Regularization of 31 FDCs declared rational: Drugmakers told to submit application within 6 months
New Delhi: In order to regularize Fixed Dose Combinations (FDCs) declared rational by the DTAB in respect of 294 FDCs, the Central Drugs Standard Control Organization (CDSCO) has issued a letter asserting that all manufacturers who already hold licenses from State Licensing Authorities for specified 31 FDCs but have not received ( No Objection Certificate) NOC from DCGI are required to submit an application to CDSCO at the earliest within 06 months.
The list of 31 FDCs includes Amoxycillin plus Lactic acid bacillus, Cefadroxvl plus Lactic acid bacillus, Cefixime plus Lactic acid bacillus, Cefpodoxime plus Cloxacillin plus Lactobacillus, Dicyclomine plus Ranitidine, Ondansetron plus Ranitidine, Torsemide plus Spironolactone, Aloe plus Tocopherol, Domperidone plus Paracetamol and others.
This came in continuation of the Directorate letter of even number dated 27.02.2019 and 08.09.2020 whereby a detailed pathway was issued for obtaining permission from this Directorate in respect of 83 FDCs and subsequently 03 FDCs declared as rational.
Furthermore, as per the report of DTAB dated 13.04.2021 and recommendations of the subcommittee of DTAB as approved, 31 more FDCs have been considered as rational under the 294 FDC category. The list of these 31 FDCs is enclosed below.
Through the latest issued notice, the Drugs Controller General (India) has directed all manufacturers who are already holding licenses from State Licensing Authorities for such FDCs and have not obtained NOC from DCG (I), to submit their applications to this Directorate at the earliest within 06 months.
In view of the above, the Drugs Controller General (India) further urged all State/UT Drugs Controllers to direct all concerned stakeholders to submit applications on Form CT-21 as per the defined pathway for clearance of the cases.
In addition to this, the DCGI further requested all State/UT Drugs Controllers to ensure that product licenses in respect of these 31 FDCs are issued after the approval of DCG (I) in favour of the applicant.
List of these 31 FDCs
S.No. | Name of the FDC | Recommendations |
1. | Amoxicillin+ Cloxacillin+ Lactic acid bacillus | Rational. |
2. | Amoxycillin+ Clavulanic acid+ Lactic acid bacillus | Rational. |
3. | Amoxycillin+ Lactic acid bacillus | Rational. |
4. | Amoxycillin+ Lactobacillus acidophilus+ Flucloxacillin Sodium | Rational. |
5. | Ampicillin+ Cloxacillin+ Lactic acid bacillus | Rational. |
6. | Ampicillin+ Lactic acid bacillus | Rational. |
7. | Calcium dobesilate+ Lignocaine+ Hydroco rtisone | Rational for short term use. |
8. | Cefadroxvl+ Lactic acid bacillus | Rational |
9. | Cefdinir+ Lactic acid bacillus | Rational |
10. | Cefixime+ Lactic acid bacillus | Rational |
11. | Cefixime+ Lactobacillus+ Dicloxacillin | Rational if Dicloxacillin is in sustained release form in twice daily doses schedule and Indication of the FDC should be restricted to skin & soft tissue infections. |
.12. | Cefpodoxime prozetil+ Lactic acid bacillus | Rational |
13. | Cefpodoxime+ Cloxacillin+ Lactobacillus | Rational if Cloxacillin is in sustained release form in twice daily doses schedule and Indication of the FDC should be restricted to skin & soft tissue infections. |
14 | Cefprozil+ Lactobacillus | Rational |
15. | Cepodoxime+ Cloxacillin+ Lactic acid bacillus | Rational if Cloxacillin is in sustained release form in twice daily doses schedule and Indication of the FDC should be restricted to skin & soft tissue infections. |
16. | Dicyclomine+ Ranitidine | Rational |
17. | Domperidone+ Paracetamol | Rational. FDC is indicated for management of acute migraine. |
18. | Domperidone+ Paracetamol+ Tramadol | Rational provided that dose of paracetamol is 325mg. FDC is indicated for manaqement of acute miaraine. |
19. | Doxvcvcline+ Lactobacillus | Rational |
20. | Drotaverine+ Nimesulide | Rational. FDC is indicated for dvsmenorrhoea. |
21. | Drotaverine+ Paracetamol | Rational. FDC is indicated for dysmenorrhoea. |
22. | Lincomvcin+ Lactobacillus | Rational |
23. | Ofloxacin+ Lactic acid bacillus | Rational |
24. | Ondansetron+ Ranitidine | Rational |
25. | Torsemide+ Spironolactone | Rational |
26. | Allantoin+Dimethicone + Methvl oaraben+ Proovloaraben | Rational |
27. | Aloe vera+Vit-e acetate | Rational if FDC is in cream and lotion dosage form only. |
28. | Aloe+ Tocopherol | Rational if FDC is in cream and lotion dosage form onlv. |
29. | Aloevera+Glycerine+PEG 100 stearate+Vit E | Rational if FDC is in cream and lotion dosage form only. |
30. | Ampicillin+Flucloxacillin Sodium Salt | Rational |
31. | Ampicillin+Flucloxacillin Sodium Salt+ Lactobacillus Acidoohilus | Rational |
Also Read: CDSCO asks stakeholders to submit data on rationality, safety, & efficacy of older FDCs
