Pharma companies seek more teeth for agencies to fight fakes

India's leading drug makers have urged the Supreme Court to empower police and drug inspectors to conduct investigations against those suspected of manufacturing counterfeit drugs.

In a petition filed last week, the Indian Pharmaceutical Alliance (IPA)-a grouping of 23 leading Indian drug makers-urged the top court to direct the health ministry to formulate guidelines for filing of FIRs and the procedure for arrest of those selling and manufacturing counterfeit drugs, both of which are punishable under the Drugs and Cosmetic Act, 1940.

A senior industry executive alleged that the police have been reluctant to cooperate with state drug inspectors in enforcing laws related to counterfeit drugs.


This, the person said, started after the Supreme Court, in a 2020 case, prohibited police from prosecuting manufacturers of counterfeit drugs.

With no training or protection, drug inspectors are hesitant to take up planned operations to bust units that make counterfeit drugs, the executive said, adding that lack of enforcement has weakened the deterrent effect, and that may have led to a surge in counterfeit and spurious drugs in the market. In at least four cases where counterfeit drugs were found, no action was taken, the executive said.

The IPA declined to comment. The alliance's move follows a crackdown by central and state drug regulators in August that found medicines of over 50 leading brands to have lower potency than the mandated standards.

In regulatory parlance, this is referred to as 'not of standard quality' (NSQ). Among these brands are Shelcal, Pan-D, Clavam and Telma H. The makers of these drugs denied that such brands were made by them, labelling them as non-genuine and spurious.


On behalf of its members like Torrent, Sun Pharma, Alkem and Glenmark, the IPA issued a statement on September 29 denying that the drugs were made by its member companies. Instead, on internal lab tests, the industry body noted that they were supplied by units making spurious or counterfeit drugs.

"Manufacturing spurious drugs is a serious criminal offence that threatens public health," Sudarshan Jain, secretary general of IPA, had said. "The outrageous linking of spurious products with legitimate manufacturers has severe reputational and financial impact. Moreover, this tarnishes India's reputation as a reliable supplier of medicines on a global stage."

His assertion was that the NSQ drugs are confusingly seen as spurious or counterfeit drugs that contain no active ingredients and are passed into the market with deceptive packing.

NSQ drugs may lack the potent ingredients, but spurious drugs are drugs that have no active substance and are made by fly-by-night bogus units.