The DCGI has approved the company's remdesivir 100 mg per vial for restricted emergency use in India as part of the regulator's accelerated approval process to address urgent, unmet needs amid the evolving COVID-19 pandemic, Mylan said in a statement.
Last week, Zydus had received approval from Indian authorities to start human trials for its COVID-19 vaccine contender - the second Indian pharmaceutical firm to get such nod amid a surge in novel coronavirus infections worldwide.
WHO says a review of the interim results showed hydroxychloroquine and lopinavir/ritonavir "produce little or no reduction in the mortality of hospitalized COVID-19 patients when compared to standard of care."
Aiming to launch an indigenous COVID-19 vaccine by August 15, the Indian Council of Medical Research has written to select medical institutions and hospitals to fast-track clinical trial approvals for the vaccine candidate Covaxin being developed in collaboration with Bharat Biotech. Twelve clinical trial sites have been identified at present and the apex health research body has asked the medical institutions and principal investigators to ensure that the subject enrollment is initiated no later than July 7.
The assent for human trials was given after the company submitted data of clinical trial on animals to the DCGI, in which the vaccine candidate was found to be successful with respect to safety and immunogenicity, sources said.
The NPPA has allowed for upward revision of heparin injection 1000IU/ ml and heparin injection 5000IU/ ml under para 19 of DPCO 2013 by 50%. The ceiling price of the drug is now fixed at Rs 24 and Rs 60.
Gilead has issued licences to nine generic drug companies to make and sell remdesivir. Six of the companies are Indian - Hetero, Cipla, Dr Reddy's Laboratories, Zydus Cadila, Jubilant Life Sciences and Syngene/Biocon. Besides Hetero, Cipla is the only other Indian company to receive marketing approval from India's drug regulator.
At a recent meeting at the Central Drugs Standard Control Organisation (CDSCO)-the regulatory authority of India, subject experts recommended the Drug Controller General of India (DCGI) to grant permission to the company for starting human trials.