
CDSCO’s latest drug alert exposes serious manufacturing lapses
A nationwide quality audit conducted by the Central Drugs Standard Control Organisation (CDSCO) in coordination with state drug regulators has uncovered significant lapses in pharmaceutical manufacturing standards across the country. As many as 205 drug samples were declared ‘Not of Standard Quality’ (NSQ) in the drug alert issued on Wednesday evening, with Himachal Pradesh emerging as the single largest contributor.
Of the total substandard drugs identified, 49 were manufactured in various industrial clusters of Himachal Pradesh, accounting for a staggering 23.09 per cent of the national tally. Other states that figured prominently in the list include Uttarakhand (39 samples), Gujarat (27), Madhya Pradesh (19), Tamil Nadu (12) and Haryana (nine). Telangana and Chennai reported seven samples each, while Sikkim and Puducherry accounted for five each. Maharashtra reported four, Punjab and West Bengal three each and two samples each were traced to Mumbai, Andhra Pradesh, Jammu and Kashmir, Karnataka, Rajasthan and Uttar Pradesh. One drug sample from Kerala was also found to be substandard.
Within Himachal Pradesh, pharmaceutical units located in Baddi, Barotiwala, Nalagarh, Solan, Kala Amb, Paonta Sahib and Una have come under regulatory scrutiny for multiple deficiencies. In a particularly troubling finding, five drug samples from a single Kala Amb-based unit failed quality parameters, highlighting serious non-compliance with prescribed manufacturing norms.
The drugs flagged in the alert are widely used for treating common ailments such as bacterial infections including typhoid, lung, urinary tract and gastrointestinal infections, as well as respiratory disorders like cough, bronchitis, asthma and allergies. Medicines related to digestive health — acidity, ulcers, gas and constipation — also feature prominently in the list.
More concerning is the inclusion of drugs used to manage chronic and life-threatening conditions such as diabetes, hypertension, cardiac ailments, neurological disorders, skin diseases and inflammatory conditions. The affected categories span antibiotics, painkillers, anti-diabetic medicines, cough syrups, iron supplements and injectable drugs, amplifying the potential public health risk.
According to the CDSCO’s November 2025 drug alert, several samples failed the dissolution test, casting doubt on their absorption and therapeutic effectiveness. In some cases, the active pharmaceutical ingredient was found below prescribed limits, while others failed description and identification tests. Experts warn that such technical deficiencies can severely compromise drug efficacy and patient safety.
In response, authorities have ordered batch recalls and initiated risk-based inspections of the erring units. State Drugs Controller Dr Manish Kapoor confirmed that show-cause notices have been issued to all concerned manufacturers. “Any compromise on drug quality will not be tolerated. Protecting public health remains the government’s top priority,” he said, adding that field staff have been directed to conduct thorough investigations.























































