Enhancing Access to Self-Medication: The Need for a Formal OTC Drug Framework in India

“The Organisation of Pharmaceutical Producers of India (OPPI) highlights the growing importance of self-medication in India, especially due to the increase in chronic and lifestyle-related diseases. Key points include:

1. Benefits of Self-Medication:

• It can help manage common conditions, reduce healthcare costs, and promote preventive care.

1. Lack of OTC Drug Category:

• India does not have a legally recognized category or list of Over-the-Counter (OTC) drugs.
• Currently, prescription drugs are regulated under specific schedules of the Drugs Rules, 1945, while OTC drugs are not clearly defined.

1. Need for Rx-to-OTC Transition:

• There is an urgent need for a formal process to switch drugs from prescription (Rx) to OTC status, which would help reduce regulatory ambiguity and improve access to safe self-medication options.
• At present, new drugs in India are approved for sale only with a prescription, and there is no structured procedure for this transition.

1. Ideal Regulatory Changes:

• A formal framework should include a clear definition of OTC drugs, proper regulations for handling them, a list of approved ingredients, and proper labeling guidelines.
• A dedicated chapter in the Drugs Rules, 1945 for OTC drugs would ensure better regulation, safer usage, and broader access for the public.

These changes are essential to ensure the safe use of OTC drugs while improving the accessibility of self-medication for the public in India.
Source:https://www.indiaoppi.com/wp-content/uploads/2024/08/OPPI_FAQs-Over_the_Counter_Drugs.pdf##~https://www.indiaoppi.com/publications/

Region: India