Wednesday, July 13, 2011

Data Exclusivity Laws In India

Data exclusivity is a protection that has been demanded by pharmaceutical companies for long. If data exclusivity protection is extended, others cannot use the data submitted by pharmaceutical companies for manufacturing generic version of the corresponding medicine.

The generic drug manufacturers can do their own research and development and generate their own approved data. However, it can take substantial amount of research, expenditure and time.

Allaying fears against conferring data exclusivity in India through bilateral trade agreements, the Commerce and Industry Minister of India has recently given assurances that India will reject any efforts to include "data exclusivity" clauses in bilateral trade agreements.

India’s insistence upon not extending data exclusivity protection may make the foreign trade agreements like EU India FTA tough and difficult to negotiate. However, despite various differences, including intellectual property rights difference and generalised system of preferences (GSP) scheme differences, positive development between EU and India is expected.

There are also talks in progress to extend utility models protection in India. Further, although we have no data protection laws in India yet India is gearing itself for the same. Further, we have no trade secret laws in India as well and the growing incidences of theft of trade secrets through cyber crimes are a cause of concern world over.

Overall the call to allow or disallow data exclusivity legal framework in India is a tough one and Indian government must consider all the aspects before taking a decision in this regard.