New Delhi: Ministry of Law and Justice has notified the long awaited Drugs and Cosmetics (Amendment) Act, 2008 (26 of 2008) on 5th Dec, 2008 in Gazette of India (extraordinary) Part-II, section 1.

This Act and provisions of enhanced penalties would be effective from such date as the Central Government may, by notification in the official Gazette, appoint. A provision is also made in the Act for different dates for commencement for different provisions of the Act.

The Drugs and Cosmetics (Amendment) Bill, 2008, was passed by Parliament with a voice vote in November without taking into account the industry concerns.
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.