Regulation of Over-the-Counter (OTC) Medications in India
India's top advisory board on drugs is evaluating a new plan aimed at regulating the sale of over-the-counter (OTC) medications. The objective is to reduce misuse and ensure patient safety.
Proposed Guidelines for OTC Medications
- Only 27 drugs will be allowed for sale without a doctor’s prescription.
- Restrictions will apply to dosage and quantities.
- The list includes:
- Antipyretics
- Painkillers
- Antacids
- Cough syrups
- Oral contraceptives
- Antiseptics
- Laxatives
- Nasal sprays
- Domperidone (anti-emetic)
- Iron and folic acid tablets
- SOS medication
Certain drugs currently sold without prescriptions will be restricted to doctor-approved sales only.
Decision-Making Process
- The Drugs Technical Advisory Board is scheduled to review the recommendations.
- The Central Drugs Standard Control Organisation formed an eight-member sub-committee to create an OTC framework.
- Clinician suggestions were incorporated into the framework.
Statements from Leading Authorities
The chairman of the OTC sub-committee emphasized the dual focus on accessibility and patient safety. The report aims to increase access to commonly used medicines while ensuring safety.
Recommendations for Safe Use
- Smaller pack sizes are recommended to align with the treatment duration, particularly for drugs with misuse potential.
- Pack sizes should not exceed doses for a maximum use of five days, dependent on the drug's toxicity.
Regulatory Challenges
The term ‘over the counter’ lacks definition in India’s Drugs and Cosmetics Act, 1945, unlike in countries like the US and the UK where clear guidelines exist for non-prescription sales.
