Union health minister Mansukh Mandaviya on Sunday directed drug regulatory authorities to ensure that medicines made in India meet the highest quality standards, amid heightened concerns about the quality of Indian drugs stirred by three international alerts over the past five months.
“It is of critical importance to ensure that the regulatory mechanisms of the country are of impeccable standards,” Mandaviya said, addressing a brainstorming conclave in Hyderabad called to review drug quality regulation and enforcement and central and state regulatory capacities.
Central and state officials, drug industry executives, and health researchers are attending the two-day closed-door conference. Mandaviya asked central and state drug officials to work together to “remove loopholes in regulatory mechanisms,” the ministry said, releasing excerpts of his address.
The conference sessions will focus on strategies to enhance “trust and confidence” in the quality of drugs in the domestic and global market, transparency and accountability in the regulation of drug quality, and effective enforcement of regulations, the ministry said.
The conclave comes against the backdrop of lingering concerns about drug quality triggered by both routine year-round drug inspections heightened by three foreign alerts since October 2022 — from the Gambia, Uzbekistan, and the US — on the quality of specific medicines from India.
Routine drug inspections in 2022 had labelled as “substandard” 569 (3.6 per cent) samples of medicines from among over 15,000 because they failed quality tests that assessed the amount of the medicine in the sample or its capacity to be absorbed by the body.
The Central Drugs Standards Control Organisation, the country’s apex drug regulatory authority which releases monthly alerts on substandard drugs, in January 2023 recorded 67 (5 per cent) samples as substandard among 1,348 tested.
“Technical glitch”
The health ministry had on Sunday morning circulated a YouTube link for Mandaviya’s inaugural address at the brainstorming session on drug quality but minutes into his talk, the link broke down. A health ministry official told The Telegraph that the breakdown was due to a “technical glitch” and said there was no recording available.
However, one viewer who had watched the few minutes live streamed posted on Twitter that the minister had expressed concern about states and the Centre not working together and substandard drugs exported spoiling India’s image before the link broke down.