Editorial: Reforming the drug regulatory system

The deaths in Gambia and now Uzbekistan have been a wake-up call for authorities to be more vigilant and ensure strict quality controls

First, 70 children died in Gambia, and now 18 children in Uzbekistan have died from adulterated cough syrup produced by Indian pharmaceutical companies. Both tragedies have dealt a severe blow to India’s reputation as a global pharmaceutical hub. This has set off alarm bells for authorities to be more vigilant and ensure strict quality control. Haryana-based Maiden Pharmaceuticals has been accused of supplying tainted cough syrup to the West African country, and reports of a similar tragedy in Uzbekistan have cast a pall over the country’s drug regulatory system even before any corrective action is taken. While teams from the Central Drugs Standard Control Organization (CDSCO) and Uttar Pradesh Drug Control and Licensing Authority are conducting a joint investigation into the case involving Noida-based Marion Biotech in connection with the death in Uzbekistan, urgent steps are needed to resolve the case. Drugs to reform the regulatory system and send the right message to the world. The CDSCO’s recent decision to conduct joint inspections of high-risk manufacturing units across the country in conjunction with state drug controllers is a much-needed process correction. It is hoped that the move will kick-start a sweeping effort to clean up the country’s drug regulatory system. The government’s candor with Sonepat-based Maiden Pharma, despite the World Health Organization’s warning of medical products over Gambian deaths, has apparently sparked a serious re-examination of the drug regulatory structure. Pharmaceutical unit promoters guilty of criminal negligence should be prosecuted. The Indian pharmaceutical industry, which ranks third in the world, must learn from these two tragedies and appropriate reforms must be initiated to make the regulatory process more effective.

Initial investigations by Indian authorities earlier revealed that Maiden Pharma was licensed to manufacture the four products, but only for export, and only to supply medicines to Gambia. None of the four drugs are marketed in India. The results of belated efforts to tighten regulatory processes and strictly adhere to standard operating procedures must now be critically assessed. India’s status as a major global player in the pharmaceutical industry has taken a hit. Much of the criticism is directed at the regulatory system. The quality control crisis has been compounded by allegations of lax, inefficient and rampant corruption in the drug approval process, which does not follow the strict standards applicable in other parts of the world. Zero tolerance for breaking the rules is the foundation upon which the pharmaceutical industry stands. The stakes are high not just for the company, but for the country’s broader pharmaceutical industry, worth about $50 billion. Indian drugmakers have achieved global success due to their price competitiveness and good quality, accounting for 60% of the world’s vaccines and 20% of generic drugs. Moreover, Africa is an important market as India supplies half of its generic drug needs.