Pharma unit loses licence over spurious cardiac injection in export consignment

Spurious medicines pose a serious threat to public health as they can lead to treatment failure, toxic reactions, worsening of diseases and even death, particularly when used in life-saving situations.

Confirming the action, Assistant Licensing Authority Garima Sharma said the unit was initially issued a “stop manufacturing” order and subjected to a risk-based inspection after the matter was flagged by officials of the Central Drugs Standard Control Organisation (CDSCO).

According to Sharma, a communication received from the Drugs Controller General of India (DCGI), based on a report of the Government Analyst at the Central Drugs Testing Laboratory, Mumbai, declared a sample of Adenosine Injection bearing batch number WADG25002A as spurious.

Officials said the injection, marketed through a Mumbai-based firm, was approved only for domestic distribution but was exported in violation of regulatory norms. The product was subsequently declared spurious in an African nation, bringing embarrassment to the pharmaceutical industry and raising concerns about regulatory compliance.

Taking serious note of the violation, the DCGI directed CDSCO officials in Baddi to conduct a detailed inspection in coordination with the state drug control administration. The inspection revealed deficiencies in manufacturing practices, prompting authorities to first halt production and later revoke the firm's licence.

The company has been prohibited from manufacturing, selling or distributing any drugs under provisions of Section 18(c) of the Drugs and Cosmetics Act. The case has also highlighted concerns over alleged collusion between marketing firms and manufacturers seeking profits through regulatory violations.