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Centre insistence on 6 months time frame for trial approvals by DCGI helps to pick up clinical research in India

Nandita Vijay, Bengaluru
Tuesday, July 22, 2014, 08:00 Hrs  [IST]

Union government has taken steps to prove its support to the pharma, biotech and clinical trial companies by insisting that approval of clinical trials from the Drugs Control General of India’s (DCGI) office should be granted within six months. The government has also levied a dialogue fee to be paid to the DCGI by companies if they needed to ascertain the status of submissions before the stipulated time of six months. It is also forming an expert committee to assess the new drug applications (NDAs).

Earlier the approval process took a minimum two years and this latest effort from the Centre is seen as the biggest benefit for Indian and global clinical research companies as there is a time frame for approval and an opportunity to discuss with DCGI, said Prof Ranjit Roy Chaudhury, Chairman of the Expert Committee on Clinical Trials constituted by the Ministry of Health and Family Welfare.

Further, the government is working towards forming a panel of experts to review and assess the New Drug Applications. The pool of scientific experts would be selected randomly from across India and this would prevent any bias during the evaluation of drug applications.

“The two endeavors by the Union government would only go to increase the confidence levels of the Indian and global clinical trial industry. A few more norms are being scheduled for announcement by the government before the month-end,” said Prof. Chaudhury.

Referring to the approval of clinical trials from the DCGI, office, he said pharma companies and clinical research organizations (CROs) were forced to put up with the uncertainty after they submitted a drug applications seeking permission to conduct a clinical trial. Now the companies could also approach the DCGI office to ascertain the details of the trial which is put before the regulatory authority for clearance. However, they will need to pay a dialogue fee to find out the status of their submissions related to the human study. In turn the DCGI or the concerned officials in his office could explain to the pharma, biotech and CRO on the exact stage of the approval process, he said.

The Centre’s strategic efforts are now seen to create some momentum in the clinical trial space where human studies came to an absolute standstill. However, in the last few months, the approvals of applications are at a faster pace and trials are also taking place, said Prof Chaudhury.

The sector has been facing uncertainty since January 3, 2013, after  the Supreme Court slammed the government for its failure to stop illegal clinical trials and also stating that fatality from human studies were on the rise. Now the government has geared up to support the sector and this is seen as reprieve for both India and global pharma and CROs. The unpredictability of the duration for approval or response from the regulatory authority was seen to hamper progress of drug research, pointed out Prof Chaudhury.

India with its qualified-competent doctors, science researchers, large naïve patient pool and healthcare infrastructure was positioned as an important hub clinical trials. “We will get back to regain the success, as the government is now working to put in place the systems to ensure clinical trials will be conducted in a transparent and efficient manner,” said Prof Roy.


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