Editorial of the Day (25th Jan): India’s Problem – Different Drugs, Identical Brand Names

Context: The issue of different drugs having identical or similar brand names in India is a significant problem that poses serious risks to patient safety.

Background

• Different drugs with entirely different active ingredients and uses share identical or confusingly similar brand names in India. This poses a serious risk of patient harm due to medication errors.
• Examples:
  • Linamac: ‘Linamac 5’ is used to treat multiple myeloma, which is a type of cancer, the other drug bearing the name ‘Linamac’ is a drug used to treat
  • Medzole: Used for a sedative, stomach acidity treatment, deworming, and antifungal medication.
  • Medpol, Medrol, Metrozole: Phonetically similar to Medzole, increasing confusion.
  • i-Pill and i-Pill Daily: 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.

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Factors Increasing Risk

• Data Deficiency in Prescription Errors: In India, there is an absence of systematic data collection on prescription errors which hinders the understanding of the problem’s magnitude and challenges the development of impactful solutions.
• Regulatory Shortcomings in Pharmacies: A significant number of pharmacies in India distribute medications without the necessary prescriptions and lack stringent regulatory oversight.
• Language Hurdle in Drug Labelling: The majority of drug labels and packaging in India are in English, a language spoken by a minority (under 10%) of the population which adds complexity for numerous patients in correctly understanding medication information.

Judicial Interventions

• Ruling by the Supreme Court of India (2001) And 59th report by the Parliamentary Standing Committee on Health and Family Welfare: The Supreme Court, in the case between Cadila HealthCare Ltd. and Cadila Pharmaceuticals Ltd. and also report by the Parliamentary Standing Committee , highlighted the importance of having unique names for drugs.
  • It recommended that the Ministry of Health take steps to avoid the confusion caused by drugs with similar names.
• Intervention by the Delhi High Court (2019): In a notable case involving pharmaceutical trademark infringement, Justice Pratibha M. Singh underscored the critical nature of the issue.
  • Her involvement brought heightened attention and urged regulatory authorities to tackle the ongoing problem of drug name confusion more effectively.
• Drugs and Cosmetics (Thirteenth Amendment) Rules, 2019: Companies self-certify non-confusing names during licence applications.
  • Required searches for similar names in limited databases.
  • Flaws in the Approach:
    • Self-certification ineffective (existing name confusion evident).
    • No national database of drug names – makes thorough searches impossible.
    • Collecting data from 36 diverse drug controllers is a logistical hurdle.

Suggestive Measures

• Build a national database of all pharmaceutical brand names.
• Adopt mechanisms like those in the US and Europe for naming drugs to avoid confusion.
• Establish a dedicated division within the drug regulator to oversee drug names.
• Collect data on prescription errors to quantify the problem.

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