Issue:
- India has the problem of identical brand names being used for different drugs to treat different medical conditions. This issue has been a concern for the medical community for many years. E.g.,
- Two different drugs had identical brand names — ‘Linamac’.
- ‘Linamac 5’ is used to treat multiple myeloma (a type of cancer), the other drug bearing the name ‘Linamac’ is used to treat diabetes.
- The problem is not limited to identical names but also extends to similar names that are phonetically and visually similar to each other. E.g.,
- ‘Medzol’ is a drug used as a sedative.
- ‘Medpol’ is a brand that sells paracetamol.
- ‘Medrol’ to sell a corticosteroid.
- ‘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.
Concerns:
- Potential risk to patients: The use of such identical or similar names can lead to confusion and potential harm for patients in India for two reasons.
- 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.
- 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 increase the possibility of errors in dispensing drugs. Hence, identical or similar sounding brand names of drugs, and the possibility of prescription errors increases even further.
- Lackadaisical approach by MoH:
- The Supreme Court of India (2001) and the Parliamentary Standing Committee on Health and Family Welfare in its 59th report (2012) urged the Ministry of Health (MoH) to put in place processes to prevent the use of names for drugs that are confusingly similar.
- 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.
However, the recommendations of the Court and Parliament have largely been ignored by the Ministry of Health.
- Lack of database of pharmaceutical brand-names: The Ministry of Health brought in the Drugs and Cosmetics (Thirteenth Amendment) Rules, 2019.
- These rules require 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”.
- 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.
However, this framework of self-certification did not help as 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.
Further, India has no data on prescription errors. Only after maintaining such a database, the Ministry of Health can start the reform process by replicating mechanisms of regulation such as those that exist in the United States and Europe, to avoid confusion and minimize prescription errors.