As the domestic drug industry wins the confidence of high level inter-ministerial committee constituted to examine the need of a special provision for protection to undisclosed information, it is learnt that the 14 member panel is not in favour of creating a new provision granting data exclusivity in India.

According to informed sources, while the industry presentations called by the Committee on the issue held this week in New Delhi, it has taken the views of the local industry bodies that strongly opposes a new dispensation of Law for data exclusivity, with due consideration.

Moreover, the joint presentation made by the Indian Drug Manufacturers Association (IDMA) and Bulk Drug Manufacturers Association has created waves among the panel members in favour of the local industry. Though the other local drug industry association, Indian Pharmaceutical Alliance (IPA), could not make its presentation due to technical reasons, it had expressed its views earlier saying that an additional provision for data exclusivity cannot be justified as the Article 39 of the TRIPS Agreement does not have any mention of the same. However, the IPA would present its views on the subject on April 20 before the Panel.

Although the multinational drug companies through the Organization of Pharmaceutical Producers of India (OPPI) kept persuading the need of having additional protection for the undisclosed information beyond the existing legal provision under Schedule Y of the Drugs and Cosmetics Act, it is learnt the local industry could successfully counter the same by exposing this as an intention of multinationals to extent the patentability of molecules beyond the actual expiry.

It may be recalled that the government constituted the 14 member high level Committee under the chairmanship of the secretary, Department of Chemicals, 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.

With the Committee, the government has 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.

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.