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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

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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