Globally, cultural trends and social attitudes are redefining consumerism. But, consumerism in health calls for an ecosystem that empowers consumers to make wise choices. And it’s here that over-the-counter (OTC) medicines essay a critical role in helping many self-treat or manage their own health conditions.

Consumers benefit from well-defined OTC regulations that support a favourable environment for responsible self-medication. However, India lacks defined OTC regulations thereby compromising patient safety. With the Ayushman Bharat roll out, the government needs to consider a well -regulated OTC framework that will help accelerate the process of expanding access to medicines.

In the context of India’s healthcare infrastructure and the established trend of under-the-counter sales of prescription medicine, it is imperative to encourage responsible self- medication among Indian patients as a means to improve overall health outcomes. In fact, just on Friday (October 12), the Organisation of Pharmaceutical Producers of India (OPPI), representing the research-based pharmaceutical companies, released a study on “Shaping India’s OTC Policy 2018.”

The study highlights the need to create an ideal regulatory framework for OTC medicines, which includes creating a robust list of OTC medicines with regulations, which are distinct from the current laws governing prescription medicine. Ensuring large-scale availability of quality OTC medicines through distribution channels beyond conventional pharmacies is also necessary.

Other highlights from the study include — educating consumers and pharmacists on the judicious use of OTC medicine through clear and responsible messaging; creating a system of checks and balances related to the safety, efficacy, promotion, and consumption of OTC medicines, such that their benefits are maximised and risks mitigated; creating a pricing paradigm that encourages investment in the production and responsible promotion of OTC drugs that provides wider consumer choice and creating a regulatory pathway for prescription or Rx-to-OTC switches based on established safety and efficacy profile.

The study proposes the need for a legislation that would serve as the principal law regulating import, manufacture, promotion, distribution and sale of OTC drugs. Hence, the suggestion is to include a separate Rule and a separate Schedule on OTC (proposed nomenclature Schedule “O”) in the Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945.

The proposed OTC Schedule could also include the list of Active Pharmaceutical ingredients (API) that can be used in OTC drug products.

Most of these APIs are included in the Indian Pharmacopoeia and in the National Formulary of India and the ones which are not included are proposed for inclusion.

Further, the study stresses on the need for essential parameters such as quality, safety and efficacy standards to remain the same as for “prescription” drugs. Regulations related to manufacture, stability/shelf life studies, quality control, quality assurance, facility inspection and approval, clinical trials, post-marketing safety monitoring, risk management, storage and distribution, import, etc, should apply equally to OTC drug products too.

The roles and responsibilities of OTC marketers, pharmacists and consumer bodies who have a collective responsibility towards driving the judicious use of OTC medicines should also be well defined.

The overarching vision of Ayushman Bharat in delivering good health begins with greater patient empowerment and self-care. This study is the first step in that journey.

The author is Chairman-OPPI OTC Taskforce and Managing Director, South Asia, Nestle Skin Health India Pvt. Ltd.

Related Topics
comment COMMENT NOW