The novel Coronavirus popularly known as the "Covid-19" was traceable in India in January 2020 after its major outbreak in China. The country still grapples with Covid-19 because of the presence of the virus’s infectious variants and multiple mutations, which over the months have transformed from an Epidemic into a Global Pandemic. The virus, because of its novelty, made it difficult for India to combat it and, as a result, the country witnessed around two lakh deaths in the year 2020. The government soon realised the severity of the virus and, seeing the upsurge in the death toll, it was compelled to release a vaccination for the citizens, considering it to be the most plausible option in such times. The country’s Prime Minister, Narender Modi on 16 January 2021, flagged off India’s Covid-19 vaccination drive and then began the inoculation process for around 300 million priority groups who were at high risk of exposure to the SARS-CoV2.

The onset of the first phase of vaccination and the trust of various governmental agencies in its efficacy led people to heave a sigh of relief. However, within a month into the vaccination drive, the country witnessed the death of nearly 27 people after taking the jabs of the vaccine by either developing an acute coronary syndrome or by a cerebrovascular accident or even respiratory infection resulting in sudden death. At the moment, over 17 million people in India have been fully vaccinated, ranking India fifth in the world for vaccine administration. A total of 180 deaths have been reported, and many people have developed severe allergic reactions, with a few, such as a 40-year-old volunteer from Chennai, even experiencing acute Neurological Dysfunction.

In the midst of all of these disasters, the government waived its social and legal liability. Further, through its consent letter, it held the manufacturers liable for "any and all adverse effects" arising from the vaccine, stating that all other consumer claims would ultimately be determined by the courts. This shows that the vaccine, which is referred to as the saviour for the common people, has no accountability and ultimately becomes "an asset with mere liability" for its adverse effects. The government’s response shows its callousness by waiving off its own responsibilities and leaving the citizens with only one option, which is: to ask the Courts to look into an arena of governance for which the government should hold the responsibility.

The Central Drugs Standard Control Organization has approved two Covid-19 vaccines in India: (a) COVAXIN-developed and manufactured by Bharat Biotech India Limited and ICMR, wherein, according to the provisions of the 'Drugs and Clinical Trial Rules 2019', a person harmed during the clinical trial can be compensated for all side-effects caused in the due process, but the terms of liability are unclear.

There are also the provisions of ‘Product Liability’ under Chapter-VI (Section 82 to 87) of the Consumer Protection Act, 2019 where:

• Section 82 states that a ‘product manufacturer’ or a ‘product seller’ or a ‘product service provider’ is liable to compensate for any harm caused to a consumer because of the defective product being sold or manufactured.
• According to Section 83, a complainant may file a 'product liability action against the following parties:
• Product manufacturer
• Product service provider
• Product seller
• Section 84 deals with the liability of ‘Product Manufacturer’

Section 84 (1) states that an action may arise if the product has:

• Manufacturing defect
• Defective design
• Deviation from manufacturing specifications
• Non-conformity to express warranty
• Fails to incorporate adequate instructions or warning

Section 84 (2) holds the product manufacturer to be liable even after no negligence or fraud is found on their part.

• Section 85 deals with the liability of ‘Product Service Provider’ where action may arise if:
• Inadequate or imperfect quality
• Harm by the omission of an act or negligence
• Inadequate instructions or warning
• Deviation from the terms of the contract or express warranty
• Section 86 mentions the liability of ‘Product Seller’ where action may arise if the person has:
• Control over product design, manufacturing, packaging or labelling
• Alteration or modification caused harm
• Failure of express warranty
• Identity is not known or not subject to the law in force in India.
• Failure to exercise reasonable care in following warnings or instructions of danger
• Section 87 deals with the ‘Exceptions’ to product liability action, where no action arises when the product is:
• Section87 (1): Altered, misused or modified by the buyer
• Section87 (2): Non-obedience to the warnings or instructions and person under the influence of alcohol
• Section87 (3): An obvious danger is commonly known to the consumer

Though there exist the aforementioned provisions for the protection of the consumer, in the present circumstances of force majeure, the liability is very conditional as the manufacturers or seller would cover only "death" or "adverse side effects" under the clause of Product Liability. Moreover, till now there has been no medical insurance that would cover the costs of potential vaccine side effects. As a result, in such a situation, the manufacturers must be indemnified by the government to be protected from lawsuits for vaccines used during a pandemic. The chief executive officer of SII, Adar Poonawalla, demands that the government needs to indemnify the manufacturers so that they can prioritise their task of production rather than deviation by frivolous litigation arising from unforeseeable side effects of the vaccine and dispel the claims of the citizens, which could either lead to scepticism among the general public or worsen the situation by affecting the reputation of the manufacturers in the market and further creating a dreadful alarming situation nationally.

Conclusion
At this climacteric stage, when the country is witnessing nearly eighteen lakh cases with more than one lakh deaths, the government of India must be held accountable for the vaccine's side effects as they hold the "Primary Responsibility" against the interests of citizens and must share responsibility with the manufacturers. All over the world, various governments considering the severity of the pandemic have shared the responsibility with the vaccine makers, such as – in the USA, the government granted manufacturers immunity from lawsuits and the people are compensated for the side effects by a formal government fund. Similarly, in the UK, the government agreed to pay anyone who receives disability through vaccination under the Damages and Payments Act even though the WHO has developed a "no-fault" compensation scheme for liability issues for the vaccine makers.

As a result, the country with the second-largest population, while facing a plethora of Covid cases as well as unforeseeable medical complications, requires the "Government to Act." It should act as the "Indemnifier" for vaccine makers, allowing them to focus on their task of mass production rather than dealing with citizens' inane claims, and it should act as the "Redeemer" for the people's plight.

References:
The Hindu. (2021, January 31). Coronavirus live updates: Total active cases in India dropped to 1.68 lakh. https://www.thehindu.com/news/national/coronavirus-january-31-2021-live-updates/article33707856.ece

Pilla, V. (2021, January 19). Why are potential vaccine-related legal liabilities a source of concern?Covid-19 vaccine makers. Moneycontrol. https://www.moneycontrol.com/news/business/companies/why-potential-vaccine-related-legal-liabilities-worry-covid-19-vaccine-makers-6365681.html

EP News Bureau. (2021, March 1). Liability for COVID vaccines in India: Where does the buck stop? Express Pharma. https://www.expresspharma.in/latest-updates/liability-for-covid-vaccines-in-india-where-does-the-buck-stop/

Sethi, S., & Janardhanan, B. (2020, July 24). Product Liability under the Consumer Protection Act, 2019: Let the manufacturer/seller beware! Bar and Bench-Indian Legal News. https://www.barandbench.com/columns/product-liability-under-the-consumer-protection-act-2019-let-the-manufacturer-seller-beware

Our Bureau, Agencies. (2020, December 20). Poonawalla bats for vaccine makers, demands indemnifier against lawsuits. Telegraph India. https://www.telegraphindia.com/india/poonawalla-bats-for-vaccine-makers-demands-indemnifier-against-lawsuits/cid/1801131

India Code: Consumer Protection Act, 2019. (2020, August 6). INDIA CODE Digital Repository of All Centers and States. https://www.indiacode.nic.in/handle/123456789/15256? view_type=browse & sam_handle=123456789/1362

(2021, April 6). Govt: No provision to compensate the vaccinated in case of adverse events. The Times of India. https://timesofindia.indiatimes.com/india/govt-no-provision-to-compensate-the-vaccinated-in-case-of-adverse-events/articleshow/81923434.cms

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