5 formulations declared as spurious including Sun Pharma's Ursocol 300, Glenmark's Telma H
New Delhi: In the latest spurious drug alert, the apex drug regulatory body, the Central Drug Standard Control Organization (CDSCO), has declared 5 formulations to be spurious, adulterated, or misbranded for August 2024, which includes some commonly prescribed medicines, including Sun Pharmaceuticals' Pulmosil (Sildenafil Injection), Sunpharma laboratories' Pantocid (Pantoprazole Tablets IP) and Ursocol 300 (Ursodeoxycholic Acid Tablets IP), Glenmark's Telma H (Telmisartan 40 mg and Hydrochlorothiazide 12.5 mg Tablets IP), and Macleods' Defcort 6 Tablets (Deflazacort).
The medication samples failed due to a number of reasons, including issues with the assay, identification test, particle matter, volume in the container, sterility, and description.
In response to the alert mentioned above, a statement was issued by Sun Pharmaceuticals, Sunpharma Laboratories, Glenmark Pharmaceuticals, and Macleods Pharmaceuticals, which said,
" 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. The product is purported to be spurious, however, the same is subjected to outcome of investigation."
Section 17B and Section 33EEA of the Drugs Act define spurious drugs. According to the 1940 Drugs and Cosmetics Act,
"A drug shall be deemed to be spurious,—
(a) if it is manufactured under a name that belongs to another drug; or
(b) 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
(c) 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
(d) if it has been substituted wholly or in part by another drug or substance; or (e) if it purports to be the product of a manufacturer of whom it is not truly a product."
List of Drugs, Medical Devices, Vaccines, and Cosmetics declared as Spurious/Adulterated/Misbranded for August 2024 |
S.N o | Name of Drugs/medical device/cosmetics | Batch No. | Date of Manuf acture | Date of Expiry | Manufactured By | Reason for failure | Drawn By | From | Firm reply |
1. | Pulmosil (Sildenafil Injection) | KFA0300 | 06/2023 | 05/2025 | M/s Sun Pharmaceuticals Ind., Ltd., Halol-Baroda Highway, Halol- 389350, Dist- Panchmahal, Gujarat, At Survey No. 250- 252,Turkapally-Village- Shameerpet Mandal, Ranga Reddy District- 500078, Telangana | Test for Description, Volume in container, Particulate matter, sterility and Assay of Sildenafil Citrate equivalent to Sildenafil. | Drugs Inspector, East Zone,CDSCO | NRS Medical College 138 AJC Bose Road, Kolkata 700014 | The actual manufacturer (as per label claim) has informed that the impugned batch of the product has not been manufacturer by them and that it is a spurious drug. The product is purported to be spurious, however, the same is subjected to outcome of investigation. |
2. | Pantocid (Pantoprazole Tablets IP) | SID2041A | 07/2022 | 06/2025 | M/s Sunpharma laboratories ltd. Plot no. 107- 108, Namli Block, P.O. Ranipool, East Sikkim-737135 | Identification and Assay | Drugs Inspector, East Zone,CDSCO | The actual manufacturer (as per label claim) has informed that the impugned batch of the product has not been manufacturer by them and that it is a spurious drug. The product is purported to be spurious, however, the same is subjected to outcome of investigation. |
3. | Ursocol 300 (Ursodeoxych olic Acid Tablets IP) | GTE1350A | 06/2023 | 05/2025 | M/s Sun Pharma Laboratories Ltd. Vill. Kokjhar, Mirza Palashbari Road, P.O. Palashbari, Guwahati, Dist. Kamrup, Assam- 781128 | Assay of ursodeoxycholi c Acid, Description | Drugs Inspector, East Zone,CDSCO | The actual manufacturer (as per label claim) has informed that the impugned batch of the product has not been manufacturer by them and that it is a spurious drug. The product is purported to be spurious, however, the same is subjected to outcome of investigation. | |
4. | Telma H (Telmisartan 40 mg and Hydrochlorot hiazide 12.5mg Tablets IP) | 18230080 | 02/2023 | 01/2026 | Glenmark Pharmaceuticals Ltd, Village-Kishanpura, Baddi, Himachal Pradesh 1732025 | Dissolution & Assay of Telmisartan | Drugs Inspector, East Zone,CDSCO | The actual manufacturer (as per label claim) has informed that the impugned batch of the product has not been manufacturer by them and that it is a spurious drug. The product is purported to be spurious, however, the same is subjected to outcome of investigation. | |
5. | Deflazacort Tablets ( Defcort 6 Tablets) | GDB23041A | 05/2023 | 04/2026 | Macleods Pharmaceuticals Ltd., 367/7, Kabra Industrial Estate, Kanchigam, Daman-396 210 (U.T) | Test of Identification and Assay of Deflazacort | Drugs Inspector, SLA Delhi | The actual manufacturer (as per label claim) has informed that the impugned batch of the product has not been manufacturer by them and that it is a spurious drug. The product is purported to be spurious, however, the same is subjected to outcome of investigation. |
To view the official notice, click the link below:
