Alarmed by the new provisions on spurious drugs in the Drugs & Cosmetics (Amendment) Bill 2006, the Confederation of Indian Pharmaceutical Industry is planning to take up the issue with the Union ministry of health and the members of Parliaments. The CIPI will also discuss the issue with the Drug Controller General of India (DCGI) on December 24.

"One advantage we are seeing now is that the amendment would be notified only part by part in a due course of time. We could request the government to bring in changes in the provisions before notification of the relevant part of amendment. We are also planning to discuss the issues with some 10 to 20 members of Parliament so that we can raise the matter in Rajyasabha and Loksabha," president, T S Jayshankar, said. The confederation will also emphasise that while the amendments are said to be based on Mashelkar Committee report, the government has followed the suggestions of the committee only in part and missed various vital parts of the report.

The CIPI has sent a fresh representation to the Union health ministry to have an in-depth study on the provisions before notification. The confederation suggested that the ministry should re-look at the legal options mentioned in the amendment, as provisions make the small and medium scale pharma manufacturers vulnerable to undue harassment.

With lack of definition for substandard drugs in the amendment, conditions like poor or badly performing public drug testing laboratories and unstable storage conditions, the legitimate manufacturer is vulnerable to become a producer of substandard drug which will then be considered as spurious drug according to the new norms. The situation will affect the small scale pharma industry in the country, CIPI pointed out in a letter to the health ministry.

"The genuine small scale units run by technocrats / professionals since ages, having their goodwill in the market, will be forced to quit as no body would like to operate under the threat of undue harassment and loss of goodwill due to arrest / refusal of bail for even not of standard quality report, but charges framed otherwise. It is against the very concept of promoting small scale industry in the country," explains the letter.

The letter sought the ministry to take steps to amend the act by examining the entire issue in-depth. The letter suggested that the 'criminal intent' mentioned in the amendment must be investigated by concerned officers before launch of prosecution, frame policy for prosecution and its guide lines which should be issued to all state drug controllers under sec 33-P of the Act, amend rules 51 and 52 making sanction from controlling authority, a pre condition before launch of any prosecution and not to file First Investigation Report unless the controlling authority satisfies himself on 'criminal intent'.