Even as data submissions were pending from nearly 18 states and five Union Territories, the Central Drugs Standard Control Organisation (CDSCO) reported a total of 205 drug samples as Not of Standard Quality (NSQ) during November 2025.

Of the total NSQs identified during the month, state drug control laboratories reported 141 samples, accounting for about 69 percent of the total. The remaining 64 samples were declared NSQ by CDSCO laboratories, according to the regulator’s latest update.

Samples identified as NSQ by CDSCO laboratories included Pheniramine Maleate Injection labelled as manufactured by Sanofi India, pantoprazole tablets IP 40 mg and atorvastatin and clopidogrel capsules labelled as manufactured by Intas Pharmaceuticals, ferric carboxymaltose injection 50 mg/ml labelled as manufactured by BDR Pharmaceuticals International, pantoprazole sodium gastro-resistant and domperidone prolonged-release capsules labelled as manufactured by Aristo Pharmaceuticals, compound sodium lactate injection by Paschim Banga Pharmaceutical, and calcium and vitamin D3 tablets by public sector unit Bengal Chemicals and Pharmaceuticals.

The NSQ list compiled from state laboratories included four drug samples from Tamil Nadu-based Sresan Pharmaceuticals, which has recently faced regulatory action over alleged contamination of cough syrup. These included ranitidine oral solution, a combination syrup containing terbutaline sulphate, ambroxol hydrochloride and choline theophyllinate, and two samples of cyproheptadine hydrochloride syrup.

Other NSQ samples reported by state labs included trypsin–chymotrypsin tablets labelled as manufactured by Torrent Pharmaceuticals, telmisartan and hydrochlorothiazide tablets by Mankind Pharma, ciprofloxacin hydrochloride tablets 500 mg by Cadila Pharmaceuticals, clopidogrel and aspirin capsules by Hetero Labs, and Cyclopam by Indoco Remedies.

Public sector manufacturers were also featured in the list, including glimepiride tablets IP 2 mg labelled as manufactured by Kerala State Drugs and Pharmaceuticals, and calcium and vitamin D3 tablets labelled as manufactured by Bengal Chemicals and Pharmaceuticals.

According to CDSCO data, NSQ reports for November were pending from states including Andhra Pradesh, Arunachal Pradesh, Assam, Bihar, Chhattisgarh, Goa, Haryana, Jharkhand, Madhya Pradesh, Manipur, Meghalaya, Mizoram, Nagaland, Punjab, Rajasthan, Sikkim, Uttarakhand and Uttar Pradesh. Data from Union Territories such as Andaman and Nicobar Islands, Dadra and Nagar Haveli and Daman and Diu, Delhi, Ladakh and Lakshadweep were also pending.

While CDSCO also listed data as pending from additional states including Karnataka, Gujarat, Kerala, Tamil Nadu, Telangana, Tripura, Maharashtra, Odisha, West Bengal and Himachal Pradesh, as well as the Union Territories of Puducherry, Jammu and Kashmir and Chandigarh, the detailed annexure showed that NSQ samples from these regions were nevertheless included based on reports from state laboratories.

The regulator reiterated that increased participation from states and Union Territories is essential for effective drug quality monitoring and timely regulatory action against substandard medicines.

CDSCO had reported the highest number of NSQs in recent months during October 2025, when 211 samples were declared substandard, with nearly 70 percent originating from state laboratories. Monthly NSQ figures throughout 2025 have remained elevated, reflecting a sustained increase in reporting from state and Union Territory regulators.

Over the years, reporting of NSQ drug samples by states and Union Territories has risen sharply. From just 125 NSQs reported in 2019, the number increased to 339 in 2024, indicating nearly a three-fold rise over five years.