Strengthen drug regulatory system

The World Health Organisation’s medical product alert for four ‘contaminated’ cough and cold syrups manufactured by Haryana-based Maiden Pharmaceuticals has raised uncomfortable questions about India’s drug regulatory system. The agency has said it is investigating whether the death of 66 children in The Gambia, a West African country, from acute kidney injuries were linked to the use of cough syrups produced by Maiden Pharmaceuticals, which sells its products in countries in Asia, Africa and Latin America. According to WHO's laboratory analysis of the cough syrup, it contained “unacceptable” amounts of diethylene glycol (DEG) and ethylene glycol, which can cause acute kidney injury. WHO has said that the products under investigation may have been supplied to other countries, too. So, there is a worldwide alert to detect and remove these products from circulation to prevent further harm.

India’s Central Drugs Standard Control Organisation (CDSCO) and Haryana’s drug control agency have also started an investigation and, according to initial reports, one of the cough samples has confirmed unacceptable amounts of toxic chemicals. It is a serious matter and must be probed fully to fix accountability and to punish those who are guilty of wrongdoing. DEG is known to be used to adulterate cough syrups, and it is not clear whether the batch of cough syrups that allegedly caused the death of the children was tested for its presence. It is possible that that such checks did not take place. There was a similar case of cough syrup poisoning in India, too. In December 2019, 14 children died in Udhampur in Jammu & Kashmir after they were given a cough syrup, allegedly adulterated with DEG, manufactured by a Himachal Pradesh-based company. Worryingly, the investigation into that incident has still not concluded.

India has a developed and thriving pharma industry and the country has earned the tag “pharmacy of the world”. But there have also been complaints that the regulatory mechanism is not strong and there are flaws in the monitoring of manufacturing processes and supply chain management. Maiden Pharmaceuticals is a repeat offender but was allowed to continue its business. The Haryana drugs controller gave it a compliance certificate making it eligible to export its drugs. Recently, there were reports that a large number of fake drugs were circulating in the country. It also came to be known that some drugs were being manufactured without licence. All this underlines the need to improve and strengthen the drug regulatory system. Incidents like The Gambia deaths will seriously damage the reputation of the country’s pharma industry. It is not just a matter of reputation, the lives and health of people, in India or elsewhere, should not be endangered.