Editorial: Reform drug regulatory system

Gambia and now Uzbekistan deaths are a wake-up call for the authorities to pull up their socks and ensure strict quality control

First, it was the death of 70 kids in Gambia and now it is that of 18 children in Uzbekistan linked to adulterated cough syrup manufactured by pharma companies in India. The two tragedies have dealt a serious blow to India’s reputation as a global pharma hub. It is a wake-up call for the authorities to pull up their socks and ensure strict quality control. Even before any corrective measures could be taken in the case of Haryana-based Maiden Pharmaceuticals, blamed for supplying contaminated cough syrups to the West African country, the reports of a similar tragedy in Uzbekistan have cast a shadow over the country’s drug regulatory system. While a joint inquiry is being conducted by the teams of Central Drugs Standard Control Organisation (CDSCO) and Uttar Pradesh Drugs Controlling and Licensing Authority into the case involving Noida-based Marion Biotech, linked to Uzbekistan deaths, urgent steps are needed to reform the drug regulatory system and send the right message to the world. The recent decision of the CDSCO to conduct inspections of risk-prone manufacturing units across the country jointly with State drug controllers is a much-desired course correction. Hopefully, this move will set in motion a comprehensive action to clean up the country’s drug regulatory system. The government’s clean chit to Sonepat-based Maiden Pharma, notwithstanding the WHO’s medical product alert over the Gambian deaths, apparently triggered a serious relook at the drug regulatory structure. Criminally negligent pharma unit promoters should be prosecuted. The Indian pharmaceuticals industry, ranked third worldwide by volume, must learn lessons from both tragedies and appropriate reforms must be initiated to make the regulatory process more effective.

The preliminary inquiry by Indian authorities earlier showed that Maiden Pharma had permission to make the four products for export purposes only, and that it had supplied the medicines only to Gambia. None of the four drugs is sold in India. Now, the outcome of the belated efforts to tighten the regulatory processes and stringent compliance with standard operating procedures must be critically evaluated. India’s standing as a major global player in the pharmaceutical sector has already taken a hit. Much of the criticism is directed at the regulatory system. The quality control crisis has been compounded by charges of lax, inefficient and corruption-ridden drug approval processes that do not follow exacting standards applied in other parts of the world. Zero tolerance for violation of rules is the foundation on which the pharma sector is expected to stand. The stakes are high not only for the company but for the country’s broader pharmaceutical industry which is worth around $50 billion. Indian drugmakers, enabled by their price competitiveness and good quality, have made a global mark, accounting for 60% of the world’s vaccines and 20% of generic medicines. And, Africa is an important market as India supplies half of its generic medicine needs.

---