Getting the generic drug plan right
I recently posed this question to a few young doctors recently on branded generics: “Do you know what it is and how it is different from generics?” None of them could give me the correct answer, which left me astounded. For them, generics are the medications available in Jan Aushadhi centres. Most of them prescribe medications under this category all the time, yet are still unaware of the third category called branded generics. In India, many doctors rely on branded drugs due to the goodwill and trust built over the years as they ensure quality, efficacy and accessibility.
The brand producing a new molecule gets a patent to be able to have selling rights. Once a drug loses its patent protection, it can then be produced by several other drug manufacturers and is called a ‘generic’.
A generic drug is defined as a drug product that is comparable to a brand/reference-listed drug product in dosage, strength, route of administration, quality and performance characteristics and intended use. Branded generics are those that are given a unique name by their marketers to enable doctors and patients to identify a product they can trust from the ocean of numerous alternatives.
Though efforts have been made to draw the government’s attention to the substandard quality of some generic drugs floating across the country there is still no clarity on the definitions of all three categories. The confusion is not just limited to laypersons and is prevalent among doctors too, which is worrying.
There is a need to have in place stringent criteria for government agencies to ensure that there is no difference in the dose, efficacy, potency and side-effects between generics and the branded ones. The government’s decision to ask doctors to prescribe a generic name has made things complicated. How can I decide to prescribe a certain generic when I don’t know where it was manufactured?
Current regulations allow doctors to prescribe branded as well as generic drugs, but one needs to understand that generic drugs can also be produced by brands (branded generic). Hence the latest regulation needs a lot more clarity before it is rolled out. In such a scenario, if I prescribe ofloxacin for example, a consumer will go to a chemist who will give him neither the most expensive nor the cheapest one. Those are not his criteria as there are some chemists who will look to have a higher margin. This is often because chemists do not have a way to know about the differences in quality as patients do not come back and inform them about their recovery. So, who do we want to make the decision for a patient? A doctor or a chemist? The government should ensure that all pharmacies have qualified pharmacists and that basic quality is maintained for all generics produced in India. In short, there should be a sort of star-rating for quality certification, helping people to understand the quality of the generic.
There are doctors who are apprehensive about prescribing any generic medication. At the same time, I know of patients who are also reluctant to consume them because of a longer recovery time. It is never too late for the government to promote generics. As doctors, we are happy to stand by it but what we would not want is to prescribe a drug whose quality is not assured. The government’s intention to promote generics will reach its goal only if these three important factors (clarity in definition, safe quality and standardised quality certifications along with qualification of pharmacists) are considered.
Dr. Neelam Mohan is Director, Paediatric Gastroenterology and Hepatology, Institute of Digestive and Hepatobiliary Sciences, Medanta, The Medicity, NCR.
