The quality of some Indian drugs has come under scrutiny, once again, after cough syrups led to the deaths of at least 12 children across Madhya Pradesh and Rajasthan. The deaths were allegedly caused by high levels of diethylene glycol — a chemical that can cause kidney failure and death when ingested even in small amounts — in cough syrups. This is not the first time cough syrups made in India have caused fatalities in children. DEG-tainted cough syrups have claimed dozens of young lives in Jammu, Bihar, Chennai and Gurugram. In recent years, Indian cough syrups have been linked to child deaths in Uzbekistan, Iraq and The Gambia, revealing regulatory gaps in India’s pharmaceutical industry. This is worrying because India produces one in every five generic medicines consumed globally and supplies vaccines to more than 150 countries. Such instances of Indian-made medicine failing to meet international safety standards are not only an embarrassment, but they also damage New Delhi’s diplomatic capital.
The problem facing the country is a combination of structural impediments and poor regulatory oversight. The Drugs and Cosmetics Act of 1940 divides responsibilities between the Centre and the states: while the Central Drugs Standard Control Organisation handles approvals for new drugs and oversees imports, state regulators are responsible for manufacturing licences and routine inspections. This dual structure has led to duplication, delay and, more dangerously, dilution. State drug controllers vary widely in capacity and capability. The CDSCO itself has been stretched thin. With roughly 3,500 inspectors nationwide overseeing nearly 10,500 manufacturing units, inspection frequency is woefully inadequate. In this context, the government’s proposal to introduce safety and quality standards on a par with global norms — the Indian Pharmacopoeia Monographs — to reinforce India’s reputation as a global leader in drug manufacturing is heartening. But merely having laws is of no use when they are flouted with impunity. Take, for instance, the laws on prescription medicines. A probe in Rajasthan after the recent deaths showed that children are often prescribed and given medicines meant for adults: is there then a nexus that involves physicians, dubious drugs and regulators as well? It is also well-known that prescription drugs like painkillers are sold over the counter. Mandatory audits of each drug sold against valid prescriptions — a practice that is commonplace in developed countries — can go a long way towards not only preventing deaths by overdose but also checking antimicrobial resistance.