Reports

Major Lapses Found in Domestic Drug Quality — 112 Batches Fail Nationwide, Himachal Pradesh Leads

The breakdown of failures by state: Himachal – 49, Gujarat – 16, Uttarakhand – 12, Punjab – 11, Madhya Pradesh – 6, and three each from Sikkim, Telangana and Andhra Pradesh. Karnataka and Maharashtra reported two each, and one failure apiece was logged from West Bengal, Rajasthan, Uttar Pradesh, Haryana and Jammu & Kashmir.

• By Newsdesk
• Shimla
• Oct 25, 2025

Reports

The Central Drugs Standard Control Organisation (CDSCO) has uncovered serious quality-failures in its September drug‐safety bulletin, reporting that 112 samples of domestically manufactured medicines across India did not meet required standards. Among the states, Himachal Pradesh accounts for the largest share of flagged products, with 49 failed samples originating from the region.

The failed drugs cover a wide spectrum of therapeutic uses — from treatments for heart disease, diabetes and high blood pressure to asthma, infections, pain/inflammation, cancer, anaemia and epilepsy. Notably, three cough syrups were among the non-compliant batches; one of those has been classified as counterfeit.

CDSCO officials emphasised that the failures apply only to specific tested batches and not to all products of the same brand or maker. “The failure is limited to the tested batch and should not be construed as affecting other medicines currently available in the market,” the statement clarified.

The breakdown of failures by state: Himachal – 49, Gujarat – 16, Uttarakhand – 12, Punjab – 11, Madhya Pradesh – 6, and three each from Sikkim, Telangana and Andhra Pradesh. Karnataka and Maharashtra reported two each, and one failure apiece was logged from West Bengal, Rajasthan, Uttar Pradesh, Haryana and Jammu & Kashmir.

In particular, two sub-standard cough syrups manufactured in Haridwar (Uttarakhand) and Sirmaur (Himachal Pradesh) drew attention. Another syrup — marketed under the name “Besto-Cough Dry Cough Formula” for dry cough — is under probe, with manufacturer details still being verified.

The findings shine a spotlight on manufacturing and regulatory challenges in major pharmaceutical-producing states such as Himachal Pradesh and Gujarat. The CDSCO says it will initiate further inspections and compliance actions against the firms responsible for the sub-standard batches, and steps are already underway to trace and recall defective batches from the market to safeguard patient safety.