There should be a change in SOP parameters for evaluating FDCs: Dr RK Sanghavi

A sub-committee of DTAB has asked manufacturers of FDCs which were considered irrational by Prof Kokate Committee to present their perspective

The Sub-committee of Drugs Technical and Advisory Board (DTAB) is examining the fixed-dose combinations (FDCs) which are considered irrational by Prof Kokate Committee. The committee has asked the concerned applicants to present their perspectives on their FDCs which are classified as irrational.

A sub-committee of DTAB constituted under the chairmanship of Dr Nilima Kshirsagar, Emeritus Scientist and former Chair in Clinical Pharmacology, Indian Council of Research (ICMR) will be examining it.

Earlier, DTAB had carried out a massive exercise in the second quarter of 2018 to evaluate the safety and efficacy of State-Licensing Authority (SLA) permitted Fixed Dose Combinations (FDCs) with an intent to regularise those already being prescribed and consumed for over many decades barring the glaringly irrational or unsafe – the latter in the context of recent scientific data.

“Establishing rationality being a highly subjective conclusion, most of the 349 FDCs – barring six, under scrutiny were axed. Surprisingly, even many of these were deemed unsafe without the authorities providing glaring evidence for the same in a real-world context,” said Dr RK Sanghavi, who had represented the cause as an independent consultant as well as Chairman of Medical Committee of IDMA.

 He further continued, “FDCs to be scrutinised should be evaluated by experts based on their expertise and not on parameters such as approval by other countries, etc.”, opined Dr Sanghavi.

Incidentally, Sanghavi spearheaded on the industry’s behalf the cause for the very first lot of 294 irrational SLA-approved FDCs and was able to convince the expert panel and save approximate 50 per cent of the discussed combination products.

“It is the old school of thought that is yet deeply ingrained in many senior colleagues that FDCs are all unwarranted and irrational because such was the preaching in the medical curriculum lectures and the same could be the basis for its mass axing”, added Sanghavi. 

He added that India has assumed a leadership role in introducing FDCs and even regulated countries, having realised their importance, kick-started approval of such combination products. So much so, that there are guidelines for approval of FDCs in the US, Europe and even by WHO.

Dr Nilima KshirsagarDr RK SanghaviDTABFDCsfixed dose combinationsIDMAProf Kokate Committee
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