New Delhi: Even as the drug regulators in the country have announced a total of 167 drug samples tested during the month of December as Not of Standard Quality (NSQ), 16 states and six Union Territories (UTs) in the country did not submit the data with the central drug regulator, according to official data.
The states, listed by the Central Drugs Standard Control Organisation (CDSCO) as yet to submit the data for the month of December include, Andhra Pradesh, Arunachal Pradesh, Bihar, Goa, Gujarat, Haryana, Jharkhand, Karnataka, Madhya Pradesh, Manipur, Meghalaya, Mizoram, Nagaland, Sikkim, Uttarakhand, and Uttar Pradesh.
The UTs listed by the CDSCO as yet to submit the data for the month of December include Andaman Nicobar, Chandigarh, Dadra and Nagar Haveli and Daman and Diu, Ladakh, and Lakshadweep.
While the pending list also include the names of Chhattisgarh, Odisha, and Tamil Nadu, and the UT of Jammu and Kashmir, the detailed list of NSQs published by the CDSCO shows that samples tested in the laboratories of these States and UT were also reported and counted in the total number of NSQs announced for the month.
The CDSCO has announced a total of 167 drug samples tested across the country during the month of December, 2025 as NSQ, including 74 reported by the Central Drug Laboratories, and 93 from the State Drugs Testing Laboratories.
The samples failed the quality test in the State laboratories include ceftriaxone & sulbactam IP for injection (Keftragard-1500) from Ipca Laboratories, levocetirizine tablets IP 5mg (Levocet) from Hetero Healthcare, amoxycillin & potassium clavulanate tablets IP (Clavam 625) from Alkem Health Science, and a formulation of aceclofenac & paracetamol tablets and another formulation of ciprofloxacin tablets IP 500mg from public sector undertaking Hindustan Antibiotics Ltd.
A combination of dextromethorphan hydrobromide, phenylephrine hydrochloride and chlorpheniramine maleate syrup (Respolite-D) from Sresan Pharmaceuticals, which faced action from the regulators for the alleged contamination in its cough syrup formulation Coldrif, also failed the test during the month. Seven samples of albendazole tablets IP 400 mg from Mancare Laboratories, tested in the state laboratory of Chhattisgarh, also failed in meeting the quality standards.
The samples failed the quality test in the Central laboratories include two samples of combination drug aceclofenac 100 mg, serratiopeptidase 15 mg & paracetamol 325 mg tablets Zerodol-SP from Ipca Laboratories, deflazacort tablets 6 mg Defcort 6 from Macleods Pharmaceuticals, among others.
During the month of December, a total of seven drug samples were identified as spurious.
This include four drugs sample tested in the Regional Drugs Testing Laboratory, Chandigarh – telmisartan tablets I.P. 40 mg (Telma 40), telmisartan 40 mg and amlodipine 5 mg tablets IP (Telma-AM), montelukast sodium and levocetirizine hydrochloride tablets IP (Montina-L), and pantoprazole sodium gastro-resistant and domperidone prolonged -release capsules IP (Pantop-D SR).
Two samples tested in the Maharashtra FDA’s laboratory – trypsin-chymotrypsin tablets (Chymoral Forte), and telmisartan 40mg and amlodipine 5 mg tablets IP (Telma-AM) – and one sample tested in Gujarat FDA’s laboratory – trypsin-chymotrypsin tablets (Chymoral Forte) – were also declared as spurious.
CDSCO said that the products are purported to be spurious, however, the same is subject to outcome of investigation.
“The actual manufacturer (as per label claim) has informed that the impugned batch of the product has not been manufactured by them and that it is a spurious drug,” it added.
These drugs were manufactured by unauthorized manufacturers using brand name owned by other company and the matter is under investigation and action will be taken as per Act & Rules, it added.
“This action of identifying NSQ and spurious medicines is taken on regular basis in collaboration with state regulators to ensure that these drugs are identified and removed from of market. It also demonstrates an active, strong and responsive regulatory system in a country,” added the regulator.
