Covid-19, vaccines and India's compensation mechanism | Economic Times

Till now, vaccines remain the only protection against Covid-19, cutting down the risk of transmission, and reducing the severity and mortality of the infection significantly. But in rare cases, they have been linked to side effects, even fatalities.Take the senior citizen from Mumbai who reportedly died from anaphylaxis — allergic reaction — on March 8 after receiving a vaccine shot earlier the same day. This was officially the first death due to ‘inconsistent causal association’ with the vaccine. Such adverse cases after Covid vaccination occur only in 0.01% of the total doses administered, with fatalities even fewer. But how families of those reacting badly to Covid vaccinations are compensated — if at all — remains unaddressed. India has no legal provisions of compensation for recipients of Covid-19 vaccines in case of any side effects or medical complications. The only option left for the family members of, say, a deceased is to approach the courts of law for a compassionate redressal.Unlike the precautions needed to stave off Covid, or tackling matters when infected with the virus, there is not much medical literature or information readily available regarding the possible side effects of vaccines. The vaccines currently in use in India have received ‘emergency approvals’, these approvals coming through an accelerated regulatory process with limited testing. Adverse events need to be continuously studied, especially with a vaccination drive of such unprecedented scale. These two realities — low awareness of risks from Covid vaccines and the difficulty of approaching courts —severely work against a compensation process.Compensation itself has a dodgy history in this country. It took more than a decade to settle the Bhopal gas tragedy of December 2-3, 1984. The compensation allocated for the dead was Rs 1- 3 lakh while for those left with permanent or partial disability, between Rs 50,000 and Rs 2 lakh. Most cases reportedly received only Rs 25,000.In 2018, GoI decided that the 4,700-odd Indian patients who had received faulty Johnson & Johnson (J&J) acetabular surface replacement (ASR) hip implants between 2004 and 2010 be compensated between Rs 30 lakh to Rs 1.25 crore. Healthcare activists and lawyers expected this to set a precedent. But matters have crawled, with little clarity in sight.In December 2018, J&J approached the Delhi High Court challenging GoI’s orders to pay compensation, the absence of law enabling the company’s position. In May 2019, the court directed J&J to pay an interim compensation of Rs 25 lakh each to patients. The case however, is still pending in court. Bottomline: There is still no law that bestows the rights of compensation to a patient suffering from a serious adverse event, or to her or his family in the event of death. GoI contemplated changes in the Drugs and Cosmetics Act, 1940 to make pharma firms liable to pay compensation for injuries and damage caused to consumers by their products, including drugs and medical devices. That, too, has not seen light of the day. Under existing law, companies pay compensation only in case something goes wrong during a clinical trial.While Pfizer is adamant on an indemnity clause before it brings its vaccine to India, there is no such bargaining power for people who may face an unforeseen crisis as a fallout of medical intervention. If GoI does negotiate an indemnity clause for vaccine-makers, it should exhibit the same commitment for its people. It must fulfil its constitutional obligations to protect the safety and health of the public by putting in place a mechanism for compensation. Till then, the people of India remain the sitting ducks.