The Central Drugs Standard Control Organisation (CDSCO) in its monthly surveillance report pan-India has declared 908 as standard quality (SQ) based on analysis and testing done on 931 in April 2021 done through its random sampling exercise.
It concluded that there were 23 samples (22 legal and one survey sample) which were declared as not of standard quality (NSQ).
The manufacturers of the drugs are based in Tamil Nadu, Himachal Pradesh, Uttarakhand, New Delhi, Gujarat and Maharashtra.
The 22 NSQ include Instant Sterile Mopping Pad (absorbent gauze- BP type 13 with x-ray detectable thread) manufactured by Ramaraju Surgical Cotton Mills Ltd, Tamil Nadu failed the test of threads per stated length. Rutin (rutosidetrihydra TE 95%) (AS per FM) manufactured by Ningbo HiTech Biochemicals Co., Ltd, China which failed the test of water, related substances and assay.
For detailed NSQ list April 2021, click here
Realhim-10 (tadalafil tablets IP 10 mg) manufactured by LifecareNeuro Products Limited, Himachal Pradesh, Pantowel- 40 (pantoprazole sodium tablets IP 40 mg) manufactured by Akums Drugs & Pharmaceuticals Ltd, Uttarakhand, L-CETAM 500 (levetiracetam tablets IP 500 mg) manufactured by Synokem Pharmaceuticals Ltd, Uttarakhand.
Glucorid (metformin hydrochloride sustained release tablets IP 500 mg) manufactured by Ridley Life Science, New Delhi, TLM -80 (telmisartan tablets IP 80 mg) manufactured by Shine Pharmaceuticals, Gujarat, Olanzapine tablets IP 5 mg manufactured by Bharat Parenterals Ltd, Gujarat, and Ultraflox-500 (ciprofloxacin tablets IP) manufactured by Bal Pharma Limited, Uttarakhand for failing the test of dissolution.
Spinobak-10 (baclofen tablets IP 10 mg) manufactured by Sirmour Remedies Ltd, Himachal Pradesh, and Misoprostol tablets I.P. 200 mcg manufactured by Unimark Healthcare Ltd, Uttarakhand failed the test of assay based on the analysis done by Central Drugs Laboratory (CDL), Kolkata.
Other drugs include Orvastin-20 (atorvastatin tablets IP 20 mg) manufactured by Morepen Laboratories Ltd, Himachal Pradesh which failed the test of dissolution. Revol-CC (calcium carbonate, magnesium oxide, manganese sulphate, zinc & Vitamin D3 tablets) manufactured by Mascot Health Series Pvt Ltd, Uttarakhand for failing the test of assay of vitamin D3 based on the analysis done by Central Drugs Testing Laboratory (CDTL), Mumbai.
It also includes aceclofenac, paracetamol and serratiopeptidase tablets (Acepro-SP tablets) manufactured by Shri Sai Balaji Pharmatech Pvt. Ltd, Himachal Pradesh failed the test of assay of serratiopeptidase. Paracetamol tablets IP 650 mg (mecipar 650 tablets) manufactured by Sotac Pharmaceuticals, Gujarat, and Progesterone sustained release tablets (Fulgest SR 200 tablets) manufactured by Synokem Pharmaceuticals, Uttarakhand which failed the test of dissolution.
Telmisartan tablets IP 40 mg manufactured by Caremax Formulations, Himachal Pradesh for failing the test of uniformity of weight & dissolution. Chlorhexidine gluconate and ethyl alcohol antiseptic solution (Corub) manufactured by Gag Pharmaceuticals, Punjab, and 70% isopropyl alcohol hand rub (Icandy) manufactured by RGG Cosmetics Pvt, Ltd failed the test of identification.
Tranexamic Acid tablets IP manufactured by Rhydburg Pharmaceuticals Ltd, Uttarakhand, and Tranexamic acid tablets IP 250 mg (tyrodin tablets 7) manufactured by Canixa Life Sciences Pvt. Ltd, Uttarakhand which failed the test of related substances based on the analysis done by Regional Drugs Testing Laboratory (RDTL) Chandigarh.
Zinc sulphate dispersible tablets IP 20 mg manufactured by Hindustan Laboratories, Maharashtra is also in the list for failing the test of disintegration based on the analysis done by RDTL Guwahati.
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