Friday, 18 April 2014

Should doctors prescribe only generic drugs by Dr. Ambrish Mithal, Chairman & HOD Diabetes & Endocrinology. Medanta The Medicity. (Disclaimer: Hospital Guide Foundation provides a neutral platform for Patients/attendants & Doctors to express their opinions/experiences. These views are of the writer.)

The issue of generic vs patented drugs has been featured in the media repeatedly of late. It has been made to sound by many (including Mr Aamir Khan) as if patented drugs are prescribed by doctors only because of the perceived doctor-multinational nexus, and one should only use or prescribe generics! I wish to make a few points in this regard..

A generic drug (generic drugs, short: generics) is a drug defined as "a drug product that is comparable to brand/reference listed drug product in dosage form, strength, route of administration, quality and performance characteristics, and intended use.” It has also been defined as a term referring to any drug marketed under its chemical name without advertising. If there were no original molecules, there would be no generics!!

The original formulation is what is sold as a branded drug. Drug companies and scientists spend billions of dollars and 15-20 years to develop a molecule from bench to bedside. It is a laborious often frustrating task. These companies then have a right for a few years- (practically 10-12 years) to manufacture and sell that drug exclusively, during which time they recover their investment and make profits. Subsequently the drug can be made by any company, which substantially lowers the cost since their no cost in R & D at this stage. The key point here is the regulations regarding generics- there has to be strict quality control- in the US according to USFDA guidelines. This ensures that the generic is not only cheap, making it more accessible, but also of the same quality as the original. This is big challenge in a country like India, for reasons that we all know. Even our top companies have been found wanting by the FDA in this regard from time to time.

In India, because of different regulations, there is a third category- 'branded generics'. These are generics made by Indian firms, some of which are reputed and have international standing. So they are are sold by different names. The same drug can be available as numerous (sometimes >50!!) brands. One expects that the 'better' Indian companies (again a question of reputation- no objective criteria) would have strict quality control and ensure better formulations. There is huge variation in the price of 'branded generics'. They cost less than the original molecule, but more than the 'unbranded' generic preparations.

How should a doctor choose a drug? Let us presume for a moment that doctors actually want their patients to respond and recover. (Yes, that is true, despite what the current environment may lead us to think!!). One option is to go with the original, branded drug. There is a wealth of data behind that drug, backed by years of research, and numerous clinical trials. This leads to a certain confidence that your patient is receiving what you are prescribing. Cost, however can be a limiting factor. One could therefore choose to go with a branded generic- again from a reputed Indian company (subjective!!)-- the cost will be less, and one is more or less assured about the quality. The third option is to go for cheapest generics- either from lesser known companies or ones with no brand at all- just the chemical name. Great, and politically correct, except that it is based on the presumption that our regulatory authorities ensure quality control. 

It is big challenge in India to ensure quality control. We are still grappling with fake/spurious drugs, so there is no way we can ensure quality of generics at present. To be safe, doctors tend to prescribe either brands or branded generics. If the regulatory authorities are able to ensure that, like the US or UK, our generics are as good as the brands, doctors will have no hesitation in prescribing only generics. After all 'branded generics' do rule the roost in India- they are much cheaper than the original brands but the doctor has faith that reputed Indian companies will supply quality drugs. This is attributed to faith in the Indian 'brand', not to our regulatory authorities. It therefore becomes a matter of subjectivity and perception rather than quality control.

It is not unusual for us to have high ranking government and army officials request prescriptions for brands we trust, rather than the ones available to them through their sarkari sources. Often they themselves don't trust their supplies. On the other hand the affluent often want the original brand, not generic brands. It is difficult for doctors to figure out the patient's perception. I remember on old lady who visited me several years ago for her osteoporosis – I chose a particular injection for her. The original brand, which is the only one I had used till then- was quite expensive by Indian standards, and branded generics from leading Indian companies had just become available at half the cost. After some deliberation and discussion I chose to go with the Indian brand. By the evening I got a call from her aggressive sounding son from New York, as to why I was choosing cheap local brands for his mother. His words were "I do not expect a leading doctor like to you to prescribe local stuff- wonder why you did so.? " On the other hand, I prescribed the original brand to a very wealthy, leading lawyer, who called me back to say- "I found out that this drug is available for much lower cost under a different name- I did not expect you to put me on such expensive medication if alternatives are available.."..

And then there are those, where the cost really matters- one just goes for a reasonably priced branded generic for them. You will agree it is difficult to constantly figure out for a doctor which BRAND to prescribe, rather than which DRUG to prescribe. It is very subjective and you can't keep everyone happy. One can't truly figure out the quality of all branded generics, and there is no way to keep track of the prices...If the doctor was to prescribe by the actual chemical/generic name, it would give the chemist a free hand to dispense whatever he feels like. Is that preferable to the doctor choosing the drug for you??

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