After shying away from tabling the Patent Amendment Bill in the Parliament in a polarising political clime, the state is now thinking of a "tactical delay strategy" on the other intellectual property-related demand from drug MNCs - 'protection' of costly and time-consuming clinical research data.

Government sources told ET that taking a final view on the complex issue now would be risky as its political acceptability could be decided by ideology rather than rationality.

Besides, delaying the final report on data protection could give the state a handle in future negotiations with the US and wrest some gains.

Despite repeated assurances, the government did not feel confident about introducing the patents bill in the Parliament even as the BJP kept its cards close to its chest while the Left parties opposed many provisions it felt were unfavourable to the local pharma industry.

The term 'data protection' is explained differently by different ministries as well as sections of the industry, which are lobbying to get a favourable interpretation as the final view could lead to changes in the Drugs and Cosmetics Act and the Pesticides Act.

It would directly impact the entry of a drug's generic equivalent not only in the local market, but also in the $10bn global generics market.

MNC drug makers do not want Indian rivals directly or indirectly relying on the 'knowledge' they have developed through costly and time-consuming clinical trials.

A section of the government believes there is a difference between what the MNCs want and what they ask forBig pharma demands that the safety and efficacy of data should be exclusive for their use, while what they actually want is the exclusive use of their 'knowledge' about the same. Indian health authorities do not examine the innovator's data for approving a copy, but okay a drug if it has been approved in another country. This is only due to reliance on their knowledge and not on their data," said an official.

The science behind this is that if a drug can be shown biologically equivalent to another, then it can be presumed that the safety and efficacy would also be the same without separate examination of data for this purpose.

"Therefore, the big pharma's aim of blocking a second approval by an Indian generic firm cannot be achieved even if the government concedes to their demand that their 'data (not knowledge)' will not be relied upon," said sources.

However, even with this view, if the state agrees to make a provision to this effect in the Drugs and Cosmetics Act, which would not harm the domestic industry, there could be sharp political divisions.

"The MNC demands are 'TRIPS plus', while the Left parties' views are 'TRIPS minus minus'. Therefore, we doubt if it is the right time even to announce a stance that is TRIPS-compliant but not TRIPS plus," say sources.

The government has now asked the independent members in a committee looking into the issue to give their views in writing.