Clinical trials: pharma firms, labs told to justify benefits for India – The Hindu Business Line
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Pharmaceutical companies, research labs and others looking to conduct clinical trials will now have to justify the research. India is seen as a cheap destination for clinical trials and companies often test products meant for overseas markets here.
A new order issued by the Central Drugs Standard Control Organisation makes it compulsory for these entities to prove why the research needs to be conducted in India.
Parameters set
The order has made it mandatory for them (companies/research labs) to furnish details on three new parameters while filing applications. They are: assessment of risks versus benefits to patients; details on innovation vis-à-vis existing therapeutic options; and details on unmet medical needs in the country.
In 2013. only 17 applications for global clinical trials received approval in India, against 55 in 2012. The number has been falling following controversies.
The new requirements come almost a year after the Supreme Court passed an order, in October 2013, asking the Government to assess clinical trial applications on these parameters.
The parameters have been set to protect the rights of Indian patients, said Suresh Menon, executive committee member of the Indian Society for Clinical Research, speaking to BusinessLine. “In practice, these parameters are being looked at for about a year now, but now sponsors will have to justify their applications at the onset,” he said.
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