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THE PHARMA REVIEW (SEPTEMBER – OCTOBER 2017)

Understanding Importance of Self-Care Management and Evaluating Parameters to Establish Switch Pathway for Rx to OTC Drugs in India

Gaurav Agnihotri*1, Sonal Shidhore1 & Dr. Deepak Pandurang Belsare2

Introduction: Responsible self-care allows everyone to maintain their healthcare status. Self-medication empowers patients to treat themselves for short term. To help India reach at much higher stage, OTC category has lots of cards to play which will enable India stand out as benchmarking country in terms of health care credentials.
If we deep dive in our current regulations, we can evaluate need of having OTC as recognized category. Goal of switching is the diversification of portfolios by expanding into consumer products, while addressing prescription market challenges and simultaneously building stable and predictable revenue streams and managing the product lifecycle. Considering current situation in India, OTC segment doesn’t have formal structured process to differentiate it from Rx status. Finding out strategies to frame policy for changing the status of Rx drug to non-prescription drug will bring regulation in place & help better healthcare system to benefits. Recognized switch guidance will provide Industry a proper channel with uniform process & precise requirements to be followed for getting registration to switch Rx drug/molecule to OTC category, irrespective of state where applicant wants to file his application. Pharmacist being critical healthcare player, gains highest responsibility to voice up for need of OTC as separate category and convey it to right forum for consideration. Giant markets like U.S., E.U., Australia, New Zealand, etc., have implemented categorization of drugs as prescription drugs & non-prescription drugs, the one which is recognized as – ‘Over The Counter’. And as a result of it, these markets could provide patients speedy recovery with lowering the burden on Medical practitioners. 

 

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