This gazette notification lists drugs, medical devices, and cosmetics declared as Not of Standard Quality, Spurious, Adulterated, or Misbranded for April 2017.
The list includes the name of the product, batch number, manufacturing and expiry dates, manufacturer, reason for failure, and the zone and lab that conducted the testing.
Key Changes
A total of 23 products are listed as Not of Standard Quality/Spurious/Adulterated/Misbranded.
The reasons for failure include pH, Sterility, Bacterial Zone, endotoxins, Dissolution, Uniformity of Dispersion, Description & Dissolution, Assay & Related Substances, Assay, Related Substances & Disintegration, Assay, Uniformity of Weight, Disintegration.
Impact Analysis
Manufacturers
Manufacturers should review their quality control processes, testing protocols, and supplier qualifications.
Distributors and Retailers
Distributors and retailers should verify the authenticity and quality of products from these manufacturers before future procurement.
Consumers
The government should ensure that information regarding affected products is readily available to the public.
Regulatory Authorities
Stringent enforcement actions against manufacturers of substandard drugs are required to deter future violations.
Key Entities Referenced
M/s. Shivalik Remedies Pvt. Ltd., Khasra No. 509/1-2 & 520, Vill-Bhagwanpur, Roorkee-Dehradun Road, Uttarakhand-247667: Manufacturer of Almefkem - 500 Tablets
CDSCO: Central Drugs Standard Control Organisation, the national regulatory body for pharmaceuticals and medical devices in India.
DCO: Drugs Control Officer
RDTL: Regional Drugs Testing Laboratory
CDTL: Central Drugs Testing Laboratory
M/s. BDH Industires Limited, Nair Baug, Akurli Road, Kandivli (E), Mumbai - 400101: Manufacturer of Donica-SR (Indomethacin Extended Release Capsules USP 75 mg)
M/s. Life Vission Healthcare, 140, EPIP, Phase 1, Jharmajri, Baddi, Solan (H.P): Manufacturer of Swinrab-DSR (Rabeprazole 20 mg & Domperidone 10 mg (IR), Domperidone 20 mg (SR) Capsules)
M/s. Nikvin Healthcare (I) Pvt. Ltd., Baddi, Barotiwala Road, Behind Govt. Timber Depot, Vill. Katha, Baddi (H.P.) - 173 205: Manufacturer of Ciphi 200 (Cefixime Dispersible Tablets)
M/s. Minopharm Laboratories Pvt. Ltd., Hyderabad 500 073, Work: Opp. I.D.A. Pernamitta, 523: Manufacturer of Erythromycin Stearate Tablets I.P. 250 mg
M/s. Bharat Parenterals Ltd., Survey No. 144 & 146, Jarod Samlaya Road, Vill: Haripura, Tal.: Savli, Distt. Vadodara 391 510, Gujarat, India: Manufacturer of Methyl Ergometrine Maleate Tablets I.P. 0.125 mg
M/s. Ratnamani Healthcare Pvt. Ltd., Survey No. 750/1, Ahmedabad-Mehsana, Vill: Indrad 382721, Tal.: Kadi, Distt. Mehsana, Gujarat, India: Manufacturer of Metformin Tablets I.P. 500 mg
M/s. Biogenetic Drugs Pvt. Ltd., Jharmazri, Baddi-174103, Dist-Solan, HP: Manufacturer of Paracetamol tablets IP 500 mg
M/s. Medoz Pharmaceuticals Pvt. Ltd., Chanal Majra, Tah. Nalagarh, Dist. Solan, (H.P.): Manufacturer of Avotine (Promethazine Theoclate Tablets I.P. 25mg)
M/s. Vama Pharma, Plot No. 2, Maruti Audyogik Vasahat, Near, M.I.D.C., Wadi, Nagpur-440023, Maharashtra: Manufacturer of Diclofenac Tablets IP 50mg
M/s. Kwality Pharmaceuticals Ltd., Nag Kalan, Majitha Road, Amritsar-India: Manufacturer of Paracetamol Paediatric Oral Suspension IP 125mg/5ml
M/s. Unital Formulations Plt.No. 114-B EPIP, Phase-1 Jharmajri Baddi Distt. Solan (H.P): Manufacturer of Rabeprazole Sodium Tablets IP (Rabtal-20 Tablets) and Enteric Coated Pantoprazole Sodium and Domperidone Sustained Release Capsules (Pantover-DSR Capsules)
M/s. Karnataka Antibiotics & Pharmaceuticals Limited 11, Western Extension Area, Faridabad-121001(India): Manufacturer of Calcium and Colectciferol Tablets BP (500mg+250IU) (Calcium and Vitamin D3 (Colecalciferol) Tablets
M/s. Aurochem Laboratories (India) Pvt. Ltd., 333, Gundecha Industrieal Complex, 3rd Floor, Akurli Road, Kandivil (East), Mumbai-400101: Manufacturer of Hydrochloride, Tretinoin, Mometasone Furoate Cream (Skinlite Cream)
M/s. Twenty First Century Pharmaceuticals Pvt. Ltd., 360, SIDCO Estate, Chennai-600098: Manufacturer of P - 500 Tablets
M/s. Ridley Life Science Pvt. Ltd., D-1651, DSIDC Indl. Complex, Narela,Delhi-110040: Manufacturer of Astharid Tablets
M/s. Unicure India Ltd.,C-22 & 23, Sector-3, Noida-201301: Manufacturer of Zinc Sulphate Tablets