Indian Committee Mulls Tighter Data Exclusivity Rules

April 11, 2005

A government committee studying reforms to India's Drugs and Cosmetics Act could recommend a tightening of protection on data submitted under new drug applications. However, any ensuing legislation is only likely to bring the country into line with TRIPS, providing clinical trial data protection without guaranteeing marketing exclusivity. While this will no doubt prove adequate for the needs of the growing local R&D outsourcing sector, it is unlikely to satisfy foreign drug firms.

The recently passed Patent Law does at least protect patents once they have been issued, but many will be concerned over the authorities' ability to enforce data ownership in the period between registration, patent recognition and the issuance of a marketing licence. India has awarded only a very few drugs exclusive marketing rights in recent years.

Some consolation can be taken from the committee's likely decision to allow marketing exclusivity for "essential" drugs on the basis of a prior registration in another country, thus eliminating the requirement to carry out local trials in such cases. In general, any improvement of India's recognition of foreign submissions will be a welcome change.

Further, reports suggest penalties against the misuse of data or breach of confidentiality could be tightened, making anyone guilty of such infringements liable to injunctions and payment of compensation. Despite these positive moves, however, many drug firms will no doubt pay close attention to India's progress on enforcing trial data and patent protection.