Curious case of drug branding in India

The Wall Street Journal recently carried an article: ‘What Covid Vaccine did you get? You probably don’t know its name.’ If you did not know that Pfizer’s Covid-19 vaccine is called ‘Comirnaty’ and Moderna’s is called ‘Spikevax’, you are not alone. The article points out that despite a year of continuous coverage and debate over these vaccines, their trademarks are far from well-known. It takes around two years to settle on a name of a medication in the USA due to stringent naming requirements of the US Food and Drug Administration (FDA).

The aim is to make sure the names of medicines are distinct and patients use the right prescription drugs. Regulatory requirements even impose handwriting tests to ensure that names are not confusing. As reported, machine learning-based computer models are used to make sure a name is at least 70% dissimilar to other names. The process is complicated and time-consuming since thousands of names are screened at a time.

This article brings back to light an old but serious issue in India: pharmaceutical branding. The regulatory regime in India stands in contrast to the regime in the US. Brand names of Covid-19 vaccines such as Covishield and Covaxin are widely known. Even Baba Ramdev’s Coronil’ tablet is well-known.

The relaxed regulatory regime in India allows pharmaceutical companies to launch their ‘brands’ in the market quickly. However, the brands that are launched are not always unique and can cause serious confusion in the market.

This problem has plagued the Indian pharma market for years. Patients, doctors, pharmacists and everyone in the chain can easily be confused by medicines that have similar names. For example, an antifungal medicine was named almost similar to medicine for treating hypertension. An anti-hypertension drug and an antipsychotic drug were also named similarly. Your doctor or local pharmacist will surely be able to give you more such examples.

Obviously, confusion between medicines that cure different ailments can have disastrous effects! Unlike most other consumer goods where confusion may lead to mere inconvenience, confusion with respect to pharmaceuticals can lead to serious health consequences.

Unlike the US, the approval process for trade/ brand names of medicines remains largely unregulated in India. The Indian Trade Marks Registry mainly oversees this process. According to the annual reports of the Indian Trade Marks Office, pharmaceutical trademarks are the single largest category of registered trademarks. As it so happens, pharmaceutical trademarks are often very similar. The Trade Marks Registry is barely equipped to examine and approve names of medicines. Trademarks are handed out without considering things like therapeutic class or disease that the medicine seeks to treat. The process adopted is random and unscientific.

Similar-sounding pre-fixes and suffixes that contribute to the confusion are commonly used and accepted for registration. There are neither requirements of dissimilarity to other brand names nor handwriting tests. Thus, look-alike and sound-alike brand names continue to threaten patients.

While the Supreme Court has directed the Trade Marks Registry to adopt stricter standards, regulatory changes have not been forthcoming. In addition to the trademark registration process (which in itself is not mandatory), the Indian regulatory regime only requires pharmaceutical companies to self-certify that the names of their medicines are not similar to others.

As pointed out in a letter, with comments on the existing regulatory set-up, by the Citizens for Affordable, Safe and Effective Medicine (CASEM), in most jurisdictions, regulators have to approve the trade name of a drug since confusing drug names are seen as a threat to patients.

Obviously, a self-certification mechanism is suspect and does not carry the same weight as an independent regulatory process. Another regulatory attempt to address this problem was made in 2016 by the Medical Council of India (MCI). The MCI directed doctors to prescribe medication using the medication’s scientific /non-proprietary name (that is accepted the world over) rather than its brand /proprietary name in the written prescription.

This was thought to reduce the chances of confusion in dispensing medicines. As studies show, this attempt has not been very successful for various reasons — enforcing this requirement is not straightforward. Non-proprietary names are complicated, patients lack confidence in names they cannot understand.

There is, therefore, a serious need to reconsider name approval processes for medicines in India because settling for a medicine’s name is a little more than rearranging Scrabble tiles.

(The writer is a lawyer based in Bengaluru)