Centre mulls law change: Firm should test before selling drug

The various ministries concerned — Health, Commerce, Chemicals and Fertilisers, Science and Technology — however, differ on the need for the amendment. The PMO has called a meeting of the ministries and the Centre for Scientific and Industrial Research on July 12, 2006.

According to the existing law, a pharmaceutical company provides test data for safety and efficacy to the drug regulatory authority to get first-time approval or registration for a new medicine before marketing it. For drugs already registered in other countries, the Drug Controller in India relies on the data already submitted to their counterparts for approval in other countries such as the US, UK or Europe.

The generic manufacturers in India only need to provide a ‘bio-equivalence certificate’ to prove that the drug produced by them is equivalent to the original. The amendment in the existing law would mean that generic manufacturers have to conduct their own tests before seeking approval for marketting the drugs in India. The data exclusivity is not likely to be restricted to patented drugs but new use or innovation of old drugs as well.

The Ministry of Health is opposing the amendment as it believes the cost of treatment will go up. ‘‘We are not against innovation or foreign investment but have to find some middle path and not go for extremes,’’ said Secretary (Health) PK Hota.

Generic drug manufacturers have already made representations to the expert group against an amendment. ‘‘Various submissions have been made to the expert group that India need not go beyond what is in the TRIPS agreement. Our immediate obligation is to complete the TRIPS agreement so that data is protected against unfair commercial use and not made available to competitors,’’ said DG Shah, secretary-general of the Indian Pharmaceutical Alliance. ‘‘This provision will create monopolies in the market which will lead to increase in the prices of the medicines as generic companies cannot cover the cost of clinical research. Even if they do, the research will take years and the generic versions will come late into the markets.’’

Those in favour of the amendment say it will help rid Indian companies remove of the copycat tag. ‘‘Indian companies are feeling unsafe to submit clinical data as it is passed to rivals in the market. So we need to feel safe to do drug trials in the country. Besides, it will encourage multinationals to do research in diseases affecting the country, which has not been happening in the past,’’ said Harinder Sikka, president of corporate relations at Nicholas Piramal.