials to follow in letter and spirit.
The industry will soon approach the Amar Singh committee and convince the committee members about the need to make further amendments in the Act to take care of the concerns of the genuine drug manufacturers. The industry will also apprise the parliamentary committee of the series of developments on the issue ever since the Bill was passed by Parliament last year, sources said.
Ever since the Bill was passed, the industry has been expressing its concern over the misuse of several provisions in the Bill. When the industry raised the voice of concern over the Act, the Drug Controller General of India (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.
Meanwhile, when the government notified the Bill on August 10 this year, the Ministry conveniently avoided notifying the guidelines as was promised by the senior ministry officials, leaving the industry in the lurch.
Even though the DCGI Dr Surinder Singh has taken up the issue and is leaving no stones unreturned to get the guidelines notified, the industry is not charmed as the issue has been pending for quite some time without any tangible result.