Almost 4percent of the drug samples tested turned out to be not of standard quality in July

New Delhi, August 16, 2022 :

The Central Drugs Standard Control Organisation (CDSCO) has declared 53 samples of drugs it has tested as not of standard quality and one sample as misbranded during the month of July, 2022. The samples tested not of standard quality include batches from Cadila Pharmaceuticals, Morepen Laboratories, Ajanta Pharma Ltd, among others.

The drug regulator has tested a total of 1,337 samples during the month of July and declared 53 out of them as not of standard quality. While one sample was declared as misbranded, there were no spurious drugs among the samples, according to data released by the CDSCO.

The percentage of drugs declared as not of standard quality is one of the highest in the recent past, at around 3.96 per cent of the total samples tested. The instances of not-of-standard quality drugs among the total number of drugs tested by the CDSCO have been in the range of 2-3 per cent for the last several months, show the data.

The sample of batches that failed the test include a batch of tinidazole tablets IP 300 mg manufactured by Cadila Pharmaceuticals Ltd in Samba, Jammu and Kashmir, Caciquick-500 (calcium and vitamin D3 tablets IP) from Morepen Labotaroties in Baddi, Himachal Pradesh, and Canate (antioxidant tablets with vitamins and minerals) from Ajanta Pharma Ltd, manufactured at Aurangabad.

Some of the other drugs which failed the tests include several batches of rabeprazole drugs manufactured by Revat Laboratories, Accretion Pharmaceuticals, Applied Communication and Controls, and Plena Remedies, paracetamol tablets IP 650 mg by Parth Orgichem Pvt Ltd, samples of ofloxacin and omidazole tablets IP from Sano Cito Therapeutics (a Meridian group company) and Naskar Lifesciences, among others.

In the month of July, the drug regulator has tested a total of 1,096 samples of drugs, medical devices and cosmetics and declared 26 of them as not of standard quality, including batches manufactured by the government-owned Hindustan Antibiotics Ltd (HAL) and Karnataka Antibiotics and Pharmaceuticals Ltd (KAPL), among others.

In the month of June, the drug regulator has declared 41 out of the 1,233 samples collected during the month as not of standard quality.

It may be noted that in April, 2022, the CDSCO has declared 27 samples out of the total of 1,164 samples it collected during the month, as not of standard quality.

Around 3.3 per cent of the total drug samples it tested during the month of March, 2022, through various Central Drugs Laboratories in the country were not of standard quality. There were no spurious or misbranded drugs identified during these months.

The drug regulator comes out with the list of drugs, medical devices and cosmetics which are declared not of standard quality/spurious/adulterated or misbranded, every month.

The test samples were drawn by the zonal and sub zonal offices of CDSCO, and tested in the drug testing laboratories in Kolkata, Mumbai, Chandigarh, and Guwahati.  Phrmabiz