CDSCO seeks details of 16 FDCs named as irrational for further examination
New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has issued a notice seeking all the manufacturers of the 16 Fixed Dose Combinations (FDCs) which were earlier considered as irrational in an expert panel report to submit the information in a prescribed format for further evaluation.
This comes in connection with the decision of the 86th meeting of the Drugs Technical Advisory Board (DTAB) on April 13, 2021, which examined the expert committee report of Prof. Kokate Committee with respect to the FDCs considered as irrational. The meeting in principle agreed to the recommendations of the Committee and recommended that the sub-committee under Dr Nilima Kshirsagar, Emeritus Scientist, former Chair in Clinical Pharmacology, ICMR, Mumbai, shall examine the 16 irrational FDCs in detail as per the procedures.
In order to give an opportunity to the manufacturers of the said FDCs, and the concerned stakeholders for presenting the precise data with respect to these FDCs, the Subcommittee has desired that the manufacturers and other stakeholders submit the information in a prescribed format. The CDSCO, in its latest notice, released the format, which has to be submitted along with the supporting documents, for further action.
“Accordingly, all the manufacturers of said FDCs and the concerned stakeholders are hereby requested to submit the information in the prescribed format and the relevant supporting documents in hard copy as well as soft copy (i.e. in C.D form) to this office latest by April 30, 2023 till 5 pm,” said the FDC division of the apex drug regulatory body.
The format for submission of information seeks details including the name and address of the applicant, the name and designation of the licensing authority, date and year of product license, whether the FDCs is approve by the Drugs Controller General (India), whether FDC is pre-1988 and if yes, details thereof, particulars of the drug, indications, copy of approved package insert currently provided, therapeutic details, one-page summary with highest level of evidence supporting the claim of postulated advantage or rationale, pharmacokinetic and pharmacodynamics rationality, regulatory status of the FDC in other countries, among others.
List of 16 FDCs in 294 FDCs recommended as irrational by Prof. Kokate Committee
SI.no. | Name of FDC |
1. | Acetyl salicylic acid + Ethoheptazine |
2. | Aloe extract + Allantoin + Alphatocopherol acetate + D-PanthenoI + Vitamin A |
3. | Aloe extract + Vitamin E + Dimethicone + Glycerine |
4. | Aloe vera + Jojoba oil + Vitamin E |
5. | Aloe vera + Ora e oil |
6. | Aloe vera + Jojoba oil + Wheat germ oil + Tea tree oil |
7. | Aloe vera + Vitamin E + Herbal |
8. | Dicyclomine + Paracetamol + Clidinium Bromide |
9. | Dicyclomine + Paracetamol + Clidinium Bromide + Chlordiazepoxide |
10. | Gliclazide + Chromium Picolinate |
11. | Paracetamol + Lignocaine |
12. | Amoxicillin + Serratiopeptidase + Lactobacillus Sporogens |
13. | Amoxicillin + Cloxacillin + Lactic acid bacillus + Serrapeptase |
14. | Amoxicillin + Serratiopeptidase |
15. | Cefadroxyl + Probenecid |
16. | Cefuroxime + Serratiopeptidase |
