Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

India’s problem — different drugs, identical brand names

India's problem — different drugs, identical brand names - Rau's IAS

Central Idea:

The article highlights the longstanding issue of identical or similar brand names for drugs in India, posing serious risks of confusion and prescription errors. Despite past recommendations, the problem persists due to poor regulatory oversight and a lack of comprehensive databases. The consequences are particularly alarming in a country with a multilingual population and lax pharmacy regulations.

Key Highlights:

  • Identical brand names for drugs treating different conditions, such as ‘Linamac,’ raise concerns about patient safety.
  • The problem of similar names extends beyond identical matches to include phonetically and visually similar names.
  • The article points out that India’s pharmacies are poorly regulated, increasing the likelihood of errors, especially with drug names being predominantly in English.
  • Previous recommendations from the Supreme Court and Parliamentary Committee were ignored until 2019 when the Ministry of Health introduced rules, but they seem ineffective.

Key Challenges:

  • Lack of comprehensive data on prescription errors in India hampers understanding and acknowledgment of the problem.
  • Weak regulatory mechanisms and self-certification by pharmaceutical companies contribute to the persistence of confusing drug names.
  • The absence of a centralized database for pharmaceutical brand names complicates efforts to prevent confusingly similar names.
  • Limited political will within the Ministry of Health’s Drug Regulation Section to implement reforms exacerbates the issue.

Key Terms:

  • Pharmaceutical Trademark Infringement: Legal disputes among pharmaceutical companies over trademarks.
  • Undertaking: A commitment or assurance made by pharmaceutical companies regarding the uniqueness of their drug brand names.
  • CDSCO (Central Drugs Standard Control Organisation): The central regulatory body for pharmaceuticals and medical devices in India.

Key Phrases:

  • Identical trade names for drugs with different active ingredients”
  • “Phonetically and visually similar trade names”
  • “Poorly regulated Indian pharmacies”
  • “Flimsy system” for preventing confusing drug names

Key Quotes:

  • The consequences of confusion between these medications at the pharmacy can be serious for patients.”
  • “The problem of similar or identical trade names for drugs has been known for several decades.”

Key Statements:

  • “The Ministry of Health brought in the Drugs and Cosmetics (Thirteenth Amendment) Rules, 2019, putting in place a flimsy system…”
  • “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.”

Key Examples and References:

  • Dr. Vincent Rajkumar’s shock over drugs with identical names treating different conditions.
  • Example of the brand name ‘Medzole’ used by different companies for drugs treating various medical conditions.

Key Facts:

  • English language used on drug packaging, spoken by less than 10% of the population.
  • Poor regulation of Indian pharmacies dispensing drugs without prescriptions.

Critical Analysis:

The article critically assesses the inadequacies of the regulatory framework, emphasizing the ineffective self-certification system and the absence of a centralized database. It underscores the lack of political will to address a long-standing issue that jeopardizes patient safety.

Way Forward:

  • Establish a comprehensive database of pharmaceutical brand names.
  • Strengthen regulatory mechanisms to prevent confusingly similar drug names.
  • Implement effective measures, possibly modeled after systems in the United States and Europe, to minimize prescription errors.
  • Increase awareness among pharmaceutical companies about the importance of unique and easily distinguishable drug names.
  • Advocate for policy changes that prioritize patient safety in drug nomenclature.

In conclusion, addressing the issue requires a multi-faceted approach involving regulatory reforms, data collection, and industry awareness to ensure patient safety in the pharmaceutical landscape in India.

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