India’s over-the-counter (OTC) drug market is facing significant regulatory challenges in the absence of a formal legal framework for these widely used medications ranging from paracetamol tablets to cough suppressants, said industry experts. While prescription drugs are clearly categorised under specific schedules in the Drugs Rules, 1945, OTC drugs remain undefined. This has led to uncertainty in their manufacturing, marketing and sale creating confusion within the industry.
Many drugs marketed as non-prescription fall into a grey area, leading to inconsistencies in how they are sold and used. Industry associations and pharmacists have long advocated for the creation of a separate category for OTC drugs, which could include an approved list of OTC ingredients and clear guidelines for Fixed Dose Combinations (FDCs).
“The absence of a formalised framework for OTC drugs in India highlights a significant regulatory gap that requires urgent attention. We strongly believe that establishing a clear and structured regulatory approach for OTC drugs is not only an industry necessity but also a public health imperative,” said Anil Matai, Director General, Organisation of Pharmaceutical Producers of India (OPPI), that represents the research-based pharmaceutical companies operating in India.
Although discussions have taken place within the Drugs Consultative Committee (DCC) and the Drugs Technical Advisory Board (DTAB), progress has been slow. Experts believe that a well-defined regulatory framework could ease the burden on India’s healthcare system, reduce out-of-pocket expenses for patients and encourage responsible self-medication practices.
“While committees such as the DCC and the DTAB have engaged in valuable discussions on the matter, the lack of a legally recognised category for OTC drugs continues to create challenges in ensuring their safe manufacture, distribution, and use,” said Matai.
Pharmaceutical experts have called for a more structured regulatory framework recommending to include formally defining OTC drugs, establishing a clear process for transitioning prescription drugs to OTC status, and setting stringent guidelines for labelling, advertising and distribution.
“India must introduce a dedicated chapter within the Drugs Rules, 1945, to formally define and classify OTC drugs. This should include a dynamic positive list of OTC drugs, clear procedures for transitioning prescription medicines to OTC status, and stringent standards for their sale, labelling, advertising, and licensing. Such a framework would provide much-needed clarity for the pharmaceutical industry while empowering consumers with safer access to medications with proven efficacy,” said Matai, adding that by promoting responsible self-medication, we can alleviate the burden on the healthcare system, encourage informed healthcare decisions, and improve health literacy.
The Indian OTC drug market is valued at approximately Rs 74,000 crore in 2024 and is expected to grow at a compound annual growth rate (CAGR) of 14% reaching around Rs 1,57,000 crore by 2030. This growth is driven by increasing self-medication practices, greater health awareness, and the expansion of product portfolios by pharmaceutical companies. As the demand for self-care solutions continues to rise, addressing these regulatory gaps has become increasingly urgent, experts said.