The government has constituted a high-level inter-ministerial committee to consider steps to be taken in the context of the provisions of an article of the TRIPS agreement for the protection of undisclosed information.

Faced with mounting pressure from multinational drug companies and stiff opposition from domestic drug firms over 'data exclusivity,' the government set up a panel to examine whether data protection can be offered under the existing legal provisions or an appropriate new dispensation was required for it.

The committee which has secretary, department of chemicals and petrochemicals as its chairman, has 14 members, including Biswajit Dhar of Indian Institute of Foreign Trade, advocates Praveen Anand of Anand & Anand, Pallavi Shroff of Amarchand Mangaldas & Suresh Shroff and drug controller general of India Ashwani Kumar, official sources said. It also has the joint secretaries of departments of industrial policy and promotion, health, agriculture, science and technology, biotechnology, scientific and industrial research, legal affairs, chemicals and Y Tsering, secretary of the Central Insecticides Board.

While multinational drug and chemical companies were putting pressure on the government for introducing an enabling provision, domestic companies and associations were opposed to the idea saying the provision was already present in the Schedule Y of the Drugs and Cosmetics Act.

Before a new patented drug enters the market, it is put through a series of studies and trials, results of which are submitted to the drug controller, whose approval is based on the data submitted.

MNCs want generic producers and drug control authorities not to be allowed to use the data provided earlier (on grounds of the protection of undisclosed information), which is termed as data exclusivity. 'Undisclosed information' is recognised in Article 39.3 of the TRIPS Agreement as an intellectual property to be effectively protected against unfair competition.

The domestic drug lobby, however, feels this would defeat the purpose of the Doha Declaration and lead to the evergreening of patents. - Agencies