The Central Drug Standards Control Organisation (CDSCO) declared Pantoprazole Gastro-Resistant Tablets IP (PAN-40) and Amoxycillin and Potassium Clavulanate Tablets IP (AUGMENTIN 625 DUO) as “spurious drugs.” PAN-40 is commonly used to treat stomach ulcers, gastroesophageal reflux disease, heartburn, and oesophagus inflammation-related conditions, while AUGMENTIN 625 DUO is prescribed for the treatment of bacterial infections.
What is a ‘spurious drug’?
The term “spurious drug” is defined under Section 17-B of the Drugs and Cosmetics Act, 1940. According to the CDSCO, a drug is considered spurious if it meets any of five criteria:
a. If it is manufactured under a name that belongs to another drug
b. If it imitates or substitutes another drug, resembles another drug in a deceptive manner, or bears the name of another drug on its label or container without being plainly marked to indicate its true identity
c. If the label or container bears the name of a fictitious or non-existent individual or company as the manufacturer
d. If it has been wholly or partially substituted with another drug or substance
e. If it falsely claims to be a product of a manufacturer of whom it is not truly a product
As part of ongoing regulatory surveillance, drug samples are collected from sales or distribution points and analyzed. The actual manufacturers of both drugs, as listed on the labels, informed the CDSCO that the disputed batches were not produced by them and are, therefore, spurious drugs. However, the CDSCO has not disclosed the names of the manufacturers in its alert.
The CDSCO stated that while both drugs are currently deemed spurious, this designation is subject to the outcome of further investigation. In its September alert, the CDSCO had classified Urimax-D, SHELCAL 500, PAN-D, and DecaDurabolin 25 Inj. as spurious drugs. In October, Pan-D, TAXIM-O 200, and Rosuvas 10 were also declared spurious drugs.
Additionally, the CDSCO flagged 111 other drugs and formulations as “Not of Standard Quality” (NSQ). Notably, in its alerts, the CDSCO has named the manufacturers of the drugs that failed to meet quality standards.
