Medicine Shortages Likely As DCGI Orders Action Against Marketers Tied To Non-Compliant Drugmakers

Last Updated:September 13, 2025, 08:00 IST

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. Representational image/PTI

India’s apex regulatory agency has warned that action will be taken against drug marketers for selling products of drugmakers who failed risk-based inspections, News18 has learnt.

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", said an order dated September 12.

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 also the marketers are responsible for supplying related compliance. “…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…"

Move could disrupt availability of drugs

India—the world’s largest supplier of generic medicines, also known as “pharmacy to the world"—starting in 2022, has faced recurring questions over the quality of some of its pharmaceutical exports and domestic supplies. From contaminated cough syrups linked to child deaths abroad to US FDA warning letters on manufacturing lapses, regulators worldwide have flagged gaps in adherence to good manufacturing practices (GMP).

Experts say that while India’s pharma industry is globally competitive in scale and cost, repeated instances of substandard or adulterated drugs have raised concerns about weak compliance systems and the accountability of both manufacturers and marketers. Risk-based inspections were initiated by the drug regulatory authority after such complaints were highlighted by several regulators.

However, with this move, experts cautioned that it could also disrupt medicine availability. If manufacturing licenses are suspended or entire product lines are halted due to non-compliance, patients may face gaps in the supply of commonly used drugs. “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."

Himani Chandna

Himani Chandna, Associate Editor at CNN News18, specialises in healthcare and pharmaceuticals. With firsthand insights into India's COVID-19 battle, she brings a seasoned perspective. She is particularly pass...Read More

Himani Chandna, Associate Editor at CNN News18, specialises in healthcare and pharmaceuticals. With firsthand insights into India's COVID-19 battle, she brings a seasoned perspective. She is particularly pass...

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