India's Regulatory Framework for OTC Drugs
India is on the verge of establishing a streamlined regulatory framework for over-the-counter (OTC) drugs. The Drugs Technical Advisory Board (DTAB) has approved recommendations from a special OTC sub-committee constituted by the drug regulator.
Key Developments
- Around 27-30 drugs, primarily analgesics, topical ointments for pain, and cough-and-cold medications, are proposed to be part of India’s first comprehensive OTC drugs list.
- The framework will allow pharmaceutical companies to advertise these brands to enhance public awareness.
- More drugs may be added to the list in the future.
Sub-Committee Insights
- The OTC sub-committee studied 126 drugs and finalized around 30 suitable for the OTC category after thorough research and stakeholder consultation.
- This initiative aims to enable patients to purchase medications for day-to-day ailments with short usage durations to avoid misuse.
- The sub-committee has suggested flexible dosage durations, for instance, in cases of prolonged topical ointment use for sprains.
Expert Opinions
Dr. Anupam Prakash, chairman of the OTC sub-committee, emphasized the importance of establishing regulations and mechanisms to determine OTC drug qualifications. This is India’s first comprehensive attempt to regulate OTC drugs since Independence.
Risks and Market Impact
- Experts caution against self-medication, particularly regarding antibiotics and NSAIDs, due to potential health risks and side effects.
- Nirali Shah, an analyst, warns that a clampdown on OTC sales might affect the Indian Pharma Market's (IPM) volume growth, particularly in acute therapy segments.
- Industry insiders believe that allowing advertisements for OTC drugs will increase patient awareness and potentially reduce healthcare costs.
Conclusion
The establishment of a formal OTC category is anticipated to improve regulation and availability, benefiting both the pharmaceutical industry and consumers, despite potential impacts on market volumes.
Booster Dose
- The DTAB approved a report recommending 27-30 drugs for the OTC list, including analgesics and cough medications.
- Pharma companies are now permitted to legally advertise approved OTC drugs.
- India currently lacks a formal OTC category.
```
