The thriving Indian generic pharmaceutical industry has, over the past decade, earned its stripes globally as a source of reliable and cheap generic versions of exorbitantly priced medicines made by multi-national pharmaceutical companies. However, India’s pre-eminent position could take a hit if the changes in the Indian patent regime sought by the U.S. Trade Representative (USTR) are put in place.
Last week, in its annual report on IPR (intellectual property rights) laws and patents and its partner countries, the USTR announced it was continuing to keep India under ‘priority watch’ list even as it stopped short of imposing an out-of-cycle review of India’s IPR laws. The report said China and India were the sources of the most counterfeit pharmaceuticals shipped to the U.S.
The report praised the Government efforts to increase bilateral engagement in IPR matters. But the industry was surprised with the Indian Prime Minister’s statement that India needed to align its patent laws with international standards. There have also been fears raised on the unpredictability of India’s IPR regime.
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“India should not buckle under any pressure as our patent laws are already TRIPS-compliant,” D. G. Shah, Secretary General, Indian Pharmaceutical Alliance (IPA) said. On a possible fall in foreign direct investment (FDI) in the sector if it did not comply, he said, “Multi-national pharma companies have been divesting their interests here and world-wide, there is no correlation between an IPR and FDI.”
“Increased levels of intellectual property — over and above what international rules mandate — will not bring in ‘investments’ but create exclusive rights for profiteering and further serve to undermine what remains of generic competition in India,” a letter addressed to the PM and Commerce Minister from Delhi Network of Positive People (DNPP) an outfit that works with AIDS patients said.
The industry particularly wants the government not to introduce data exclusivity, which bars Indian Food and Drug Administration (FDA) from approving a competitor’s product as long as exclusivity on the data lasts even for off-patent medicines.
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Granting data exclusivity does away with the recourse to pre-grant oppositions and compulsory licensing. “Being a major producer of generic drugs, it would also hinder bulk procurers like MSF and bring into question the future of the public procurement programmes,” Leena Mehenganey, India Manager, Access Campaign, MSF (Doctors without borders), said. “Accepting it would lead to monopolies on patented and non-patented products through a regulatory process.”
A new IPR policy was to have been announced in early 2015 and the industry is still optimistic that the government will not alter the very regime that enabled India’s generic industry to grow.