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Maha FDA calls for joint efforts with pharma industry to fight against counterfeit drugs
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Laxmi Yadav, Mumbai
September 21 , 2017
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The Maharashtra Food and Drug Administration (FDA) has emphasized the
need for collaboration among state and central drug regulators and
pharmaceutical industry to curb the menace of counterfeit drugs in the
country.
Though 13 samples (0.0245%) out of 47,012 samples were
found to be spurious and 3.16% out of 1,850 samples were not of standard
quality (NSQ) in national drugs survey, we as drug regulators must not
be complacent with it, as there should be zero tolerance of spurious
drugs, said Om Prakash Sadhwani, joint commissioner, Maharashtra FDA
while speaking at Pharmasafe conference held in Mumbai recently.
The
drug survey was conducted by Noida based National Institute of
Biologicals (NIB) in collaboration with Indian Statistical Institute
(ISI), Kolkata and Hyderabad and National Sample Survey Office (NSSO)
from 2014-2016.
Though a majority of drug makers comply with
GMP, GLP and other regulatory norms, there is laxity on the part of
manufacturers in ensuring proper safeguards in supply chain to rule out
entry of spurious drugs in the system, he said.
It is high time
pharmaceutical units put in place a robust mechanism which is
responsible for handling counterfeit drug issue. We have also appealed
to the government to facilitate collaboration between state and central
drug regulators in investigation of counterfeit drug cases to ensure
that culprits get caught in no time, said Sadhwani.
Awareness
about counterfeit drugs need to be created among stakeholders including
medical professionals, medical representatives, consumers etc. There are
several instances wherein authorised dealers of the drug makers were
found to be cheating them by purchasing certain quantity of drugs from
sources unknown to the said drug companies and circulating it in the
market. This has serious effect on business of drug companies as well as
health of consumers. Such incidents can be detected by the alert field
force of drug companies who often report drugs' secondary sale figure to
the companies.
Drug regulators and manufacturers need to work together to bring perpetrators of counterfeit drugs to justice, he stressed.
He
exhorted drug makers to take samples from the market on noticing
decline in their sale in a specific area and test them in the laboratory
and subsequently report to drug regulators if the sample is found fake
to put culprits behind bars.
Sadhwani also suggested certain
measures for consumers to ensure that they get safe medicines. He asked
them not to buy medicines without bills and purchase drugs under the
supervision of pharmacists at licenced pharmacies on the prescription of
a medical practitioner.
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