Inclusion of AYUSH drugs within the purview of data protection is turning out to be another reason for prolonging the final recommendations of the inter-ministerial committee on data protection. 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 still awaiting the specifics of the categories of AYUSH drugs that can be considered for data protection to discuss in its next meeting. The committee is yet to fix a date for the next sitting, informed sources.
The inclusion of data protection for AYUSH medicines in its agenda had virtually steered the last meeting of the committee in a different direction. For a change, the committee members spent more time on a new topic instead of repeating the same old arguments on the pros and cons of data protection (data exclusivity). The Department of AYUSH, backed by a leading domestic pharmaceutical major, had explained the need to bring in data protection on AYUSH drugs that are validated using modern techniques. The committee wanted 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.
On the routine issues, the committee had refrained from making any concrete suggestions. The impression gained was that the committee 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. As reported earlier, the committee may prefer a middle path, giving both options that incorporate as well as avoid data exclusivity, to the government.