A policy on data exclusively may be indefinitely delayed as there is no indication of its finalization by the government. The inter-ministerial committee for protection of undisclosed information under Article 39.3 of TRIPS agreement under the chairpersonship of chemicals secretary Satwant Reddy is yet to finalise the report, it is learnt.
The sources said, that the report would be forwarded 'soon' as the committee had already heard the views of most of the concerned parties. The engagement of the officials with the ongoing process of finalizing the National Pharmaceutical Policy and pending of a final decision on the R A Mashelkar Committee report on Patent Act are believed to be the reasons behind the delay, it is felt.
Given the divergent views between the Ministries and the interested groups including the pharma companies, the committee is likely to include all views in its report, as the Government wanted an amicable view with least controversies.
As per the current indications, data exclusivity is to be for five years with sufficient in-built safeguards to overrule the exclusive rights in case of national emergency. The exclusivity clause is not to be applicable for export of drugs.
The committee, almost one year into the process of holding discussions and meetings with the concerned teams, was expected to submit the report months ago. But the controversy over the piracy allegations of the Mashelkar committee report on patent law and subsequent resignation of the eminent scientist as the head of the expert committee, and the belated efforts to shape the pharma policy have hogged more attention of the pharma circles, leaving the data exclusivity committee to remain less in headlines.