New Delhi: India has started approving speedily applications for early-stage human trials for new drugs, earning applause from the country’s drug makers. But experts caution lack of expertise in the testing business should be factored in while clearing such requests.
Such trials, also called Phase I drug testing, are the first time a drug gets tested on humans (typically, in a group of less than 10) after extensive animal testing. Indian laws allow such tests of only locally-developed drugs, not those discovered by foreign drug firms.
The contrast is evident in a comparison as recent as the year’s beginning. In January, half a dozen of what are called investigational new drug or IND applications were submitted to the regulator, drugs controller general of India, or DCGI, seeking permission for Phase I trials.
The hearing for the applications came up only in July—a lag of six months. It was only two months later, in September, that companies involved were informed of the status of their application. Miffed with the delay, Swati Piramal, director, strategic alliances, Nicholas Piramal India Ltd, in her capacity as senior vice-president of industry lobby Associated Chambers of Commerce and Industry wrote to Prime Minister Manmohan Singh earlier this month urging decisions on such trial applications be made within 30 days keeping with the practice in the West.
Surinder Singh, the current DCGI, says the January to September delay came about because a committee tasked with IND approvals, usually headed by the director general of the Indian Council of Medical Research, or ICMR, had to be reconstituted. Since its reconstitution, the committee has met twice—on 11 September and 26 September—and cleared pending IND applications.
At the first meeting, two drug molecules filed by Ranbaxy Laboratories Ltd and one from Natco Pharma Ltd were approved for Phase I clinical trials. Some additional information was asked for on the applications of Nicholas Piramal,Lupin Ltd, Cadila Healthcare Ltd and the state-run Council of Scientific and Industrial Research, and the Piramal trials were approved at the second meeting.
Singh insists the approval process at the IND committee will not take longer if the applicants can give all information needed, including the rationale and logic behind the proposed human trials. The IND committee will try to meet at least once a month, he said.
But this new-found zeal in such approvals may prove costly, says an expert. Editor of the Monthly Index of Medical Specialities C.M. Gulati says regulatory approvals for Phase I human trials should be given carefully considering there have been cases in the US and UK where molecules that did not show any effect on animals have killed humans. “If the approval is given, and someone dies during the clinical trial, the responsibility comes upon the government,” he says.
Phase I trial applications are still in single digits in India. Until April 2008, according to DCGI data, India had 32 Phase I trials in progress against the US’ 6,324.
N.K. Ganguly, a former ICMR director general, who also heads the IND committee, says the one-month time frame within which approvals are given are only for those applications that have no hints of problems in its toxicity report and other data. “This timeline is fine for a molecule that we find is logical and safe, else it could take longer,” he clarifies.
Still, there are calls to beef up the IND approval team. Piramal has asked for separate committees for each therapeutic speciality. “The current IND committee doesn’t have the kind of expertise required for the diverse candidates awaiting approval. We have requested for a dedicated team of experts,” says Venkat Jasti, chief executive of Suven Life Sciences Ltd, which recently got the regulator’s nod for human trials of a molecule aimed at treating Alzheimer’s disease.
M. Venkateswarlu, a former DCGI, suggests taking a step further. He strongly supports permitting Phase I human trials in India of drugs developed by foreign-owned firms. “This will help us in building both expertise and experience... (and) will only improve India’s infrastructure and standing in this area,” he says.
Despite the speeding up of approvals, some firms are not happy. Glenmark Pharmaceuticals Ltd, a drug maker with the most molecules at various stages of clinical testing, for instance, has not initiated a single Phase I clinical trial on humans in the country. It primarily works with overseas research organizations with rich experience in such clinical trials. “A secondary reason could be (delays in Indian) regulatory approvals but we haven’t even reached that issue yet,” says Glenmark managing director Glenn Saldhana.