CDSCO reviewing Cipla, Dr Reddys, others applications for Remdesivir on priority: Health Ministry
The CDSCO is awaiting the data and is providing complete support to these companies. It has already waived off the requirement of local clinical trials for these companies by invoking emergency provisions.;
New Delhi: The Centre on Sunday said that six Indian companies -- Hetero, Cipla, BDR, Jubilant, Mylan and Dr. Reddy's Labs -- have applied to Indian Drug Regulatory Agency, Central Drug Standard Control Organisation (CDSCO) for permission to manufacture and market the Remdesivir drug in India.
In a release, the Health Ministry said that five of these have also entered into an agreement with Gilead, a biopharmaceutical company, which had applied to CDSCO, for import and marketing of Remdesivir on May 29. After due deliberations, permission under Emergency Use Authorization was granted on June 1 in the interest of patient safety and obtaining further data.
"The companies are at various intermediate stages of inspection of manufacturing facilities, verification of data, stability testing, emergency laboratory testing as per protocol. Being an injectable formulation, testing for assay, identity, impurities, bacterial endotoxin test, and sterility become very critical for patient safety and this data needs to be provided by the companies," the release read.
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