With an aim to resolve ambiguity in implementation of pharmacovigilance programme, the Central Drugs Standard Control Organisation (CDSCO) in collaboration with Indian Pharmacopoeia Commission (IPC), Ghaziabad has released the much awaited revised draft guidelines on post marketing surveillance of pharmaceutical products in India.

The guidelines direct marketing authorisation holders (MAHs) of pharmaceutical products comprising importers and manufacturers to establish a pharmacovigilance (PV) system with a medical officer or a pharmacist who will act as a pharmacovigilance officer-in-charge (PvOI) for collection and analysis of adverse drug reaction reports related to pharmaceutical products marketed by them in India.

The PvOI is responsible for individual case safety report (ICSR) collection and collation, processing, assessment, reporting and follow-up, detection of signal (if any), corrective and/or preventive action(s) (CAPA), preparation & submission of periodic safety update report (PSUR) of new drugs, risk management system(s) including risk management plan for each pharmaceutical product.

All ICSRs received by MAHs shall be submitted to National Coordination Centre
-Pharmacovigilance Programme of India (PvPI), in electronic transmission of individual case safety report (E2B), XML format in a timely manner as per the norms stipulated in Schedule-Y of Drugs & Cosmetics Act, 1940 and Rules 1945.

PvOI will also be responsible for development of training modules & organizing training for Pv-System staff; identification of PV activities and framing of standard operating procedures (SOPs), revision of SOPs; establishment & maintenance of
quality management system (QMS) of pharamacovigilance department.

The main focus of this guidelines is to identify the risks associated with pharmaceutical products and establish a Pv system at MAHs site to mitigate such risks.

This document includes following category of pharmaceutical products: New drugs, subsequent drugs approved after 4-yearsb Biologics, radiopharmaceuticals and phytopharmaceutical products. This guidance document excludes veterinary products and medical devices.

It contains role and responsibilities of regulatory authorities including CDSCO, PvPI at IPC and six modules including Pharmacovigilance System Master File (PvMF), Collection, processing & reporting of individual case safety reports, preparation & submission of PSUR, Site performing pharmacovigilance quality management system, Audits and inspections of pharmacovigilance sites, Submission of risk management plan.

The PvMF file shall be located at the site in India where the PV activities of MAHs are performed. The PvMF shall contain all the information related to MAHs Pv system.

ADRs can be sourced from medical information inquiries, “Contact us” e-mails, website inquiry forms and helpline, Product Market complaints, MAH employees involved in PV activities, spontaneous information from patient, Published literatures, Spontaneous reporting by public and or HCPs, Reports from internet or digital media or social media, Patient-support programmes, Reports from Regulatory Authorities/NCC-PvPI, IPC, Contractual partners involved in Pv activities.

As per the guidelines, the quality assurance team of company needs to supervise the internal & external audits of PV system. The audit report must be documented within the quality system; with a brief description of CAPA associated with the significant finding-- the date it was identified and the anticipated resolution date(s) with cross reference to the audit report and the documented corrective and preventive action plan(s).

To ensure that MAHs comply with PV regulatory obligations and to facilitate compliance, Pv inspection at the place where PV activities are performed will be done jointly by the representatives from CDSCO, PvPI and concerned state licensing authority.

Inspections can be routine as well as targeted to MAHs suspected of being non-compliant. The focus of these inspections is to determine that the MAH has personnel, systems and facilities in place to meet their regulatory PV obligations for the marketed products in India.

When non-compliance with Pv regulatory obligations is detected, the necessary action will be taken on a case-by-case basis. It includes re-inspections, issuance of show cause notice for non-compliance actions against MAH, suspension of marketing authorization, pre-authorization inspections and delays in approvals of new marketing authorisation applications until corrective and preventive actions have been implemented.

The revised guidelines for MAH has been issued based on recommendations of a 15-member committee representing 60 pharmaceutical companies, set up with Dr Jamal Anwar Baig, country head, pharmacovigilance, Merck Sharp & Dohme as point of contact. The committee submitted measures in December last year to be adopted to ensure smooth implementation of regulation of post marketing surveillance of pharmaceutical products.

The recommendations were aligned with draft regulation of post marketing pharmacovigilance issued in March 2016.

“I feel very excited on being very closely associated with guidelines from the beginning. Now it is in final stages of getting approved, currently it circulated to various associations like IPA and OPPI once there comments are received by the CDSCO, the guidelines will be published officially. This will be a very significant step for ensuring patient safety in India and it will reduce the gap between India and other developed countries that currently exists in pharmacovigilance and drug safety space,” said Dr Baig.