Based on representations from manufacturers to give sufficient time to present precise data on 324 irrational fixed dose combinations (FDCs), the Union health ministry has extended the deadline for its submission till August 16, 2019 from the earlier deadline of June 30, 2019.
This exercise is meant to evaluate the quality and efficacy of FDCs which were considered irrational in the assessment report of the union health ministry appointed Prof. Kokate Committee.
The Union health ministry had earlier directed the manufacturers to submit specific information on irrational FDCs in the prescribed format along with supporting documents by June 30, 2019.
Besides other things, it has also been asked to submit a one-page summary with highest level of evidence, supporting the claim of postulated advantage or rationale.
The evidence should be enclosed in the form of maximum of five relevant full text articles in peer-reviewed journals or relevant information from textbooks. Pharmacokinetic or pharmacodynamics rationality with half-life details of individual ingredients, dosage schedule of individual drugs and dosage schedule of FDC has to be provided, as per the health ministry directive.
The Drugs Technical Advisory Board (DTAB) of the Union health ministry had constituted a sub-committee to evaluate 324 irrational FDCs based on Prof C K Kokate Committee’s final report and has directed the sub-committee to come out with final report in three months time.
The matter was deliberated at the 82nd meeting of the DTAB held on April 2, 2019.
The sub-committee has been formed under the chairpersonship of Dr Nilima Kshirsagar, Chair in Clinical Pharmacology, Indian Council of Medical Research (ICMR), Mumbai to evaluate Kokate Committee report.
After examining 418 applications of FDCs, the Kokate Committee found 324 FDCs as irrational, 28 FDCs as rational, 2 FDCs require further generation of data and 4 FDCs require further deliberation after evaluating all the data submitted.
Details to be shared are related to the composition of product (FDC), details of all ingredients, strengths/dosage forms, brand name/s if any, name and address of the applicant, whether the applicant is manufacturer, marketer, name of the licensing authority with year of license and other relevant informations, if any submitted to licensing authority while obtaining the license.
It has also been asked to submit the name and designation of the licensing authority, date and year of product license, whether the FDC is approved by Drugs Controller General of India (DCGI), If so details or evidence thereof, whether the FDC is pre 1988, if so details or evidence thereof, indication(s), provide a copy of the approved package insert that is currently provided, state the category under which FDC approval is claimed as per drugs and cosmetics rules and pharmacological classification, therapeutic justification/rationale for each ingredient and quantity contained in the FDC.