Marketers Linked to Defaulting Pharma Units Under DCGI Lens
New Delhi: The Drugs Controller General of India (DCGI) has warned that action will be taken against drug marketers for selling products of drugmakers who failed risk-based inspections, reports News18.
In two specific cases, the state drug controllers of Gujarat and Delhi have been asked to initiate action against marketers linked with non-compliant manufacturers. Authorities highlighted a critical finding that “the marketers’ addresses mentioned on the labels of the drugs have also been found to be non-existent in a few cases.”
“Based on the market data, names of a few of the marketers of the drug were obtained and RBI of the associated manufacturers was carried out. It was observed that in most of the cases, several critical observations were reported by the inspecting team," the Drug Controller General of India (DCGI) wrote in an order sent to all states and union territories, accessed by News18.
It was observed that in most cases, the order said, “several critical observations were reported by the inspecting team." “Based on the recommendations of the inspecting team, the concerned State Licensing Authority (SLA) has taken action, such as the issuance of a stop manufacturing activity order. Cancellation of the manufacturing section, suspension of product permission and issuance of warning letters."
SLAs in Action
Following these findings, State Licensing Authorities (SLAs) have issued a series of enforcement measures, including “issuance of stop manufacturing activity, cancellation of manufacturing section, suspension of product permission and issuance of warning letters," an order dated September 12 read as quoted by News18.
The order also reminded the industry that, under drug laws, it is not just the drugmakers who are responsible for making the best quality drug, but “the marketer of drugs is also responsible for the quality of drugs as well as other regulatory compliances along with the manufacturer," the order mentioned.
Moreover, the regulator has asked state offices to “sensitise the marketers of drugs under your jurisdiction against such violations and take action in cases warranted…”
Possible Impact on Drug Supply
Experts cautioned that the enforcement drive could disrupt availability of medicines. “When regulators clamp down on non-compliant units, it immediately affects production volumes, and since marketers are also being held accountable, the distribution chain gets disrupted," an industry veteran explained.
According to another industry official, representing a top pharma company based in Mumbai, “The para invoked by the regulator under ‘Liability of marketer under rule 84(E) of the observation of risk-based inspection and critical observation’ is a very serious concern of the industry. How can the manufacturer be equated with a marketer having a different role? In my view, it is an alarming situation for the industry."
