Regulatory Affairs

Pharmacovigilance (PV) plays an analytical role in ensuring drug safety and public health. This research explores the regulatory frameworks and PV systems in India and Japan, focusing on the Central Drugs Standard Control Organization (CDSCO) and Pharmaceuticals and Medical Devices Agency (PMDA), respectively. Historical developments, adverse drug reaction (ADR) reporting systems, risk management protocols, and international harmonization practices are discussed.1 India's PV system has evolved through programs such as the Pharmacovigilance Program of India (PvPI), whereas Japan’s system emphasizes structured post-marketing surveillance (PMS) and risk management plans (RMPs). Although both systems have made significant progress, challenges such as underreporting in India and regulatory burden in Japan persist. This comparative analysis offers insights into upgrading global pharmacovigilance through interactive learning and harmonization.

A new pharmaceutical entity can cost several millions of rupees or dollars to develop. Astonishingly, even a few month deferrals in taking it to the market can have notable impact on the pecuniary status of the company. One of the major activities of the regulatory specialist is to ensure that the label of the product and related information of the patient has correctly been established and even a small error in any of the regulatory activities can make the product to be ready for recall in addition to the loss of several millions of money which is eventually bound to give rise to fall in self assurance of financiers, health experts and the patients. aRegulatory Affairs is a comparatively new profession which developed from the desire of government to protect public health by controlling the safety and efficacy of products in areas including pharmaceutical, veterinary medicines, medical device, pesticides, agrochemical, cosmetics and complementary medicines, biologics and functional foods. Keywords- Regulatory Affairs, cosmetics, agrochemical