Generic vs patented drugs: a story of trust deficit

A conversation with a medical doctor last week re-kindled a debate that refuses to die down. At a dinner party the doctor argued that patented drugs are better than generics. This sounded patently off-the-mark to me. When questioned on the logic of his argument, he got peeved. This theme is not a new one Last year, even the government got into it. An advisory was issued by the Ministry of Health and Family Welfare last year mandating that doctors include names of generic medicines too in their prescriptions. The order was withdrawn within 21 days after massive protests from doctors.

How do those outside the medical fraternity make sense of it? Listening to Dr Vijay Hulikal, chairman of the Bengaluru-based Bioorganic and Applied Materials, offers much perspective.

Consider Dolo 650, a well-known brand of paracetamol. Now, paracetamol is a pain reliever and fever reducer found in almost every household. You could walk into any pharmacy and find several generic versions of paracetamol, each containing the same active ingredient that makes the drug effective. However, Dolo 650 is now a household name—not because it is chemically different, but because of the significant marketing effort that has gone into it. Advertising campaigns, doctor recommendations, and the sheer power of brand recognition have made Dolo 650 a go-to choice for many, despite the availability of cheaper, equally effective generic alternatives.

Once upon a time, Dr Hulikal led a drug discovery team at the global pharma major Astra Zeneca. It is difficult then to ignore what he says. He goes on to make the case that this is emblematic of the broader discussion around patented versus generic drugs. When a pharmaceutical company develops a new drug, it invests years of research and billions of dollars into its creation, testing, and perfection. The drug is then patented, giving the company exclusive rights to produce and sell it for a set period. During this time, the company can set a high price to recoup its investment and fund future innovations. The production of these drugs is tightly controlled, and rigorous quality checks are put in place to maintain efficacy and safety. For consumers, this often translates into a sense of confidence—they believe they are getting a product that has been crafted with the utmost care.

When the patent expires, the original blueprint becomes available for other manufacturers to produce generic versions. These generics are chemically identical to the original, containing the same active pharmaceutical ingredient (API). It’s akin to other companies producing a smartphone with the same specifications as the original model, but without the brand’s premium label. Despite the identical core, the price difference can be significant because generic manufacturers do not have to bear the same research and development costs.

Dr Samit Chakrabarty, a neuroscientist at the University of Leeds at Cambridge, argues that if the molecule—the core of the drug—is identical, the therapeutic effect should be the same. This view is reinforced by studies showing that generics must meet the same rigorous standards set by regulatory authorities like the FDA, ensuring that they are just as safe and effective as their branded counterparts.

When asked if they endorse the advisory by the government, the answer begins to get nuanced. “It depends,” says Dr Chakraborty. “In most cases, I’ll go with the generic version.”

But this makes Dr Sangeeta Rawat, a neurologist and Dean of Seth GS Medical College & KEM Hospital, uncomfortable. “I am okay with prescribing the generic versions of some drugs. But there are many companies where we don’t know their manufacturing conditions, their drug content, or if they are following standardization protocols.”

That said, a blanket ban on generic drugs by all doctors is unacceptable as well when there is research that shows they offer the same therapeutic benefits at a fraction of the cost. This affordability can be a lifeline in resource-limited settings. In this complex interplay of cost, access, and clinical effectiveness, informed decision-making is key, both patented and generic drugs have their place in healthcare. Understanding the story behind the drugs we take empowers us to make informed choices—whether it’s reaching for Dolo 650 or its generic equivalent.