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CDSCO declares almost 5% of drug samples tested in February as NSQ
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Gireesh Babu, New Delhi
March 23 , 2024
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The Central Drugs Standard Control Organisation (CDSCO) has declared 58 drug samples it tested in the month of February as Not of Standard Quality (NSQ) and two samples purported to be spurious drugs on which it is conducting further investigation.
The drug regulator has tested a total of 1,167 drug samples during the month, of which 1,018 samples were declared as 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 according to data from the CDSCO.
CDSCO has said that a batch of blood pressure lowering drugs Telma AM (telmisartan 40 mg and amlodipine 5 mg tablets) and Telma 40 (telmisartan 40 mg) which were labeled as manufactured by Glenmark Pharmaceuticals failed the quality tests and the company informed that the said batch of products were not manufactured by them and it is a spurious drug.
The drug regulator said that the products are “purported to be purported to be spurious, however, the same is subject to the outcome of further investigation.”
The drug samples failed the quality test conducted by various government-run drug testing laboratories and declared as NSQs include Zole-F (miconazole nitrate and fluocinolone acetonide ointment) labelled as manufactured by Sun Pharmaceuticals Industries Ltd, Pyricool 500 (paracetamol tablets 500 mg) by Alkem Health Science, which is a unit of Alkem Laboratories Ltd, Defarasirox by Glenmark Lifesciences, Moxonidine tablets 0.3 mg from Micro Labs Ltd, and Medmoxil 125 (amoxicillin oral suspension) by Laborate Pharmaceuticals India, among others.
The other drug samples which were declared as NSQ include Acepik-P (aceclofenac and paracetamol tablets) manufactured by Nexkem Biotech Pvt Ltd, in Himachal Pradesh, Calcigiant 500 tablets (calcium carbonate and vitamin D3) manufactured by Nutra Life Healthcare, in Uttarakhand, Oflab 100 DT (ofloxacin dispersible tablets 100 mg) manufactured by Concept Pharmaceuticals, Aurangabad, Mahakali 500 (calcium and vitamin D3 tablets) manufactured by Hanuchem Laboratories, Himachal Pradesh, Serrizym tablets (serratiopeptidase) by Arnav Research Laboratories, Gujarat, XL-Mont (montelukast sodium and levocetirizine hydrochloride tablet) by DWD Pharmaceuticals, Gujarat, Hyprovan 500 injection (propofol injection IP 500 mg/50ml) by Protech Telelinks, Himachal Pradesh, Heparin Sodium injection 25,000 IU/5ml by Sai Parenterals Ltd, Telangana, among others.
More than one sample from some of the companies such as Orchid Bio-Tech, Uttarakhand, M Sea Pharmaceuticals, Himachal Pradesh, and Ridley Life Science Pvt Ltd, Delhi, were declared as NSQs during the month of February.
The drug regulator also said that Sun Pharma Laboratories has informed that the samples of anticonvulsant drug Levipil 500 (levetiracetam tablets) labelled as manufactured by the company, and failed in the quality test in the month of January, has not been manufactured by the company and that it is a spurious drug. The CDSCO said that the product is purported to be spurious, however, the same is subject to the outcome of further investigation.
The Organisation has tested 932 samples in January, out of which almost five per cent or 46 samples, were declared as NSQs. No samples were declared as spurious or misbranded during the month.
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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