Tuesday, 13 November 2018

OPPI releases Shaping India’s OTC Policy 2018

12 October 2018 | News

In collaboration with CubeX and the Nicholas Hall Group of Companies, this Study calls for a well-regulated OTC framework.

On behalf of the pharmaceutical industry in India, the Organisation of Pharmaceutical Producers of India (OPPI), along with a few members from the domestic pharmaceutical industry and consumer industry, released a study titled Shaping India’s OTC Policy 2018 at the Annual CubeX-Nicholas Hall OTC Conference, held in Mumbai, recently.  In collaboration with CubeX and the Nicholas Hall Group of Companies, this 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.

While proposing the policy for India, the study- Shaping India’s OTC policy 2018- considers the best practices that have been adopted by the most evolved OTC markets of US and UK, the most dynamic OTC market of China, the well-defined OTC market of Australia and the evolving OTC markets of Brazil, Indonesia and Mexico.

Commenting on the release of the Study, A. Vaidheesh, President-OPPI and Managing Director-India & Vice President- South Asia, Glaxo SmithKline Pharmaceuticals Ltd said, “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. 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.”

“OTC medicines save health systems valuable resources and can save consumers time and money. However, consumers need to be educated on the practice of healthy living habits and self-care.  OTC medicines have played a significant role in expanding access to safe and effective treatments in developing regions of the world,” said G. Sathya Narayanan, Chairman-OPPI OTC Taskforce and Managing Director, South Asia, Nestle Skin Health India Pvt Ltd.

Some key recommendations of the Study include:

  • 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 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 need for essential parameters such as quality, safety and efficacy standards to remain the same as for “Prescription” drugs

Kanchana TK, Director General, OPPI added, “OPPI keeps the patient at the core of all our activities.  A well-regulated OTC guideline promotes a favourable ecosystem that educates patients on responsible self-medication, empowering them to manage their health by themselves.”

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