A total of 186 drug samples were found to be ‘not of standard quality’ (NSQ) in May 2025, with 49 of them manufactured in Himachal Pradesh, Minister of State for Health and Family Welfare Anupriya Patel informed the Rajya Sabha on Tuesday in a written reply.

She was responding to a question from MP Dr. Sikander Kumar, who asked whether the government was aware of substandard drugs recently reported from Himachal Pradesh, and if any stringent measures were taken to ensure the quality and integrity of pharmaceutical products throughout the distribution process across the country.

The minister confirmed that over the past two years, 2,275 drug samples from pharma companies based in Himachal Pradesh were tested. These included a wide range of medicines such as vitamins, antibiotics, antipyretics, analgesics, antihistamines, corticosteroids, antineoplastics, anticoagulants, antidiabetics, antacids, antihypertensives, antilipidemics, and antihelminthics.

Details of the NSQ drug samples and their manufacturers are publicly available on the Central Drugs Standard Control Organization (CDSCO) website under the Drug Alert section.

Patel stated that the concerned manufacturing firms have been instructed to recall the affected drugs and halt further distribution in the market. 

 “Further, based on investigation outcome, actions are taken by the licensing authorities concerned under the provisions of the Drugs and Cosmetics Act and Rules made thereunder, such as stop production orders, stop testing orders, license suspensions/cancellations, warning letters, and showcause notices,” she added.

She also highlighted several regulatory measures undertaken by the CDSCO and the Ministry of Health to ensure the production of quality medicines for all people across the country. These include risk-based inspections of drug manufacturing and testing units, which began in December 2022. So far, 905 units have been inspected, leading to 694 enforcement actions.

Additionally, the CDSCO issued new regulatory guidelines in February 2024 for drug, cosmetic, and medical device sampling by central and state drug inspectors.

To enhance lab coordination, the government launched SUGAM Labs, an online platform, in September 2023, integrating the drug testing labs of the CDSCO.

An important regulatory change was also introduced through an amendment to the Drugs and Cosmetics Rules, 1945, making it mandatory for drug manufacturing establishments to be jointly inspected by both central and state drug inspectors before the issuance of a manufacturing license.