Data exclusivity proposal for pharma sector turned down

The commerce ministry has rejected demands to grant data exclusivity to pharma companies.

"We are against any proposal to provide data exclusivity to pharmaceutical companies," a ministry official said. The department of fertilisers has been demanding that India enact a data exclusivity law.

The rejection comes even as a high-level committee headed by secretary of the fertiliser department is finalising a report on the issue. The rejection benefits the indigenous generic drugs industry as it can continue to use data of other companies including MNC giants, which invest heavily in R&D.

Data exclusivity provides for a period of protection during which test and clinical trial data for a drug manufactured by one company cannot be used by another company to get the right to market a similar drug.

The commerce ministry has been discussing the issue with its chemicals and fertilisers counterpart. The former is of the view that data exclusivity is not mandatory.

"Data exclusivity is not mandatory under the TRIPS agreement and there is no need to have such a law. India has provisions for data protection, which is mandatory under TRIPS," the official added.

When manufacturers of generics apply for approval for their drug, they claim having a similar molecular structure to the originator's product and thus escape the need to themselves conduct tests. Instead, they just make a reference to competitor's data submitted for approval at the patent office.