The Union health ministry appears to have put a decision on the long awaited data exclusivity policy on the backburner as more than one and half years down the line after the Satwant Reddy panel submitted its report to the government, the ministry is yet to take a decision on the issue. More interestingly, there has been no serious discussion on the issue for the last several months.
According to sources in the health ministry, there has been no meaningful dialogue on the issue for the last several months and a discussion on the issue is not in the agenda of the ministry for the immediate future. The issue is learnt to have been put in the cold storage, at least for the time being.
Meanwhile, senior officials in the Union chemicals ministry said that the ministry has done its bit and now it is in the court of health ministry to take a final decision on the issue.
The industry sources said that there has been no discussion on the issue for a long time. Though there was some heated debate on the issue immediately after the submission of the report in May last year by Satwant Reddy panel, the file concerning the issue has been gathering dust in the shelves of the health ministry. "There has been no active discussion on the issue for a long time," IPA director general DG Shah said.
The Satwant Reddy panel, constituted by the Union chemicals ministry in February 2004 to frame a government policy on data exclusivity issue, 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, suggested five year data exclusivity for pharmaceuticals with a number of safeguards.
It 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. Proprietary herbal drugs also would get a five-year data exclusivity.
As per the report, the data exclusivity period will begin from the time the drug was launched anywhere in the world by an MNC. They cannot claim for data exclusivity two years after it was launched elsewhere. It also means that the global leaders should launch it in India too at the earliest.