CDSCO declares hypertensive drug as spurious
The Central Drugs Standard Control Organisation (CDSCO) has said that a joint investigation team of its East Zone office and the State Licensing Authority (SLA) of Sikkim have declared the samples of Glenmark Pharmaceuticals’ blood pressure-lowering drug Telma 40 failed in the quality tests in February, 2023, as spurious.
The sample was one among 59 declared as Not of Quality Standards (NSQ) in February, this year. While according to the CDSCO list released in February, the sample was manufactured by Glenmark Pharmaceuticals Ltd in the Industrial Growth Centre at East Sikkim, the company declared the batch to be not manufactured by them and informed the regulator that it is a spurious drug.
“After enquiry, Joint Investigation Team of CDSCO (EZ) and SLA (Sikkim) have declared the said drug as spurious under section 17B(e) of Drugs and Cosmetics Act, 1940,” said the drug regulator after conducting necessary investigation.
Under the Section 17B(e) of the Drugs and Cosmetics Act, a drug shall be deemed to be spurious if it is manufactured under a name which belong to another drug or if it is an intimation 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 level 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. 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 if it has been substituted wholly or in part by another drug or substance, or if it purports to be the product of a manufacturer of whom it is not truly a product, the drug shall be deemed as spurious.
It may be noted that a sample of Glenmark’s anti-hypertensive drug telmisartan 40 mg and hydrochlorothiazide 12.5 mg tablets IP, under the brand Telma H, tested in February 2022 and declared as NSQ, was also declared later by the CDSCO as spurious. Another drug sample labelled as Glenmark’s Telma AM, failed test in May, 2022, was declared by the CDSCO as spurious in September, last year.
“After enquiry, Assistant Drugs Controller and Licensing Authority, Government of NCT Delhi, has declared the said drug as Spurious within the meaning of Section 17 B (e) of Drugs and Cosmetics Act, 1940 (Purports to be the product of a manufacturer of whom it is not truly a product)”, said the CDSCO in September, 2022.
Again, a sample labelled as the company’s Telma-AM tablets comprising telmisartan 40 mg and amlodipine 5 mg tablets, manufactured in East Sikkim Facility failed the quality test conducted by the authority in the month of March, 2023.
The company issued a statement that the drug sample considered for the quality testing was a counterfeit one.
“We have investigated the matter and found that the Telma AM tablets (telmisartan 40 mg and amlodipine 5 mg tablets IP) batch number 18220076 from the NSQ list of “March 2023 Month Drugs Alert” are counterfeit medicines and have not been manufactured by Glenmark. We have requested the CDSCO to take action on this and also made an appeal for removal of the product from the drug alert list,” told a company spokesperson.
Similarly, there were instances earlier where either the drug regulator or the company declared the samples as spurious or deemed to be spurious after the drug alerts from CDSCO declared the samples labelled as manufactured by companies including Abbott India and Sun Pharma Laboratories as NSQ.
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