More than two years after 12 children in Jammu and Kashmir died after taking an adulterated cough syrup manufactured in Kala Amb, Himachal Pradesh’s Drugs Control Administration is yet to even finalise its probe, on the basis of which a chargesheet could be filed in court. The drug firm’s manufacturing licence has also been restored. For the regulator, citing a host of complexities and challenges cannot hide the fact that a test case to fix accountability and deliver justice has little to show, with more questions than answers.
The cough syrup was found to have diethylene glycol, a toxic industrial solvent that attacks kidneys, when the severely ill children were brought to PGI, where doctors were quick to inform the apex drug regulator, the Central Drugs Standard Control Organisation, and the Himachal regulator of their findings in February 2020. A major public health threat should require regulators to bring substandard-medicine cases to court quickly, and why that has not been happening calls for serious consideration at the highest levels.
Few substandard-drug cases reach the prosecution stage in India. There is a school of thought that sees the solution in uniting India’s regional regulators into a single entity, which would help insulate it from state-level pressures, both political and industrial. Another requirement is a prosecution wing, comprising trained professionals adept at building strong cases. Extending any leniency to the pharmaceutical units or choosing to ignore red flags can prove to be a fatal error. Quality control is the foundation of the sector, and a regulatory mechanism hamstrung by local or extraneous factors is a systemic aberration that needs correction.
