The industry has urged the government to rectify the Drugs and Cosmetics (Amendment) Bill, 2005 by incorporating certain provisions defining the word 'substandard drugs' which is missing in the Bill at its present form. An industry delegation met the DCGI in this regard.

Industry sources said that representatives of major industry associations like IDMA, FOPE and CIPI met DCGI Dr Surinder Singh and urged him 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.

The delegation asked the DCGI to take up the issue with higher authorities like secretary in the Union health ministry to convince them on the need to take some corrective measures to meet the concerns of the genuine drug manufacturers. Meanwhile, the industry is making efforts to meet Union health minister Dr Anbumani Ramadoss to apprise him of the industry's concerns in this matter.

Industry is concerned about the lack of provisions to safeguard the interests of the genuine drug manufacturers. One of the major concerns of the industry in the Bill is the lack of definition on substandard drugs. 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, which was passed by Parliament with a voice vote, has been sent to Rashtrapathi Bhawan for the President's approval. The industry is agitated over the fact that the Bill was passed without taking into account the concerns raised by the industry. The industry alleged that it did not get sufficient time to react to the provisions in the Bill as while it was busy studying the provisions in the Bill, the government rushed the Bill in Parliament which was passed even without a discussion.