How legal is COVID-19 vaccine ?

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The DCGI has approved Oxford-AstraZeneca's Covishield and indigenously developed Covaxin of Bharat Biotech for restricted emergency use in India, under Indian Drug law.

After months of effort, the COVID-19 vaccines are ready to administer. The distribution has begun and some countries have started inoculations.

India's drug regulator has granted restricted emergency use to Oxford-AstraZeneca's Covishield and the indigenously developed Covaxin of Bharat Biotech in the country.

But, what if the vaccine recipients experience severe side effects after getting a COVID-19 vaccine?

Adar Poonawalla, the chief executive of Serum Institute of India that is manufacturing Covishield, wants indemnity.

But, the Centre has said nothing on the matter. So legally speaking irrespective of the stance that the government takes on indemnification, vaccine recipients still have some existing recourse in case of an adverse effect following immunisation.

The compensation mechanisms may be different for recipients in India depending upon the vaccine they inoculate.

The Drugs Controller General of India (DCGI) has given different kinds of approvals to Covishield and Covaxin.

The DCGI has licensed the indigenous product developed by local firm Bharat Biotech for “emergency use in a clinical trial mode”. With this, the government has clarified that Covaxin’s use is an extension of phase III trials.

As the regulator has given its approval to Covaxin in clinical trial mode, the recipients of the jab will qualify as trial volunteers and will be eligible to receive compensation in case of a vaccine injury under New Drugs and Clinical Trial Rules, 2019.

This means the recipient would be eligible for compensation, which includes meeting medical costs (medical management) - as well as compensation for loss of livelihood (financial compensation).

In such a case, if the volunteers experience AEFI, it is up to an ethics committee to give its opinion on appropriate compensation.

The compensation regime for possible vaccine injuries caused by Covishield may be completely different, as the SII has received permission in Form CT-23 (permission for manufacture for sale and distribution) says nothing about clinical trials.

This suggests that those who get the SII vaccine will not be trial volunteers and therefore, do not have the protection of the New Drugs Rules, 2019, including care and compensation.

However, if the vaccine recipients of Covishield experience adverse side effects they may approach the court on the grounds that the drug was spurious, mislabelled, adulterated, or had manufacturing defects. The Drugs and Cosmetics Act addresses such an issue.

A recipient can also approach the court under the Law of Torts, which seek civil remedies, or the Consumer Protection Act if anything is wrong with the underlying formulation of the drug.

Dr Ajay Kummar Pandey
Advocate and Consultant
4C Supreme Law International
www.4csupremelawint.com

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बिहार पुलिस के सर्कुल ने बिहार प्रेस बिल की याद दिला दी है

How legal is COVID-19 vaccine, COVID-19, Vaccine, Corona, Corona Vaccine, 4c Supremelaw International, International Advocate, International Lawyer, Supreme Court Advocate, Supreme Court Lawyer, Best Advocate in India, Best Lawyer in India, Ajay Kummar, Law Partener
Italy court orders Facebook to pay $5 million in damages for copying app

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Foreigner To Deposit Cash Amount For Bail

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WhatsApp's private chat leaked on Google, anyone can read your personal talks

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Do you know 18 must Laws for every Indian?

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Why should I trust you or your business?

How legal is COVID-19 vaccine, COVID-19, Vaccine, Corona, Corona Vaccine, 4c Supremelaw International, International Advocate, International Lawyer, Supreme Court Advocate, Supreme Court Lawyer, Best Advocate in India, Best Lawyer in India, Ajay Kummar, Law Partener
Do you need clearance from your RWA to employ your maid?

How legal is COVID-19 vaccine, COVID-19, Vaccine, Corona, Corona Vaccine, 4c Supremelaw International, International Advocate, International Lawyer, Supreme Court Advocate, Supreme Court Lawyer, Best Advocate in India, Best Lawyer in India, Ajay Kummar, Law Partener
क्या तलाकशुदा पत्नी घरेलू हिंसा अधिनियम के तहत निवास के अधिकार का दावा कर सकती है?

How legal is COVID-19 vaccine, COVID-19, Vaccine, Corona, Corona Vaccine, 4c Supremelaw International, International Advocate, International Lawyer, Supreme Court Advocate, Supreme Court Lawyer, Best Advocate in India, Best Lawyer in India, Ajay Kummar, Law Partener
SC grants Woman's Right to Residence Under the Domestic Violence Act

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Corporate War: Cookie King who fought with TATA and Ambani

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HINDU MARRIAGE ACT : DIVORCE GRANTED TO HUSBAND ON THE GROUND OF MENTAL CRUELTY CAUSED BY WIFE

How legal is COVID-19 vaccine, COVID-19, Vaccine, Corona, Corona Vaccine, 4c Supremelaw International, International Advocate, International Lawyer, Supreme Court Advocate, Supreme Court Lawyer, Best Advocate in India, Best Lawyer in India, Ajay Kummar, Law Partener
Facebook love or chat can land you in Jail

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Financer can take way Car in case of payment default

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18000 Crore Company, 8000 Crore personal worth, wife & sons living in street

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Do you love your wife and children?

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When the second marriage of a married woman / man becomes an offense under section 494

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Is Rhea Chakraborty guilty?

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Daughters have equal right in ancestral property

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Is second wife entitled for share in Property?

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How to save your hard-earned wealth from legal hassles?

How legal is COVID-19 vaccine, COVID-19, Vaccine, Corona, Corona Vaccine, 4c Supremelaw International, International Advocate, International Lawyer, Supreme Court Advocate, Supreme Court Lawyer, Best Advocate in India, Best Lawyer in India, Ajay Kummar, Law Partener
What will happen to property of Hindu after his death?

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Are you safe at home?

How legal is COVID-19 vaccine, COVID-19, Vaccine, Corona, Corona Vaccine, 4c Supremelaw International, International Advocate, International Lawyer, Supreme Court Advocate, Supreme Court Lawyer, Best Advocate in India, Best Lawyer in India, Ajay Kummar, Law Partener
Can sex with your own wife land you in jail ?

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Can you land in jail for sharing Obscene Message online in private?

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Legally speaking who discovered America?

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47 years old legal dispute finally decided

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Are you a victim of Covid-19 Goonda Raj? Part-2

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Are you a victim of Covid-19 Goonda Raj ?

How legal is COVID-19 vaccine, COVID-19, Vaccine, Corona, Corona Vaccine, 4c Supremelaw International, International Advocate, International Lawyer, Supreme Court Advocate, Supreme Court Lawyer, Best Advocate in India, Best Lawyer in India, Ajay Kummar, Law Partener
Can RWA stop your maid from coming to your home?

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Can you escape Contractual Obligation under Covid-19?

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Coronavirus: Is vaccine found for India Inc?

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Is Wife Entitled to Maintenance Even If She Runs A Business & Earns Income?

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Who will pay rent for lockdown period?

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Legal consequences of being whatsapp group admin

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