Despite repeated directives from India’s national drug regulator, the Rajasthan state drug controller has failed to take action against a pharmaceutical company selling a homeopathic tablet branded as ‘insulin.’ This product, while bearing the same name as the hormone essential for diabetes management, has no relation to actual insulin used for treating diabetes.
The Drug Controller General of India (DCGI) and the Union Ayush Ministry had both instructed the Rajasthan homeopathy director to address the issue, emphasizing that the license for the product should be reviewed and appropriate legal measures be taken under the Drugs and Cosmetics Act, 1940.
Dr. KV Babu, an RTI activist who initially raised concerns about the product in January, reported that the Rajasthan State Licensing Authority (SLA) has ignored these directives. The state drug controller, Raja Ram Sharma, responded to the DCGI and Ayush Ministry stating, “No complaints have been received, and no specific instructions from the DCGI regarding product misuse have been issued. The product was approved long ago based on official references and recognized monographs for homeopathic medicines. Thus, no further action is deemed necessary.”
Sharma’s letter continued, “The product is labeled as a homeopathic medicine, and no violations of Rule 106 A (C) of the Drugs and Cosmetics Act, 1940 have been identified.” The state drug controller concluded that, according to the norms, no additional steps are required at the state level.
Dr. Babu, who received the RTI response on August 2, contends that the DCGI had validated his concerns about the labeling’s legal violations and had instructed the state authority to act on multiple occasions. The continued inaction by the Rajasthan authorities has raised significant concerns about regulatory compliance and consumer safety.
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