It is ‘shameful’ that despite numerous regulatory bodies at the national and state levels for ensuring quality of medicines being manufactured at various places, contaminated cough syrups were allowed to reach the market, leading to tragic deaths of over 20 toddlers. This has raised many questions about the accountability of the watchdogs and exposed serious flaws in the drug regulatory system. How could such a grievous failure occur under the watch of multiple agencies, and why have those responsible to regulate the quality have been left to go scot-free?
The silence and inaction in the face of such a tragedy reflect a systemic rot that demands to be addressed on urgent basis. It has become a matter of ‘national shame’ that a country which boasted on all platforms of being one among the largest suppliers of pharmaceuticals has to face such a situation that the World Health Organisation (WHO) has to issue an alert against three “substandard” oral cough syrups identified in India — Coldrif, Respifresh TR and ReLife.
Reportedly, WHO has urged national regulatory authorities worldwide to immediately notify it if these are detected in their country? It has also advised healthcare professionals to report the detection of these substandard products and any incident of adverse effects, or lack of expected effects to their national regulatory authorities or National Pharmacovigilance Centre.
The alert comes after at least 22 children, mostly under the age of five, have died due to suspected kidney failure after being administered Coldrif in Madhya Pradesh. Besides, at least three children have allegedly died in Rajasthan after consuming cough syrup in different districts of the state. What is intriguing is the fact that the government agencies responsible for regulating the quality of medicines manufactured across the country have been allowed to go scot-free as if it was none of their business.
What is required to ensure that such things do not repeat is fixing the accountability of the regulatory bodies having the onus of checking the quality of medicines produced in establishments coming under their jurisdiction because these are being nurtured for ensuring the quality of medicines and not for sitting and remaining in deep slumber.
It is time that action should be taken against the real culprits including the manufacturers and those having the responsibility to check the reliability of processes and quality of medicines produced. For sure, such oversights not only lead to tragedies but can also affect the business of pharmaceutical industry due to loss of faith among the clients which are spread all across the globe, for India being a tycoon in this business.
