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Source: The post issues related to naming of drugs in India has been created, based on the article “India’s problem — different drugs, identical brand names” published in “The Hindu” on 25th January 2024.
UPSC Syllabus Topic: GS paper2- governance- Issues relating to development and management of Social Sector/Services relating to Health.
News: The article discusses the issue in India where different drugs have identical or similar brand names, leading to confusion and potential health risks.
What are the issues related to drug naming in India?
Use of Identical or Similar Names: Drugs with different purposes are often sold under identical or similar names, leading to confusion. For example, ‘Linamac’ is used for a cancer drug and a diabetes drug, and ‘Medzole’ is used for drugs treating sedation, stomach acidity, deworming, and fungal infections.
Phonetic and Visual Similarity: Medzole’ is used for various drugs treating unrelated conditions like sedation, stomach acidity, deworming, and fungal infections. Similarly sounding drugs names like ‘Medpol’, ‘Medrol’, and ‘Metrozole’ add to the confusion.
What are the reasons behind such issues?
Lack of Prescription Error Data: India does not collect data on prescription errors, making it difficult to assess the scope of the problem and implement effective solutions.
Challenges in Pharmacy Regulation: Many Indian pharmacies dispense drugs without proper prescriptions and are not adequately regulated. It increases the risk of dispensing wrong medications due to name confusion.
Language Barrier: Drug packaging in India is mostly in English, which less than 10% of the population speaks. This further complicates the issue for many patients.
What initiatives have been taken to overcome these issues?
Judicial Initiatives:
Supreme Court of India’s Ruling (2001): In the Cadila Health Care Ltd. vs Cadila Pharmaceuticals Ltd. case, the Supreme Court emphasized the need for distinct drug names and advised the Ministry of Health to implement measures to prevent confusion from similarly named drugs. The 59th report of the Parliamentary Standing Committee on Health and Family Welfare also made similar recommendations.
Delhi High Court’s Direct Involvement (2019): Justice Pratibha M. Singh, during a case of pharmaceutical trademark infringement, emphasized the seriousness of the issue. Her involvement led to increased awareness and pressure on regulatory bodies to address the problem of confusing drug names.
Legal and Regulatory Measures:
Drugs and Cosmetics (Thirteenth Amendment) Rules, 2019: Introduced a system requiring pharmaceutical companies to provide an “undertaking” that their drug’s brand name would not cause market confusion. This includes checking trademarks registry, central database for drug names, literature, and internet sources.
Despite these rules, there is no complete database of all pharmaceutical brand names in India, limiting their effectiveness.
What should be done?
To address drug name confusion in India, a centralized database for drug names should be established. Strict enforcement of naming regulations is needed, along with better training for pharmacists. Improving pharmacy regulation to ensure compliance with prescription laws and employing trained pharmacists can significantly reduce medication errors stemming from similar drug names.
Question for practice:
Discuss the issues related to drug naming in India and the initiatives that have been taken to overcome these issues.