The most common perception of public health in India
is that it is a continuing disaster that still hasn’t touched bottom. Even poor
people prefer private care though the cost can be ruinous. The patient outcomes
for serious illnesses are not much better either, but private healthcare
flourishes as state-run facilities are considered death traps.
Despite all the suspicions, often well grounded, about public healthcare, India’s immunisation programmes have all been spectacularly successful. Smallpox has been eradicated, leprosy is all but gone, the number of people with tuberculosis has declined dramatically, and even malaria, a big annual killer, is not a mortal threat though it is still feared. There are other successes, in diphtheria and polio, with the numbers of infections falling off steeply over the decades. Given the massive populations to be covered, the variations in amenities and the area, this is a low-cost high-impact success story with few parallels. Public health administrators have every reason to be proud of their work here. But the task still remains formidable.
In 2016, the World Health Organization declared India free of Type 2 polio and advised the government to suspend vaccination for the particular strain. Accordingly, manufacturers were told to stop the trivalent vaccine and switch to bivalent. Late last year, it turned out that Uttar Pradesh-based manufacturer Bio-Med had shipped some 1.5 lakh lots of oral polio vaccine with Type 2 as well.
It is not clear if the entire stock was used up, but there is no doubt that thousands of children in three states, Maharashtra, Telangana and Uttar Pradesh were given the contaminated vaccine. WHO has played down the threat to the children at risk, but given the size of the population affected it is clearly understating the problem.
The risk may be small, but the fact is that India was declared polio-free only in 2014, after three years in which not a single case of infection by the wild polio virus was reported. The idea of stopping the trivalent strain was to reduce the risk of vaccine-induced polio, but this kind of contamination adds a completely unnecessary complication to the programme. According to Dr T. Jacob John, emeritus professor at Christian College, Vellore, “Babies born after April 24, 2016, when Type 2 virus was withdrawn, are without immunity to it. They would be susceptible to infections caused by the Type 2 virus that may regain neuro-virulence and spread.”
The potential fallout of Bio-Med’s derelictions is hard to grasp because it is early days yet. But reports say the virus was found in stool samples of the children who got it. So it would have entered the sewage system by now. From there it could eventually make its way into the systems of children who have no immunity to the virus, mutate into more virulent forms and infect future generations. This is, however, a worst case scenario, not an inevitable chain of events destined to happen. Things could clear up in another couple of months if no infections are reported among the children given the vaccine.
In the meantime, the authorities have their work cut out. They must monitor the health of each and every child who took the contaminated vaccine for at least six months if not more to ensure against outbreaks. We run one of the largest world’s immunisation programmes. A misstep could put literally crores of lives at risk. It is against this background that the criminal callousness of Bio-Med’s conduct must be viewed.
The instructions were clear; trivalent vaccine was to be destroyed in 2016 and only the bivalent strain was to be manufactured. Yet in 2018 the former turned up in 1.5 lakh doses. So Bio-Med either ignored the order or decided this was an opportunity to make some money from waste. The inspection system is obviously slack enough for such fraud to take place. The Ranbaxy Laboratories scandal (2013) is proof that a sufficiently powerful company can find a way around regulators and inspections. Ranbaxy’s officials lied and cheated their way to billions of dollars in profits with products that were the result of deceit and manipulation.
Bio-Med, too, has previous. In a public notice dated March 14, 2018, the Central Drug Standard Control Organisation said batches of its typhoid vaccine were found to be “not-of-standard-quality”. In an ideal world a company like this would be run out of town but no one is holding their breath though an FIR has been filed against Bio-Med’s directors.