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THE PHARMA REVIEW (JULY – AUGUST 2016)

Menace of Irrational Fixed Dose Combinations in India

Vinuth Chikkamath & Anantha Naik Nagappa

Introduction: Fixed dose combinations (FDCs) have recently been in news. In March 2016, the Government of India (GOI) banned (order number DCGI/MISC/2016 32) 344 FDCs. It was initiated by GOI in public interest due to safety, drug abuse, potential public health and fictitious claims of benefits1. FDCs were declared and considered as irrational, as pharmacological activity claimed leading to therapeutic utility was hypothetical and has not been supported with clinical trials or observational clinical evidences. For example, FDC with Nimesulide, a Cox-2 inhibitor used for symptomatic relief of pain and anti-inflammation in rheumatic arthritis has been a popular and abused prescription drug, leading to self medication. Nimesulide is known to be Nephro toxic and Cardio toxic, was withdrawn and banned in most countries over the last decade. In India, Nimesulide is classified as a schedule H and J drug and therefore should require a prescription by registered medical practitioner, dental practitioner, nurse and along with registered veterinary physicians. However, due to India’s inadequate regulatory control mechanisms, Nimesulide is sold even without a prescription. There are numerous brands of Nimesulide with FDCs which are sold all across the country2. Given the callous attitude of the regulatory bodies and the public’s increasing demand for instant pain relievers, the drug is sold like hot cakes by the pharmacies and drug stores who virtually sell everything over-the-counter (OTC). The entire regulatory system of the country has failed in combating the free accessibility of schedule H and J drugs. The illegal sale of schedule H1 (prescription medicines) and other drugs is a major imputes for self medication. Self medication practices have sprouted based on misbelieves and myths regarding safety3. 

 

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