The Central Government had previously issued various notifications prohibiting the manufacture for sale, sale and distribution of 294 Fixed Dose Combinations (“FDCs”) with immediate effect while those FDCs were under consideration.
A sub-committee under the Drugs Technical Advisory Board (“DTAB”) was formed who would determine the rationality and safety of these FDCs. The sub-committee after examining the 294 FDCs submitted its report to the DTAB for its consideration and 83 FDCs were found to be rational. [Click HERE for the list.]
Now, to regularise these 83 FDCs, which were licensed to manufacture and market by State Licensing Authority without prior approval from of Drugs Controller General of India, (“DCGI”) the following procedure is required to be followed:
- One will have to submit Form 44 mentioning dosage form and strength (duly filled, signed and stamped) alongwith treasury challan of INR 15,000 for each FDC.
- Name and Composition of FDC.
- Copy of Product Permission issued by Service Level Agreement (“SLA”) to any firm prior to 28.11.2007 as documentary evidence.
- Copy of manufacturing license in Form 25/28 and Form 29 for manufacturers who are not holding product permission from SLA and want to apply for these FDCs.
- Serial Number of FDC as per the list available on website.
- Stability studies data (06 months accelerated data of 03 batches), and
- Test specifications of the FDC along with Method of Analysis
All the manufacturers who are already holding licenses from State Licensing Authorities for such FDCs and did not obtain No Objection Certificate from DCGI are required to submit their applications to the Directorate General of Health Services at the earliest but not later than 31st May, 2019, failing which their applications will not be considered and their licenses will have no legal validity.
Source: Directorate General of Health Services
