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The sample tests conducted by the Central Drugs Standard Control Organisation (CDSCO) for Not of Standard Quality (NSQ), spurious and misbranded drugs during the month of December, 2022 has identified five batches of cough syrup manufactured by Haryana-based Maiden Pharmaceuticals - which allegedly manufactured and exported cough syrups that caused the death of 66 children in Gambia - in its Himachal Pradesh factory as not of standard quality.
In the month of December, the nation's drug regulator had informed the World Health Organisation (WHO), which issued an alert on four products of Maiden Pharmaceuticals alleging that it caused serious adverse events including death of children in Gambia, that the tests it has conducted on the samples of the medicine manufactured in Haryana were not contaminated with diethylene glycol (DEG) or Ethylene Glycol (EG) and the WHO’s statement was exaggerated by the global media.
The Health Ministry earlier said that the cough syrups manufactured by the company in the Haryana facility were only for exports and not sold in the domestic market. The samples which failed the tests now are from a different factory, while the Haryana facility is shut down following the concerned State drug regulator's order.
According to the monthly report of the CDSCO on the sample tests conducted by various drug regulatory offices across the country and tested in the government drug testing laboratories in various States, five batches of CSP Cough syrup for throat and chesty coughs 100 ml, manufactured by Maiden Pharmaceuticals in a facility in Solan, Himachal Pradesh, were picked up by the Drug Control Department of Himachal Pradesh. Three of them failed the assay test of Diphenhydramine Hydrochloride, Codeine Phosphate, Sodium Citrate and Menthol. One sample failed the assay of Codeine Phosphate, Sodium Citrate and Menthol, while another one on the test for assay of Codeine Phosphate and Menthol.
The samples, manufactured in the month of August, 2021, with expiry date on July, 2024, were tested in the Central Drug Laboratory, Kolkata.
Interestingly, the 70 samples which were declared as NSQ during the month of December also include samples allegedly from GlaxoSmithKline Pharmaceuticals (GSK), Cipla Ltd and public sector undertaking Karnataka Antibiotics and Pharmaceuticals Ltd (KAPL).
Out of this, GSK has already notified the drug regulator regarding availability of spurious or counterfeit of the particular batch of skin cream and the CDSCO said that investigation is under process.
The samples of Betamethasone and Clioquinol Cream BP (Betnovate-C Skin Cream) manufactured in January 2021, with the label of GSK, were picked up by Drug Control Department of Delhi and were marked as failed in the quality test by the Regional Drugs Testing Laboratory, Chandigarh.
A sample of Cipla's Junior Lanzol 15 mg (Lansoprazole Orally Disintegrating Tablets 15 mg) manufactured in Himachal Pradesh and picked up by the CDSCO sub-zone office in Indore failed the test for quality standards due to issue with hardness of the drug, said the drug regulator.
Two drug samples of KAPL - Ciprofloxacin 250 and Metronidazole Tablets IP 400 mg - were declared as NSQ, during the month.
Seven samples of RL 500 ml, Compound Sodium Lactate Injection IP (Ringer Lactate Solution for Injection I.P.) from Ives Drugs (India) Pvt Ltd in its Indore facility, were declared as NSQ. The list of NSQ includes multiple samples from certain companies.
The CDSCO and state regulators tested around 1375 samples in total during the month of December, 2022, of which 70 samples, which is five per cent of the total samples, were declared as NSQ.
The list of NSQ drugs also include a sample of Orthorium - MSM (Diacerein, Glucosamine Sulphate and Methyl Sulfonyl Methane Tablets) without batch number, manufacturing date or expiry date mentioned, and allegedly manufactured by LV Life Sciences, in Himachal Pradesh factory was identified as failed in description and misbranded.
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