REGULATORY REQUIREMENTS FOR OVER-THE-COUNTER (OTC) MEDICINES AS PER CDSCO IN INDIA: A COMPARATIVE STUDY WITH SOUTH AFRICA

Over-the-counter (OTC) medications have long been a vital component of health care systems worldwide. Their easy accessibility, however, carries potential risks. This review explores the current scenario of OTC drug use in India in the context of global best practices, highlighting the lifecycle of prescription versus OTC medicines, their benefits, and the regulatory processes involved in transitioning drugs from prescription-only to OTC status. A noticeable shift toward self-medication with OTC drugs has occurred globally in recent years. Key drivers include increased consumer awareness, wider access to essential medications, and socio-economic benefits to public health systems. However, self-medication also poses risks such as overdose, polypharmacy, drug abuse, and adverse drug interactions. These risks can be mitigated through a well-defined OTC regulatory framework. Recognizing this need, the Government of India has emphasized the development of robust policies for effective OTC drug utilization, including efforts to modify existing laws or create new regulations. Prioritizing consumer safety, the term “OTC” has been recommended as a distinct legal category of drugs in India. Patients often consult pharmacists for minor ailments such as cough, cold, allergies, pain, fever, acidity, diarrhea, and skin conditions. While OTC drug sales are legally recognized in most countries, India lacks a formal legal definition of OTC drugs; technically, all drugs are considered OTC unless explicitly categorized as prescription-only. OTC drugs offer faster and more affordable access to healthcare, but misuse and adverse effects remain concerns. Optimizing OTC drug use in India will require legal recognition of OTC as a distinct category, patient awareness programs, and support from pharmacists and pharmaceutical companies, aligning national practices with global standards.