Drug Quality, price and risk: repost

(c) Dr. Rajas Deshpande

Sir, What about the responsibility of quality of drugs used for the treatment? These are the only weapons with which we fight a disease. Does it make pharma a share holder of responsibility in case of adverse outcome ? This is another grey zone to elaborate.

Dear Dr. Sachin Jaybhaye,
Thank you for asking this question.

We must demand as doctors that we will only prescribe local medicines / stents/ catheters, needles etc., but then make it compulsory for everyone including the ministers, govt officials, the actors who comment irresponsibly etc. to only use Indian / cheap healthcare products. Let us see how many rich and famous want to use local drugs / stents / caths for themselves or their families!

We have a society so immature that it does not blame the government for allowing production and sale of low quality medicine / not guaranteeing and monitoring quality of each drug locally produced and marketed, and banning the costly drugs, but thinks that the Doctor should take responsibility of their “Multimillion Health” by prescribing cheapest drugs and tests available, produced locally without any knowledge of their quality!

There are set international standards of quality control for manufacturing of Medicines / Drugs. These apply with minor legal (but not scientific) variation to all pharmaceutical companies. Along with the major international players, there are also major/ minor Indian players in this industry. Many major international pharmaceuticals have been legally tried and punished for manipulating drug related information / bribing or compromising upon its quality: billions of dollars worth such punishments have been on record. There are no examples like this in India, which must mean, the entire industry and the government’s arms dealing with it must be absolutely innocent and honest, and all drugs produced in India must be absolutely good!

Secondly, the control over quality is not over with production of the drug. The transport, storage, sales and instructions given to the patient with each single drug also matter.. You know very well how many Indian drugs even have “readable” information printed upon them.. Leave aside the separate printout/ labels about precautions that must accompany every sale.. All this information is left for the Doctor/ Nurse / Pharmacist to tell the patient, forget the waste of time. This reduces the price of the medicine at the cost of the Doctor’s / Nurse’s time, while everyone else in this chain of sale earns their profit..

Then the after-sales feedback and documentation of serious adverse effects / ineffectiveness of each single drug marketed has to be recorded and reviewed / analysed. We all know this system does not exist in our country… there have been no cases about the drug quality at all: in fact the Doctor is automatically presumed responsible for either greed or guilt of prescribing any drug, either way! If you know the horror of real life story called “Rosche Versus Adams”, it will blow your mind to think what must be going on in a country widely infamous for corruption in all fields..

Always in shortage and underpaid, shouldering all nonmedical aspects of healthcare (which are social / govt. responsibility), the Indian doctor does not have the time / money / power / authority to monitor / report / check / complain against any medicines. If he / she does, we know what might happen. There are mighty, powerful, political, medical, corporate, international, kingmaker people who own much of pharma sector, some mafia too. Can we imagine a simple doctor will be able to fight these?

I am not accusing anyone, but these two links are enough embarrassing, and we can understand that money and power can gag almost each and everyone in India from a ministers to media, so these news will be rare.

http://articles.economictimes.indiatimes.com/…/47705608_1_d

http://www.fiercepharma.com/…/indias-quality-lap…/2014-03-18

There are some good and standard pharmaceuticals, who tell the doctors about their quality control, ask for feedback, and also update the certifications, accreditation etc… so we know they are standard. There are those whose brands have been internationally reviewed, those which are in the market for decades, with established safety. There are new ones with no data, where the only trust is about the maker’s reputation. The onus is upon the doctor to choose. I know most doctors would prefer the best for their patients, and some would consider a relative safety if price can be reduced. Honestly, no doctor can assure the quality of a given medicine, he / she has no way to assure that. But if you prefer Indian made smartphones, Indian made clothes / perfumes / cars, etc. etc., you may also rely upon Indian made drugs/ stents / catheters. The difference is then you absolve the doctor about the responsibility of what he thinks is best for the patient. I know some Indian pharma which have excellent quality of drugs, but most also have heard of frauds. Knowing this, a good doctor cannot vouch for the safety of any drug, Indian or International. The patient must make a choice.
There are umpteen examples of ineffective / low quality Tuberculosis and other drugs scandals (sold in some Govt hospitals) some years ago, but there was never any case decided against this. There were / are examples of doctors making and prescribing their own medicines, which they may know the quality of.
The effective percentage of the active ingredient, its purity, its binding with the excipients, its bioavailability after consumption, its effects on the liver / kidney, brain, eyes, heart etc are all also linked to how much and how rapidly it is absorbed and metabolized. The doses we use are all western-standardised, and we Indians have a tendency (even in Medicine) to presume that those biostats will exactly apply to our population, irrespective of genetic / ethnic/ cultural (food) differences.

A drug may kill (either by its action or inaction) if its quality is not accurate, and this “quality” NO doctor knows. Doctors can only go by their own experience about that particular drug and the company that makes it. So if the patient insists upon buying a certain medicine brand produced in a certain country, it is his / her prerogative and responsibility.

We call many things “ Chinese” and usually mean it as a cheaper / “no guarantee” quality.. We cannot blame if some western / other countries felt same about Indian made medicines, even after the racist / competitive aspect is excluded. Pharma industry has good and bad in ALL countries, including India. The only difference is that we know the levels at which corruption works in our country : Every!

It is easy for filmstars who shoot outside India, drive foreign cars, endorse foreign brands, wear foreign clothes and run to foreign countries for every health issue to cry on national TV and urge everyone to use :Generic” / local drugs. It’s not their life, and if something happens there’s always the Indian Doctor to blame!
We must demand as doctors that we will only prescribe local medicines / stents/ catheters, needles etc., but then make it compulsory for everyone including the ministers, govt officials, the actors who comment irresponsibly etc. to only use Indian / cheap healthcare products. Let us see how many rich and famous want to use local drugs / stents / caths for themselves!

© Rajas Deshpande

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