Regulatory Data Protection in India

Though India was required to fully implement TRIPs-level intellectual property rights protection including regulatory data protection by January 1, 2000, India is not yet fully TRIPs compliant. India conditions its marketing approvals on prior approvals in another country and does not require submission of data to the Indian Regulatory Authority; Govt. of India’s argument is that Art. 39.3 of TRIPs does not apply to Data Exclusivity. Rules 122 A and 122B of the Drugs and Cosmetics Rules, 1945 provide that the Drugs Controller General of India, for granting marketing approval for the import and /or manufacture of a new drug, can exercise its discretionary power and rely on ‘data available from other countries’. For several years, the Drugs Controller General has exercised this discretion as a rule rather than an exception.

TRIPs, however, does not expressly limit Data Exclusivity Protection to data submitted directly to a government. TRIPs requires that data submitted should be protected against disclosure as well as against reliance, but India relies on test data submitted by the originator/inventor to the concerned authority of another country/jurisdiction.

CLG Regulatory Data Protection Practice

CLG has been actively involved in a number of research and policy matters on Regulatory Data Protection. Keeping in view India’s TRIPs commitments and the need to encourage Research and Development further more, Corporate Law Group has been espousing for introduction of a proper Data Exclusivity law in India.