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The Central Drugs Standard Control Organisation (CDSCO) has declared 1064 drug samples as standard quality (SQ) based on analysis and testing done on 1095 samples last month as part of the random sampling. However, it concluded that there were 31 samples which were declared as not of standard quality (NSQ), spurious and misbranded.
The manufacturers of the drugs are based in Rajasthan, Punjab, Chandigarh, Gujarat, Maharashtra, Himachal Pradesh, Uttarakhand and Goa.
The 31 NSQ drugs include Ibuprofen manufactured by Vikram Laboratories Pvt Ltd., Muzaffarnagar, Pancure Tablets (Pantoprazole) manufactured by Sterlife Pharma Pvt Ltd, Gujarat, Diaset 2 (Glimepiride Tablets I.P. 2 mg) manufactured by Stadmed Private Limited, Lucknow, UP which failed the test for dissolution based on analysis done by Central Drugs Testing Laboratory (CDTL), Chennai and CDL Kolkata, Thyrocure - 100 (Thyroxine Tablets I.P. 100 mcg) manufactured by Unicure India Ltd, UP having failed the test of assay based on analysis done by Central Drugs Laboratory (CDL), Kolkata, OCONA-CT Scalp Solution (Coal Tar & Ketoconazole Solution) – 50 ml manufactured by Akums Drugs & Pharmaceuticals Ltd, Uttarakhand had foreign matter based on analysis by CDL, Kolkata, Tranexamic Acid Injection I.P. 500mg /5 ml manufactured by Redico Remedies, Himachal Pradesh and Gentamicin Injection I.P. 80 mg / 2ml manufactured by Sai Parenterals Pvt. Ltd, Hyderabad had particulate matter based on analysis by CDL, Kolkata.
Other drugs like Climox 1.2g (amoxycillin & potassium clavulanate injection I.P.) and Oxytocin Injection I.P. manufactured by Jackson Laboratories Pvt Ltd, Amritsar, Punjab failed the test of particulate matter and clarity of solution, extractable volume, assay based on analysis done by CDL, Kolkata, Hemosponge (Absorbable Gelatin Sponge U.S.P.) manufactured by Goodwill Lifesciences, Surat failed the test of sterility based on analysis by CDL, Kolkata, Vomiros-4MD (Ondansetron Orally Disintegrating Tablets IP) manufactured by Sridhara Life Science Pvt. Ltd, Haridwar and Carbamazepine Tablets I.P. 200 mg manufactured by Medico Remedies Limited, Palghar, Maharashtra failed the test of Disintegration based on analysis by Central Drugs Testing Laboratory (CDTL), Mumbai, Fusigen Ointment (Sodium Fusidate Ointment BP) manufactured by Geno Pharmaceuticals Private Limited, Mapusa, Goa failed the test of assay based on analysis by CDTL, Mumbai, Ciprofloxacin Tablets I.P. 500mg manufactured by Omega Biotech Ltd, Roorkee, Uttarakhand failed the test of Dissolution based on analysis done by Regional Drugs Testing Laboratory (RDTL), Guwahati.
Other drugs include Cefpodoxime Proxetil Dispersible Tablets (Eziprod 200)
manufactured by Vee Laboratories, Himachal Pradesh, Paracetamol Tablets I.P 650 mg (Pelmol-650) manufactured by M Sea Pharmaceuticals Pvt. Ltd, Himachal Pradesh, Paracetamol Tablets I.P 500 mg manufactured by Omega Biotech Ltd, Uttarakhand failing on Assay and Disintegration and Dissolution test with(Dexamethasone Sodium Phosphate Injection IP) manufactured by Zee Laboratories Ltd, Himachal Pradesh, Heparin Injection IP 25000 units (Azzirin Injection) manufactured by Health Biotech Ltd, Chandigarh and B-Complex Tablets manufactured by Jackson Laboratories Pvt. Ltd, Chandigarh failing on quality tests.
In a list of drugs, medical devices and cosmetics declared as NSQ, spurious, adulterated or misbranded, the CDSCO has revealed that for the month of March 2019, there were 2011 drug samples tested at four laboratories-- CDL, Kolkata, CDTL, Mumbai, RDTL, Guwahati and RDTL, Chandigarh. Of them, 1,888 samples were found to be SQ and 50 samples were found to be NSQ.
The data of SQ and NSQ drugs was released by CDSCO on April 15, 2019 after Union health ministry approved a proposal in this regard.
The proposal to issue guidelines for releasing data of drugs declared SQ by CDL and RDTL was sent to the health ministry by Drugs Controller General of India (DCGI) following a representation by Laghu Udyog Bharati.
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