Concerns Related to Drug Naming in India

Context: 

This editorial is based on the news “India’s problem — different drugs, identical brand names” which was published in The Hindu. This article expresses concerns over the identical name of two different drugs, treating entirely different conditions that can lead to confusion and can have  serious consequences for patients.

Drug Naming in India: 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. 
• Examples: 
• • Linamac: To treat multiple myeloma, a type of cancer, and to treat diabetes. 
  • Medzole: It is used by four different companies to treat entirely different medical conditions- as a sedative, to treat stomach acidity, as a deworming treatment for children and as a powerful antifungal drug to treat diseases such as “black fungus”.

What Are the Concerns Related to Drug Naming in India?

• Advisory in English: 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. 
• Poor Regulation: Indian pharmacies are poorly regulated. Not only do many pharmacies in India routinely dispense drugs without prescriptions. 
• Confusion and Adverse Consequences: It is not always that different companies use similar names to sell different active ingredients. Sometimes, the same company uses a successful and similar brand name for one formulation to promote a second formulation. 
  • Example: The company that uses the brand name ‘I-Pill’ to sell an emergency contraceptive (ECP), uses the brand name ‘i-Pill Daily’ as a daily contraceptive pill. 
  • An ECP is used after sexual intercourse to prevent fertilization, while a daily contraceptive is used to prevent ovulation and fertilization. These are not interchangeable, and any confusion at the pharmacy can cause unwanted pregnancies.

Various Recommendations to Restrict the Use of Such Identical or Similar Names

• The Supreme Court of India– In Cadila HealthCare Ltd. vs Cadila Pharmaceuticals Ltd., 2001.
• The Parliamentary Standing Committee on Health and Family Welfare in its 59th report (2012).
• 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

The Drugs and Cosmetics (Thirteenth Amendment) Rules, 2019

• The Ministry of Health brought a flimsy system that required pharmaceutical companies to provide an “undertaking” to State drug controllers, along with their applications for manufacturing licenses. 
• This framework was pointless for two reasons: 
• • Self-Certification: It just does not work in India, as evident from the fact that many drugs in India continue to have confusingly similar names. 
  • Lack of Database: Even if a company wanted to comply with the new rule, there is no database in India of all pharmaceutical brand-names. 
    • The Central Drugs Standard Control Organisation [CDSCO] would first have to build such a database by collecting data from the 36 different drug controllers in each State and Union Territory.

Conclusion

It is a very serious and concerning issue, which is intensified when as a country, India has no data on prescription errors. To counter this challenge India need to adopt the following measures:

• Data Collection and Maintenance: The Ministry of Health needs to take serious and strict actions to collect and maintain the data.
• Follow International Mechanisms: In the United States and Europe, 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 minimize prescription errors. 

DOWNLOAD PDF