The industry, along with global health activists and patients' groups, have made representations to the government to initiate talks with the negotiating countries of TPP.
Patent experts, who have reviewed the document leaked by WikiLeaks, said provisions sought by the US attempt to block generic entry through intellectual property interventions. For instance, the proposal seeks to protect patents for brand name medicines in some participating countries and curtail access to low-cost generic drugs, experts said. The suggested provisions also attack section 3 (d) of the Indian patent law, which prevents patenting of incremental innovation.
The Indian pharmaceutical industry, a major supplier of generics to the world, is worried that the US proposal poses a huge threat to its export revenue. According to the Pharmaceuticals Export Promotion Council of India (Pharmexcil) data, around 60 per cent of the total pharmaceutical generics produced in India are exported, clocking annual revenue of $14.7 billion. This is growing at 30 per cent yearly.
While the US is the largest importer of such products from India, domestic majors supply to various other markets, including Europe, Japan and Russia. Pharma is the fifth largest commodity exported out of India.
With so much revenue dependence on export, the domestic drug manufacturing industry is concerned that the proposed provisions in the TPP are a concerted effort of multinational corporations to obliterate the generic producing industry, which poses a serious threat to innovator companies. "It is of serious concern for the industry. We have been raising this issue for a long time and WikiLeaks have exposed it. These are concerted efforts by the European Union and the US to contain Indian exports by creating obstruction," said D G Shah, secretary-general, Indian Pharmaceutical Alliance. The IPA represents 19 domestically-based companies, such as Ranbaxy, Wockhardt, Lupin and Sun Pharma.
Industry officials are also sceptical of the government's ability to intervene and stop such provisions. India is not a party to the TPP, being negotiated between 12 countries, including the US and Japan. Other nations drafting the proposed partnership are Australia, Brunei, Canada, Chile, Malaysia, Mexico, New Zealand, Peru, Singapore and Vietnam.
China, the world's largest trading nation and also on the Pacific rim, is not one of the negotiating parties.
Medecins Sans Frontieres (MSF), an international humanitarian organisation working in 70 countries worldwide to make generic medicines accessable, said the TPP proposals currently include some of the harshest provisions against access to medicines ever included in a trade agreement with developing countries, gutting public health safeguards and leaving these countries unable to take the steps needed to protect the lives and health of their people.
Leena Menghaney, India Manager of MSF's Access Campaign, said various representations had been made to the Indian government. "We are also briefing and initiating talks with negotiating countries like Vietnam, New Zealand and others, convincing them to ask the US to take these provisions off the table," she said.
The industry is particularly concerned that in the absence of government support, the international lobby is trying to malign the domestic generic industry and delay approvals and launches.