FDA/CE approval not mandatory for COVID-19 testing, clarifies ICMR

A complete lockdown has been announced in 19 states and union territories, besides partial lockdown in six other states in view of the coronavirus outbreak, said the Union health ministry on Sunday (March 23).

Addressing a joint press conference, Lav Agarwal, joint secretary, health ministry, said a total of 415 confirmed cases have been reported from the country with seven deaths, and 23 patients have been discharged so far.

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“A complete lockdown has been announced in 19 states and union territories. Some parts of six states and union territories have been kept under lockdown,” said Agarwal.

The states and UTs under complete lockdown are Chandigarh, Delhi, Goa, Jammu and Kashmir, Nagaland, Rajasthan, Uttarakhand, West Bengal, Ladakh, Jharkhand, Arunachal Pradesh, Bihar, Tripura, Telangana, Chhattisgarh, Punjab, Himachal Pradesh, Maharashtra, and Andhra Pradesh.

Regarding the testing of patients, the Indian Council of Medical Research (ICMR) said 12 laboratory chains have been registered and have started functioning. These 12 laboratories have 15,000 collection centres across the country, said ICMR Director-General Balram Bhargava.

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He said process of kit manufacturing has also been fast-tracked at ICMR-NIV, Pune. “Two kit manufacturers have already been approved. I’d like to clarify that FDA/CE approval isn’t mandatory. ICMR-NIV approved tests which will be done there on fast-track basis will also be acceptable for #COVID testing,” he said.

Regarding the usage of hydroxychloroquine, he said it is recommended only for a healthcare worker who is treating a COVID-19 patient. “Secondly, it’s recommended only for persons staying and caring for a household positive patient. They can take that only for prevention,” he said.