The pharma industry may soon drag the government to court on the issue of implementation of the Drugs and Cosmetics (Amendment) Act, which gives sweeping powers to the authorities including the drug inspectors and the police to act against manufacturing and marketing of spurious drugs.

According to sources, the industry is left with no other option, as the legal cell of the Union health ministry is learnt to have turned down the recommendation to frame some guidelines to the Act to safeguard the interests of genuine drug manufacturers from misuse of the Act by the authorities.

The Drugs and Cosmetics (Amendment) Bill, which stipulates stringent penalties for manufacturing and marketing spurious drugs, was passed by Parliament in October last year and it received President Pratibha Patil's assent in December last year. But the union health ministry is yet to notify the Act as the ministry, due to the outcry from the industry, had agreed to rectify the adverse features in the Bill to allay the fears of the genuine drug manufacturers by introducing certain guidelines on the Act.

As the industry voiced its concerns on the misinterpretation of certain provisions in the Act, the DCGI constituted a sub-committee under deputy drug controller (south zone) D Roy to come out with some effective safeguard measures to curb possible abuses of the provisions of the Act. The committee, which heard the views of the industry associations, came out with its recommendations.

The ministry also decided to notify the Act in a phased manner to allay the fears of the industry about the Bill. The ministry is also learnt to have decided to shelve the harsh provisions of the Act such as manufacturing and marketing of spurious drugs a non-bailable offence. This would have been a big relief to the industry, especially to the small manufacturers, who have been apprehensive of its misuse.

But, as the legal cell of the ministry has turned down the proposal to attach the guidelines with the Act, the industry does not have much option but to knock at the doors of the court, sources said.

Genuine drug manufacturers fear that if the Act is implemented in its present form, it will have far reaching consequences as there are several provisions in the Act which can be misinterpreted and misused by the authorities, especially the drug inspectors who have been given sweeping powers in the Act. The industry fears that some of the provisions in the Act are so anti-industry that there will be no option for the genuine drug manufacturers but to leave the industry.

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.