INDIAN OFFICIALS CRITICISE DATA EXCLUSIVITY PLANS

As an Indian government panel prepares to issue recommendations for the country's first data exclusivity rules, the powerful Commerce Ministry has already spoken against introducing the provisions. The Health Mnistry is also reported to have "reservations" over introducing data exclusivity in India.

R&D-based drug firms complain that a failure to ensure data exclusivity — a concept not included in India's TRIPS-compliant patent law — eases generic drug firms' capacity to reverse engineer-patented drugs using supposedly confidential data submitted to regulators.

At present, India lacks a clear regime for data protection, although officials insist that linkage mechanisms between the patent office and market regulators are functional. Meanwhile, the panel is also expected to suggest a clear definition for new chemical entities (NCEs), a key term in legal protections for innovator drugs.