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.

Also Read:Zuventus Healthcare Gets CDSCO Panel Nod To Manufacture, Market Ferrous Ascorbate suspension for iron deficiency anaemia

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