The Committee for Protection of Undisclosed Information under Article 39.3 of TRIPS Agreement under the chairpersonship of Satwant Reddy, Secretary, Ministry of Chemicals and Fertilizers is likely to refrain from making solid recommendations on whether or not to go for data protection with non-reliance of regulatory test data clauses in pharmaceuticals. The committee may prefer a middle path, giving both options that incorporate as well as avoid data exclusivity, thereby avoiding any 'hard decision'.
According to sources, the final report is to present the committee's views in case of a political decision to provide data protection and also register the opposing views expressed by the Department of Health and the Department of Economic Affairs. Data protection for a maximum period of 5 years with in-built non-reliability on test data for regulatory approval clause is to be included as one of the recommendations, it is learnt.
Official sources informed that the final meeting of the committee is yet to take place and the current discussions are based on the demand for inclusion of AYUSH drugs also under the scope of data protection.
"The committee is examining all the issues related to data protection. The demand for inclusion of AYUSH drugs is a recent development and we are trying to understand the type of AYUSH drugs that may be considered for data protection. The committee is yet to take a final view," sources said.
As reported, the committee had recently asked Department of AYUSH to prepare a report, with assistance from Drugs Controller General of India (DCGI), Department of Health and Indian Council of Medical Research (ICMR), on the exact nature of protection that is sought for herbal products. The AYUSH report is yet to reach the committee, it is learnt.
The last meeting of the committee had seen the Department of Industrial Policy and Promotion suggesting safeguards while including non-reliance of test data clause along with five-year data protection. The department felt that the protection should not exceed the patent life and should be restricted to New Chemical Entities that has not been previously approved for any other application. It also suggested that the period of protection should be counted from the date of first marketing approval granted to the product anywhere in the world. The meeting had decided that all conflicting views should be accommodated in the final report.