Left with no other option to stall the 'dangerous looking' Drugs and Cosmetics (Amendment) Bill which has already received the President's assent early this month, the drug companies, as a last resort, have approached the Union health ministry to halt the notification of the controversial Bill. The ministry is learnt to have received hundreds of telegrams from individual drug companies in this regard.

Now that the Bill has received the President's approval, the only formality left with the ministry to make this Bill into a law is to issue a notification to decide the date of its validity. The industry wanted to rectify the Bill as certain provisions in this Bill will have far-reaching consequences on the genuine manufacturers. It is apprehensive of certain provisions which may be misinterpreted and even the genuine manufacturers may end up in jails for no faults of theirs.

While the industry associations like IDMA, FOPE, SPIC and CIPI are working overtime to influence the government at high level to rectify the Bill to safeguard the genuine drug manufacturers, the individual companies have started approaching the health ministry directly by sending telegrams to stall the notification of what the industry termed as 'dangerous looking' Bill.

"Drugs Act Amendment 2008 lacks safeguards for honest manufacturers Government eliminating SME by unfair laws to facilitate swindling of consumer by multinational takeover starting Ranbaxy," read a telegram to secretary, health ministry, Naresh Dayal. "Lack of safeguards for honest manufacturers in drugs act amendment 2008 is another unfair law to eliminate SME encouraging multinational takeover to rip off consumer," read another telegram.

The Drugs and Cosmetics (Amendment) Bill, 2005, was passed by Parliament with a voice vote in November this year without taking into account the industry concerns. Though the industry had voiced its concerns over some of the provisions in the Bill, the industry has itself to blame for the goof up in the entire matter as it responded to the Bill at the eleventh hour only and by that time the Bill was on its way to the passage in Parliament.

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. Since this is a non-bailable offence under this Act, the manufacturer will be arrested and by the time he proves his innocence, the damage will be done. The industry is of the view that if the Bill in its present form will adversely affect the industry as even the genuine manufacturers can be falsely framed in the absence of any definition on substandard drugs.