The department of pharmaceuticals (DoP) of the Union chemicals ministry has decided to re-open the issue of data exclusivity, which was earlier turned down by both the Satwant Reddy panel and the Union health ministry. "There does not appear to be any need for a separate statute for data protection in India. Adequate provisions of data protection can be introduced in the Drugs and Cosmetics Act, 1940 and the Insecticides Act, 1968. Suitable amendments to be made in this regard have been recommended," the Reddy report had said.

According to sources, the DoP will soon re-open the issue and will have a comprehensive discussion with the stakeholders on the issue. However it is not yet clear whether the department will once again involve other industry associations other than the OPPI which represents multinational companies in India who are the only supporters of data exclusivity.

The Satwant Reddy panel, constituted by the Union chemicals ministry in February 2004 to frame a government policy on data exclusivity issue, had submitted its report on May 31, 2007. The panel, set up to decide on the protection of undisclosed information under Article 39.3 of TRIPS Agreement, recommended necessary changes in the Drugs and Cosmetics Act so that the protection to data qualifying as trade secrets is ensured. However, during the transition period, the government would make minimum protection to the MNCs against leakage or unauthorised use of their data.

The Union health ministry is also against granting data exclusivity to pharma companies in India. The ministry had made its position clear in this regard in an affidavit to the Delhi High Court in the Bayer vs Cipla case recently.

Union commerce ministry is also opposing the data exclusivity.

Data exclusivity is one of the most controversial issues in the current discussion on pharmaceutical intellectual property policy-making globally. It is aimed at protecting and safeguarding pharmaceutical registration files, i.e. the data submitted by pharmaceutical companies to drug regulatory authorities for the purpose of obtaining marketing approval for new drugs. Data exclusivity refers to a practice whereby, for a fixed period of time, drug regulatory authorities do not allow the registration files of an originator to be used to register a therapeutically equivalent generic version of that medicine.