The Prime Minister's Office (PMO) has asked the data exclusivity committee set up by chemicals ministry to finalize its views on providing data exclusivity to pharmaceuticals within three weeks. The committee is likely to come out with its views by July 20, 2006 it is learnt.

With the deadline set, the inter-ministerial meeting on data exclusivity called on July 12 has gained more significance. According to sources, the inter-ministerial meeting is to finalise its approach on pharmaceuticals on the basis of the two alternatives suggested by the chemicals ministry.

The meeting would also highlight the views expressed by the members of the data exclusivity committee. The chemicals ministry had recently asked all 15 members of the high level committee on data protection to finalize their observations on the need for ' data exclusivity' provisions under TRIPS agreement within a week. The committee, formed two years ago, had failed to arrive at a consensus due to the conflicting demands made by the multinational and domestic segments of drug industry.

The two options given by the chemical ministry are (a) protection against disclosure without any data exclusivity and (b) protection against disclosure and fixed-term data exclusivity for three years with sufficient safeguards. While the domestic industry concerns were solved in the first option, the second one is favouring the demands of the research based multinational companies. The government is under severe pressure to yield some data exclusivity to the research based companies and is likely to favour a partial control over using regulatory data for subsequent approval.

The ministry had also proposed a periodic review of the decisions that would be taken on data exclusivity provisions that may be adopted by the government in the coming months. Meanwhile, the committee is ready with its interim-report that recommends data exclusivity on fertilizers.