Recently, oncologist Dr. Vincent Rajkumar expressed his shock on social media over the fact that two different drugs, treating entirely different conditions, had identical brand names — ‘Linamac’. While the drug bearing the name ‘Linamac 5’ is used to treat multiple myeloma, which is a type of cancer, the other drug bearing the name ‘Linamac’ is a drug used to treat diabetes. The consequences of confusion between these medications at the pharmacy can be serious for patients.
An old problem
The use of identical trade names for drugs with different active ingredients is an old problem in India, and the medical community has been complaining about the issue for several decades. The most popular example cited by doctors is that of the brand name Medzole, which is used by four different companies to sell four different active ingredients treating entirely different medical conditions. The first company uses ‘Medzol’ to sell a drug containing Midazolam which is used as a sedative. The second company uses the name ‘Medzole-DSR’ to sell a combination of domperidone and pantoprazole which is used to treat stomach acidity. A third company uses the name ‘Medzole 400’ for a formulation containing albendazole that is used in deworming treatment for children. A fourth company uses ‘Medzole 200’ for a formulation containing Itraconazole, which is a powerful antifungal drug used to treat diseases such as “black fungus”.
The use of identical trade names is only one part of the problem. The more wide-ranging problem is the use of similar trade names which are phonetically and visually similar. For example, while one company uses the brand ‘Medpol’ to sell paracetamol, a second company uses the brand ‘Medrol’ to sell a corticosteroid and a third company uses ‘Metrozole’ to sell an antibiotic. These names sound phonetically similar to ‘Medzole’ and also similar to each other, with only a letter or two substituted.
It is not always that different companies use identical or similar names to sell different active ingredients. Sometimes, the same company will harvest a successful brand name for one formulation to promote a second formulation. For example, the company that uses the brand name ‘I-Pill’ to sell an emergency contraceptive (ECP) containing Levonorgestrel, uses the brand name ‘i-Pill Daily’ as a daily contraceptive pill containing Levonorgestrel and Ethinylestradiol. An ECP is used after sexual intercourse to prevent fertilisation, while a daily contraceptive is used to prevent ovulation and fertilisation. These are not interchangeable, and any confusion at the pharmacy can cause unwanted pregnancies.
The use of such identical or similar names is especially worrying in a country such as India for two reasons. First, the packaging of all drugs in India bears the name and prescription advice in the English language, a language spoken by less than 10% of the population. Second, Indian pharmacies are poorly regulated. Not only do many pharmacies in India routinely dispense drugs without prescriptions, but several also do not comply with the legal requirement to operate only with trained pharmacists who are registered with the Pharmacy Council of India. These factors already increase the possibility of errors in dispensing drugs. Add to this deadly combination, identical or similar sounding brand names of drugs, and the possibility of prescription errors increases even further.
Judiciary’s recommendation
The problem of similar or identical trade names for drugs has been known for several decades. The Supreme Court of India (in Cadila Health Care Ltd. vs Cadila Pharmaceuticals Ltd., 2001) and the Parliamentary Standing Committee on Health and Family Welfare in its 59th report (2012) urged the Ministry of Health to put in place processes to prevent the use of names for drugs that are confusingly similar. After all, even the Registrar of Companies and the Office of Registrar of Newspapers for India have systems in place to ensure that no two companies or publications have identical or similar names.
Regrettably, the recommendations of the Court and Parliament were ignored by the Ministry of Health, until in 2019 when Justice Pratibha M. Singh of the Delhi High Court, a former intellectual property lawyer, hauled up the Drugs Controller General of India (DCGI) in yet another case of pharmaceutical trademark infringement that landed on her docket. Pharmaceutical companies regularly litigate against each other under trademark law in courts across India over same or similar sounding trademarks.
Under Justice Singh’s watch, the Ministry of Health brought in the Drugs and Cosmetics (Thirteenth Amendment) Rules, 2019. These rules put in place a flimsy system that required pharmaceutical companies to provide an “undertaking” to State drug controllers, along with their applications for manufacturing licences, that the brand name of the drug for which they were seeking a manufacturing licence was unlikely to cause “confusion or deception in the market”. To this end, the rules required pharmaceutical companies to carry out a search for similar names “…in trademarks registry, central database for brand name or trade name of drugs maintained by Central Drugs Standard Control Organisation [CDSCO], literature and reference books on details of drug formulations in India, and internet”.
This framework was pointless for two reasons. First, self-certification just does not work in India, as evident from the fact that many drugs in India continue to have confusingly similar names. Second, even if a company wanted to comply with the new rule, there is no database in India of all pharmaceutical brand-names. The CDSCO would first have to build such a database by collecting data from the 36 different drug controllers in each State and Union Territory.
No data in India
As a country, India has no data on prescription errors. And for the Ministry of Health, the absence of data is the absence of a problem. Once the Ministry of Health accepts that there is a problem, it can start the reform process by replicating mechanisms such as those that exist in the United States and Europe. Both jurisdictions have specific divisions within their drug regulators to examine the names of drugs on a number of factors to avoid confusion in order to minimise prescription errors. There is not an iota of political will within the Drug Regulation Section of the Ministry of Health to undertake similar reforms in India.
Dinesh Thakur and Prashant Reddy T. are the co-authors of The Truth Pill: The Myth of Drug Regulation in India (2022)
