Pharmacy Daily | India trials blocked

New pharmaceutical clinical trials in India have ground to a halt, with the approval process stalled by the Drug Controller General of India (DCGI) which is now taking extreme caution in evaluating submissions. Between Jul and Aug 2013, the DCGI had received up to 1,122 applications - 285 of which were approved by India’s New Drug Committee but just 162 were cleared by the DCGI, according to India’s Pharmabiz.com website. Then the clinical trial process was further stalled last year when the Supreme Court of India issued an order in October staying all of the 162 DCGI approvals. The court’s judgement said it considered that the number of uncontrolled clinical trials sponsored by drug companies across India outstripped the country’s ability to safely monitor them, potentially resulting in “hundreds of deaths” from unethical practices. Only 25 Indian clinical trials have received approval to proceed in the first half of 2014.

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