Fixed Dose Combination
Faster Approvals Leading to Enhanced Access to Markets !
In the Indian regulatory context, Fixed Dose Combinations (FDCs) refer to products containing two or more active ingredients used for a particular indication(s). The development of FDCs is becoming increasingly high either to improve compliance or to benefit from the added effects of the two or more active drugs given together. As FDCs are being used in the treatment of a wide range of conditions and are particularly useful in the management of chronic conditions, they should always be based on convincing therapeutic justification.
Each fixed dose combination should be carefully justified and clinically relevant (e.g. in cases when each component of the FDC has several possible dosages, dosages that have shown benefit on clinical outcomes may be preferable). Hence, Appendix VI of Schedule Y (Drugs & Cosmetics Rules 1945) specifies the requirements for approval for marketing of various types of FDCs.
FDCs are considered to be new drugs under Rule 122(E) of Drugs and Cosmetics Act & Rules if any or all active ingredients used for a particular indication(s) have not been used in the country to any significant extent and has not been recognized as effective and safe by the Indian licensing authority (CDSCO). All activities with reference to a New Drug, including Import, Manufacturing, Testing, Conduct of Clinical Trials, Marketing etc., have to be approved by the Central Drug Regulator – CDSCO.
In brief, there is a set procedure of application submission, review and approvals from various stakeholders that are required to initiate any and all activities indicated. The approvals are usually in the form of Approval Letters, No Objection Certificates/Letters, Licences etc.,
Vyomus Consulting provides both Product Registration Services and Authorized Agent Services to all categories of FDCs in India. An end-to-end service offering which will help you import, manufacture, test, conduct clinical trials and sell your product in India (Market Authorisation), efficiently so as to achieve faster product approvals leading to enhanced access to Markets and Opportunities.
This service offering includes vendor identification & management, various stakeholder regulatory submissions, approvals management, independent audit, regulatory reporting, regulatory dossier review and submission to the regulator.
Our services include the following :
- Regulatory Strategy Consulting and Liaison
- Complete New Drug Life Cycle Management
- Compilation of India specific submission dossiers
- Submission management leading to approvals from ALL Stakeholders (IEC, EC, CDSCO, DGFT, DAC’s etc.,)
- India Specific 0 Labelling and Patient Information / Instructions for Use leaflets
- Post marketing services including Complaint handling, Adverse incident Reporting & Management and product recall support as part of Product safety reporting, Query management, PSUR Writing & Submission activities
- All statutory Marketing Authorization holder’s requirements
- Act as your India Regulatory Department by Applying and Maintaining required approvals, Prepare and review regulatory submission material for compliance to India legislation etc.,
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