The Drugs Controller General of India (DCGI) Dr Surinder Singh has called an industry-government meeting on May 19 to finalise guidelines to safeguard the interests of genuine drug manufacturers from misuse of recently amended spurious drugs Act. The DCGI has asked the industry to come out with its own specific suggestion in this regard.

The Drugs and Cosmetics (Amendment) Act 2008, stipulating stringent penalties for manufacturing and marketing spurious drugs, was passed by Parliament last year and the President gave her assent in last December. The only formality left on the Bill is its notification which the ministry will be doing soon.

But the industry is annoyed with certain provisions in the Bill and wanted to rectify the Bill. As the Bill has already received President's assent, the ministry is left with not much option but to come out with some guidelines to safeguard the interests of the genuine manufacturers.

Genuine drug manufacturers in the country 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.

When the industry raised 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, will also come out with its recommendations soon.

Meanwhile, the health ministry is learnt to have 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 Act such as manufacturing and marketing of spurious drugs a non-bailable offence. This will be a big relief to the industry, especially to the small manufacturers, who have been apprehensive of its misuse.