Wednesday, March 16, 2016

Fixed Doze Combination Drug Ban in India: An Unbiased Analysis!

In a surprise move on 10th March 2016, the central government of India has banned about 340 combinations of orally consumed drugs produced and marketed by modern pharma companies in India for various ailments such as cough, allergy, fever, cold, influenza, etc.(See this report) Many of these so called medicines have been in common use for quite some years and have been used by the common folks as over the counter (OTC) medicines without the prescriptions by any medical doctor.

The following gives the list of the banned  combinations- also called fixed dose combination (FDC) drugs - of medicines that are banned in accordance with the powers entrusted with the government under section 26A of the Drugs and Cosmetics Act 1940 and the Drug Rules 1945 of India:


 

  

  

I do not know whether this sudden action by the government is the right initiative or not. Apparently, the government has done this to safeguard the citizens health. However, all industry experts and users may not agree to this (Click here to read this!). I too am of the same opinion, as governmental decisions are mostly seen as governed by political or extraneous considerations and not always based on well informed and logical reasoning! (Also read my earlier blog on 'the politics and strategy of bans') 

The India government combination drug ban is estimated to cause the immediate disappearance of nearly 1500 popular prescription and over the counter English medicines from the medical shops across the length and breadth of India which is likely to cause much difficulties for the patients, doctors, the drug retail shops and the pharmaceutical companies. The problem would have been less severe, had the government did this in a planned manner with due diligence and planning!

The following are some of the very common medicine brands that would disappear:

Anti diabetic drugs : Tribet, Gemer P, Gluconorm, Triexer
Cough syrups : Phensedyl, Tossex, Ascoril, Zedex
Fever, cold, pain relief: Sumo, Vicks Action 500, Zerodol-P

There are hundreds of others for other kinds of ailments!

The governmental action is reportedly on the basis of several research studies which suggest possible adverse effects of using such fixed combinations of more than one drug. However, all these research findings are debatable issues as there are other research studies which support alternative views.

The authorities have been telling the pharma companies and the medical community not to use brand names while prescribing medicines. Instead, they were advised to use the original chemical name (generic name). However, the pharma companies and the medical doctors have just ignored these guidelines for quite some time now.

The pharma companies have been making huge profits from the medicine business. Most of the medicine suppliers are not original manufacturers of the basic drug. Many of them import or buy the basic medicine in bulk fro original drug producers from India or abroad and convert it into very small tablets, capsules, injectables, oral syrups, etc containing few milligrams of the original drug and market those in various kinds of fancy trade names. 

The sales representatives of these pharma companies, called the medical representatives, go to the hospitals and the medical doctors and educate them about the method of use of these so that the doctors remember these names to prescribe them to the needy patients. There exists an unholy nexus in this business and this is known to all concerned. The companies have devised their own systems wherein the prescribing doctors and the medical shops get good rewards when a particular brand of medicine gives good sales returns to the company.

There is nothing very surprising in this. Doctors, hospital managements, the medical shop owners and the pharma company people are all humans and they are all in this business for making some profits or earning a livelihood. 

But the markets operate in a competitive environment. The government allows so many drug makers to start business and operate. They simply cannot exist, unless they make profits. So they too are compelled to device marketing techniques of various kinds.

Fixed combination drugs are essentially a kind of marketing technique. In this method, more than one drug combination allow the pharma company to market a drug combination product under a brand name different from that of its competitors and reap better benefits and returns commensurate with its own marketing efforts.

While the law of the land has been in existence for decades, the drug enforcement authorities have never been publicly against any pharma company as the pharma companies know pretty well how to take care of the statutory authorities. It has been a win-win situation for every one. Even the poor patients too benefited to some extent as many had the choice of buying the medicines over the counter without actually being in the crowded lines in front of the hospitals and the medical doctors for small ailments like cough and cold that is so common. Their experience with the drugs have been better than many of the doctors!

And India is no USA, Canada or the European Union. In the latter, the prime responsibility of the citizens' health vests with the government and the government and the medical systems reportedly work pretty well unlike in India.

So India has been different so far and we call it as the Indian way of working. Even the foreign companies understood how to work in India. They work differently in India as compared to their own mother nations. So they make and market drug combinations that they do not make and sell in their own countries.

When we consider all these, the sudden ban of the combination drugs looks a bit absurd and perhaps even motivated with agendas other than citizens' health. What will happen when all these common remedies vanish from the medical shops? What will the common man do? Rush to the already overcrowded hospitals for seeking alternatives? Will our doctors be competent to prescribe non-combination alternative medicines to manage an ailment in such a short notice? We should consider the fact that they have been in the practice of remembering mostly trade names of common combination drugs!

Will this cause a sudden shortage of all kinds of life saving drugs and medicines when the pharma companies retaliate with their own methods?

Muhammad-bin-tugluq thought of many good things to give better administration to his people of his time. But all those good ideas became miseries for the people and this ruler has never been admired for his good ideas and deeds!

Is the present government doing such a thing by the many bans that it has initiated in the name of good governance?

Only time will tell!  

9 comments:

  1. I need to give you a chance to understand that Please continue posting since this is astonishing post you shared.

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  2. Thank you for the Information, some of the drugs are being suspended effectively is a good thing. Instead of just suspending the drugs it should be banned completely by the regulators. We can't take risk on human lives. An popular drug was banned recently and not suspended. I have added the link to that issue below. Popular drug banned Recently by the Indian health ministry

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  3. Really thankful for this information, but I think banning anything is not solution we can find the substitutes in http://tinyurl.com/hv4hbb8 and also modify the medicines.

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  8. Hi,

    Thank you for the Information, some of the drugs are being suspended effectively is a good thing.



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