Towards a more robust model of drug regulation
The Centre is exploring a common standard of drug regulation and a central database. It can remove problems exposed by a string of deaths
Since the beginning of the pandemic, the Indian pharmaceutical industry has taken on a larger global profile, with the country catalysing the export of drugs, medical equipment, and, most importantly, vaccines to other nations. The enhanced contribution of Indian drug manufacturers and cutting-edge innovation cemented India’s place as a pharmacy to the world. Yet, in the middle of this success story, a string of episodes in the past six months have threatened to tarnish this reputation. The first came in October last year, when World Health Organization director-general TA Ghebreyesus said the agency was investigating whether the deaths of 66 children in The Gambia from acute kidney injuries, which were linked to cough syrups manufactured by an Indian firm, Maiden Pharmaceuticals. Then, last December, Uzbekistan said that 19 children died after consuming a cough syrup manufactured by Marion Biotech because the drug contained a toxic substance and was administered in doses higher than what is standard for children. And finally, in February, the Centers for Disease Control and Prevention in the United States said the outbreak of an eye infection that killed one person and caused permanent vision loss in another five was found to be linked to an eye drop manufactured by Global Pharma Healthcare Pvt Ltd.
India’s national drugs regulator and law enforcement agencies are conducting their investigations. Some people have been arrested, production facilities shut down and licences cancelled, but such piecemeal action has done little to repair the infirmities of drug regulatory and monitoring systems. But now, a major change may be in the offing. On Friday, this newspaper reported that the Union health ministry is considering formulating common standards for drug regulators at the Centre and in the states and maintaining a central database to regulate better the manufacturing, sale, and distribution of drugs. This is a big move, one that has the potential to transform the drug regulatory system by erasing the overlapping patchwork of monitoring authorities, and bringing it up to global standards. As an article on these pages by Dinesh Thakur and Prashant Reddy explained, the country has 38 drug regulators — one for each state and Union Territory, plus the national regulator, Central Drug Standard Control Organisation — each with its network of laboratories, inspectors, and jurisdiction. Moreover, transparency and access remain significant hurdles since only a handful of drug-testing laboratories make their results available in a consolidated database and states maintain their inspection and quality control records in different formats.
To be sure, this is a huge enterprise — one that needs political will, administrative diligence and regulatory deftness. After all, health is a state subject, and implementing a uniform set of standards will require stakeholders’ participation — something the Goods and Services Tax experience has shown needs years of meticulous groundwork. Yet, the importance of such a step is undeniable. Hopefully, it will iron out deficiencies in the system and propel the rise of the Indian pharma industry.