



Regulator may make pharma inspections public as it steps up scrutiny
In a first, India plans to publicly disclose findings from inspections of drug manufacturing units, marking a shift towards greater transparency and quality monitoring, according to two government officials and documents reviewed by Mint.According to the proposal being discussed, the country’s apex drugs regulator, Central Drugs Standard Control Organization (CDSCO), will publish details of inspected firms and audit recommendations on its website, as India's pharmaceuticals sector faces heightened scrutiny over quality.The plan assumes significance for the country's $50 billion pharmaceutical market in the backdrop of Indian-manufactured cough syrups being linked to over 140 deaths in countries, including Gambia, Uzbekistan and Cameroon, due to ethylene glycol poisoning.The office of Drugs Controller General of India (DCGI), headed by Rajeev Raghuvanshi, conducts these risk-based inspections (RBI) to ensure compliance with regulatory requirements under the Drugs and Cosmetics Act and Rules.“It has been desired that CDSCO may examine the feasibility of displaying brief details of firms inspected under RBI along with the recommendations of the inspection team, after due consideration of legal implications," according to the documents reviewed by Mint. "During such inspections, inspection teams make observations and recommendations based on risk assessment.
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