A Comparison of The Effectiveness of Regulatory Frameworks Governing the Sales of Prescription and Over-The-Counter (Otc) Drugs in India and Ireland

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Binsa, Jose
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Background: The dissertation will compare prescription and OTC drug sales regulation in India and Ireland. India's drugs regulatory system is evolving over time to meet the country's expanding healthcare requirements. On the other hand, the Irish healthcare system is heavily regulated, and its medication regulatory framework prioritises patient safety and quality of service. This research compares medication sales regulation regimes in India and Ireland to identify strengths and weaknesses.

Method: The effectiveness of the drug sales regulations in both countries was analysed by secondary and primary research. The regulations and guidelines pertaining to the distribution of prescription and non- prescription medicines available in the official website of Indian regulatory authority (CDSCO) and Irish regulatory authority (HPRA) were the foundation for the literature review. Form the detailed literature review it was identified that India lacks a specific regulation for over-the-counter drug sales. It was also observed that there is no separate drug sales list existing in India. Ireland had a very detailed OTC and prescription drug sales regulation with regularly updated drug sales list. The primary research strategy was quantitative and qualitative surveys focusing on the Pharmacist working in India and Ireland.

Results: The comparative efficacy of the regulatory framework governing the sale of prescription drugs in Ireland and India suggests that the former is more efficacious. According to the findings, it can be inferred that Ireland's approach to drug sales regulation implementation is more efficacious than that of India due to the utilisation of

a combination of various strategies. As per a respondent from India, there are doubts regarding the efficacy of the implementation strategy. According to the data, it can be inferred that the standard of regulatory inspections in India is comparatively lower than that of Ireland. The study's results suggest that the regulatory framework in India requires consistent updating, while in Ireland, it is updated on a regular basis. It has been observed that the regulatory bodies in India may be insufficiently enforcing regulations, which could potentially lead to drug abuse and noncompliance with regulatory standards. Overall, the regulatory measures implemented in Ireland have been deemed to be more effective than those in India

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