Ensuring compliance: On the Indian pharmaceutical sector. 

Firms that make poor quality drugs must face consequences. 

Atmanirbhar Bharat is an aspirational ideal well worth pursuing, but not without a sustained quality control framework in place. Time and again, there have been serious threats to the goal of ‘making in India’, particularly in the pharmaceutical sector. The issue of quality of cough syrups has repeatedly been raised, and India with great ambitions in the global pharmaceutical sector has often been short of what is required to build a robust and trustworthy industry. Recently, the Union Health Ministry sought strict drug compliance from all Indian drug manufacturers, in line with the revised Schedule M norms for pharmaceutical products in India. This came after a report from the Tamil Nadu Drugs Control Department found above permissible limits of diethylene glycol (DEG) in samples of Coldrif, a cough syrup being manufactured by a private company. The tests were initiated after cough syrup was suspected to be behind the recent deaths of at least 16 children in Rajasthan and Madhya Pradesh. Strangely, while the Health Ministry ruled out the presence of DEG, in initial tests conducted on samples from the two States, it was detected in one of the batches lifted by Tamil Nadu within the State. The State’s Drugs Control Department also recorded several non-compliance factors in the Good Manufacturing Practices and Good Laboratory Practices of the Drugs Rules, at the manufacturing facility. Its report mentioned that the contaminated batch was manufactured using non-pharmacopoeial grade propylene glycol as an excipient. It mentioned that this might have contaminated the drug with DEG and ethylene glycol, known nephrotoxic substances. The Central Drugs Standard Control Organisation has recommended cancellation of the firm’s manufacturing licence. Meanwhile, a doctor who reportedly recommended the cough syrup to many of the children who died in Madhya Pradesh was arrested.

While these measures are good to address the situation in the instant case, what the Indian state must do is have a zero threshold for poor quality drugs. Hawk-like monitoring is necessary, and action when violations are detected. It is criminal to act only when deaths have occurred; that is indefensible. A framework of proven Good Laboratory Practices already exists; what is needed is seriousness in handling every such reported violation, along with regular, surprise inspections of drug batches, with appropriate action taken for every violation. It is important to send the message down the assembly line that the government will not brook any shoddiness or violations that endanger the lives of people.