After almost two years of discussions with various stakeholders, the Centre is learnt to have accepted the recommendations of Dr Satwant Reddy committee on data exclusivity and may offer 'protection against disclosure' to the pharma companies. However, the government may take some more time to announce its decision on 'Protection against unfair commercial use' as the Union ministry of health and the department of pharmaceuticals wanted stakeholders to get further engaged in a dialogue before final details are worked out.
According to sources, the government has accepted the recommendations of Dr Satwant Reddy committee as far as 'protection against disclosure' is concerned and may announce the same soon. "Government should take adequate steps to ensure that specified undisclosed data submitted for seeking marketing approval for pharmaceutical products is not disclosed to any third party. Officials in the office of Drug Controller General of India should be under obligation to keep secret the undisclosed information submitted to Drug Regulator for approval of new drug," the Dr Reddy committee had recommended.
A decision on data exclusivity in the context of Data Protection Provisions of Article 39.3 of Trips Agreement has been on hold for the last more than five years. An inter-ministerial consultative committee headed by Dr Satwant Reddy, then secretary in the chemicals ministry, was constituted in February 2004 to assist the government to recommend appropriate measures on the obligations for the protection of trade secrets, especially the proprietary test data submitted by innovators to government.
Dr Reddy committee, which recommended a 'calibrated approach' for implementation of Regulatory Data Protection, submitted its recommendations to the government on May 31, 2007 and since then the government has been engaged in discussions with the stakeholders.
The Regulatory Data Protection has two parts, protection against disclosure and protection against unfair commercial use. While the government has more or less decided on the former and will announce the same soon, discussions are on with stakeholders on protection against unfair commercial use of the test data which would be submitted by the innovator companies to the government for various purposes including marketing nod for the product.