Fake drugs Bill a casualty of logjam

Fake drugs Bill a casualty of logjam

The government failed to introduce a much anticipated law that would have prescribed stringent penalties for makers and sellers of fake drugs, blaming a Parliamentary furore over the Indo-US nuclear deal that saw several important pieces of legislation stall.

The Union minister for health and family welfare, Anbumani Ramadoss, had made a statement in Parliament, in response to several questions on fake drugs, that the Bill would be tabled in the just concluded monsoon session.

The ministry of health and family welfare blamed its inability to introduce the fake-drugs-related legislation on a session that was cut short by four days. It is now saying the bill would be introduced in Parliament in the winter session. A senior ministry official predicted smooth sailing for the fake drugs legislation when it is introduced.

“The Bill for stringent penalties for spurious drug makers is fully ready and should be tabled in the next session. I expect this Bill to get through smoothly. The government wants it, society wants it, consumers, industry, media, everybody wants it," said M. Venkateswarlu, drug controller general of India.

Venkateswarlu’s office is also planning a national survey to map the extent of fake drugs in India, which has been the focus of a series of articles inMint in recent months, prompting Ramadoss to say, on 6 July, that the legislation would be introduced in the monsoon session itself.

Calls to his office elicited no response for this story.

The monsoon session of Parliament, between 10 August and 10 September, concluded four days early amid furore over the Indo-US nuclear agreement.

According to PRS Legislative Research, which tracks legislation, 25 Bills were planned for introduction, of which only 16 were actually introduced. Only 11 Bills were cleared.

As many as 74 Bills are currently pending in both houses of Parliament. They include Bills for provision of social security payments for unorganized sector workers, setting up of a pension fund regulator and creation of a new pension system which seeks to provide old age income security for all individuals, including those in the unorganized sector.

As for the drugs Bill, companies as well as some consumer groups had hoped for an early passage for the proposed law aimed at tackling what is seen as high levels of counterfeit and spurious drugs sold in India and exported to countries such as those in the EU.

First introduced in May 2005, the fake drugs Bill seeks to amend the Drugs and Cosmetics Act, which lays down penalty for makers of counterfeit and spurious drugs. The punishment has been diluted from the initially proposed death penalty to life imprisonment.

The offence will also become non-bailable and cognizable, lending more teeth to the law that has largely failed to curb this menace.

A drug industry executive said the government has been “found wanting" on the fake drugs Bill. “I was hoping to see the fake drugs Bill passed in this session and that the health ministry would respond to my public interest litigation (PIL)," said Harinder Sikka, director with drug maker Nicholas Piramal India Ltd, who, in his personal capacity, has filed a PIL in a Delhi court seeking information on the status of the Bill. The PIL is pending.

The ministry of health and family welfare did, however, introduce a Bill prohibiting the advertisement and regulating the trade of cigarettes and other tobacco products. It was approved by Parliament.

Bills for regulating clinical establishments and setting up the Central Drugs Administration, too, were introduced though they await Parliament’s nod. The latter has been referred to a standing committee and a report is due in three months. Another Bill tabled was on fixing the tenure of directors of AIIMS and Post-Graduate Institute of Medical Education & Research. .

Rahul Chandran contributed to this story.