India is set to streamline OTC drug access with a first-ever official list aimed at safer self-medication.
In a significant move aimed at regulating the sale of self-medication drugs, India’s premier drug advisory panel is reviewing a proposal to strictly limit over-the-counter (OTC) access to a defined list of medicines. The plan, which is currently under discussion, seeks to allow only 27 essential drugs to be sold without a doctor’s prescription, each with specified dosage and quantity limits.
According to Drugs Control report, the proposed list includes widely used medications such as antipyretics, analgesics, antacids, cough syrups, oral contraceptives, antiseptics, laxatives, nasal decongestants, domperidone (used to treat nausea and vomiting), iron and folic acid supplements and other SOS (emergency-use) drugs.
Notably, several drugs that are currently easily available over the counter have been excluded from this list, as the expert panel believes they require medical supervision. The Drugs Technical Advisory Board (DTAB) is expected to convene this week to finalize and approve the recommendation.
Experts from OTC sub-committee, confirmed that the report had been submitted to the regulatory authority. “The primary objective was to strike a balance between accessibility and safety. All SOS medications are included, but many others despite their availability at pharmacies have been deliberately dropped to ensure they are dispensed only under medical advice,” he said.
The Central Drugs Standard Control Organization (CDSCO) had set up an eight-member sub-committee last year to establish a framework for categorizing OTC drugs. As reported in the Drugs control report, the committee’s mandate was to outline clear guidelines for identifying which medicines can be sold without a prescription, with inputs from clinicians and experts. Under the proposed framework, OTC drugs would be permissible only for short-term use not exceeding five days without a doctor’s consultation.
Unlike countries such as the US and UK, where the concept of OTC drugs is well-defined in their drug regulatory laws, India’s Drugs and Cosmetics Act of 1945 does not provide a formal classification. The proposed move seeks to address this regulatory gap and streamline the availability of non-prescription drugs across pharmacies.
If implemented, this could mark a pivotal shift in India’s pharmaceutical policy, ensuring that patient safety is prioritized while retaining access to essential medications.
