NEW DELHI: Despite repeated directions from India’s drug regulator, Rajasthan’s state drug controller continues to defy orders to take action against a pharma company selling a homeopathic medicine named ‘insulin.’
The Rajasthan-based pharma company was found to be selling a homeopathic tablet named ‘insulin,’ which has nothing to do with the actual insulin used to control diabetes.
Not only the Drug Controller General of India (DCGI) but also the Union Ayush Ministry had asked the state homeopathy director to take appropriate action against the company, stating that “the licence issued to the said product may be reviewed and appropriate action taken as per the Drugs and Cosmetics Act, 1940 and Rules thereunder may be initiated against the alleged product.”
However, RTI activist Dr KV Babu, who first flagged the issue in January this year, said that the Rajasthan State Licensing Authority (SLA) had overruled the directions of the DCGI and the opinion of the Ayush Ministry.
In its letter to the DCGI and Ayush Ministry, the Commissioner of Food Safety and Drugs Control, Rajasthan, said, “The state has received no complaint, and no directions have been received from the DCGI regarding the misuse of product labelling. It is also submitted that these products were approved in the state and other states a long time ago due to an official monograph reference book regarding the homeopathic medicine and reference products available in the indigenous and internationally recognised manufacturers market. So, further action is not required.”
“As far as labelling of the medicine is concerned, it is clarified that there is no violation of Rule 106 A (C) of the Drugs and Cosmetics Act, 1940 and Rules 1945 made thereunder, as it does not have any proprietary name,” said the letter, signed by Raja Ram Sharma, Rajasthan’s Drug Controller.
“The subject drug ‘Insulin’ is claimed to be a homeopathic drug, and on the label of the drug, it is mentioned as ‘homeopathic medicine,’ and this has been labelled as per norms. Given the above, no further action is pending at the level of the Commissionerate, Food Safety and Drug Control, Rajasthan,” the letter added.
Kerala-based opthalmologist Babu, who received the RTI reply on August 2, said the DCGI had agreed with his contention that the labelling of the medicine violated the Drugs and Cosmetics Act, 1940 and had given directions to the state licensing authority (SLA) to take action not once but twice.
Misnomer
The Rajasthan-based pharma company was found to be selling a homeopathic tablet named ‘insulin,’ which has nothing to do with the actual insulin used to control diabetes. The Drug Controller General of India and the Union Ayush Ministry had asked the state homeopathy director to take appropriate action against the company.