HONG KONG – India’s conditional approval on Jan. 3 of a COVID-19 vaccine developed domestically by Bharat Biotech International Ltd. but still in phase III trials has sparked concerns about its safety. The Drugs Controller General of India (DCGI) gave emergency authorization to the product, Covaxin, along with the Astrazeneca plc and Oxford University vaccine Covishield. The DCGI said the conditional approval granting “restricted use in emergency situation” for Covaxin was done in “clinical trial mode” to account for the fact that the shot is still being tested. But the rush to approve it has created controversy and confusion.
NEW DELHI – Recent changes to India’s rules on medical devices have evoked mixed reaction among industry and legal experts with concerns over their impact on patenting of innovations tinged with a welcome reception of a new clause for mandatory registration and licensing of medical devices in the country to improve adherence to quality requirements.
HONG KONG – Indian authorities have apparently given medical device manufacturers a one-year extension to register for market authorization that was originally to be done by the New Year.
