Industry lobby seeks clinical trial approval in 30 days

October 6th, 2008 - 6:27 pm ICT by IANS  

Manmohan SinghNew Delhi, Oct 6 (IANS) An industry lobby Monday sought Prime Minister Manmohan Singh’s help to get approval for clinical trial of drugs within 30 days of a pharmaceutical firm fulfilling the requisite norms.The Associated Chambers of Commerce and Industry of India (Assocham) Monday said at present, a pharmaceutical firm has to wait at least eight months before the clinical trial is approved.

“India takes a minimum of eight months to accord clinical trials approvals whereas in Canada, the UK, and the US, clinical trials approval are given in a month’s time,” Assocham senior vice-president Swati Piramal said.

Piramal, also director of strategic alliances with pharma major Nicholas Piramal, said she had given representation to Prime Minister Singh, requesting him to direct the ministry concerned for speedy approval of clinical trial requests.

“The delay in granting approvals needs to be corrected as domestic pharmaceutical companies spend huge money on research and development (R&D) to come out with most innovative medicines and life saving drugs,” she said in a statement.

Assocham has also urged the prime minister to allow pharma companies to hike price of non-schedule drugs or drugs which can be bough over the counter by 20 percent every year in view of rising input costs.

“Instead, the ministry of chemicals and fertilisers is threatening the industry by bringing non-schedule drugs under price control,” Piramal said.

“If such a hostile attitude of the government continues towards pharmaceutical industry, many more multinational companies will devour the domestic pharma units just as Ranbaxy was recently taken over by a Japanese multinational firm (Daiichi Sankyo),” she added.

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