“The doctor asked me to get the medicine prescribed here and not what you have given,” said a customer at a medical store adjacent to Hyderabad’s Nizam’s Institute of Medical Sciences (NIMS) on Wednesday. At the heart of the conversation was the issue of generic drugs and branded drugs. The mix-up involved Itragee-100 Itraconazole capsules instead of the prescribed Candiforce-200 tablet, both of which share the same chemical composition for treating fungal infections but belong to different brands.
While such occurrences are not uncommon for those who frequent medical shops, a potential change is on the horizon. Medical professionals express varying opinions with the new guidelines released by the National Medical Commission (NMC) on August 3 emphasising that all Registered Medical Practitioners (RMPs) must prescribe medications using generic names in a legible and clear manner. Some doctors believe the power balance will shift from physicians to pharmacists.
The guidelines further underscore the importance of rational drug prescription, discouraging the unnecessary use of medications and irrational combinations of fixed-dose tablets. To ensure transparency and accuracy, prescriptions provided by RMPs and medications dispensed by pharmacies should explicitly state the drug’s generic name, according to the NMC directive. The rationale behind these directives, according to the NMC, is to reduce healthcare costs for the population by advocating the use of generic drugs, which are often 30 to 80% cheaper than branded counterparts.
However, the Indian Medical Association (IMA) said the notification is unfair. “It is an injustice to doctors who always hold the interest of their patients as non-negotiable,” said a statement issued by IMA in Delhi.
The owner of the medical shop noted that his establishment operates along the main road, incurring substantial rent costs. He pointed out that if the option arose to provide medicines based on generic names, the shop might prioritise providing those with higher profit margins. Branded medicines yield a 20% margin, while generics could offer margins of 30 to 40%. Despite the financial aspect, both types maintain the same chemical composition and quality, the owner added.
The customer, who regularly purchases medication for his father, mentioned that shifting to generic medicines in recent months has significantly reduced his expenses. Formerly spending ₹5,000 monthly, his costs have come down to ₹2,000.
While generic medicines are not opposed, concerns over their bioavailability, efficacy, and overall effectiveness in treating diseases remain. President of the Indian Medical Association’s Telangana State chapter B.N. Rao emphasised that beyond cost, the potential side effects of generics must be considered. He also voiced concerns about the lack of accountability associated with these medications.
Dr.Rao added that instead of asking doctors to prescribe generic drugs, the government should try to reduce the price of branded drugs by reducing taxes and providing infrastructure at a lower cost.
A generic drug is defined as a drug that is comparable to brand/reference listed product in dosage form, strength, route of administration, quality and performance characteristics, and intended use. A branded generic drug is one which has come off patent and is manufactured by drug companies and sold under different brand names. These drugs may be less costly than the branded patent version but costlier than the bulk-manufactured generic version of the drug. There is less regulatory control over the prices of these branded generic drugs.
The NMC’s guidelines also encourage patients to purchase drugs from Jan Aushadhi Kendras and other generic pharmacy outlets, while advising against branded generic medicines. In Telangana, 67 such shops have been established in the past three years.
“When we are dealing with human lives, the NMC should properly provide guidelines rather than putting blanket conditions. Generic medicines are definitely good but only in certain conditions. With systemic diseases, they can be given on a trial-and-error basis but with serious ailments, there should be no compromise at all. Maintaining quality is much more important than controlling the price,” said IMA-Telangana Scientific Committee convenor Kiran Madala.
In response to a query in the Lok Sabha on August 11, the Ministry of Chemicals and Fertilizers conveyed that India’s pharmaceutical industry ranks third globally in terms of volume and 13th in terms of value. The country’s prowess is evidenced by the production of over 60,000 generic drugs across 60 therapeutic categories.
