Indian Generic Group Tells New Department Of Pharmaceuticals That Industry Is Under Attack By Multinationals
This article was originally published in PharmAsia News
Executive Summary
With the setting up of a new Department of Pharmaceuticals, the Indian Pharmaceutical Alliance, a powerful lobby of the top 11 Indian generic drug makers, has upped its ante against brand-drug multinational companies
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With the setting up of a new Department of Pharmaceuticals, the Indian Pharmaceutical Alliance, a powerful lobby of the top 11 Indian generic drug makers, has upped its ante against brand-drug multinational companies. Through the IPA, the generic drug makers in a letter sent to Ashok Kumar, the new secretary to the department of pharmaceuticals, has alleged that new initiatives are being taken by the innovator industry to create road blocks for growth of Indian generics. A July 9 letter says bodies such as the International Medical Products Anti-Counterfeiting Task Force, Standards Employed by Customs for Uniform Rights and the Anti-Counterfeiting Trade Agreement are lobbying the World Health Organization, the World Custom Organization and the European Commission to "club 'generic' with counterfeits." "If successful, they could seriously impact India's exports of generics," IPA Secretary General D.G. Shah wrote. The IPA also alleges that concerted efforts are being made by the Pharmaceutical Research and Manufacturers of America, "supported by the U.S. government, to force India to go 'TRIPS-Plus' on data protection, patentable subject matter and introduce 'patent linkage' for regulatory approvals in India." Specifically, Shah is referring to PhRMA's position that India should adopt data exclusivity as in the U.S., which provides five-years of data protection, or the European Union, which effectively provides 11 years of data protection. [Editor's note: The law firm Finnegan Henderson recently provided an in-depth look at India's data exclusivity deliberations as part of PharmAsia News' Insider Analysis series (Also see "Insider Analysis From Finnegan Henderson: India's Indecision - How To Provide Pharma Companies With Clinical Trial Data Exclusivity" - Scrip, 17 Sep, 2007.).] PhRMA also is opposed to Section 3 (D) of the Indian Patent Act, and is lobbying to modify the law to allow "incremental" changes for patenting of existing compounds (Also see "IP Protection Concerns Grow In India, PhRMA Says" - Scrip, 6 Jan, 2008.). In addition, the U.S. trade group supports an initiative by the Drug Controller General of India to refrain from issuing product licenses to generic companies for drugs that have been granted product patents (Also see "Patent Registration-Marketing Linkage Row in India" - Scrip, 17 May, 2008.). But according to Shah: "India has introduced a TRIPS-compliant regime of data protection and patentable subject matter while avoiding patent linkage having regard to: (1) Public health concerns of the developing countries for access to affordable medicines (2) Indian industry's efforts to move up the value chain in R&D and independent studies have shown that IPR protection beyond a point is counter-productive for innovation." Pointing at the increasing vulnerability of the Indian generic industry, the IPA has sought government support to strengthen the Indian pharmaceutical industry. The IPA says, as a fall out of divestment by Dabur Pharma and Ranbaxy to foreign innovator companies Fresenius-Kabi and Daiichi Sankyo recently, the Indian drug industry "would be vulnerable to takeover pressures" (Also see "Ranbaxy Alleges Rivals Of Meddling With Daiichi Sankyo Deal; U.S. House Committee Enters Fray" - Scrip, 18 Jul, 2008.). The letter also seeks a review of the current government-controlled pricing policy. "A domestic pricing policy that is not sensitive to the current trends and challenges in the global markets, ignores risk taking and does not reward enterprise could dampen initiative and growth," the letter states. |