Last Updated on October 9, 2024 by The Health Master
Information on 16 Fixed Dose Combinations
The Central Drugs Standard Control Organisation (CDSCO) has called for information on the 16 fixed dose combinations (FDCs) that were earlier classified as irrational in a report by an expert panel.
The decision was made in relation to the Drugs Technical Advisory Board’s (DTAB) 86th meeting, held on April 13, 2021, which in principle agreed to the recommendations of the committee report on FDCs.
The CDSCO has requested manufacturers and stakeholders to submit the required information in a specified format to allow for further evaluation of the FDCs.
CDSCO Format for Submission of Information:
The CDSCO has released a prescribed format for submission of information, which includes:
- The name and address of the applicant
- The name and designation of the licensing authority
- Date and year of product license
- Whether the FDCs are approved 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 the 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 Considered Irrational:
The list of 16 FDCs considered irrational among the 294 FDCs recommended by the Prof Kokate Committee includes:
- Combination of acetyl salicylic acid with ethoheptazine
- Aloe extract with allantoin, alpha tocopherol acetate, D-panthenol and vitamin A
- Aloe extract with vitamin E, dimethicone and glycerine
- Aloe vera with jojoba oil and vitamin E
- Aloe vera with orange oil
- Aloe vera with jojoba oil, wheat germ oil and tea tree oil
- Aloe vera with vitamin E and herbal
- Dicyclomine with paracetamol and clidinium bromide
- Dicyclomine with paracetamol, clidinium bromide and chlordiazepoxide
- Gliclazide with chromium picolinate
- Paracetamol with lignocaine
- Amoxicillin with serratiopeptidase and lactobacillus sporogenes
- Amoxicillin with cloxacillin, lactic acid bacillus and serrapeptase
- Amoxicillin and serratiopeptidase
- Cefadroxil and probenecid
- Cefurosime with serratiopeptidase
Background
The CDSCO received complaints from Consumer Associations in 2007 regarding FDCs not approved by the Drugs Controller General (India) but marketed in the country.
In response to the complaints, the DCG(I) prepared a list of 294 FDCs and directed all State and Union Territory drug controllers to withdraw these drugs, which were licensed without the approval of the central drug regulator.
The manufacturers association obtained a stay from the High Court of Madras in respect of the directions.
The matter was then placed in the DTAB in its 56th meeting held on January 16, 2008, and a subcommittee was formed to examine these FDCs.
According to the subcommittee report, out of the 294 FDCs, 17 had inadequate data to prove their rationality, safety, and efficacy, while 49 required further data generation in terms of safety and efficacy by conducting clinical trials and other studies.
The CDSCO received complaints from Consumer Associations in 2007 regarding FDCs not approved by the Drugs Controller General (India) but marketed in the country.
In response to the complaints, the DCG(I) prepared a list of 294 FDCs and wrote to all State and Union Territory drug controllers to withdraw these drugs, which were licensed without the approval of the central drug regulator.
The manufacturers association obtained a stay from the High Court of Madras in respect of the directions.
The matter was then placed in the DTAB in its 56th meeting held on January 16, 2008, and a subcommittee was formed to examine these FDCs.
According to the subcommittee report, out of the 294 FDCs, 17 had inadequate data to prove their rationality, safety, and efficacy, while 49 required further data generation in terms of safety and efficacy by conducting clinical trials and other studies.
Conclusion:
The CDSCO has issued a notice seeking information from all manufacturers of the 16 irrational FDCs earlier considered by an expert panel report.
The information is to be submitted in a prescribed format along with supporting documents for further evaluation by the sub-committee under Dr. Nilima Kshirsagar. This decision has been taken in connection with the complaints.
List of approved FDCs (Fixed Dose Combinations) Updated
Govt extends implementation date of track and trace system for exports of drugs
USFDA issues Form 483 with zero observation to Piramal
Pharmacopoeia standards for Ayurveda, Siddha, Unani & Homoeopathy drugs: Soon
Drug alert: 59 out of 1251 samples declared as NSQ in February 2023
Calibration of Laboratory Instruments
Drug recall: 50,000 contaminated eye drops recalled
Glutathione: Lets talk about its dose and health benefits
NPPA fixed retail price of 25 formulations: March 2023
Difference: Disintegration and Dissolution test in pharma industry
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
