The industry associations' concerted efforts to rectify the Drugs and Cosmetics (Amendment) Bill, 2005 by incorporating certain provisions to safeguard the genuine manufacturers may not succeed as the Bill, which was passed by Parliament, has already been sent for the President consent. Once the Bill gets the President's seal of consent, the only formality left is to notify the Bill to decide the date of its validity.

According to sources, senior health ministry officials have expressed their helplessness in the matter as the Bill has already gone out of the ministry's jurisdiction. The only department which can interfere at this late stage is the PMO (Prime Minister's Office) and the probability of PMO interference in this matter is remote, sources said.

Alarmed, rather lately, over the consequences of the Bill, major industry associations like IDMA, FOPE, CIPI, SPIC, etc had met senior health ministry officials urging them to take up the issue with higher authorities in the government. The industry expressed its view that if the Bill is implemented in its present form in letter and spirit, it will adversely affect the industry as even the genuine manufacturers can be falsely framed in the absence of any definition on substandard drugs.

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 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. Since this is a non-bailable offence under the proposed Act, the manufacturer will be arrested and by the time he proves his innocence it will be months, or even years.

The Drugs and Cosmetics (Amendment) Bill, 2005, was passed by Parliament with a voice vote in November without taking into account the industry concerns.

Meanwhile, there is a view that the industry has itself to blame for the goof up in the matter as it responded to the Bill at the eleventh hour only when the Bill was on the verge of its passage in Parliament. Had the industry mobilised the kind of pressure it exerted in the case of CDA Bill, the industry could well have thwarted the Drugs and Cosmetics (Amendment) Bill, 2005 in Parliament, observers feel.