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PVPI yet to reach vast population in India after 7 years of its launch
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Laxmi Yadav, Mumbai
March 27 , 2017
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Even though seven years have passed since Pharmacovigilance Programme of
India (PvPI) started in India, a vast population in the country is yet
to be covered under the drug safety programme.
PvPI was initiated
in July 2010 by Central Drugs Standard Control Organization (CDSCO)
under the aegis of Ministry of Health & Family Welfare (MoHFW), at
the All India Institute of Medical Sciences (AIIMS), New Delhi as the
National Coordinating Centre (NCC) to safeguard health of Indian
population. On April 15, 2011, the NCC was shifted from AIIMS to Indian
Pharmacopoeia Commission (IPC) which has gained recognition as the first
WHO collaborating centre for safety of medicines and vaccines in South
East Asia region.
So far 210 adverse drug reaction (ADR)
monitoring centres have been inducted under the PvPI which have reported
2.5 lakh adverse drug reaction cases to WHO monitoring centre at
Uppsala. These 210 centres comprise of Revised National Tuberculosis
Control Programme (RNTCP) centres, Antiretroviral therapy (ART) and
Bedaquiline centres, ADR centres at medical colleges, public and private
hospitals have covered only 20 per cent of the target population. Most
of the centres are located in urban areas. Medical colleges and health
facilities in rural areas need to be encouraged to have ADR monitoring
centres for patient safety reporting which helps identify and analyse
risk benefit ratio of marketed medicines, generate evidence on safety of
medicines and support regulatory agencies in decision making, said Prof
C Ramesh of IIHMR University, Jaipur.
He said that IPC, Medical
Council of India and CDSCO have exhorted medical colleges to put in
place ADR centres on their premises to improve drug safety monitoring
but the response is not encouraging. Its high time the government makes
it mandatory for public hospitals having 1000 beds to have ADR
monitoring centres. It should also be made mandatory for private
hospitals as well as medical colleges to set up ADR monitoring cells.
Small scale industries especially startups also need to be encouraged to
put in place ADR monitoring units.
India has a vast population
that exhibits genetic and ethnic variability, there also exists a vast
variation in disease prevalence. The ADR data so generated will help to
make vital policy decisions regarding safe use of medicines in Indian
population, he opined.
Prof Ramesh also emphasized the need for
revamping the PvPI programme in line with global standards to streamline
monitoring processes and improve surveillance, collection and analysis
of an even broader body of drug safety data.
Human data
extrapolated from animal studies does not give conclusive proof about
adverse drug reactions. Clinical trial being conducted in minimum
population in specific geographical locations can not produce conclusive
evidence about ADR. Drug acceptance and toxic effects of drugs vary
from country to country which can be attributed to difference in genetic
pattern, food habit and cofounding disease factors. All these
necessitate revamping of existing PvPI programme, he said.
Indian
pharma industry aptly called pharmacy of world and is expected to reach
USD 55 billion by 2020 and is driving force behind PvPI employing
around 16,000 workforce. With the Indian drug manufacturers’ capability
to develop and market new drugs out of their own research increasing,
its important that pharmacovigilance standards are strengthened in line
with global standards to monitor ADRs of products first launched in the
country, he said.
Third party monitoring at pharmacovigilance
departments of companies carried out by MHRA, USFDA needs to be adopted
by Indian regulatory body under PvPI.
With the rapid
technological advancements impacting pharmacovigilance obligations, he
called for software upgradation of existing ADR monitoring units in
respect of signal detection, quality review etc to improve ADR
monitoring.
Signal detection and clinical assessment of
Individual Case Safety Reports (ICSRs) is an inseparable domain of
pharmacovigilance. The WHO defines a Signal as “Reported information on a
possible causal relationship between an adverse event and a drug, the
relationship being unknown or incompletely documented previously”.
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