Jul 22, 2011
Update: the Madras High Court has ruled in favor of a three-month extension of Dr. Surinder Singh's position as DCG(I); he will have to resign his post on October 31, 2011. The court has also ordered the Indian government to quickly identify a successor to Dr. Singh within that three-month period.
Drugs Control General of India (DCG(I)), the country’s regulatory agency overseeing medical devices and pharmaceuticals, is currently lacking a director, stalling all product approvals until the director’s reappointment.
The Indian government had originally granted a nine-month extension to Dr. Surinder Singh as head of DCG(I), but the Madras High Court has stayed that reappointment until further notice, according to Pharmabiz.com.
Singh may not re-assume his position at DCG(I) until further order from the court; in the meantime, an interim head may be appointed if the case is sent to India’s Supreme Court. The case’s petitioner has argued that the Indian government did not follow all aspects of the Drugs & Cosmetics Acts and Rules in extending Singh’s appointment.
Until resolution of this issue, DCG(I) decisions regarding device approvals are expected to slow significantly.
Indian regulators are adding staff and resources to the Central Drugs Standard Control Organization (CDSCO) in order to enforce more stringent clinical trial guidelines for medical devices and pharmaceuticals.
The Drug Controller General (India) (DCGI) has announced plans to prescreen registration applications for medical devices and pharmaceutical products upon receipt beginning December 1, 2011.
India’s Central Drugs Standard Control Organization (CDSCO) has published new guidance documents covering registration and re-registration of notified medical devices, as well as guidances for manufacturing and import licensing.
Based on an initial analysis by Emergo Group, the medical device registration process in India generally remains the same. However, manufacturers should bear in mind several small changes:
Dr. V. G. Somani has been named Drug Controller General of India (DCGI) as of October 31, 2011.