The domestic pharmaceutical manufacturers have suggested the introduction of a pre-grant opposition system as prescribed under Patent Act before the grant of 'data exclusivity (DE)'. The Indian generic manufacturers preferred the introduction of a "negative list" much similar to the one existing for patented drugs to prevent the companies from acquiring DE for several key life saving drugs. They also wanted the government to ensure that the term (period) of DE begins from the date of the first marketing approval of the original molecule anywhere in the world (and not from the data of application filed in India).

The suggestions, by Indian Drugs Manufacturers Association (IDMA), has been submitted before all concerned ministries as a last alternative, as the association still gives more importance to the "Brazilian model" that rejects data exclusivity provisions in pharmaceutical sector.

According to the domestic industry submission, the surest result of DE will be rise in prices of critical drugs. "It will severely restrict competition and create additional monopoly rights. It will delay competitive generic production which is not good for the masses," IDMA has stated.

Among the safeguards suggested by the association in the eventuality of granting DE is the need for a clear definition of the law in terms of constitutional validity and in the light of Right for Information Act. "The benefits to DP holder should be commensurate with evidence based cost data of clinical work. The filing of cost data should be made compulsory", the statement suggested. Power to override DE through compulsory license or take over the drug in public health emergencies, freedom for anyone to generate the same data afresh and co-terminus of DE with the term of patent were some of the other safeguard measures suggested by the association.