Concerned over absence of data exclusivity in the country, multinational pharmaceutical companies on Wednesday said India could lose out on foreign investment in the pharma sector as protection of test data was the key to company decisions on location of clinical trials.
Stating that data exclusivity was in India's interest, Jacques J Gorlin, President of Washington-based Gorlin Group said, "Protection of test data is key to company decisions on location of clinical trials."
Speaking at a roundtable on data exclusivity organized by Assocham, Organisation of Pharmaceutical Producers and CropLife, Gorlin said the Indian pharmaceutical companies and researchers, especially in the biotech sector, will benefit from diffusion of knowledge that will result from partnerships and increased integration.
"India's technological and research and development base will expand, with resultant economic benefits," he said.
While the multinational pharmaceutical companies have been putting pressure for inclusion of such a clause in the Patents Act itself, the domestic pharma companies are opposed to such a move saying that the Schedule Y of the Drugs and Cosmetics Act had adequate provisions for protecting the clinical data.
Speaking on the occasion, Susan Phinston, associate vice president of PhRMA, an association of US pharma companies, said with such a provision Indian researchers will gain increased access to clinical trials in the country and the patients will gain from accelerated access to new medical therapies.
She said some of the Latin American countries and some developing countries had introduced such provisions in their laws.
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