DCGI directs manufacturers to follow procedure for regularisation of 31 FDCs declared as rational out of 294 FDCs

The Drugs Controller General of India (DCGI) has directed manufacturers to follow a procedure for regularisation of 31 Fixed Dose Combinations (FDCs) declared as rational out of the 294 FDCs as per the recommendations of Drugs Technical Advisory Board (DTAB).

As per the report of DTAB dated April 13, 2021 and recommendations of subcommittee of DTAB as approved, 31 FDCs have been considered as rational under 294 FDCs category.

These FDCs were licensed to manufacture and market by the State Licensing Authorities (SLAs) without prior approval from the DCGI.

The DCGI has directed all concerned stakeholders for submission of application in Form CT-21 as per the defined pathway for clearance of the cases. It has also been urged to ensure that product license in respect of these 31 FDCs are issued after the approval of DCGI in favour of the applicant.

The drug regulator had in February 27, 2019 and September 8, 2020, issued letters with detailed pathways for obtaining permission from the directorate for 83 FDCs and subsequently three FDCs were declared as rational.

It has said that all the manufacturers who are already holding licenses from SLA for the 31 FDCs and did not obtain NOC from DCGI are required to submit their applications to this directorate at the earliest within six months.

The list of these 31 FDCs include Amoxicillin+ Cloxacillin+ Lactic acid bacillus, Amoxycillin+ Clavulanic acid+ Lactic acid bacillus, Amoxycillin+ Lactic acid bacillus, Amoxycillin+ Lactobacillus acidophilus Flucloxacillin Sodium, Ampicillin+ Cloxacillin+ Lactic acid bacillus, Ampicillin+ Lactic acid bacillus, Calcium dobesilate+ Lignocaine+ Hydrocortisone 8. Cefadroxyl+ Lactic acid bacillus, Cefdinir+ Lactic acid bacillus, Cefixime+ Lactic acid bacillus, Cefixime+ Lactobacillus+ Dicloxacillin, Cefpodoxime prozetil+ Lactic acid bacillus, Cefpodoxime+ Cloxacillin+ Lactobacillus, Cefprozil+ Lactobacillus, Cepodoxime+ Cloxacillin+ Lactic acid bacillus, Dicyclomine+ Ranitidine, Domperidone+ Paracetamol, Domperidone+ Paracetamol+ Tramadol, Doxycycline+ Lactobacillus, Drotaverine+ Nimesulide, Drotaverine+ Paracetamol, Lincomycin+ Lactobacillus, Ofloxacin+ Lactic acid bacillus, Ondansetron+ Ranitidine, Torsemide+ Spironolactone, Allantoin+Dimethicone +Methylparaben+ Propylparaben, Aloe vera+Vit-e acetate, Aloe+ Tocopherol, Aloevera+Glycerine+PEG 100, Ampicillin+Flucloxacillin Sodium Salt and Ampicillin+Flucloxacillin Sodium Salt+ Lactobacillus Acidophilus.