Sonia Tanwar and Anshuman Panchal*
In India, CDSCO controls all the activities related to importing, exporting, manufacturing, warehousing, and selling drugs, biologics, and medical devices. The CDSCO's intention to expedite the evaluation and licensing of a COVID-19 vaccine was announced in the Vaccine Notice, which was released at the start of the pandemic. After getting authorization from the CDSCO, the hospitals/medical institutions may import or produce the unapproved medicine as long as the unapproved drug is undergoing Phase-III clinical trials in India or elsewhere. CDSCO issued a notice regarding the launch of the online platform for adverse event reporting of medicines through the SUGAM portal. Under extraordinary circumstances, the CDSCO may only modify the eligibility criteria for importing drugs with a shorter shelf life if they have not passed their expiration date. Manufacturers of medical devices are no longer required to seek a manufacturing or import license before manufacturing or importing the regulated devices under the medical devices compliance orders. India's leading drug regulatory authority CDSCO permitted Covaxin and Covishield vaccines developed by Bharat Biotech Ltd. and Serum Institute of India Ltd., respectively, for restricted use in an emergency. The Subject Expert Committee's recommendations grant authorization for restricted use in emergencies ("SEC"). Manufacturers of vaccines in India must supply at least 50 percent of vaccines to the Government of India to fulfil the demand. In this review, most of the regulatory guidelines related to the import, export, manufacture, warehouse, and sale of drugs, biologics, and medical devices, especially related to COVID-19, have been discussed.
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