The manufacturers of fixed dose combinations (FDCs), which were not cleared by the office of the Drug Controller General of India (DCGI), will be given an opportunity to present their case with all possible justifications before the DCGI as part of proving the safety and efficacy of the FDCs, even as the expert panels have reportedly begun the exercise of examining the applications.
In a communication, the DCGI has asked the manufacturers to be ready to make presentations, as and when directed, and also to bring the samples of the FDCs. The presentations should include the name of the product with composition and indication, rationale, pharmacokinetic/pharmacodynamic interactions and pharmacokinetic rationale (with half life details of individual drugs, dosage schedule of individual drug along with reference, the notice said.
The manufacturers, through the respective state licensing authorities, have also been asked to produce published data regarding safety and efficacy of applied FDC, original data generated by the applicant, PMS data generated, regulatory status of FDC in other countries, details of similar FDCs approved by the DCGI and details of further studies planned.
After the DCGI asked the industry to prove the efficacy of the FDCs permitted by the SLAs without concurrence of the DCGI, thousands of applications came to the DCGI office. The authorities then set up a committee to work out the modalities on how to examine the applications as there were no guidelines and norms in this regard.
The DCGI also appointed 10 panels recently to go into the applications for regularisation of the FDCs and decide on the efficacy and safety of those FDCs. It is learnt that the panels had already started examining the applications based on the details submitted to it.
“The State Drug Controllers were requested by vide letter of even number dated 15.01.2013 that manufacturers are required to prove the safety and efficacy of such FDCs which are licensed by State Licensing Authorities without prior approval of DCGI before the office of the DCGI within 18 months. In this connection, a subsequent letter was issued on 05.07.2013 and 26.08.2013 that in order to examine the safety and efficacy of such FDCs in timely manner, the manufacturer should submit the application to the office of the DCGI or the respective zonal/sub zonal officers of the CDSCO by 30.08.2013 in Form 44 along with requisite fees and supporting documents,” according to an earlier notice by the DCGI.