|
CDSCO declares 33 drug samples as not of standard quality in December, 2021
|
|
Gireesh Babu, New Delhi
January 19 , 2022
|
|
|
Sample batch of Hetero Labs’ Covid-19 management drug Covifor, GlaxoSmithKline Pharmacceuticals’ skin cream Betnovate-N cream, and Sun Pharmaceuticals’ Volini pain relief spray, Colgate Dental Cream Anticavity Toothpaste from Colgate Palmolive among others were identified as not of standard quality by the central drug regulator during the month of December, 2021.
The Central Drugs Standard Control Organisation (CDSCO) has declared 33 drug samples, it has tested during the month of December, as not of standard quality in its routine testing on drugs, medical devices and cosmetics.
This is around 2.4 per cent of the 1,385 total drug samples it has tested during the month. There were no spurious or misbranded drugs identified during the month, according to an update by the regulator.
Apart from this, a single batch of two drugs - Diazepam injection IP (diazelab) from Laborate Pharmaceutical India and Primaquine tablets IP from a manufacturer whose name was not visible in a conspicuous manner on the label - were identified as mis-branded.
A batch of Covifor (remdesivir for injection 100 mg/vial) from Hetero Labs Ltd, manufactured at Telangana-based Aspiro Pharma Ltd failed the test of Central Drug Laboratory, Kolkata, in terms of particulate matter, clarity of solution and identification and assay.
A batch of beta Ethan’s one valerate and neomycin skin cream (Betnovate-N Cream), from GSK Pharma in a Goa plant and a batch of diclofenac diethylamine in combination with linseed oil, methyl salicylate and menthol topical spray (Volini pain relief spray) from Sun Pharma, manufactured in Himachal Pradesh, failed the test conducted in Regional Drug Testing Laboratory (RDTL), Chandigarh.
A batch of Colgate Dental Cream anticavity toothpaste manufactured by Colgate Palmolive (India) Ltd from an unknown facility failed the test of the same RDTl for its appearance, dispensing, particle feel on butter paper, total microbial count, total yeast and mould count.
Sample batch of Vermikind -12 (ivermectin dispersible tablets) from Innova Captab Ltd failed the test for uniformity of dispersion. It may be noted that ICMR has removed the drug from usage to manage Covid-19 in September, 2021. Themidon (trimetazidine dihydrochloride tablets IP), from Themis Medicare Ltd failed the assay test by Central Drug Testing Laboratory, Mumbai, according to the data released by the CDSCO.
It may be noted that the CDSCO has declared almost two per cent of the total drugs, medical devices and cosmetics products samples it has tested in the month of November, 2021, as not of standard quality. CDSCO, in the month of November, tested 1,102 samples, out of which 22 were declared as not of standard quality. The rest of 1,080 samples were declared as having standard quality as per the requirements of the regulations.
In the month of October, almost 3.4 per cent of the drug samples the drug regulator drew from across the country were declared not of standard. Out of the 1061 samples tested during the month 36 turned out to be not of standard quality during the period.
In September, the CDSCO declared that it has tested 1,227 samples, of which 42 were not of standard quality, while in August, the total tested was 1,245 samples of which 37 were found not of standard quality.
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.
|
|
|
|
|
|
|
|
TOPICS
|
That foods might provide therapeutic benefits is clearly not a new concept. ...
|
|
|
|
|