Breather for local drug firms

A government committee has ruled out the possibility of India stopping its local pharma firms from relying on drug trial data of multinational pharma companies. This implies that local companies will continue to use this data for selling copycat versions of drugs invented by MNC firms.

It has also suggested that data protection be given for five years to those firms that produce medicines based on traditional systems such as ayurveda.

Similar protection will be extended for three years to agro-chemicals such as pesticides.

Once accepted, these proposals would provide temporary relief to domestic drug companies. Public interest groups in India have been demanding data protection for the pharmaceutical sector.

Because of the high costs, research is dominated by foreign MNCs and this order is a setback for them. The inter-ministerial committee, headed by chemicals secretary Satwant Reddy, submitted the report on May 31 to the ministry of commerce. The committee took three years to finalise the report.

However, the committee has sent a positive signal to multinational companies by suggesting that the government explore the possibility of introducing a five-year data protection system for pharma in the future.

"We have recommended a series of measures to strengthen the privacy of undisclosed data submitted by drug companies to the drug regulator (Drugs Controller General of India) for marketing approval purposes. There is also a need to ensure that the drug regulator grants relaxation in the generation of test data for generic companies after the expiry of a "specific time period" in which the originator's drug was available in foreign markets."

Gurdial Singh Sandhu, joint secretary, Department of Chemicals and Petrochemicals said.

The government has been under tremendous pressure from the US to introduce a system of data protection in pharmaceuticals. The primary reason why India figures in the Priority 301 Watch List of the US Trade Representative as a country that lacks adequate intellectual property protection is the absence of 'data protection' in pharmaceuticals.

With the committee suggesting the continuation of existing drug approval system with suitable modifications to Drugs and Cosmetics Act 1940 and Drugs and Cosmetics Rules 1945, hopes for data protection have temporarily subsided.