Gujarat FDCA suspends sale and manufacturing of 12 drug brands due to inferior quality
Gujarat state Food and Drug Control Administration (FDCA) has banned the sale and use of multiple batches of certain widely prescribed drug brands as the products are found inferior in quality, which did not pass the lab analysis for efficacy and potency. The state drug control department found these substandard brands following a sample survey conducted in the last few months. The FDCA commissioner, S P Adeshara, informed that following the laboratory reports on the samples drew during this period, the department has suspended sales 12 batches of 12 brands manufactured in Gujarat as well as other states.
The prohibited drugs, which manufactured in Gujarat State are Perizest Capsule, Batch No.CFZ-104, of M/s.Coral Laboratories Ltd, Baroda, Calcivet, Batch No.C 2010, of M/s.Morvel Laboratories P. Ltd Mehsana, Haemolar Plus Capsule, Batch No.C 203.07, of M/s. Alar Laboratories P Ltd, Ahmedabad, Loparamide Hydrochloride Tablet USP, Batch No. T-082, of M/s. Kesar Health Care, Vapi, Gentamicin Skin Cream BP, Batch No.090, of M/s. Gujarat Pharma Lab P. Ltd, Ahmedabad, Lyrocin-500, Batch No.T-481, of M/s. Lypobion Remedies P. Ltd, Ahmedabad, Pracetamol Tablet IP 500mg. Batch No.107, of M/s.Infinitive Pharmaceutical Industries, Disa.
The products, which are suspended but manufactured in other States are Loxilin-500 (Ampicillin & Cloxacillin Injection) Batch No.AM-01, of M/s. Amicus Pharmaceutical P. Ltd, Mumbai, Doxy-T Tablet (Doxycycline Hydrochloride Tablet) Batch No.T-023, and Erythromicin Stearate Tablet IP, Batch No.T-304, of M/s. Omega Biotech Ltd, Gaziabad, Dexamethasone & Neomycin Eye/Ear Drops, Neocort, Batch No.DN/01, of M/s. Parkson Pharmaceutical, Sannkhol, Vetabion Injection Batch No. VT-30, of M/s. Systochem Laboratories Ltd, Loni.
Adeshara said that the sample survey in the state has been strengthened in the state now though it has been a routine exercise by the drug inspectors in the department. "In order to check the circulation of substandard and spurious drug products in the market, we draw the samples from the entire supply chain including manufacturing units, government depots and hospitals, wholesale and retail outlets and from the premises of practicing general practitioners," he added.
"Once the laboratory report proves that the product is not of required quality, we make the public aware of the same through media and simultaneously we issue show cause notice to the manufacturer and also asks the manufacturer to stop the production and to withdraw the defected stock from the market," Adeshara said. In case the manufacturer is not from the state the FDCA normally inform the concerned state department regarding the same along with copy of the test report.