Opinion: India’s drug regulator has ignored red alerts on Covaxin, imperiling millions of lives
In a shocking turn of events, the World Health Organization warned United Nations agencies against procuring Covaxin, India’s indigenously developed and manufactured Covid-19 vaccine, just five months after granting approval to the made-in-India vaccine. The warning came after a WHO inspection of a manufacturing facility owned by Bharat Biotech International Ltd. revealed “deficiencies in good manufacturing practices.”
The WHO has not revealed the extent or nature of the deficiencies at Bharat Biotech’s facility; but given its recent instructions to U.N. agencies, the deficiency must have been significant from a public health perspective. Violations of current good manufacturing processes is nothing new to the Indian pharmaceutical industry. There is a sordid history of warning letters from the U.S. Food and Drug Administration documenting systematic compliance issues over the last decade. Foreign inspections all but ceased during the pandemic. Agencies such as the WHO rely on national regulatory agencies like the Central Drugs Standard Control Organisation (CDSCO), which regulates the pharmaceutical industry in India, to assess compliance before granting approval for commercial use of a drug.
