Last Updated on November 9, 2020 by The Health Master
Recently NPPA expressed displeasure over approval of FDCs of two or more drugs saying that it may compromise the rationale in the usage of the drugs and may lead to over medication. The authority also expressed the apprehension that fixation of retail price of these FDCs may lead to a higher price being fixed than the sum of the price of their individual components resulting in profiteering by the companies.
The remark by the drug price regulator about FDCs came in the wake of applications moved with it to fix the prices of new drugs which mainly consisted of FDCs. The FDC applications were discussed during a meeting on October 26, 2020 chaired by NPPA chairperson Shubhra Singh. The meet was attended by A K Pradhan, deputy drug controller (DDC), CDSCO among others.
Subsequently, NPPA emphasized the need to look into the guidelines in the usage of these FDCs, stating that the matter may be highlighted to the Indian Council of Medical Research (ICMR), New Delhi.
Expressing concern over the NPPA’s remark against approval of FDCs, Dr R K Sanghavi, who has spearheaded the FDCs concerns and deliberated issues with regulators as Chairman of IDMA’s Medical and Nutraceutical Committees earlier, said “The development of FDCs is becoming increasingly important from a public health perspective. These are being used in the treatment of a wide range of conditions including in the management of human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS), malaria and tuberculosis, which are considered to be the foremost infectious disease threats in the world today.”
“There are separate guidelines for FDCs in India and, in fact, FDCs have gained importance across the world. There are even international guidelines for approval of FDC drugs – including in regulated markets such as USA, Australia, European Union (EU) as well as World Health Organization (WHO),” he said.
FDCs have been demonstrated to be safe and effective for their claimed indications and have contributed immensely to the overall therapeutic options for patient’s health management perspective. “There are real clinical benefits in the advocating of FDCs and the treatment guidelines for various chronic ailments, especially heart and diabetes, have defined specific criteria when 2 or 3 drugs are necessary for management in their concerned guidelines like for type 2 diabetes mellitus and hypertension,” Dr Sanghavi, who is also a practicing clinician, opined.
Terming the apprehension raised by NPPA regarding profiteering by drug companies from FDCs as baseless, he said “The cost of an FDC is usually likely to be less on the contrary. What is more important is, in a country like India is patient compliance challenges in chronic healthcare management. That the FDCs afford better patient compliance by reducing pill burden is undebatable and a foregone conclusion. For example, any diabetes patient requiring triple-drug therapy for the rest of his / her life, would definitely prefer a single-pill FDC rather than 3 separate tablets.”
In August this year, the Drugs Controller General of India (DCGI) came out with a list of 471 new FDCs related to vitamins, minerals and micronutrients and directed the State Licensing Authorities (SLAs) to ask drug makers to get manufacturing licenses for the same. This has been a positive step with far reaching patient benefit.
Also the Subject Expert Committee (SEC) has time and again waved a green flag for proposals of rational FDCs. “Neither the regulators nor the medical professionals will in normal course of duty ever subject any patient to any unnecessary drug intake as has been alleged, and is the misperception of the NPPA”, added Dr Sanghavi with near 40 years of experience as a practising clinician and equal period as an healthcare consultant for the pharma industry.
India has been a leader in the world regarding acceptance and introducing FDCs. Let not this momentum be reversed especially since more and more countries are introducing FDCs in hypertension, diabetes, pain management besides many other therapeutic segments. “Including private practicing doctors as external experts in the panel would surely allay fears and apprehensions of NPPA on relevant matters, including pertaining to FDCs,” he opines.