Production of vaccines in large capacity for Covid’19 is indispensable. However, it is a question of integrity if it is at the cost of compromising on quality standards. Every citizen in this country has the right to live and the right to receive quality medicines at affordable prices. But the quality of drugs produced in the country is deplorable, although India is acclaimed as ‘The Pharmacy of the World’.
India undoubtedly has the pharmaceutical infrastructure which no other country has. Even a country like China was envious of the Indian pharma ecosystem. With the help of this infrastructure, India manufactured generic drugs and even exported them to EU and American markets. However, the shocking confession by Ranbaxy before the American court in 2013 concerning the quality and manufacturing of generic drugs left the whole country perplexed. Despite this incident, there was no conscientious enhancement in the quality of medicines, and manufacturing issues only worsened. In 2019, CDSCO revealed that 49 out of 1,336 samples of medicines tested are of poor quality, which means 4% are of poor quality, that too in the very small sample size. India is home to 3000 pharma companies and over 10,000 Pharma factories. Do our regulators have enough resources to assess all the drug samples produced in India adequately? According to The Food and Drug Control Administration (FDCA), Gujarat is the only state where non-standard quality (NSQ) is around 2-2.5% compared to all India's average of 5-6%. These percentages might seem small, but the consequences are severe.
Apart from quality issues, India is facing water contamination. What do lakes in cities like Hyderabad, Bengaluru, and Pune have in common? It is water pollution through undertreated effluents from pharma factories. The stiff competition in manufacturing generic drugs allows prices to plummet, which means pharma manufacturing facilities will trade-off their environmental commitments to sell drugs at lower prices.
There is no denying in the fact the patent holders are exploiting the patients for their profits. This reminds me of what Mahatma Gandhi says, “the world has enough for everyone’s needs, but not everyone's greed”. However, is the patent waiver a right solution to vaccinate the global population? Should there be any case for compulsory licensing of Covid Vaccine? If such liberalized policy is brought in, how do we ensure the quality of the drug? How do we motivate the pharma companies to invest in vaccine research if they are forced to give up their patents to vaccinate everyone against Covid? Every now and then, we see reports in the newspaper and local media that children succumb to polio due to inefficiencies in producing and inoculating quality vaccines. The reason, as stated by experts, is due to vaccine contamination. There are two ways oral vaccine viruses can cause polio. The first is called Vaccine Associated Paralytic Polio (VAPP). Here, on infrequent occasions, the vaccine virus mutates into a virulent version of itself and causes disease in the child who received the vaccine or in a person who has come into contact with the child. However, VAPP causes isolated incidents and not outbreaks because it does not spread from person to person. The second way the vaccine can cause polio is through circulating vaccine-derived poliovirus (CVDPV). Again, the vaccine virus mutates into a virulent version but spreads from person to person, causing outbreaks. To do this, however, the vaccine virus must have been circulating among people for at least 12 months. During this transmission, the virus can mutate. This usually happens in communities where vaccination rates are low. CVDPV is also extremely rare. The Polio vaccine was introduced in 1955, and we still have reported and unreported cases of post-paralysis due to vaccination in third world countries such as India.
If this, the case with polio, don’t we all deserve a promising quality vaccine for Covid’19 to avoid considerable collateral damage, which the poor quality of vaccines can cause? Of course, we cannot wait for years in a row for a good quality vaccine. But the pharmaceutical policymakers should ensure the quality of the vaccine to be the foremost priority and thus should be assessed, monitored, and legitimized. We cannot have quality if pharma companies and research institutes are in competition to produce mass vaccines with pre-set targets, both in terms of revenue and otherwise. Consumerism cannot be encrypted into the mission of pharma companies because medicine is a necessity and not a commodity. As a necessity, it deserves quality more than anything else.
~Authored by Swathi Vajjhala