CDSCO publishes Draft Pharmacovigilance System Inspection Guidelines

Sep 28, 2018 | by Avantis RegTech Legal Research Team


The Central Drugs Standard Control Organization (CDSCO), had specified certain requirements in Schedule-Y of Drugs and Cosmetics Rules, 1945 vide GSR notification No. 287(E) dated March 08, 2016.

This Notification emphasises that all Market Authorization Holders (MAH) that is the companies holding Licences to manufacture and / or import of "Drugs" for an ultimate motive of marketing medicinal products in India shall have an established Pharmacovigilance System for collection, processing and reporting of Adverse Drugs reactions (ADR) to the concerned Licencing authorities.

Section 28.2 of Schedule-M which mandates that, companies holding manufacturing licences are supposed to submit the reports of serious adverse drug reactions resulting from the use of their drug products along with comments and documents to the concerned licensing authority. Similarly, it is also mandatory in Schedule-D (II) Section 2.18 that the Importers of "Drugs" shall submit the detailed PMS study Report for their marketed drug products at the time of renewal application submission.

Therefore, the CDSCO is currently in the process of examining the current status of PV-systems in companies who are manufacturing and / or importing Drug Products including pharmaceuticals, Phyto-pharmaceuticals, Human Vaccine, Blood products, rDNA technology derived drugs, stem cell therapeutics in the Indian market.

Accordingly, a comprehensive Pharmacovigilance System Inspection Guideline has been drafted which will be finalized after deliberations with the stakeholders of such products. Now, with the approval of the competent authority, the said guideline is being placed on the official website for public view and further consideration.  The guidelines provide harmonized standards on the planning, preparation, conduct and reporting of risk-based pharmacovigilance inspections of market authorization holder (MAHs) for medicinal products, approved for marketing in India.

The stake holders' valuable comments, suggestion are hereby requested for further improvement and finally rolling out a fully functional document. All such feed-back will be acceptable till October 31, 2018. Contact us at the E-mail: [email protected] and [email protected]

[File No. CDSCO/INS/PV/002/18-DCG(I)]

URL: http://cdsco.nic.in/writereaddata/dps.pdf


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