Almost nine months after the Bill was passed in Parliament, the Drugs and Cosmetics (Amendment) Bill 2005, stipulating stringent penalties for manufacturing and marketing spurious drugs, will be notified by the Union Health Ministry in a day or two as the Union health minister Ghulam Nabi Azad has signed the notification.

According to sources, as the minister has signed the notification, it may now appear in India's official Gazette any time now. Once it is notified, the peddlers of spurious drugs will face life imprisonment and/or fine of Rs 10 lakh or three times the value of the drugs confiscated, whichever is more.

And the scientists violating and conducting unsafe and unethical clinical trials will face imprisonment of five years and a fine of Rs 20 lakh. Interestingly, the fines realized in such cases will be paid to the relative of the deceased.

The Drugs and Cosmetics (Amendment) Bill was passed by Parliament with a voice vote in November last year without taking into account the industry concerns on 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. Under the law, offences relating to sale and manufacture of spurious and adulterated drugs have been made cognizable and non-bailable offences.

But, the notification was delayed due to the reservations expressed by the industry on the misuse of certain provisions in the Bill.

The industry is concerned 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 new law, the manufacturer will be arrested and by the time he proves his innocence it will be months, or even years.