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India pharmaceutical regulatory scrutiny

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2026-11-03 06:25 UTC → 2026-11-04 18:15 UTC · added ~~removed~~

Regulatory authorities in India have intensified oversight of the pharmaceutical sector following reports of widespread quality failures. The Central Drugs Standard Control Organization and state laboratories identified 330 medicine and surgical product samples that failed to meet prescribed quality standards. In Himachal Pradesh, 93 failed samples were identified, involving products from 73 companies. Non-compliant items included treatments for fever, acidity, pain, cough, anemia, allergies, high blood pressure, malaria, and thyroid disorders, as well as surgical supplies like rolled bandages and adhesive tape. Authorities are expected to initiate action under the Drugs and Cosmetics Act, including market recalls and independent testing in manufacturing hubs such as Baddi, Barotiwala, Nalagarh, and Kala-Amb. In response to regulatory concerns, the Ministry of Health and Family Welfare issued the Drugs (Thirteenth Amendment) Rules, 2026. This amendment bars the import of medicines with less than one year of remaining shelf life to ensure product longevity, though exceptions allow biological drugs and radiopharmaceuticals to be imported with at least 60 percent of their labeled shelf life remaining. To improve logistics, the government has also proposed expanding authorized import gateways to include several inland container depots, a special economic zone, and the Noida International Airport. The Supreme Court of India has questioned the government and the Drug Controller General of India regarding alleged regulatory delays. The court specifically raised concerns over the sale of Liposomal Amphotericin B, which reportedly utilized expired emergency permissions from the Covid-19 pandemic and was allegedly sold without required clinical trials and oversight for several years. Further tightening of standards is underway as the Union Health Ministry proposed stricter contamination monitoring for sterile medicine manufacturing to align with World Health Organization guidelines. The proposal targets Schedule M of the Drugs Rules, specifically Grade A cleanroom zones.

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