Summary Notes On DTAB (Drug Technical Advisory Board), P1988 FDC’s (Fixed Dose Combinations)

Drug Technical Advisory Board (DTAB):

The Drug Technical Advisory Board is a committee constituted as per the provisions of the Drugs and Cosmetics Act, 1940. Drug Technical Advisory Board is a part of the Central Drugs Standard Control Organization (CDSCO) in the Ministry of Health and Family Welfare. DTAB functions by taking policy decisions related to the technical aspects of the Drugs and Cosmetics Act and Rules. They send the recommendations to the Ministry of India for final approval.

Fixed Dose Combinations (FDCs):

Fixed Dose Combinations or FDCs are products that contain one or more active ingredients and are used for a particular indication/disease.

FDCs are divided into four groups:

• First group: includes one or more of the active ingredients in a new drug.
• Second group: contains already approved active ingredients and are combined for the first time.
• Third group: comprises already approved ingredients; however, the ratio of the active ingredients may change to make a new therapeutic claim.
• Fourth group: consist of those active ingredients used in a particular indication and their concomitant use is necessary and no claim is proposed to be made.

Summary notes on DTAB:

• The Drugs Controller General of India DCG(I) had taken an action to exclude certain drugs from the need for the safety and efficacy of Fixed Dose Combinations drugs licensed by the State Licensing Authority (SLAs) without approval from the DCG (I).
• The drug manufacturers who are involved in FDCs manufacturing and have licensed prior to September 1988, do not need further approval.
• As per notice dated 27-Feb-2019, DCG(I) listed 294 unapproved Fixed Dose Combinations and issued directions for them.
• According to the Drug Technical Advisory Board report, 83 FDCs were considered rational.
• To get the approval of such FDCs, the applicant had to submit FORM-44 describing dosage and strength along with 1500 Rs. for each FDC and other essential requirements. 
• The application pathway is defined by the DCG(I). Application through FORM-44 along with challan. It should contain the name and composition of Fixed Dose Combinations. A copy of Product Permission issued by SLA. FORM 25/28 and FORM 29 for manufacturers not having SLA permission.
• FDC’s serial no. is as per the list on the website. Stability and test specification details of FDCs along with Method of Analysis.
• In the DTAB report dated 29-Jul-2020, three more Fixed Dose Combinations were considered rational under the 294 FDCs category.
• All the manufacturers who are already having a license for rational Fixed Dose Combinations from the SLAs need to apply.
• As per the Drug Technical Advisory Board report dated 13-Apr-2021, 31 more FDCs had been added to the rational list under the 294 FDCs category. Annexure A enlists all 31 rational FDCs.
• The application for these Fixed Dose Combinations can be done through FORM CT-21 as per the defined pathway and the license could be approved by the DCG(I).
• According to the notification dated 28-Apr-2022, due to the COVID-19 pandemic and various requests received by stakeholders, the DCG(I), had decided to extend the timeline.
• The Directorate had decided to extend the timeline up till 31-October-2022, to those manufacturers who already hold the licenses from the SLA and have not yet applied.