India: PV Guidance Document

by | Dec 11, 2017 | Adamas News, Blog Of The Day, Industry Focus, Regulatory Focus

Ministry of Health & Family Welfare, Government of India, has released the Pharmacovigilance (PV) Guidance for Marketing Authorization Holders (MAHs) and it will be effective from Jan-18. 
The guidance document intends to enable the MAHs to set up a PV system at their organization as mandated by the amendment to the Drugs & Cosmetic Act, 1940 and Rules 1945, Gazette Notification, GSR 287(E), dated 08-Mar-16. According to this GSR the MAH should have a PV system in place.  This system should be managed by qualified and trained personnel and the officer in charge should be a medical officer or pharmacist trained in collecting and analyzing Adverse Drug Reaction (ADR) reports.  
The guidance document includes Modules covering various aspects of PV in detail.

  • Module 1. PV System Master File (PvMF): PvMF should be located at the MAHs organization in India. MAH should authorize a qualified and trained person, who should be a medical officer or a pharmacist, as the PV Officer-in-charge (PvOI).  The PvOI should be residing in India. PvMF should include a list of pharmaceutical products covered by the PvMF, list of contract agreements covering delegated activities, list of tasks delegated by the PvOI, audit plan, and a list of all completed audits and inspections
  • Module 2. Collection, processing and reporting of Individual Case Safety Reports (ICSRs): There should be a formal process to collect and report ADRs from; medical inquiries, ‘contact us’ emails and websites, MAH employees, contractual partners, information from the internet or digital media (including newspapers) under their management of responsibility, solicited reports from organized data collection systems, and miscellaneous sources. Literature monitoring should be performed monthly by using an electronic literature database such as PubMed
  • Module 3. Preparation and Submission of Periodic Safety Update Reports (PSURs): The format, content and timeline of PSUR submissions is detailed in this section 
  • Quality Management System (QMS) at MAH: The MAH should document the quality system, have controlled documents, adequate resources, training, facilities, compliance management, records management, business continuity, It also mentions that the MAH should ensure that audits are performed
  • Audits and Inspections: Although the title is Audits and Inspections this module refers to the planning, conducting, reporting and follow-up of PV inspections by regulatory authorities
  • Submission of Risk Management Plans (RMPs): The module indicates that RMPsof every product shall be approved by the regulatory authority and should be updated as and when required 

The guideline does state that, ‘the guidelines are for guidance of all stakeholders and not meant to substitute or rephrase the rules under Drugs and Cosmetic Act, 1940 and Rules 1945. In the event of any dispute as regard to the content of this document and the statutes, the statutory provisions shall prevail’.  
The guidance document lacks clarity in certain aspects. For example: 

  • The ICSR reporting module is unclear about domestic/foreign case submission. The term regulatory authority and licensing authority is used interchangeably. All Serious Adverse Events (AEs)/ADRs are expected to be reported to the regulatory authority/National Coordination Center (NCC) of PV Program of India(PvPI). All non-serious AEs/ADRs are required to be reported to NCC-PvPI within 30 days of initial receipt of information by MAH. However, the format for reporting is unclear.  Lack of efficacy, medication error must be reported to the regulatory authority NCC-PvPI however whether these should be reported regardless of an associated safety event is not clear  
  • The timeline for PSUR reportingcontinues to be more stringent (30 days from the data lock point) than the global
  • It is unclear whether the submission of RMPs will be required for all new products or only upon request

The industry groups such as Indian Society for Clinical Research (ISCR) PV Council are seeking clarification from the authorities with regards to the implementation. 
This will indeed be a new chapter in the PV scene in India and it would be exciting to watch how it unfolds.  
For further reading, please see the full guidance document here PV Guidance Document India