Saturday, April 29, 2017

IMA gets into semantics to beat code on generic drugs

Prime Minister Narendra Modi's resolve to ensure that doctors prescribe only generic medicines is being undone by some creative interpretation of the Medical Council of India's (MCI's) "code" for doctors, which ostensibly makes it mandatory to prescribe using generic names. Reacting to the MCI injunction that doctors should prescribe generic drugs, the Indian Medical Association (IMA) said "should means may and may means optional or preferable".

Meanwhile, doctors demanded that the PM ban companies from manufacturing any generic medicine with a trade name and ensure they produced only high-quality generics. Though the PM said he would bring a legal framework to prescribe generics, there is as yet no new law, either for the pharma industry or for doctors and chemists.

All that has happened after his announcement is that MCI has issued a notification reiterating an existing clause in its code of ethics regulations. The clause, which had earlier stated that "every physician should, as far as possible, prescribe drugs with generic names" was amended in October 2016 to "every physician should prescribe drugs with generic names", indicating the intention to make it mandatory. However, the IMA has pounced on the fact that the letter of the clause uses "should" instead of "shall" to argue that it is not mandatory. IMA president K K Aggarwal's statement on the issue further pointed out that the clause did not say doctors can prescribe "only" with generic names. So, IMA has advised doctors that they can write the generic name and add the name of the company that manufactures the drug.

"Nobody can stop you choosing the company for quality assurance," said the IMA statement. IMA advised doctors to choose drugs from the National List of Essential Medicines (NLEM) as they are cheaper and of assured quality. "When writing non-NLEM, take consent. When prescribing, write the cheapest available medicine and that will always be the generic version of that company," advised IMA.

The All India Drug Action Network (AIDAN), a civil society group working on drug pricing and accessibility, issued a statement pointing out that the proposal to make prescribing generics mandatory for doctors would be a useless, counterproductive step as a standalone measure. "This is because in India no manufacturer markets medicines in the retail market under generic names and hence medicines are not available under generic names in the Indian retail pharmacy shops," it pointed out.

AIDAN said that unless manufacturers (except those who are marketing medicines still under patent protection) are made to market medicines under generic names for the retail market, consumers would not get the benefit of "generic medicines".

Can doctors be forced to prescribe generic medicines? Is it advisable?
I'll mention two very frequently used medicines.
Saridon, which is a combination of three drugs Paracetamol, Caffeine, & Propylphenazone.

It is made by two companies whose respective price per tablet is shown in brackets.
Abbot Healthcare Pvt Ltd (Rs 1.82) & Libra Drugs( Rs 1.50)

Let us take another medicine, Ecospirin which consists of Aspirin & whose generic name is Acetyl Salicylic Acid.
This is made by 24 companies and their price varies from Rs 0.18 (Cosme Farma Laboratories) and Rs 4.50 (Torrent Pharmaceuticals) - 25 times higher.

Do you expect a doctor to write Paracetamol, Caffeine, & Propylphenazone or Acetyl Salicylic Acid.

Further most chemists will not stock the medicines of all 24 companies in the second case for the consumer to make his selection.

I have been using the site for getting alternate medicines to what the doctor prescribes.

For my cholesterol I was prescribed Rozucor ASP kit made by Torrent Pharma which was priced at Rs 11.80 per capsule. The active ingredients in this are Aspirin 75 mg & Rosuvastatin 10 mg 
On checking up with the site I found that there were two other companies, Unichem (Unistar 10+75 for  Rs 4.90 each ) and Innovative Pharma Rs (Rosutop A for Rs 13.50 each).
Since Unichem is an equally famous company as Torrent, I switched over to Unistar 10+75, without consulting the doctor and have been using it for the last three years.
During one of my recent visits to my doctor, when I informed him that I was taking Unistar 10+75, he advised that I should go back to Rozucor ASP kit, but I have not.
Doctors are given incentives to promote specific brands.

Plain Rozucor 10 (Rosuvastatin) is made by Torrent Pharmaceuticals costs Rs 11.80 each

This is made by 63 companies and the price varies from Rs 0.90 each  (Healthcare Lifesciences) to Rs 30.00 each (Dr Reddy Laboratories)
Now what could be the reason for such a large price difference?

For one, since Dr. Reddy exports their products to the US market and the USFDA have very stringent quality requirements and if the company does not meet those requirement, an adverse note from USFDA may tank the price of the shares by as much as 50 % as we have seen lately. Good companies like Dr. Reddy, Divis Lab, Aurobindo Pharma and Lupin have tanked because of remarks from USFDA.

Companies which do not export to USA and European countries have no such fears and do not have to maintain quality and can keep their prices low.
Hence, making a law to use generic is not going to help unless you make all the companies meet certain minimum standards. 

Do we have the necessary infrastructure in place to inspect the plants of the thousands of drug manufacturers in India and issue then certificates from HONEST inspectors?

Unless you have, you are just fooling the public with another Jhumla.
Instead, it would be more beneficial if they stopped the unwanted tests conducted on patients and the kickback the doctors received from the tests.
Further, keeping of dead patients under the Ventilator just to increase the patient's bills which the relatives have to cough up before taking back the body is another dastardly act which these hospitals are doing regularly.


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