Narang Prashant, Garg Vandana, Sharma Atul
Medical Affairs, Haleon (Formerly GSK Consumer Healthcare Pte Ltd.), 10th Floor, One Horizon Center, Golf Course Road, DLF Phase 5, Gurugram, Haryana 122002 India.
Medical Affairs, Haleon (Formerly GSK Consumer Healthcare Pte Ltd.), Singapore, Singapore.
Discov Health Syst. 2023;2(1):17. doi: 10.1007/s44250-023-00032-y. Epub 2023 May 22.
Over-the-counter (OTC) medication has been an integral component of an established health care system but their easy accessibility might pose significant risks. This review has attempted to highlight the present scenario of OTC utilization in India, regarding standard practices followed globally. An attempt has also been made to highlight the lifecycle of a prescription and OTC medicine and the benefits and regulatory process involved in the prescription-to-OTC switch.
A paradigm shift has been observed in self-medication practice with OTC medicines in recent times and has become a widespread practice worldwide. Numerous key drivers, such as increasing consumer awareness, broader consumer access to essential medication, and socio-economic benefits to the public health care system, have advocated this practice. On the other hand, self-medication using OTC is also inextricably linked with inevitable risks such as excessive drug dosage, polypharmacy, drug abuse, and drug interactions. Nevertheless, these issues could be further regulated by employing a defined OTC framework. The government of India has recognized the utmost need to develop a robust policy framework for the effective utilization of OTC drugs. Also, various initiatives toward modifying existing laws or developing new OTC drug policies has been taken.
Prioritizing the utmost safety of the consumers and evident need of strong regulatory framework with respect to OTC drugs, the term "OTC" has been recommended as a distinct category of drugs by Government of India. This review has highlighted various factors that can play an essential role in OTC utilization and can be considered during policy reformation.
非处方药一直是成熟医疗体系的重要组成部分，但其易于获取可能带来重大风险。本综述试图突出印度非处方药使用的现状，以及全球遵循的标准做法。同时也试图强调处方药和非处方药的生命周期，以及处方药转换为非处方药所涉及的益处和监管流程。
近年来，非处方药的自我药疗实践发生了范式转变，并在全球范围内广泛流行。诸多关键驱动因素，如消费者意识增强、消费者更广泛地获取基本药物以及对公共卫生保健系统的社会经济效益，都推动了这种做法。另一方面，使用非处方药进行自我药疗也与不可避免的风险紧密相连，如药物过量、多药联用、药物滥用和药物相互作用。然而，通过采用明确的非处方药框架，这些问题可以得到进一步规范。印度政府已认识到制定强有力的政策框架以有效利用非处方药的迫切需求。此外，还采取了各种举措来修改现行法律或制定新的非处方药政策。
鉴于消费者的最高安全至关重要，且明显需要针对非处方药建立强有力的监管框架，印度政府已将“非处方药”推荐为一个独特的药品类别。本综述强调了在非处方药使用中可发挥重要作用且在政策改革时可予以考虑的各种因素。
