Batches of Glenmak TelmaAM categorized as spurious: CDSCO revises drug alert for May 2021
New Delhi: After discovering a batch of Telma-AM as spurious, the Central Drugs Standard Control Organization (CDSCO), through a recently revised drug safety alert, has added Glenmark's Telma-AM to the list of medicine batches that failed to qualify for a random drug sample test for the month of May 2021.
This came in line with the revised list of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, for the Month of May 2021.
Earlier the Medical Dialogues Team had reported that the apex drug regulatory body, Central Drugs Standard Control Organization (CDSCO) had flagged 41 medicine batches for failing to qualify for a random drug sample test for the month of May 2021.
Following enquiry, Asst. Drugs Controller & Licensing Authority, Govt. of NCT Delhi. has declared Glenmark's Telma-AM belonging Batch No.:05201874 as Spurious within the meaning of section 17 B (e) of Drugs & Cosmetics Act,1940 (Purports to be the product of a manufacturer of whom it is not truly a product).
A drug shall be deemed to be spurious if it is manufactured under a name which belongs to another drug, if it is an imitation of another drug or if it has been substituted wholly or partly by another drug or if it wrongly claims to be the product of another manufacturer. The term "Spurious Drug‟ has been defined under Section 17-B of the Drugs and Cosmetics Act, 1940, as amended by the Drugs and Cosmetics (Amendment) Act, 1982.
Telma-AM Tablet contains two medicines, Telmisartan 40 mg and Amlodipine 5 mg Tablets IP. Both helps to control high blood pressure. It lowers the blood pressure by relaxing the blood vessels and making it easier for heart to pump blood around your body. This reduces risk of having a heart attack or a stroke. By lowering your blood pressure, it reduces risk of heart attack or stroke.
The drug control department in Delhi collected the medicine samples, which were then tested by the RDTL in Chandigarh.The medicine sample tested failed as Amlodipine failed to dissolve properly.
List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, for the Month of May 2021(Revised)
Sl.No | Name of the Drugs/me dical device/co smetics | Batch No./Date of manufacture/ Date of Expiry/Manuf actured By | Reasons for Failure | Drawn by | From | Remarks |
1 | Telmisarta n 40 mg and Amlodipine 5 mg Tablets IP (TELMAAM TABLETS) | B. No.: 05201874 Mfg dt: 10/2020 Exp dt: 09/2023 Allegedly Mfd by: M/s. Glenmark Pharmaceutica ls Ltd. Village: Kishanpura, BaddiNalagarh Road, Tehsil Baddi, Distt.Solan, Himachal Pradesh - 173205. | Dissolution of Amlodipine | Drug Control Department Delhi | RDTL, Chandig arh | After enquiry, Asst. Drugs Controller & Licensing Authority, Govt. of NCT Delhi. has declared the said drug as Spurious within the meaning of section 17 B (e) of Drugs & Cosmetics Act,1940 (Purports to be the product of a manufacturer of whom it is not truly a product) |
To read the full notice click on the following link
Also Read:53 Drug Samples Fail To Clear CDSCO Test, 1 Declared Misbranded
