Data exclusivity debate for India

A deadlock between India's generic drugmakers and research-based pharmaceutical firms on the issue of data exclusivity has led to the federal Department of Chemicals and Petrochemicals to look for a "balanced approach," via an inter-ministerial meeting.

The emergence of Indian drug firms that see their future as working with foreign partners on R&D and contract clinical trials, including in the biotechnology sector, has led to an interest group that is campaigning for tougher data exclusivity rules.

Harinder Sikka, president of corporate affairs for Nicolas Piramal India, speaks for one of the firms that sees tighter enforcement ofintellectual property rights as being the way forward for India's drugs industry. "The data protection should be for a period of five years starting when the company markets its products in India, or end with patent expiry, whichever is earlier. The DCGI [Drugs Controller General for India] should put in a mechanism to protect confidentiality, special provision of data submitted for clinical trials, to be kept confidential by the regulator," he told the Pharmabiz.com, adding that it was imperative that data exclusivity would need to be granted after a patent had been awarded in India.