India's Medical Device Approvals Stalled
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.