Expert panel on FDC to assess safety, efficacy of several FDCs on June 11

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The union health ministry’s expert panel, constituted for the massive exercise of examining and regularising the thousands of fixed dose combinations (FDCs) permitted for manufacture and sale in the country without due approval from the Drugs Controller General of India (DCGI), will hold its fourth meeting on June 11 to scrutinise several FDC applications filed by different pharma companies.

The expert panel, set up by the CDSCO following the huge number of applications, running over 5000, has already held three meetings and examined several FDC drugs. The experts who will be examining the 15 FDC drugs on June 11 included Dr Renuka Kulkarni Munshi, Dr Iqbal Kaur, Dr Subhash Giri, Dr Niranjan Mohanty and Dr B Gupta.

The panel will assess the efficacy and safety profile and presentations filed by these companies before taking any final decision.   After the DCGI asked the industry to prove the efficacy of the FDCs permitted by the SLAs without concurrence of the DCGI, thousands of applications came to the DCGI office. The authorities then set up a committee to work out the modalities on how to examine the applications as there were not guidelines and norms in this regard.

The panel will go through the applications for the FDC products filed by Hetero Labs (azithromycin 125mg/250mg/500mg + cefixime 100mg/200mg/200mg tablets); Valence Healthcare (cefixime (as trihydrate) 200mg +azithromycin drihydrate IP 250mg film coated tablets); Relax Pharmaceuticals (cefixime 200/200mg + azithromycin 250/500mg tablet); East West Pharma (cefixime trihydrate IP 200mg +azithomycin dihydrate IP 500mg film coated tablets); FDC Ltd (cefixime 100mg +azithromycin 125mg dispersible tablets); and Akums Drugs & Pharmaceuticals Ltd (azithromycin 250mw500mg +cefixime 200mg tablets).

The panel will also examine the FDC applications filed by MDC Pharmaceuticals (cefixime IP eg. to anhydrous cefixime 200mg +acetyl cysteine USP 300mg film coated tablets); Akums Drugs & Pharmaceuticals (cefixime IP eg. to anhydrous cefixime 400mg +levofloxacin hemihydrate IP eq. to levofloxacin 500mg tablets); Talent Healthcare (cefpodoximc proetile IP 200mg +azithromycin dihydrale IP 250mg film coated tablets); Macleods Pharmaceuticals (cefpodoxime proxetil 200mg +azithromycin 250mg film coated tablets); Aeon Formulations (cefpodoxime 320mg +azithromycin 500mg tablets, and cefpodoxine 100mg +azithromycin 125mg dispersible tablet); and Orbit Lifesciences (azithromycin dihydrate lP eq. to azithromycin 250mg/500mg +cefpodoxime proxetil IP eq. to cefpodoxime 200mg film coated tablets, and cefpodoxime proxetil 200 mg + dicloxacillin sodium 500 mg tablets).

The list also include Relax Pharmaceuticals (cefpodoxine proxetil 200 mg + levofloxacin hemihydrate 250 mg tablets); Akums Drugs & Phannaceuticals (levofloxacin 250mg/500mg +azithromycin 250mg/500mg tablets);Gelnova Laboratories (anhydrous azithromycin 250mg/500mg +anhydrous levofloxacin 250mg/500mg tablets); Synokem Pharma (azithromycin 250 mg/500 mg + levofloxacin 250 mg/500 mg film coated tablet); Hetero Labs (azithromvcin 250mg/500mg +levofloxacin 250mg/500mg tablets); Arion Healthcare (beclomthasone dipropionate O.025%w/v + clotrimazole l%w/v +chloramphenicol 5%w/v +gentamycin sulphate 0.3%w/v + lignocaine HCI 2%w/v ear drops); Aeon Formulations (ciprofloxacin HCI IP 250mg +phenazopyridine HCI USP 200mg film coated tablets); Alembic Pharmaceuticals (roxithromycin IP 150mg +serratiopeptidase 10mg film coated tablets); Akums Drugs & Pharmaceuticals (sulphadiazine sodium 100 mg + trimethiprim 20 mg oral powder); and Bushal Healthcare (trimethoprim IP 200mg +sulphadiazine IP 1000mg uncoated tablets).

Source: PharmaBiz

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