NEW DELHI: Despite clear directions from India’s drug regulator, the Ayush Ministry and the Rajasthan government have yet to act against a pharma company selling a homoeopathic medicine named ‘insulin’.
The Rajasthan-based company was found to be selling a homoeopathic tablet named ‘insulin,’ which had nothing to do with the actual insulin that controls diabetes.
RTI activist Dr K V Babu first flagged the issue in January. He wrote to the Drugs Controller General of India (DCGI) about the homoeopathic tablet and how it could confuse diabetic patients into stopping the actual insulin and switching over to the homoeopathic tablet, thinking they are the same.
According to Babu, despite clear directions from the DCGI to take action, the Ayush Ministry and the Rajasthan government have been sitting over the matter for the past some months.
“My complaints regarding the insulin tablets, which the DCGI found as illegal labelling and violation of the Drugs and Cosmetic Act, have been pending for five months with the DCGI, four months with the Union Ayush ministry, and three months with the Rajasthan Homeopathy Director. But no action has been taken yet,” said Babu, who is also a central working committee member of the Indian Medical Association (IMA).
He said the pharma company, instead of addressing the issue of illegal labelling, has claimed that it is a ‘licensed drug’ by the licensing authority of Rajasthan.
“My contention is not whether it is licensed or not. If the labelling was allowed erroneously by the State Licensing Authority of Rajasthan, it is their responsibility to rectify it,” Kerala-based Babu told this paper.
He said the Rajasthan authorities should have directed the pharma company to change the labelling of the ‘insulin’ tablets because of the directions given by the DCGI on February 13, followed by the communication from the Ayush ministry on March 11.
“The Rajasthan SLA should also have given direction straightaway to the pharma company to stop selling the insulin tablet drug rather than dragging the issue,” Babu said.
He said he flagged the issue as patients may get confused with a homoeopathic tablet named insulin, and could stop the use of the actual insulin which is injected through the skin into the fatty tissue.
The DCGI, Dr Rajeev Singh Raghuvanshi, on February 13, directed both the Ayush ministry and the Rajasthan Drugs Controller to “examine and take necessary action by the provisions laid down under Drugs and Cosmetics Act, 1940 and Rules there under.”
He also said, “It is pertinent to mention that as per Rule 106 A (C) of the Drugs Rules 1945 no Homeopathic medicine containing a single ingredient shall bear a proprietary name on its label.”
Insulin is a medication used in the treatment and management of diabetes mellitus type-1 and sometimes diabetes mellitus type-2, both of which are significant risk factors for coronary artery disease, stroke, peripheral vascular disease, and a host of other vascular conditions.
According to an Indian Council of Medical Research-INDIAB, which measured the prevalence of metabolic non-communicable diseases (NCDs) in the country, there are an estimated 101million people in India detected with diabetes, 136 million were found to be prediabetes and 315 million people from hypertension in 2021.
The national survey, which Dr. V Mohan, Chairman of Madras Diabetes Research Foundation (MDRF), and his institute coordinated, also said that 254 million people in India had generalised obesity, and 351 million had abdominal obesity. In addition, 213 million people had hypercholesterolaemia (high cholesterol), and 185 million had high LDL or bad cholesterol.
