Drug regulators should work together to plug loopholes: Mandaviya

Following three international alerts on the quality of made-in-India medicines in the past five months, Union Health and Pharmaceutical Minister Mansukh Mandaviya on Sunday asked the central and state regulatory agencies to work together to plug the regulatory loopholes to ensure top quality for Indian medicines.

Asking the state and central agencies to build on the strength of each other, Mandaviya said such joint working was needed to “remove the loopholes in the regulatory system.”

The minister chaired a brain-storming session in Hyderabad on the quality of pharmaceutical regulation and enforcement in India. Regulators from state and central outfits, health officials, and representatives of pharma associations attend the session.

The closed-door discussions over two days come in the backdrop of three global alerts in quick succession—from the Gambia in October 2022 and Uzbekistan in December 2022, linking specific Indian-made cough syrups to child deaths in the two countries, and an alert from the US earlier this month linking eye drops from India to bacterial infections.

“How can we ensure that the confidence of the consumers of pharmaceuticals manufactured in India is upheld? It is of critical importance to ensure that the country's regulatory mechanisms are of impeccable standards and sustainable. Let us ensure that India’s regulatory systems are the best in the world,” the minister told the participants.

Following the alerts that came from the WHO and the US FDA, Central Drug Standard Control Orgainsation officials and state regulators examined the production facilities and found multiple discrepancies. The companies have been ordered to stop producing all or specific products.

Last month, the World Health Organisation, citing the incidents linked to the Indian-made cough syrups, called on governments and regulators to improve inspections, market surveillance, and enforce measures to combat the manufacture and distribution of substandard medicines to detect and remove any substandard medical products that have been identified by the WHO as potential causes of deaths and disease.