S. Harachand is a pharmaceutical journalist based in Mumbai. He can be reached at
The pharmacovigilance sector has re- ceived a much-needed booster dose with India finalizing a regulatory
roadmap for post marketing surveillance
of pharmaceutical products. Central Drugs
Standard Control Organization (CDSCO),
the office of India’s top regulator, has
come out with a draft of revised guidelines
for surveillance of safety of pharmaceuticals approved and sold in the market.
The regulatory agency charted out the
document in association with the Indian
Pharmacopoeia Commission (IPC), which
currently co-ordinates various pharmacovigilance activities across the country. Practices like signal detection, safety updates
or risk management etc have not been
very common among the Indian firms.
Select hospitals and only a small number
of companies used to report adverse drug
reactions (ADR), as per Phramacovigilance
Programme of India (PvPI).
That is perhaps the reason why the
Government of India, in a landmark decision, mandated pharmacovigilance a legal
obligation for the pharmaceutical industry
through a notification in March last year.
It also made compulsory for firms seeking
marketing approvals to have pharmcovig-ilance system, managed by qualified and
trained personnel, in place.
The draft surveillance guidance issued
by CDSCO categorizes pharmaceutical
products under four broad groups: New
drugs, subsequent drugs approved after
4-years; biologics; radiopharmaceuticals
The focus is on identifying the risks
emerging from the use of pharmaceutical
products“circulating in the market after post
licensure period” and setting up a pharmacovigilance system at the site of importers
and manufacturers to mitigate such risks.
A site-based pharmacovigilance system
should be managed with a medical officer or
a pharmacist as a pharmacovigilance officer-in-charge (PVOI). This officer will collect
and analyse adverse drug reaction reports
related to pharmaceutical products marketed by the company in India.
The PVOI will take care of collation, processing, assessment, reporting and follow-up of individual case safety report (ICSR).
Marketing authorization holders should
submit all ICSRs to National Coordination
Centre, Pharmacovigilance Programme of
India within the prescribed timelines, in
specified electronic format as per the norms
stipulated in the Schedule Y of Indian Drugs
& Cosmetics Act, 1940 and Rule 1945—the
pharma rule book.
In a system where PVOI is at the center, the
officer also looks after detection of signal, corrective and preventive action, preparation and
submission of periodic safety update report
(PSUR) of new drugs and risk management
system for each pharmaceutical product.
The document enlists training for system
staff, framing of standard operating procedures, maintenance of quality management
system of pharamacovigilance department
are the responsibilities of the PVOI.
Delineating the roles and responsi-
bilities of regulatory authorities including
CDSCO, PvPI at IPC, it recommends that
Pharmacovigilance System Master File
(PvMF), which will contain all the infor-
mation pertaining to PV system, shall be
located at the site in India where the PV
activities are performed.
Supervision and audits of the PV system
need to be carried out by the company’s qual-
ity assurance team. Representatives from CD-
SCO, PvPI and concerned state licensing au-
thority will jointly hold inspections at the place
where PV activities are performed to ensure
compliance with regulatory obligations.
Violators will face penal actions rang-
ing from re-inspections to suspension of
marketing authorization to delays in ap-
provals of new marketing authorization
applications until corrective and preven-
tive actions have been implemented.
Several companies have already started
establishing in-house PV systems in their
organizations. While others meet the reg-
ulatory obligations through hiring services
from pharmacovigilance CROs. The guid-
ance document views contractual partners
as“potential source of ICSRs” and recom-
mends to clearly define responsibilities re-
garding PV activities among partners.
Meanwhile, CROs discern the regula-
tory move having a positive impact that
will spur the growth of India’s pharmaco-
vigilance outsourcing industry. The trend of
roping in CROs for managing Indian phar-
macovigilance compliance is more visible
since the 2016 order mandating PV cells.
However, Indian companies with a ge-
neric mindset could take some time to un-
derstand that global pharmacovigilance ob-
ligations are no different for innovators and
generic drug makers and to accept pharma-
covigilance as an integral part of their sys-
tem, according to Dr. Venkatraman.
Evidently, implementation of good
pharmacovigilance practices is expected
to improve compliance and reduce the
current gap in post marketing surveillance
and drug safety that exist between India
and other tightly regulated markets. CP
India Frames Guidance for
Outsourcing PV functions to rise.