CDSCO Publishes Not Of Standard Quality And Spurious Alert For May 2025

These lists are as follows:

  1. Dugs analyzed by CDSCO/ central laboratories,
  2. Drugs that have been analyzed by state laboratories, and
  3. Drugs, Medical Devices, Vaccine and Cosmetics declared as Spurious/Adulterated/Misbranded

Not of Standard Quality (NSQ) drugs refer to drugs that fail to meet quality standards or specifications. The term ‘standards of quality’ is defined in the Drugs & Cosmetics Act, 1940, to mean that the drug complies with the standards set out in the Second Schedule of the said Act.

Central Laboratories NSQ List of drugs/ products for May– 2025

The NSQ drug list for central CDSCO laboratories specifies a total of 58 drugs that were detected to be deficient.

Out of the 58 NSQ drugs from CDSCO/Central Laboratories, 27 were reported by Central Drug Laboratory (CDL), Kolkata; 14 was reported by Regional Drugs Testing Laboratory (RDTL), Chandigarh; 7 were reported by RDTL, Guwahati; 6 were reported by Central Drugs Testing Laboratory (CDTL), Mumbai; 3 were reported by CDTL, Indore and 1 was reported by CDTL, Chennai.

State Laboratories NSQ List of drugs/ products for May – 2025

The NSQ drug list specifies a total of 128 drugs that were detected to be deficient by the state laboratories.

Out of these 128 drugs, 16 were reported by Karnataka, 9 were reported by State Lab, Drugs Control Laboratory, Telangana; 3 were reported by Drugs Testing Laboratory, Madurai-19; 6 were reported by Modern Drug
Testing Laboratory Kathua (J&K); 12 were reported by DTL Baddi; 10 were reported by DTL, Jaipur (State
Lab); 2 was reported by DTL, Bikaner (State Lab); 17 were reported by State Drugs Laboratory, Punjab; 9 were reported by A.S Kambli Palghar-Zone-1 FDA, Lab Mumbai; 1 was reported by V.P. Mahajan, Jalna, FDA Lab, M.S. Chhatrapati Sambhajinagar, Maharashtra State; 1 was reported by B.D. Marewad, FDA Lab, M.S. Chhatrapati Sambhajinagar, Maharashtra State; 2 were reported by N.S. Bhalerao, Nanded, FDA Lab, M.S. Chhatrapati Sambhajinagar, Maharashtra State; 5 were reported by S.K, Jadhav, PuneZone 3 , FDA Lab, M.S. Chhatrapati Sambhajinagar, Maharashtra State; 1 was reported by V.P. Khedkar, Pune-Zone 2; 1 was reported by State Drug Control & Research Lab, West Bengal; 5 were reported by State Food & Drug Testing Laboratory Uttarakhand; 8 were reported by State lab, Puducherry; 9 were reported by State Drugs Testing Laboratory, Agartala, Tripura; 4 were reported by King Institute of Preventive Medicine & Research, Guindy, Chennai-32; 8 was reported by Drugs Testing Laboratory, Chennai – 6; 1 was reported by Government of NCT of Delhi

It is pertinent to note that CDSCO did not receive NSQ data as per Format & in EXCEL SHEET State Drugs Licensing Authorities of Tamil nadu, Telangana, Jammu & Kashmir, Tripura, Puducherry, West Bengal, Himachal Pradesh 13 (01 NSQ already listed in CDSCO alert for the month of May-2025), Maharashtra, Uttarakhand, Karnataka, Punjab, Delhi, Rajasthan, Ladakh, 04 (All NSQ already listed in CDSCO alert for the month of May-2025) Assam 05 (All NSQ already listed in CDSCO alert for the month of May-2025,) Jharkhand 03 (All are listed in the CDSCO alert for the month of April-2025), Haryana (Nil), Goa (Nil).

However, the State Drugs Licensing Authorities of Andhra Pradesh, Arunachal Pradesh, Bihar, Chhattisgarh, Chandigarh, Gujarat, Kerala, Manipur, Madhya Pradesh, Meghalaya, Mizoram, Nagaland, Odisha, Sikkim, Uttar Pradesh, Andaman & Nicobar Islands, Dadar and Nagar Haveli, Daman and Diu, Lakshadweep have not submitted any data in respect of the Not of Standard Quality (NSQ) Alert for the month of March, 2025

Drugs, Medical Devices, Vaccine and Cosmetics declared as Spurious for May – 2025

The term “Spurious Drug” has been defined under Section 17-B of the Drugs and Cosmetics Act, 1940. A drug shall be deemed to be spurious;

  • If it is manufactured under a name which belongs to another drug; or
  • If it is an imitation of, or is a substitute for, another drug or resembles another drug in a manner likely to deceive or bears upon it or upon its label or container the name of another drug unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such other drug; or
  • If the label or container bears the name of an individual or company purporting to be the manufacturer of the drug, which individual or company is fictitious or does not exist; or
  • If it has been substituted wholly or in part by another drug or substance; or
  • If it purports to be the product of a manufacturer of whom it is not truly a product.

This list specifies 2 batches of 1 drug as spurious, i.e Telmisartan Tablets IP 40mg (Telma 40). The drugs were manufactured in February 2024 and June 2024 and having batch numbers 05240226 and K18230707.

The actual manufacturer (as per label claim) has informed that the impugned batches of the products have not been manufactured by them and that they are spurious drugs. These drugs are subject to ongoing investigation.

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