Even as the health ministry is set to introduce the Drugs and Cosmetics (amendment) Bill, 2005 in the forthcoming Parliament session to invoke stringent penalties for manufacturing and selling of spurious drugs, the pharmaceutical industry has expressed concern on some grey areas still remaining in the proposed legislation.

Union health minister Dr Ambumani Ramadoss made it clear recently that the Bill would be tabled in the House during the session commencing on October 17 as the government wanted to wipe out spurious drugs from the markets and redeem the image of the pharma sector. He once again denied as 'incorrect' the reports, especially in the international media, that suggested huge presence of spurious and fake drugs in the country. "We want to impose stringent penalties including life imprisonment and non-bailable arrest for those engaging in the spurious drugs business," he said, on the sidelines of a function here recently.

However, the bill has attracted flaks from the industry for different reasons including the lack of clarity on the definition of spurious drugs. "A drug can be ineffective due to inadequate storage conditions and facilities. Will that also be counted as spurious and attract penalty on the manufacturer? There is still confusion about the very definition of spurious drug," said CIPI chairman T S Jaishankar.

The new bill had been framed also in accordance with the recommendations of the Mashelkar Committee which suggested even life imprisonment. The guilty will also be liable to pay a fine which shall not be less than Rs 10 lakh or three times the value of the drugs confiscated, whichever is more.

"This amendment shall prove to be like POTA for genuine drug manufacturers as there are a lot of areas left unattended where it can lead to harassment of legitimate pharmaceutical manufacturers. The most surprising part is the penalties for importing spurious drugs are same as in the past, but if manufactured in the country they have become very stringent," according to a senior functionary of CIPI in a letter to other industry leaders.

"We welcome the move to control the manufacture and sale of spurious drug, but on the other hand the interest of legitimate pharma manufacturer should be safe guarded otherwise no one would like to remain in this trade once the act is implemented as such," it said.

It was also pointed out that there is no separate definition of substandard drug in the act and it depends on the authority what charges they frame for any substandard drug. The industry has called for a micro study by all the stake holders and proper rectification to safeguard the interest of genuine manufacturers while booking the offenders.