India’s problem - different drugs, identical brand names

• Recently, an oncologist highlighted a concerning issue that two different drugs, one treating cancer (Linamac 5) and the other diabetes (Linamac), had identical brand names.
• This situation raises serious concerns about potential mix-ups at pharmacies and their impact on patient safety.

Historical Issue

• The practice of assigning identical trade names to drugs with different active ingredients has been a longstanding problem in India.
• Notably, the brand name 'Medzole' is used by four different companies for drugs addressing distinct medical conditions, illustrating the widespread confusion.

Similar Trade Names: A Wider Problem

• Beyond identical names, the issue extends to similar trade names that are phonetically and visually alike.
• This practice poses risks of confusion, with examples like 'Medpol,' 'Medrol,' and 'Metrozole,' sounding similar to 'Medzole' and each other.

Brand Name Dilemmas

• Companies sometimes reuse their successful brand names for different formulations, potentially leading to confusion.
• For example, the company that uses the brand name ‘I-Pill’ for emergency contraception, uses the brand name ‘i-Pill Daily’ as a daily contraceptive pill.
• This underscores the risks of misunderstanding and several unintended consequences.

Challenges in India

• The drug packaging in India bears the name and prescription advice in the English language, spoken by less than 10% of the population.
• Also, in India, it is common for many pharmacies to dispense drugs without prescriptions.
• Additionally, several of them fail to adhere to the legal mandate of operating exclusively with trained pharmacists registered with the Pharmacy Council of India.
• The combination of language barriers and lax regulation increases the likelihood of prescription errors, compounded by confusing drug names.

Judicial and Parliamentary Attention

• The Supreme Court and the Parliamentary Standing Committee on Health and Family Welfare have addressed this issue.
• They have urged the Ministry of Health to prevent the use of confusingly similar names for drugs.
• However, these recommendations were initially overlooked until Justice Pratibha M. Singh's intervention in 2019.

Regulatory Response

• In 2019, the Ministry of Health introduced the Drugs and Cosmetics (Thirteenth Amendment) Rules, 2019, aiming to address the problem.
• However, this framework relies on self-certification by pharmaceutical companies, which is deemed ineffective.
• Additionally, India lacks a comprehensive database of pharmaceutical brand names.

Data Deficiency and Reform Challenges

• India lacks data on prescription errors, hindering the acknowledgment of the problem by the Ministry of Health.
• The lack of political determination within the Drug Regulation Section hinders the execution of reforms.
• This is in contrast to mechanisms in the US and Europe, where thorough scrutiny of drug names is undertaken to minimize confusion and reduce prescription errors.