Sirf Ek Saridon? Understanding Fixed-Dose Combination Drugs
A formulation consisting of two or more drugs in specified doses is what is called as fixed-dose combination.
A formulation consisting of two or more drugs in specified doses is what is called as fixed-dose combination. (Photo: iStockphoto)

Sirf Ek Saridon? Understanding Fixed-Dose Combination Drugs

The other day in the clinic, one of my patients was a little perplexed. The obvious question was that when the Ministry of Health finds particular drug combinations irrational and bans them, then why within no time the Supreme Court stays that decision for some of these?

Does the combination become rational overnight? Very obviously there is disparity between what the government thinks and what the court orders, he said. I explained to him that the court has granted an interim stay pending the final disposal of the application and it is only on technical grounds that the ban has been stayed. This issue of banning FDCs is hanging afire for several years now.

The discussion then veered to understand the issue better.

Also Read : Centre Bans Saridon and 327 Other Combination Drugs

What is FDC?

A formulation consisting of two or more drugs in specified doses is called fixed-dose combination. According to an estimate, India has around 2,000 such combinations where as the United States has around 500.

What is the Need for FDC?

When multiple drugs are supposed to be taken by a patient, compliance becomes a big issue.
When multiple drugs are supposed to be taken by a patient, compliance becomes a big issue.
(Photo: iStockphoto)

When multiple drugs are supposed to be taken by a patient, compliance becomes a big issue. So that the patient does not have to take several pills at a time or during the day, two or more drugs are put in one pill and the patient can take it easily.

There are some drugs which are combined to counter or prevent the side effect of the other. For example, a component maybe added in the formulation containing a painkiller, to protect the lining of the stomach from injury.

Similarly, the drugs may be combined to potentiate the effect of each other. Further, various components of the FDC maybe acting on the same organ through different mechanisms and have a better effect. For example, common formulations for pain in the abdomen contain an antispasmodic and a painkiller and possibly an anti acid to prevent ‘acidity’.

In some cases, the cost of the formulation would be less than the individual components sold separately.

Also the FDC can be branded, by a company promising a good quality product and the formulation by particular brand name becomes reputed.

Why Does the Government Object?

Major objections of the DTAB (Drug Technical Advisory Board) through the Ministry of Health is that several combinations have come up where the combination itself is irrational with no added therapeutic value. In some cases, it has been found that there are drug interactions among the various components eventually rendering FDC not only ineffective, but also capable of causing side effects.

Some drug manufacturers brought FDC’s just to skirt the licensing issues imposed by the central government.
Some drug manufacturers brought FDC’s just to skirt the licensing issues imposed by the central government.
(Photo: iStockphoto)

Some drug manufacturers brought FDC’s just to skirt the licensing issues imposed by the central government.

What the drug manufacturers need to particularly take care of is that the components in a fixed-dose combination should have at least the same onset and duration of action. In some cases, it can be overcome by using technology for the drug delivery which makes a particular component, sustained release.

Many a time it happens that because of popularity of a brand of FDC, people continue to take it even when only one or the other component of that FDC is needed. This not only is detrimental to the health of the patient, but also costs more. And this problem emanates from the fact that India is probably one of the very few countries where anything and everything is available over the counter without prescription. Otherwise, a doctor would prescribe only what is needed and for the duration it needs to be used. Drug manufacturers and marketers take undue advantage of this fact and push these FDC’s for sale over the counter.

But for now, fifteen fixed-dose combination drugs (FDCs), including cough syrups Phensedyl and Tixylix and Saridon, will not be banned which may come as a relief, howsoever short lived, to those who have gotten used to these.

Barring a few, the other combinations can be done away with and ideally prescribed and taken seperately.

(Dr Ashwini Setya is a Gastroenterologist and Programme Director in Delhi’s Max Super Speciality Hospital. His endeavor is to help people lead a healthy life without medication. He can be reached at ashwini.setya@gmail.com)

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