Even as the pharma industry is making concerted efforts to rectify the Drugs and Cosmetics (Amendment) Bill to incorporate certain provisions to safeguard the interests of genuine manufacturers, the controversial Bill has received the assent of the President.

According to sources, the President Pratibha Patil has signed the Bill on December 5 and the President's office has sent the Bill back to Union chemicals ministry for further action. Now that the Bill has received the President's seal of consent, the ministry will soon issue a notification to decide the date of its validity.

Meanwhile, a bewildered industry has not abandoned its intense efforts to rectify the Bill as certain provisions in this Act will have far-reaching consequences on the genuine manufacturers. While the industry has appreciated the intention of bringing the Bill, 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.

"The industry will go to any extend to safeguard the interests of the genuine manufacturers. We will once again approach senior government officials and ministers to apprise them of the consequences of the certain provisions of the Bill," said BR Sikri, general secretary of Federation of Pharma Entrepreneurs (FOPE), an organisation of hundreds of pharma units in Baddi, Himachal Pradesh.

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. 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 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 entire 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.