Major industry associations in the country like IDMA, FOPE, CIPI, SPIC, etc are weighing various options to counter the situation arising out of the Drugs and Cosmetics (amendment) Bill, 2005 which was passed by Parliament without taking into account the concerns raised by the industry on substandard drugs. Left with no other option, the industry may opt for legal remedies, it is learnt.

Industry sources said that major industry associations will first meet separately to discuss the issue internally before calling a combined meeting of associations to draw a common strategy on this issue. As Diwali celebrations are round the corner, the issue will pick up momentum next week.

The industry will first ask the government to take some corrective measures to meet the concerns of the genuine drug manufacturers. It will ask the union health ministry to incorporate certain provisions defining the word 'substandard drugs' which is missing in the Bill at its present form. "While all these are options before the industry, there is legal option too as a last resort," a senior industry association leader said.

While the rejection of the proposal for the formation of a new Central Drug Authority (CDA) by the Amar Singh led Parliamentary committee was a big breather for the industry, the passing of Drugs and Cosmetics (amendment) Bill, 2005 with voice vote was a big setback to the industry as it is concerned about the lack of provisions to safeguard the interests of the genuine drug manufacturers.

Since there is no separate 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 this Act, the manufacturer will be arrested and by the time he proves his innocence it will be months, or even years.

Meanwhile, the industry has already voiced concerns in this regard. SPIC, representing mostly small scale drug manufacturers, has sought the intervention of the Prime Minister in this matter. "If no provision is made in Bill to safeguard legitimate and genuine manufacturers, most will be forced to exit the dector and very few players will remain in the field of pharmaceutical manufacturing in times to come," the SPIC has warned.