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.