IPA sees hidden agenda in MNC demand for extension of data exclusivity – delaying the launch of new products in India.
IPA sees hidden agenda in MNC demand for extension of data exclusivity – delaying the launch of new products in India
MUMBAI: Data exclusivity (DE) has been a hot issue in the pharmaceutical industry since India entered the new product patent regime in 2005. If DE is implemented, the domestic manufacturers, who have been raising a hue and cry against it, have to face another hidden problem in the issue - extension of DE.
DE assures that the information submitted by the innovator while seeking an approval for marketing will 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.
As the MNCs are pushing the government to implement DE for a minimum of 5 years, experts point out that the exclusivity may be continued even after the patent has expired. In other words, Indian generics manufacturers will not be able to manufacture or export the generic version even after the patent is expired.
DG Shah, secretary general, Indian Pharmaceutical Alliance (IPA), says, “If a drug which has been granted 20 years of patent protection in the US gets marketing nod in India in the 17th year and also gets a five-year DE, it prevents the generic version of the drug from being launched in India as well exported outside India after the patent protection has expired.”
Secondly, if a period of DE is also granted when an existing medicine obtains marketing authorisation for a second or new indication, DE could be extended beyond the period of exclusivity of the originator product.
PhRMA (Pharmaceutical Research and Manufacturers of America), which has been lobbying with the government to implement the data exclusivity clause, is learnt to have asked the government to grant DE from the date of first commercial sale, not the date of marketing approval in India.
In a letter addressed to the secretary, department of chemicals and petrochemicals, IPA has demanded the need for data protection instead of DE. The data should be protected from the competitor companies for using to make generic version and whoever uses the data for ‘unfair commercial use’ should be punished, IPA demands.
IPA says, “The PhRMA demand for 5-11 years of DE from the date of commercial launch is part of the hidden agenda for delaying the launch of new products in India, which deprive patients of access to new medicines.”
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