The health ministry will soon constitute a high-powered committee consisting of representatives from the government and the industry to look into the concerns of the industry arising out of the Drugs and Cosmetics (Amendment) Bill which has received the assent of the President recently. The Bill stipulates stricter penalties like life imprisonment and non-bailable arrest for manufacturing and selling spurious drugs.
The high-powered panel will define guidelines, based on the 1993 Drug Consultative Committee guidelines, for implementing the Act which is yet to be notified by the health ministry. The committee's recommendations will have legal teeth as these will be notified by the ministry. A decision to this effect was taken at a meeting between the senior health ministry officials and the industry held on January 12. The nitty gritties of the panel will be worked out by the ministry soon.
One of the major issues that the panel will have to address first is the apprehensions of the industry on misuse of the provisions of the Act by the drug inspectors as the Act gives sweeping powers to the drug inspectors and the police to initiate action against the erring drug manufacturers and marketers. The industry pleads that the prosecution powers should not be vested with the drug inspectors but with senior officials at DCGI level only. The panel will reach an agreement on this issue.
Another issue before the panel is the issue of solving the dispute arising out of defining the quality of medicines after testing. The industry demands that any dispute on quality on testing should be resolved by testing the controversial medicine at a government laboratory but supervised both by industry and government representatives. The panel will take up this issue too. Another major issue before the joint panel is regarding strengthening of reference standards. The health ministry officials who attended the meeting agreed to address this issue also.
The development is a major achievement for the industry as ever since the Bill was passed by Parliament, the industry has been making concerted efforts to rectify the Bill to incorporate certain provisions to safeguard the interests of genuine manufacturers.
"The health ministry officials were very positive in their approach towards the industry's concerns. They have agreed to address all the problems arising out of this issue," said SPIC vice-chairman Lalit Jain after attending the meeting.
"It is a good development that the ministry officials agreed to form the committee to address the concerns of the industry. We are positive that the committee will be able to find a solution to safeguard the interests of the genuine manufacturers," said FOPE vice-chairman Vinod Kalani.
By amending the Act, while the government is hell bent to clean the drug market of spurious drugs, the industry is wary of the unintended consequences and the resultant harassment to the licensed and bona fide manufacturers. Major concern of the industry in the Bill is the lack of provisions to safeguard the interests of the genuine drug manufacturers. There is no mention of definition on substandard drugs in the Bill. Since there is no separate definition of substandard drug in the Bill, if any drug is found substandard the manufacturer will be charged for manufacturing and selling of adulterated or spurious drugs.