|Topic: GS2 – Governance – Government Policies – Issues arising out of their design & implementation.
UPSC Relevance: Critical patient safety concern – Identical drug names in India lead to confusion, prescription errors, demanding urgent reforms for regulation.
- Oncologist Dr. Vincent Rajkumar highlighted the alarming issue of identical brand names, ‘Linamac,’ for drugs treating cancer and diabetes, posing serious risks to patients.
- India has a longstanding problem of using identical trade names for drugs with distinct active ingredients, causing confusion among medical practitioners and patients.
- Notable examples include the brand name ‘Medzole,’ employed by multiple companies for drugs treating various medical conditions.
- Similar trade names that are phonetically and visually alike further exacerbate the problem, leading to potential prescription errors and patient safety concerns.
- The use of similar names is particularly concerning in India due to drug packaging primarily in English, understood by a minority, and lax regulation in the pharmaceutical sector.
- Poorly regulated pharmacies increase the likelihood of dispensing errors, especially when compounded by confusingly similar drug names.
- Despite Supreme Court and Parliamentary Committee recommendations to prevent confusingly similar drug names, the issue persisted, prompting the Delhi High Court’s intervention.
- The Drugs and Cosmetics (Thirteenth Amendment) Rules, 2019, introduced a self-certification system for pharmaceutical companies, proving ineffective in preventing identical or similar drug names.
- Lack of a comprehensive pharmaceutical brand-name database hampers the implementation of effective regulatory measures.
- India lacks data on prescription errors, hindering acknowledgment of the problem by the Ministry of Health.
- The absence of political will within the Drug Regulation Section impedes the initiation of reforms to address the issue.
- Urgent reforms are necessary, mirroring systems in the United States and Europe, where drug regulators assess drug names to minimize confusion and prescription errors.
- Acknowledging the problem and establishing effective regulatory mechanisms are crucial steps toward ensuring patient safety and preventing medication-related errors in India.
- The rampant use of identical drug names in India poses grave risks to patient safety, demanding immediate regulatory reforms. Acknowledging and addressing this issue is crucial for a robust healthcare system.
|Practice Question: How does the prevalent use of identical brand names for diverse drugs in India impact patient safety and necessitate regulatory reforms? (150 words/10 m)