The expert committee set up by the Union health ministry to frame guidelines for the approval and use of fixed drugs combinations (FDCs) in the country held its second meeting in Mumbai on March 23.

One of the important highlights of this meeting was that, unlike the previous closed door meeting that was conducted earlier this month in Delhi, this one was open for the key stakeholders to present their views and suggestions on FDCs. According to a highly placed source from the industry, a lot of deliberation was made on this subject wherein, it was equivocally agreed upon by all that considering the importance of FDCs in preserving the healthcare needs of the nation it was of utmost important to address the lack of regulatory norms in the country with respect to approval of FDCs.

Dr H G Koshia, commissioner, Gujarat FDCA, pointed out that since India has a strong hold in developing FDCs which are used as an effective treatment option across different disease profiles it is very essential to prepare a regulatory framework that will weigh in the best interest of the patients. “But at the same time, our main focus will be to prepare an efficient and strong guideline that will help the regulators in judiciously scrutinising and controlling the grant and approval of the FDCs in the country for ensuring access to only safe and efficacious drugs to our patients,” he added.

He further informed that during this meeting, serious consideration was given on addressing key factors like pharmacokinetics and pharmacodynamics of these drugs, suggestions on how to set forth requirements to meet the stringent bioavailability (BA) and bioequivalence (BE) study for all the FDCs. Special stress was also given on finding an ideal way to understand the detailed dynamics of the medicines and its effects of the patients since FDCs basically deal with additional drug combinations wherein more than two to three drugs are combined together to get a better and effective treatment option against select diseases.

To further the discussion, the committee will be meeting the stakeholders like IDMA, OPPI, IPA etc. again for the third time in Delhi on April 15.