Pharmacovigilance in generic Indian pharmaceutical industries - Need of the moment

Abstract

Introduction: The pharmacovigilance department is liable for monitoring the safety of medicines during clinical trials and normal clinical use. The necessity of the pharmacovigilance department is an utmost requirement for effective regulations of the drug approval process and conscious pre and post-approval vigilance of the undesired effects, especially in India.

Methods: In the light of the regulatory notification GSR 287(E) dated on 8th march 2016 by CDCSO, it has become clear that it is necessary to take measures to set up and improve the operation of the pharmacovigilance of medicinal products for human use in pharmaceutical companies. 

Results: The regulators have also developed and posted Guidance document for marketing authorization holders (MAH) for Indian marketers and made clear that the MAH should be responsible for continuously monitoring the safety of its medicinal products for human use, for updating the health authorities of any changes related to the drug, and for ensuring that the product information is kept up-to-date. MAH should record all suspected adverse reactions occurring in the country, and which are brought to their attention spontaneously by the patients or their health care, or occurring in the context of the post-authorization study.

Conclusions: According to the Regulatory Guidance document, MAH is also responsible for the submission of the information on suspected adverse reactions of a newly approved drug or applicable product, in form of periodic safety update reports (PSURs), to the competent authorities.