Even as the high level committee, headed by the secretary of Chemicals and Fertilizers Ministry is busy finalising its recommendations on whether or not to grant 'data exclusivity' provisions, the Commerce Ministry has indicated that they are against any sort of 'data exclusivity' that goes beyond 'data protection.'

According to Dr Ajay Dua, secretary, Department of Industrial Policy and Promotion (DIPP), his department ensures the protection of the data that is being submitted to both the Patent Office as well as the office of the Drugs Controller General of India. However, it cannot lead to data exclusivity, which is not mandated under the TRIPS.

Dr Dua said that the committee under the Chemicals and Fertilizers secretary is very clear in its stand and is trying to finalise ways to ensure 'data protection.' The committee is attempting to see the laws that need to be amended to have this protection in place.

He agreed that there are pulls and pressures from multinational as well as domestic pharmaceutical industries on the issue of data exclusivity. The final decision will be taken keeping in view the larger interest of the country, he hoped.

Interestingly, the recent meeting of the Data Exclusivity Committee had also failed to reach at a consensus on the issue. Both DIPP and Department of Health are known to have expressed their reservations against the introduction of 'data exclusivity.' The Health Ministry had even said that no final decision on 'data exclusivity' can be taken until the Mashelkar Committee instituted to recommend the Indian definition of a 'new chemical entity' submits its report.

The data exclusivity committee is known to have decided that their final views on 'NCEs' and 'market exclusivity' should be taken only after Dr Mashelkar comes out with its recommendation.