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CDSCO declares 39 out of 1221 drug samples tested in February as not of standard quality
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Gireesh Babu, New Delhi
March 22 , 2022
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The Central Drugs Standard Control Organisation (CDSCO) has declared around three per cent of the drug samples it has tested during the month of February as not of standard quality. One sample has been declared as misbranded.
The drug regulator has tested a total of 1,221 samples of drugs, medical devices and cosmetics, during the month as part of its routine tests, out of which 1,181 samples were of standard quality, while 39 were declared as not of standard quality.
This includes a batch of Telma H tablets from Glenmark Pharma, a combination of telmisartan 40 mg and hydrochlorothiazide 12.5 mg tablets IP; a batch of ranitidine tablets IP 15 mg and a batch of citrizine syrup IP 5mg/5ml - 60 ml from public sector firm Hindustan Antibiotics Ltd. A batch of losartan tablets IP 25 mg from another public sector firm Karnataka Antibiotics & Pharmaceuticals Ltd also failed the test, according to the CDSCO.
Of the total drug samples failed, four were manufactured by Telangana-based Ortin Laboratories Ltd, two each from Uttarakhand-based Bal Pharma Ltd and Cotec Healthcare Pvt Ltd, Tamil Nadu-based Kaushik Therapeutics, Himachal Pradesh-based Pharma Force Lab, and Gujarat-based Gurumangalam international.
A batch of flupentixol and melitracen hydrochloride tablets manufactured by Jips Pharmaceuticals, for which address was not visible or not appeared in a conspicuous manner on the label, and was declared as misbranded.
The level of standard quality drugs among the total number of drugs tested by the CDSCO has been in the range of 2-3 per cent for the last several months, show the data.
A recent report quoting sources has said that the Central government is looking at keeping a tab on the companies which failed the quality tests more than twice in last year, with plans to conduct surprise inspections in their manufacturing units. This is part of the government’s efforts to wipe out the spurious and pure quality medicines from the country, said the report.
In February, the CDSCO declared that a little over two percent of the drug samples it has tested during the month of January 22, through various Central Drugs Laboratories in the country as not of standard quality. The drug regulatory has tested a total of 1,227 drug samples during the month, of which 27 were declared as not of standard quality. The rest of the 1,200 samples were of standard quality, it said.
Around 2.4 per cent (33 samples) of the 1,385 total drug samples it has tested during the month of December, 2021 were declared as not of standard quality. In the month of November, CDSCO 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 1,061 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.
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