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CDSCO declares 7% of drug samples tested in March as NSQ
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Gireesh Babu, New Delhi
April 19 , 2024
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The Central Drugs Standard Control Organisation (CDSCO) has declared seven percent of the drug samples it tested in the month of March, 2024, as Not of Quality Standard (NSQ) and one sample as misbranded. The samples that failed the quality test include drugs labelled in the name of GlaxoSmithKline Pharmaceuticals, public sector undertaking Karnataka Antibiotics & Pharmaceuticals Ltd (KAPL), among others.
The drug regulator announced that it has tested 931 samples during the month of March and 66 out of them were declared as NSQ, while 864 were of standard quality. The percentage of samples failed is one of the highest in the past several months, when the failure rate has been around four to five per cent range for the last one to two years. There were no spurious drugs identified during the sample tests, according to CDSCO.
The drug samples which failed the quality tests include a sample of Betnesol (betamethasone sodium phosphate tablets I.P. 0.5 mg (Betnesol), for the treatment of allergic disorders and others, labelled as manufactured by GlaxoSmithKline Pharmaceuticals, in Nashik.
Ranitidine tablets I.P. 150 mg, a gastrointestinal agent labelled as manufactured by KAPL, Domipen tablets (domperidone tablets IP 10 mg) labelled as manufactured by Morepen Laboratories in Himachal Pradesh, Ocured Sterile Eye Drops 10 ml, a medicine to treat allergic diseases of the eye, labelled as manufactured by Centaur Pharmaceuticals Pvt Ltd in Goa, were some of the other medicines failed in the quality test during the month.
At least two drug samples each from companies including GM Pharmaceuticals, Bidhan Pharmaceuticals,SP Life Sciences, High Tech Pharma, Swaroop Pharmaceuticals, Unicure India Ltd, Bueno Salud Care India, Meha Pharma Pvt ltd, Access Life Sciences, also failed during the quality test during the month.
Last month, the authorities declared almost five per cent of the total drug samples it tested as spurious during the month of February, 2024. The drug regulator has tested a total of 1,167 drug samples during the month, of which 1,018 samples were declared as of standard quality. Almost five per cent of the total samples tested has been declared as NSQ, which was almost the same level in the previous month of January, 2024.
It may be noted that a recent Drugs Consultative Committee (DCC) meeting has mooted preparing a list of manufacturers who repeatedly produce Not of Standard Quality (NSQ) drugs and black list them. The Committee also noted that only a few states are sharing the NSQ data with the central authority on a monthly basis and called for all the states to share the data periodically and in a timed manner for publication on the website.
“It was discussed about black listing of such manufacturers and preparing a list of such offenders so that the government procurement agencies become careful before procurement of drugs from such manufacturers,” said the drug regulator.
The Committee also looked at the status of the recommendation made with regard to the sharing of information on NSQs in the previous meeting. It observed that only a few states are sending the NSQ data on a monthly basis. The drug regulator sensitised all the States to look into the matter regarding any difficulties and to send the NSQ data periodically and in a timely manner, so that the information can be compiled and published on the website for the attention of all the stakeholders.
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