900 Pharma Units Inspected In 3 Years, 700 Actions Taken; Himachal Key In Drug Quality Crackdown
In a crackdown that exposes lapses in the pharmaceutical manufacturing sector, India's drug regulator has ramped up scrutiny, issuing almost 700 regulatory actions following risk-based inspections across India. The Central Drugs Standard Control Organisation (CDSCO), India's apex drug regulator, has inspected 905 pharmaceutical units as part of its risk-based surveillance drive — and 694 actions have been taken, leading to enforcement measures ranging from stop production orders and license suspensions to show cause notices and warning letters.
'As of now, 905 units have been inspected, resulting in 694 actions being taken." The data has been shared by the Minister of State, Health and Family Welfare, Anupriya Patel, in Rajya Sabha on Tuesday.
The scale of non-compliance, where roughly 3 actions were taken for every 4 units inspected — underscores concern about quality control in the country's pharma ecosystem. The actions on these firms include 'Stop Production Orders (SPO), Stop Testing Orders (STO), licence suspensions/cancellations, warning letters, and show cause notices, depending on the severity of non-compliance," the minister replied. 'This initiative has provided valuable insights into the ground reality of manufacturing practices and has led to relevant corrective actions, resulting in noticeable improvements in the regulatory framework," Patel said.
In Himachal alone, 2,275 drug samples from local firms have been tested in the past two years, signalling the regulatory focus on pharma hotspots.
'In the last two years, CDSCO has tested 2275 drug samples of pharma companies situated in Himachal Pradesh. These drugs include vitamins, antipyretics, antibiotics, antihelminthics, antihistaminics, antineoplastics, corticosteroids, anticoagulants, analgesics, antacids, antidiabetics, anti-lipidemic and antihypertensives etc," she said while responding to the question on 'the details of drugs of pharmaceutical companies tested by the Central Drugs Standard Control Organisation (CDSCO) during the last two years in Himachal Pradesh…"
The inspections, along with many other moves detailed by the minister in the Rajya Sabha, claim to be one of the most aggressive regulatory exercises in recent years to clean up India's drug manufacturing practices.
According to the data shared by Patel, in the latest May 2025 drug alert released by CDSCO, 186 drug samples failed quality checks and were classified as Not of Standard Quality (NSQ). Among these, 49 products were manufactured in Himachal Pradesh, one of the largest pharmaceutical manufacturing hubs in India. The flagged samples, now publicly listed on CDSCO's website, include medicines used for a wide range of conditions — from common antibiotics and antihypertensives to corticosteroids, antidiabetics, and anticoagulants.
She further added that the central government is providing regular residential, regional training and workshops to officials of CDSCO and state drug regulatory authorities on good manufacturing practices. 'In the financial year 2023-24, CDSCO has trained 22854 persons while in financial year 2024-25, 20,551 persons have been trained."
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