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.

This is not the first time that a foreign regulator has found problems with the manufacturing facility at Bharat Biotech that produces Covaxin. Exactly one year ago, the Agência Nacional de Vigilância Sanitária (ANVISA), Brazil’s drug regulator, pointed out serious lapses at Bharat Biotech’s manufacturing facility in India that makes this vaccine. ANVISA inspectors discovered issues with quality control at the facility that are meant to confirm that the live virus at the core of this vaccine has been inactivated.

At the time, the CDSCO remained a mute spectator to the affair and gave no assurances to the Indian public on measures it was taking to ensure that Bharat Biotech fixed these issues. It has followed the same path of silence since the WHO’s recent suspension of Covaxin’s procurement by the United Nations.

As I write this, not a single newspaper in India has been able to identify the exact nature of the deficiency the WHO raised, and few in India seem to be concerned about the implications of the WHO’s action, despite the fact that Covaxin is being administered to children in India.

Why are CDSCO and others treating Bharat Biotech with kid gloves?

The simple answer is that virtually all of India has thrown its weight behind Bharat Biotech because of Prime Minister Narendra Modi’s AatmaNirbhar policy, which broadly translates into a policy of economic self-reliance. This has meant special regulatory privileges for Covaxin, given its status as a made-in-India vaccine that was developed with the support of the Indian Council of Medical Research (ICMR).

Not only did the CDSCO approve Covaxin before Phase 3 trials could be completed, it also ignored — without any explanation — concerns some have raised about the integrity of data from one of the clinical trial sites for the vaccine. Meanwhile, the director general of the ICMR called the WHO warning, which should be seen as a serious red flag, “routine.” That comment all but tells how the Modi administration views the issue of compliance to current good manufacturing practices on vaccine safety.

An additional bonus of having state support from the Modi government is that any criticism of the vaccine is dismissed, if not viciously attacked, as “anti-national” by those promoting India’s growth. Such criticism has come not just from the ruling party’s infamous internet troll armies, but also from Nuthalapati Venkata Ramana, the chief justice of the Supreme Court of India (CJI), who spouted a conspiracy theory in December 2021, claiming that multinational companies had been actively foiling Bharat Biotech’s effort to get its vaccine approved by the WHO.

Two months after these statements by Ramana, and a few weeks before the WHO’s inspection, Bharat Biotech filed a defamation lawsuit against The Wire, an online digital news platform that was one of the few publications to question the approvals granted to Bharat Biotech for Covaxin by India’s drug regulator. The district court in Hyderabad hearing the suit granted Bharat Biotech a preliminary injunction without even giving The Wire and its editors a chance to be heard.

Such ex parte injunctions can be granted in exceptional situations where there is real urgency. The articles in question, however, had been published several months before the lawsuit was filed. The injunction, which ordered the removal of 14 articles from The Wire, remains in place almost two months after it was granted, and the court has yet to hear opposing arguments by The Wire.

This lawsuit had its intended effect: chilling critical coverage in the country of the WHO’s suspension of its approval for Covaxin. Most Indian newspapers have limited their coverage to merely reproducing excerpts from the press statements issued by the WHO and Bharat Biotech. Neither the CDSCO nor India’s health ministry have bothered to make a statement. Not a single publication in the country is asking the obvious question about the continued administration of Bharat Biotech’s vaccine to millions of Indians including children — it is one of only two vaccines approved for children in India — after the WHO identified deficiencies at the manufacturing facility.

The indifference of CDSCO to the health of millions of people in India, including children, should give cause for concern to all foreign regulators who rely on drugs and vaccines purchased from Indian manufacturers and the WHO. Jurisdictions like the European Union, which still rely on CDSCO to certify exports from India, need to rethink their approach to exports from the country. As for the WHO, if the organization is serious about protecting global public health, it needs to worry about made-in-India drugs that are not covered by its pre-qualification program, which is basically almost all drugs apart from the ones procured through U.N. agencies.

Just because the Indian government does not seem to care about the quality of drugs emerging from manufacturing facilities under its jurisdiction does not mean that the world should sit by and continue to import Indian drugs without adequate measures to check their quality.

Dinesh Thakur is a public health activist whose work focuses on improving the quality of affordable medicines. His foundation has made grants to one of the journalists who wrote for The Wire and was targeted by the injunction from Bharat Biotech. The author and foundation exercised no editorial control over any of the pieces published in The Wire.