Co-Sara Secures CDSCO License for CoSara PCR Pro Instrument in India
CoSara's Regulatory Milestone in India
In an important step for molecular diagnostics in India, CoSara Diagnostics Pvt. Ltd., a joint venture established by Co-Diagnostics, Inc. and Ambalal Sarabhai Enterprises Limited, has successfully received a license from the Central Drugs Standard Control Organization (CDSCO). This license permits the manufacturing and sale of the CoSara PCR Pro™ real-time PCR point-of-care instrument. The CDSCO, which oversees the regulation of medical devices, pharmaceuticals, and cosmetics in India, authorized this important instrument for decentralized PCR testing.
Significance of the CDSCO License
The CDSCO license, confirmed on Form MD-5, allows CoSara to produce the CoSara-branded Class A medical device at its manufacturing facility located in Ranoli, India. Mohal Sarabhai, CEO of CoSara, emphasizes that this