Regulatory, safety and economic considerations of over-the-counter medicines in the Indian population

BACKGROUND AND PURPOSE OF REVIEW: 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. FINDINGS: 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. CONCLUSION: 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.