The expert panel, constituted by the union health ministry 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 third meeting on June 4 to scrutinise over 15 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 two meetings and examined several FDC drugs. The experts who will be examining over 15 FDC drugs on June 4 included Dr. Kamlakar Tripathi, Dr TK Dutta, Dr B Gupta, Dr Manjula Bhargava, Dr Sayed Ahmed and Dr Buddhadar Chowdhury.
The panel will go through the applications for the FDC products filed by BRD Medilabs (3 tablets of Serratiopeptidase (enteric coated 20000 units) IP 10mg +diclofenac potassium BP 50mg & 2 tablets of doxycycline HCL IP 100mg Kit); Life Care Formulations (aceclofenac 100mg + paracetamol 325 mg + thiocolchicoside 4 mg film coated tablet); Macsur Pharma (aceclofenac 100 mg + paracetamol 325 mg + thiocolchiside 4mg/8mg film coated tablet); Synokem Pharmaceutical (aceclofenac 100mg +paracetamol 325mg +thiocolchicoside 4mg film coated tablet); Akums Drugs & Pharmaceuticals (aceclofenac 100mg+paracetamol 325mg/325mg +thiocolchicoside 4mg/8mg tablets); Talent Healthcare (aceclofenac· 100mg +paracetamol 325mg +thiocolchicoside 8mg film coated tablets); Embiotic Laboratories (aceclofenac 100mg +pamcetamol 500mg +thlocolchicoside 4mg/8mg film coated tablets); and Acme Formulations (aceclofenac 100mg +paracetamol 325mg +thiocolchicoside 4mg/8mg tablets).
The list also include Wockhardt (aceclofenac IP 200 mg + rabeprazole sodium 20 mg tablet); Akums Drugs Pharmaceuticals (aceclofenac IP 100mg +paracetamol IP 325mg +rabeprazole sodium IP 10mg enteric coated tablets); Aeon Formulations (drotaverine HCI IP 80mg + clidinium bromide USP 2.5mg + chlordiazepoxide IP 5mg film coated tablets); Talent Healthcare (lornoxicam IP 8mg +paracetamol IP 325mg +serratiopeptidase IP 15mg film coated tablets); Windlas Biotech (lornoxicam 8mg +paracetamol IP 325mg +serratiopeptidase IP 15mg tablets); and Talent Healthcare (lornoxicam IP 100mg +paracetamol lP 325mg + tramadol IP 37.5mg film coated tablets).
The panel will also examine the FDC applications filed by Windlas biotech (tramadol hydrochloride 37.5 mg + paracetamol 325 mg + lomoxicam 8 mg liim coated bilayered tablet); Orbit Lifesciences (lornoxicam 8mg +paracetamol 325mg +trypsin150000 AU tablets); Akums Drugs Pharmaceuticals (paracemmol lP 300mg +mefenamic acid IP 150mg +ranitidine HCL 100mg +dicyclomine HCIIP IOmg tablets); Vivimed Labs (tramadol HCI 37.5 mg + paracetamol 325 mg + dicyclomine Hcl 10mg capsules); Psychotropics India (tramadol HCI 37.5mg +dicyclomine HCL 20mg +paracetamol IP 500mg uncoated tablets); Wockhardt (dicycIomirie hydrochloride 10 mgl20 mg + tramadol hydrochloride 50 mgl37.5 mg + acetaminophen 325 mg capsule); Maesur Pharmaa (naproxen 30Qmgl550mg +paracetamol IP 325mg film coated tablets); and Acme Formulations (tapentadol50mg +paracetamol 325mg tablets).
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.