New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has declared five samples of drugs drawn by its zonal offices and from the State Licensing Authority (SLA) of Delhi and tested during the month of August, as spurious.
The actual manufacturers of these drugs informed the drug regulator that the particular batch of these products was not manufactured by them and that these are spurious drugs.
The list published by the CDSCO include samples of Pulmosil (sildenafil injection), Pantocid (pantoprazole tablets), and Ursocol 300 (ursodeoxycholic acid tablets) labelled as manufactured by Sun Pharmaceuticals and Sun Pharma Laboratories in Telangana, Sikkim and Assam, respectively.
“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 the outcome of investigation,” said CDSCO.
The fourth product is Telma H (telmisartan 40 mg and hydrochlorothiazide 12.5 g tablets), labelled as manufactured by Glenmark Pharmaceuticals, in Baddi, Himachal Pradesh.
The actual manufacturer as per label claim, Glenmark Pharmaceuticals, has informed that the impugned batch of product has not been manufactured by them and that it is a spurious drug. The CDSCO said that the product is purported to be spurious, however, the same is subject to the outcome of investigation.
A similar disclosure was made by the CDSCO regarding Defcort 6 tablets (deflazacort tablets) labelled as manufactured by Macleods Pharmaceuticals, in Daman. The sample was drawn by the SLA of Delhi.
It may be noted that the central drug regulator has not published the monthly spurious drugs list for the last couple of months. In May, the drug regulator released a list of drug samples which were tested in various laboratories by the states, in the month of April and declared as spurious drugs.
This include samples of antibiotic rifaximin tablets (Rifagut 400) labelled as manufactured by Sun Pharma Laboratories, antiretroviral dolutegravir tablets 50 mg (Instgra tablets) labelled as manufactured by Emcure Pharmaceuticals, hypertension management drug telmisartan 40 mg and amlodipine 5 mg tablets (Telma AM) labelled as manufactured by Glenmark Pharmaceuticals, and anti-inflammatory drug combination of domperidone and naproxen sodium tablets (Naxdom 500 ) labelled as manufactured by Pure and Cure Healthcare. These samples were reported by the drug regulator at the National Capital Territory (NCT) of Delhi.
Some of these drugs were identified as spurious based on physical comparison and analytical tests done by the manufacturer and based on the report from the SLA.
During the month of April, Jharkhand had reported one alert, on antibiotic medicine cefixime trihydrate with lactic acid bacillus tablets (Presef 200 LB tablets) labelled as manufactured by Pragti Remedies, identified based on an email from the SLA. The drug was mentioned as Not of Standard Quality (NSQ) in the CDSCO alert in April, and the regulator says that the company in the label does not exist at the given address, according to the local drug regulatory official.
