CDSCO Flags 112 Substandard Drugs in September, 49 Samples from Himachal Pradesh

The Central Drugs Standard Control Organisation (CDSCO) has flagged serious quality concerns in its latest drug alert for September, revealing that 112 domestically manufactured medicines across India failed to meet quality standards. Among these, 49 samples originated from Himachal Pradesh, the country’s leading hub for pharmaceutical production.
The failed samples include medicines prescribed for critical illnesses such as cancer, heart disease, diabetes, high blood pressure, asthma, infections, pain, inflammation, anemia, and epilepsy.
The CDSCO report noted that three cough syrups were among the failed products, with one found to be counterfeit.
Authorities clarified that the quality lapses pertain to specific batches tested and do not imply that all products of the same brand or company are unsafe. “The failure is limited to the tested batch and should not be construed as affecting other medicines currently available in the market,” the CDSCO statement said.
According to the report, Himachal Pradesh topped the list with 49 failed samples, followed by Gujarat with 16, Uttarakhand with 12, Punjab with 11, and Madhya Pradesh with six. Three samples each from Sikkim, Telangana, and Andhra Pradesh also failed, while Karnataka and Maharashtra reported two failed samples each. One sample each from West Bengal, Rajasthan, Uttar Pradesh, Haryana, and Jammu & Kashmir did not meet the standards.
Two cough syrups, manufactured in Haridwar (Uttarakhand) and Sirmaur (Himachal Pradesh), were found to be substandard. Another syrup, Besto-Cough Dry Cough Formula, used for treating dry cough, is also under scrutiny, with the listed manufacturer’s details currently being verified.
The CDSCO said that a total of 23 drug samples from three major pharmaceutical industries in Punjab, Gujarat, and Himachal Pradesh have failed the quality test.
The findings have once again drawn attention to India’s pharmaceutical manufacturing practices, particularly in key drug-producing states like Himachal Pradesh and Gujarat. Regulatory authorities are expected to initiate further inspections and compliance actions against the manufacturers responsible for the substandard batches.
Officials have assured that steps are being taken to trace and recall the defective batches from the market to ensure patient safety.
