With the PM’s recent hinting about making generic drugs prescription compulsory for all doctors in near future, I thought of doing a small primer for our Indian readers today, to shed some light on what exactly generic drugs are, and what are the pros / cons of using them.
Branded vs. Generic drugs
What do they mean?
Whenever a drug is approved for use by regulators, it first has to pass a very stringent and lengthy 3 or 4 stage testing process to gain approval, that costs a fortune to the company making that drug. This is called the NDA (New Drug Approval) route in Pharma regulations. ‘Branded’ drugs, in pharma jargon, are those which have taken the NDA route, and so have a better reliability but cost a lot.
On the other hand, once a drug molecule is gotten approved by one company through NDA route, there is an option for other companies to get the license for that drug through ANDA (Abbreviated NDA) route. In this, they only have to prove ‘bio-equivalence’ of their product, with an existing NDA complaint branded drug taken as benchmark. This saves them the huge costs of NDA testing, so that the cost benefit can be passed on to the customer. These ANDA drugs are called ‘Generic’ drugs in common parlance.
Why the terms are misnomers
Both these common parlance terms are technically flawed, since branded drugs too, have the same generic name as generic drugs; and generic drugs too are almost always having a separate brand name of their own. In my opinion, they should better be called NDA and ANDA drugs for clarity’s sake, which the real distinguishing factor.
Pros of Generic drugs
In a country like India, where affordability is the prime bottleneck for most patients, generic drugs have these major advantages.
- Much cheaper on cost due to the reduced R&D / Testing expenses.
- Create market competition by allowing smaller manufacturers to enter the market by the easier, cheaper and faster way.
Cons of generic drugs
Why there is apprehension amongst doctors about the quality of ANDA drugs has two reasons.
- ANDA drugs are allowed an upto 20% variations in some key efficacy parameters by FDA in bio-equivalence testing. This effectively means that a generic drug may be up to 20% less efficacious than the benchmark branded counterpart, and still be approved by FDA as a substitute. This margin, it is believed in practice, can prove sufficient to impact the treatment outcomes in a number of cases, though government regulators don’t think so.
- Open availability and reliability of clinical testing data of drugs has already had a dubious reputation in the past. Some doctors fear that pushing for generic drugs may create further chaos in the picture, with pharma companies doing anything under the sun to falsify each others’ claims. It is largely a sentiment in the medical community that there isn’t sufficient regulatory watch and control over the R&D in pharma, making doctors feel doubtful in deciding over the choice of drugs.
While making generic drugs compulsory can prove a welcome populist move, care needs to be taken to enforce stricter quality and transparency standards for these drugs, as well as the whole pharma industry in general.
So that was the short primer about generic drugs that everyone should know. Do feel free to ask any further questions in the comment box below.
Stay Healthy, stay Happy!
About the Author –
Dr. Harshad Rajandekar is a practising general physician based out of Nasik, India. He holds a BAMS degree from the Maharashtra University of Health Sciences, and is licensed to practise Ayurvedic and modern systems of medicine in the state of Maharashtra.
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