After more than six months of passing the Drugs and Cosmetics (Amendment) Bill 2005, stipulating stringent penalties for manufacturing and marketing spurious drugs, the Union health ministry is yet to notify it. Though the exact reason for the delay in notifying the Bill is not known, it is learnt that the ministry is under immense pressure from the industry to delay the notification as there are several adverse clauses in the Bill for the industry.

The Bill was passed by Parliament with a voice vote in November last year without taking into account the industry concerns of misuse of several features in the Bill. After the Bill was passed in Parliament, the Bill received President Pratibha Patil's nod in December and the President's office sent the Bill back to Union health ministry for its notification. But even after six months, it is not notified by the ministry.

Ever since the Bill was passed in Parliament, the industry has been demanding to the government to rectify the Bill by incorporating certain provisions defining the word 'substandard drugs' which is missing in the Bill in its present form. The industry is concerned over the fact that there are no provisions to safeguard the interests of the genuine drug manufacturers in 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.

Due to the concerted efforts of the industry, the health ministry agreed to set up a committee to look into the issues arising out of the Bill. As the Bill has already received president's assent, the ministry is left with not much option but to come out with some guidelines to safeguard the interests of the genuine manufacturers.

In fact, the ministry had announced that the Bill will be notified in two parts, to keep all the penal provisions pending and will be notified after forming the guidelines.