Solan: Citing adverse impact, govt bans 156 fixed dose combination drugs

Tribune News Service

Solan, August 26

The Central government has prohibited 156 fixed dose combination (FDC) drugs administered as painkillers, vitamin supplements, common cold, infections, etc, citing adverse health impact.

What are fixed dose combinations (FDCs)

• Sometimes, two or more drugs are combined in a fixed ratio into a single dosage form. Such drugs are called fixed dose combinations (FDCs). They are justified when they enhance therapeutic efficacy, reduce dose of individual drugs, decrease development of resistance and are cost effective.
• They can, however, cause problems when there is a mismatch between the two components where one drug exhibits antagonistic effect leading to reduced efficacy or enhanced toxicity. At times such drugs are also found to have chemical non-compatibility.

In a gazette notification issued on August 21, the government stated that the use of Amylase, Protease, Glucoamylase, Pectinase, Alpha Galactosidase, Lactase, Beta-Gluconase, Cellulase, Lipase, Bromelain, Xylanase, Hemicellulase, Malt diastase, Invertase, Papain may involve risk to human beings.

Lacking therapeutic justification for the ingredient contained in the FDCs, their consumption is considered risky by experts. The issue was deliberated upon by the Drugs Technical Advisory Board, the apex advisory body of the Central government, which concluded that since safer alternatives were available to these FDCs, these combinations having adverse health impact should be prohibited for use.

There are a large number of FDCs for common ailments like cough, cold, fever, analgesics, muscle relaxants, antimicrobials, hypertension, diabetes, psychiatric disorders, vitamin and minerals supplements, etc. Such formulations may have up to five or even more ingredients with or without rationality of their presence and in the specified quantity.

Commonly used drug formulations like Cetrizine HCL Paracetamol Phenylephrine HCL used for treating common cold, Azithromycin Adapalene used for acne treatment, menthol Aloe Vera topical spray used as an aftershave, Aceclofenac Paracetamol widely used for pain and inflammation has been prohibited in both tablet and liquid form, among other drugs.

Though FDCs are considered as New Drugs and its approvals were given by the Central Drugs Standard Control Organisation (CDSCO), after examination their data on safety, rationality and efficacy but many state licensing authorities had been issuing license for their manufacture in some states. This had become a cause of dispute in several states as these FDCs have a big market.

Dr Rajesh Gupta, president, Himachal Drug Manufacturers Association, said they respected the observations of the Drugs Technical Advisory Board but some time should have been granted to them to exhaust the market stock. Also, no adverse effect has been reported by commonly used FDCs for ailments like common cold, allergy, ear infection, etc. Their sudden prohibition will cause monetary loss to small and big manufacturers. Himachal manufactures 30 per cent of the 156 FDCs. The stakeholders should have been consulted before prohibiting their use.