The gazette notification issued by CDSCO contains a list of drugs declared as spurious for the month of September 2024.
The purpose is to inform stakeholders about identified spurious drug batches in the market based on ongoing regulatory surveillance involving sample analysis from sales/distribution points.
Key Changes
Four drugs have been identified as spurious in September 2024.
The identified drugs are: Tamsulosin and Dutasteride Tablets (Urimax-D), Calcium and Vitamin D3 Tablets I.P (SHELCAL 500), Pantoprazole and Domperidone Prolonged-Release Capsules I.P. (PAN-D), and Nandrolone Decanoate Injection IP 25mg/ml (Deca-Durabolin 25 Inj.).
The manufacturers of all four drugs, as per label claims, have stated that the impugned batches were not manufactured by them.
All four cases are currently under investigation to confirm the spurious nature of the drugs.
The reasons for failure are under investigation and include identification, assay, dissolution, and description issues.
The gazette refers to Section 17-B of the Drugs and Cosmetics Act, 1940, which defines 'Spurious Drug'.
Impact Analysis
Manufacturers
Action Item: Manufacturers should cooperate with authorities in investigations and strengthen supply chain security to prevent counterfeiting.
Distributors/Retailers
Action Item: Implement stringent verification processes for drug authenticity, purchase from authorized distributors, and stay updated on CDSCO's alerts regarding spurious drugs.
Consumers
Action Item: Purchase medicines only from licensed pharmacies, verify the authenticity of drugs, and report any suspected spurious products to the authorities.
Regulatory Authorities (CDSCO)
Action Item: Strengthen regulatory oversight, increase collaboration with manufacturers and law enforcement agencies, and raise public awareness about spurious drugs.
Key Entities Referenced
CDSCO: Central Drugs Standard Control Organization, the national regulatory body for pharmaceuticals and medical devices in India.
Drugs and Cosmetics Act, 1940: The primary legislation governing the import, manufacture, distribution, and sale of drugs and cosmetics in India. Section 17-B defines 'Spurious Drug'.
Tamsulosin and Dutasteride Tablets (Urimax-D): A combination drug used to treat benign prostatic hyperplasia (BPH).
Calcium and Vitamin D3 Tablets I.P (SHELCAL 500): A supplement used to treat calcium and vitamin D deficiency.
Pantoprazole and Domperidone Prolonged-Release Capsules I.P. (PAN-D): A combination drug used to treat gastroesophageal reflux disease (GERD).
Nandrolone Decanoate Injection IP 25mg/ml (Deca-Durabolin 25 Inj.): An anabolic steroid used to treat certain anemias and other conditions.
List of Drugs, Medical Devices, Vaccine and Cosmetics declared as Spurious for the Month of September – 2024
As part of the continuous regulatory surveillance, drugs samples are picked from sales/distribution point, analyzed and list of spurious drugs are displayed on
CDSCO portal on monthly basis. The purpose of displaying the spurious drugs list is to make stakeholders aware about the spurious drug batches identified
in the market.
S.No Name of Batch No. Date of Date of Manufactured By Reason for Drawn By Firm reply
Drugs/medical Manufac Expiry failure
device/cosmetics ture
The actual manufacturer (as per label claim) has
Tamsulosin and informed that the impugned batch of the product
Description, Drugs
Dutasteride has not been manufactured by them and that it is
GH30334 May-23 Apr-25 Under Investigation Identification Inspector,
Tablets (Urimax- a spurious drug. The product is purported to be
and Assay Odisha
D) spurious, however, the same is subject to
1.
outcome of investigation.
The actual manufacturer (as per label claim) has
Calcium and Identification, informed that the impugned batch of the product
Drugs
Vitamin D3 Aug/202 July/202 Dissolution, has not been manufactured by them and that it is
GDXD0581 Under Investigation Inspector, EZ,
Tablets I.P 3 5 Assay and a spurious drug. The product is purported to be
Kolkata
2.
(SHELCAL 500) Description. 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
3. has not been manufactured by them and that it is
a spurious drug. The product is purported to be
Pantoprazole
spurious, however, the same is subject to
Gastro-Resistant Assay of both
Drugs outcome of investigation.
and Domperidone Aug- Pantoprazole
23443507 Sep-2023 Inspector,
Prolonged- 2025 Under Investigation and
Bihar
Release Capsules Domeperidone
I.P. (PAN-D)The actual manufacturer (as per label claim) has
informed that the impugned batch of the product
Nandrolone
Drugs has not been manufactured by them and that it is
Decanoate
Inspector, a spurious drug. The product is purported to be
4. Injection IP G202620 10/2022 09/2026 Under Investigation Identification
NZ, spurious, however, the same is subject to
25mg/ml (Deca-
Ghaziabad outcome of investigation.
Durabolin 25 Inj.)
Spurious Drugs: A drug shall be deemed to be spurious;
a. If it is manufactured under a name which 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.
(The term “Spurious Drug” has been defined under Section 17-B of the Drugs and Cosmetics Act, 1940)