Well-regulated OTC guideline will expand access to medicines in India:OPPI

A well-regulated over-the-counter (OTC) framework will improve access to medicines in India, a study by the Organisation of Pharmaceutical Producers of India said Friday.

The study calls for a well regulated OTC framework that not only helps improve access to medicines but also supports responsible self-medication to achieve multiple health and economic objectives, OPPI said in a statement.

"Access to medicines in India has long ignored the critical role of the viability of OTC medicines in the remotest areas. A well-regulated OTC guideline will expand access for patients," President-OPPI and MD India & VP - South Asia, Glaxo SmithKline Pharmaceuticals A Vaidheesh said.

The study, 'Shaping India's OTC Policy 2018' is an illustration of the collaborative effort of the entire pharmaceutical industry in empowering patients to make responsible and wise choices and self-manage their health outcomes, he added.

The key recommendations of the study suggest a separate Rule and a separate Schedule on OTC in the Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945.

The study also recommended the need for essential parameters such as quality, safety and efficacy standards to remain the same as for "Prescription" drugs, it added.