Apparently apprehensive of the Union health ministry's actions in addressing the concerns of the industry over the recently passed Spurious Drugs Bill, the beleaguered industry is preparing to move court to save the genuine drug manufacturers from the harassment of the drug inspectors who have been given sweeping powers in the Bill which received President's assent recently.

"Preparations are in an advanced stage to move the court on the issue", a senior industry leader, who has been in the forefront of many a battle for the interest of the industry during the last several years, said. He, however, said that this time an NGO will move the court on behalf of the industry, to restrain the powers of the drug inspectors. The industry, especially the small and medium sector, is worried about the fallout of the Bill due to the extensive powers accorded to the drug inspectors.

Though the health ministry had recently announced that it will soon constitute a high-powered committee consisting of representatives from the government and the industry to look into the concerns of the industry, the industry is not convinced about the outcome of such an arrangement. Since the committee does not have any overriding powers, the recommendations of such a committee will not be binding on the authorities, the industry feels.

The industry is apprehensive about the 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.

By amending the Bill, while the government was 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.

Alarmed over the sweeping powers enjoyed by the drug control officers under the Act, the IDMA had also asked the government to clip the wings of these officers, including drug inspectors, by issuing written guidelines to be followed by them while initiating action against the drug companies under this new Act. The IDMA also asked for an amendment to Rule 51 and 52 to make it mandatory to get written consent from the controlling authority for filing prosecution against the drug companies.

The new Act stipulates stricter penalties, including hefty fine and non-bailable arrest, for manufacturing and marketing of spurious drugs. The Drugs and Cosmetics (Amendment) Bill, 2005, was passed by Parliament with a voice vote in November 2008 without taking into account the industry concerns.