CAG warned - no one listened: Cough syrup tragedy exposes big drug testing gaps

In 2016-17, Tamil Nadu was supposed to conduct 1,00,800 drug inspections, but only 66,331 were completed, a shortfall of 34%. Three years later, the situation worsened. In 2019-20, the shortfall hit 40%, and by 2020-21, it stood at 38%.

Similarly, there were severe deficits in drug sample testing. In both 2018-19 and 2020-21, Tamil Nadu achieved barely half its target, with a 54% shortfall in lifting drug samples for laboratory testing.

Drug inspections are a critical step in the pharma production process that aims to ensure the quality of drugs and prevent adulteration. The CAG’s findings now appear to have been an early warning that was not acted upon in time.

Toxic ingredient in Coldrif

The ongoing probe has confirmed that Coldrif syrup contained a highly toxic chemical called diethylene glycol (DEG). This substance, commonly used in the production of industrial products such as printing ink and glue, is extremely harmful to humans. Even small quantities can damage the kidneys, liver, and nervous system, and, in children, can be fatal.

When Tamil Nadu’s drug authorities tested samples of Coldrif, they found DEG levels as high as 46-48%, far beyond the permissible limit of 0.1%.

Subsequent inspections at Sresan Pharmaceuticals’ factory in Kancheepuram uncovered unbilled containers of DEG.

Action against the Tamil Nadu company

Following the revelations, the Tamil Nadu Drugs Control Authority ordered the immediate suspension of Sresan Pharmaceuticals’ manufacturing license and froze all existing stocks of the cough syrup. The company’s owner, Ranganathan Govindan, has been arrested and faces serious criminal charges.