Why States Need to Act Against Spurious Drugs

Substandard drugs are becoming a political liability; governments must do more to eliminate them from the market

- Dinesh Thakur

In the last six months, there have been tragedies in Karnataka and West Bengal due to contaminated ringer lactase solution manufactured by the same pharmaceutical company in Bengal. In total, six young mothers died, with several others hospitalized with critical illnesses. In both states, the Opposition parties heaped criticism on the health ministers. Deaths due to contaminated drugs have been political dynamite, especially when they occur in government hospitals. Yet, states are doing precious little to reform the bureaucracies responsible for drug quality.

To be fair, state health ministers are caught between a rock and a hard place because of the fragmented regulatory framework under the Drugs & Cosmetics Act, 1940, which allows only the Union government to set quality standards and leaves enforcement of these standards to individual states. As a result, India has 37 drug regulators—one for each state and Union Territory in addition to a national regulator. These 37 regulators are inept at coordinating or sharing information with each other. These issues, combined with jurisdictional issues, render these regulators incapable of dealing with a nimble-footed pharmaceutical industry which knows how to slip through the regulatory cracks. Therefore, when drugs fail testing in one state and are declared to be Not of Standard Quality (NSQ), there is no system in place to instantly share the test reports with all state drug controllers across the country, along with details such as batch numbers and sales records, which are crucial to trace the NSQ batch. Thus, even after Karnataka linked the deaths of the five young mothers in November to the contaminated ringer lactase, West Bengal did not do enough to ensure that the same drugs were recalled from its own hospitals and pharmacies.