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CDSCO releases revised draft guidelines on post marketing surveillance of pharmaceutical products
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Laxmi Yadav, Mumbai
June 23 , 2017
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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.
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