The CDSCO serves as the main authority regulating pharmaceuticals in India. To help comply with the safety, quality, and manufacturing standards, CDSCO provides a list of new updates, changes, approvals, and rejections for the fixed-dose combination. The below article entails all about the CDSCO FDC approved list updates in India.
What Are Fixed Dose Combinations (FDCs) In India?
Fixed Dose Combinations (FDCs) can be defined as the combinational dosage form that includes a fixed composition of two or more active ingredients to treat specific diseases.
Examples: Combination tablet of Chlorpheniramine and Paracetamol
CDSCO And Its Role In Approving FDCs:
Central Drugs Standard Control Organization (CDSCO) is the main regulatory authority of India regulating pharmaceutical products. FDCs are one of the key aspects regulated by CDSCO.
The CDSCO ensures the quality, safety, and efficacy of the FDCs before approving.
Some of the aspects of the CDSCO guidelines for the FDCs are as follows;
Medical Rationale:
- If the FDC is available in more than one strength, each entity is considered a separate entity.
- For market approval, the rationale of FDC should depict the use of more than two active ingredients.
- The FDC report should indicate the pharmacokinetic and pharmacodynamic properties.
- The FDC should show the bioavailability and bioequivalence studies.
- Adequate clinical trials should be conducted for the FDC following the CDSCO guidelines and reports should be submitted to the CDSCO before its approval.
After identifying “certain typographical” flaws in the original document, India’s Central Drugs Standard Control Organisation (CDSCO) revised its list of approved fixed-dose combination (FDC) items.
The list of permitted FDCs is reissued in the current notification. Five of the more than 2,100 FDC products listed in the annexe had mistakes, thus CDSCO took action to fix them.
Access the full notice here CDSCO Update.
Latest Updates In CDSCO’s FDCs List:
- CDSCO, after revising the guidelines and regulations of the FDC, CDSCO found typographical errors and revised its list for fixed-dose combination items.
- The typographically corrected error FDC list was published on April 5, 2023
- It was found that more than 2100 FDC products had been mistaken for annexes.
- CDSCO made corrections, especially at serial numbers 67, 134, 1704, 1819, and 1989.
- The update to these specific entries was updated on February 5, 2023.
- Hence, all the applicants applying for a license are required to follow the new updated FDC list.
For more detailed CDSCO FDC guidelines visit the official CDSCO page for FDC guidelines.
Importance Of FDC In Indian Healthcare:
The FDC has proven many advantages in the healthcare industry in India. Some of the advantages are as follows:
- Greater therapeutic efficacy.
- Patient compliance as the number of pills reduces to one combined dose.
- Pharmacodynamic and pharmacokinetic efficiency.
- Delivery of the exact amount of dose of active ingredient in the body.
- Reduced occurrence of adverse effects of drugs.
CDSCO Encountered Challenges For FDC Approval In India:
Some of the challenges faced by the FDC approval in India are as follows:
- Some FDCs do not have adequate scientific data to support them, which delays its approval.
- The active ingredients in the FDC may not together show a peak therapeutic effect at the same time, which hampers its effect reducing the overall therapeutic value of the combination.
- Sometimes, the combination of active drugs shows an antagonistic effect, making the combination non-liable for use.
- Some FDCs are sometimes prepared to keep in mind the marketed interest but have very little therapeutic value, which causes an obstacle to approval.
Tips To Stay Updated With CDSCO’s FDC Approvals And Regulations:
CDSCO keeps on making amendments and changes to its guidelines. Hence, the manufacturer should stay updated with its new notifications to avoid non-compliance with its FDC product.
Below are some of the tips to ensure timely updates with the new changes in CDSCO guidelines for FDCs:
- Keep visiting the CDSCO website regularly.
- Subscribe to the CDSCO newsletter.
- Follow CDSCO on all the social media platforms.
- Keep reading the new gazette notifications by the CDSCO.
- Appoint a regulatory consultant to update you with the new changes.
- Keep reading the journals and publications on FDC to know about the new changes and challenges and how to encounter the regulatory journey.
Conclusion:
FDCs are thus combinational therapeutic products that are prepared to target multiple conditions through one dosage form. However, there are a lot of aspects and prospectus that need to be studied and researched before formulating an FDC. In some cases, the FDCs may also show an antagonist effect, for such an active drug combination is not preferred. Because an FDC should not only keep in mind the marketed interest but also therapeutic efficacy. And while submission of the approval request for CDSCO, all the authentic relevant documents should be submitted to avoid non-compliance issues.
FAQs:
What is the timeline for FDC approval by CDSCO in India?
The general timeline for the FDC approval in India by CDSCO varies from 2 months to 2 years depending upon the complexity of the FDC.
Can the FDCs be exported from India, what are the special guidelines that should be followed for the export of FDCs?
Yes, the FDC can be exported from India, but there are certain guidelines that the FDC should follow such as export license, WHO certification, compliance with export country regulations, drug master file, etc.
Which are the common FDCs manufactured in India?
FDC for diabetes, which is the combination of glimepiride and metformin, FDC for hypertension, which is the combination of amlodipine and atenolol, etc are some of the common FDCs manufactured in India.
Can CDSCO recall an FDC from the market?
Yes, the FDC can be recalled from the market by the CDSCO, if the FDC has shown any adverse effect or any issues are found regarding the safety and quality of the FDC.
