CDSCO declares three drug samples as spurious, 51 as NSQ during July

August 26, 2023

The Central Drugs Standard Control Organisation (CDSCO) has declared three drug samples it tested in the month of July as spurious and another 51 samples as Not of Standard Quality (NSQ). It added that two drug samples tested as not of standard quality during June were also alerted by the manufacturer as spurious.

The central drug regulator during the month of July has tested 1,306 samples across the country and the samples declared as not of standard quality comprise almost four percent of the total samples tested.

Among the drugs tested, a batch of Pan-D (pantoprazole gastro resistant and domperidone prolonged release capsules IP), Pan 40 (pantoprazole gastro resistant tablets IP), and Clavam 625 (amoxycillin and potassium clavulanate tablets IP), labelled as manufactured by Alkem Health Sciences, a unit of Alkem Laboratories Ltd, were declared as "purported to be spurious" and further investigations were initiated.

"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. Thus, the product is purported to be spurious, however, the same is subject to the outcome of investigation."

In another drug alert, the CDSCO said that two drug samples tested in June, this year, of Pan-40 labelled as manufactured by Alkem Health Science are also purported to be spurious and the same is subject to outcome of investigation.

The drug samples tested as NSQ during the month of July include Rosuvas 10 tablets (rosuvastatin tablets IP) labelled as manufactured by Sun Pharma Laboratories Ltd, Urimax D (tamsulosin hydrochloride & dutasteride tablets) stated as manufactured by Cipla Ltd, ornidazole & ofloxacin tablets IP labelled as from public sector undertaking Hindustan Antibiotics Ltd, and tropicamide eye drops IP 1% labelled as from Vivimed Labs Ltd.

It may be noted that the CDSCO has declared almost 3.7 per cent of the total drug samples tested during the month of June, 2023 as NSQs. Apart from the two samples declared as spurious from June now, the drug regulator in June said that one sample of anticoagulant drug Heparin Injection, labelled as Flagorin, mentioned as manufactured by Gujarat-based Divine Laboratories as spurious.

According to the ministry of health and family welfare, the drug regulators tested a total of 88,844 drug samples during the year 2021-22, out of which 2545 samples (almost 2.86 per cent) was declared as NSQ and 379 samples (0.42 per cent) as spurious or adulterated.

The Ministry during the Parliament session during this month, said that the regulator has launched 592 prosecutions for manufacturing, sale and distribution of spurious or adulterated drugs.

In the year 2020-21, the regulator tested 84,874 samples out of which 2652 (3.12 per cent) were declared as NSQ, and 263 (0.30 per cent) samples as spurious/adulterated. A total of 236 prosecutions were launched for manufacturing, sale and distribution of spurious/adulterated drugs during the year.

Dr Bharati Pravin Pawar, minister of state in the ministry of health and family welfare, in response to a question in the Lok Sabha during the recently held session said that the Ministry and CDSCO has taken various regulatory measures to ensure the quality of medicines in the country, including amendments in the Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945, such as making it mandatory that before the grant of manufacturing license, the manufacturing establishment is to be inspected jointly by the Drugs Inspectors of Central Government and State
Government, and making it mandatory that the applicants shall submit evidence of stability, safety of excipients etc. to the State Licensing Authority before grant of manufacturing license by the Authority.

It also took measures including increasing the number of sanctioned posts in CDSCO significantly in last 10 years and CDSCO coordinating activities of State Drug Control Organisations and providing expert advice through the Drugs Consultative Committee (DCC) meetings held with State Drugs Controllers for uniformity in administration of the Drugs and Cosmetics Act, added the minister.

"Isolated complaints regarding spurious drugs are received in the Central Drugs Standard Control Organisation. As and when such complaints are received, based on merit, the matter is taken up by the CDSCO in coordination with the State/UT Drugs Controller for action as per the provisions of the Drugs & Cosmetics Act, 1940 and the Drugs & Cosmetics Rules, 1945," said Pawar.

PHARMABIZ.com