The Committee for Protection of Undisclosed Information under Article 39.3 of the TRIPS Agreement under the chairpersonship of Ms. Satwant Reddy, Secretary, Ministry of Chemicals and Fertilizers will soon finalise the modalities for data protection on herbal products. The committee has 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 Department of AYUSH had asked the committee to expand the scope of data protection from allopathic drugs to Indian systems of medicine also. It felt that data protection in the form of non-reliance by the regulator for subsequent approvals for herbal products could help investment in R&D in this segment. However, it was not very clear on what types of herbal products could come under this category. Since the ingredients that go into most of the herbal medicines are in public domain, it was felt that data protection may not be practical in its case.
It is to avoid this confusion, the committee suggested AYUSH to come out with a report clearly defining the term 'herbal product' for the sake of data protection. It also wanted the report to specify the level of protection that can be granted and the purpose it would serve. The Department of AYUSH is to submit its observations after consultation with the industry.
It is learnt that the industry is seeking data protection for drugs that are marketed as OTC. Such drugs are cleared by DCGI on the basis of efficacy studies carried out using modern parameters.