JSA shocked at lifting of ban on 344 combination drugs

Sunit Dhawan

Tribune News Service

Rohtak, December 2

The Jan Swasthya Abhiyan (JSA), Haryana, has expressed concern and shock at the Delhi High Court verdict of lifting the ban imposed on 344 fixed dose combinations (FDCs) of drugs by the government a few months ago.

“This is a huge setback to the efforts aimed at bringing a semblance of order into the absolute anarchy that exists in India’s pharmaceutical sector,” it said in a statement issued here today.

The JSA statement points out that all 344 FDCs that were banned are irrational and there is no scientific rationale for allowing their continued use.

“Most of these are being manufactured in gross violation of regulatory procedures and should not have been allowed to be marketed in the first place. No textbook of medicine or pharmacology recommends the use of such combinations,” it maintains.

The JSA observes that the 344 FDCs constitute the proverbial tip of the iceberg and there are thousands of other FDCs that also need to be banned.

“The use of FDCs is generally discouraged except in a handful of cases, none of which are addressed by the FDCs that were banned. The World Health Organization’s Model list of Essential Medicines includes only 24 FDCs (out of 358) and India’s national list of essential medicines includes only 16 FDCs (out of 348). Yet, an estimated 40 per cent of the Indian market for drugs comprises the FDCs,” it states.

The JSA maintains that the challenge of the ban order by drug companies, including some of the largest MNCs, was a disingenuous attempt by them to preserve their profits and to profiteer at the expense of public health. “Most of these FDCs are not even registered in countries with strong regulatory systems,” it adds.

The statement further points out that the use of FDCs increase cost of medication exposes populations to a larger array of adverse effects and limits the choice of therapy as they may combine drugs with different dosage schedules.

The continued use of FDCs contributes to a big drain on the finances of individual patients. Further, some of the cough syrups in the ban order are primarily being used as addictive substances and not therapeutic agents.

The JSA has appealed to all individual physicians, associations of medical professionals and hospitals not to prescribe the FDCs and urged the government to appeal against the order lifting the ban in the apex court.