Rx quality control for reputation and lives

A Central Drugs Standard Control Organisation (CDSCO) report has revealed that 50 cough syrup manufacturers reportedly don't meet quality standards. States had conducted the tests after reports linked India-made toxic cough syrups to 141 child fatalities globally. For the 'pharmacy of the world', this report is not just damaging but also of serious concern. The revelations, however, should not be surprising. India lacks a robust drug regulatory framework and an effective compliance mechanism. This gap gives many manufacturers the courage to cut costs and produce substandard drugs.

The issue of quality has been in focus since the global fatalities were reported earlier this year. In August, GoI made it mandatory for MSMEs engaged in making drugs to follow good manufacturing practices (GMPs) at manufacturing sites, bringing them on par with WHO standards. This measure was necessary after an assessment found that drugs manufactured in 65% of MSME units failed to meet quality standards.

Fixing the quality problem will require key steps. First, the focus must be on the choice of personnel in CDSCO. Instead of a pharma-focused bureaucracy, enlist multidisciplinary teams. This will lead to a holistic evaluation of the drug manufacturing value chain. Second, appoint an independent regulator, as CDSCO is attached to the Directorate General of Health Services. Finally, replace the existing regulatory system with a modern legal structure that provides oversight to an increasingly complex pharma industry, while protecting public health and patient rights. Addressing the quality issue is essential not just from a public health perspective but also to ensure India retains its primacy in the lucrative global drug manufacturing sector.