News: Pharma Inc split on data exclusivity

(DNA 04/08/2006) Mumbai - The brouhaha over data exclusivity in pharma is getting shriller. The rift between those supporting the regime and those opposed to it has widened further with the most prominent industry body, the Indian Pharmaceutical Alliance (IPA), itself getting divided.

Data exclusivity assures that the information submitted by the innovator while seeking an approval for marketing would be kept confidential by the government for a fixed period of time, especially from the generic drug manufacturers who could make copycat versions using the data. MNCs have long been demanding the implementation of data exclusivity. Turn to Page 21

So far, IPA has been opposed to the grant of data exclusivity saying it would reduce people’s access to cheaper medicines. It has instead proposed ‘data protection’ of up to three years. DG Shah, secretary general, IPA, told DNA Money, “In our letter dated July 8, addressed to the secretary, department of chemicals and petrochemicals, we made clear IPA’s stand.”

However, some IPA members have started seeking a bigger protection. Ramesh Adige, executive director, Ranbaxy said, the company was of the view that “up to 5 years data protection, only for new chemical entities, can be provided along with sufficient safeguards which, inter alia, will ensure that the data protection period should not exceed the patent term, thereby ensuring entry of the generic in time.”

Interestingly, IPA was the brainchild of late Parvinder Singh, promoter of Ranbaxy.

Indeed, while the helmsmen claim otherwise, IPA members have started taking the side of MNCs on the issue. Those who earlier made a hue and cry against the regime, now seem to have realised that they are also research-oriented companies and would need data exclusivity in future.

Shah, however, played these down as “the companies’ stand, not IPA’s.”

The change in the stand of IPA representatives came to the open at a workshop on data protection organised by the health ministry in New Delhi recently where a number of pharma majors including Nicholas Piramal are said to have spoken in support of DE.

Swati Piramal, director, Nicholas Piramal, told DNA Money, “As a research-oriented company, we realise the need for data exclusivity, which will support the efforts of companies launching NCEs. We quit IPA three years back arguing for data exclusivity. At that time, IPA members were not concerned about the issue. Now they also realise the need of data exclusivity to protect their innovations.” Piramal, too, is in favour of a five-year data exclusivity.