The Associated Chambers of Commerce and Industry of India (ASSOCHAM) has appealed directly to the country’s prime minister to intervene over long delays in getting clinical trials off the ground.
ASSOCHAM’s senior vice president, Dr Swati Piramal, who is also director of strategic alliances at Indian pharmaceutical company Nicholas Piramal, urged Prime Minister Dr Manmohan Singh to lean on the Ministry of Chemicals and Fertiliser over waiting times for clinical trial approvals. The association has already lobbied the ministry on the issue, as well as the Indian Health Ministry, but without making any concrete progress.
ASSOCHAM would like to see a standard 30-day approval deadline introduced for clinical trial applications by the domestic pharmaceutical industry. Dr Piramal suggested that long bureaucratic processes in the Health Ministry and other government departments were undermining the industry’s ablility to patent innovative drugs.
The “serious implication is that the competitors of domestic pharmaceutical industries take advantage, as it is difficult to keep pharmaceutical innovations confidential”, ASSOCHAM said.
As Dr Piramal pointed out, India currently takes a minimum of eight months to approve clinical trial applications, whereas in countries such as Canada, the UK, the US and the Netherlands the process only takes a month.
A recent report by PricewaterhouseCoopers identified significant delays in securing clearance for clinical trials as a regulatory barrier that diluted the attractions of pharmaceutical outsourcing to some Asian markets.
Delays of up to 12 months are “not uncommon” in China and, despite recent moves to streamline approval processes, nine-month waits are “typical” in India, the report warned.
