The license for “Insulin Tablets,” a homeopathic proprietary medicine produced by Bhargava Phytolabs, a Rajasthan-based company, has been revoked. This decision followed a complaint submitted to the Prime Minister’s public grievance cell concerning violations of Section 106 A(C) of the Drugs and Cosmetics Rules, 1945. The cancellation was officially communicated on October 23 to Dr. K.V. Babu, an ophthalmologist from Kannur and RTI activist, who had filed the initial complaint on September 23.
Dr. Babu was informed that Bhargava Phytolabs had failed to apply for the renewal of their license. The Prime Minister’s Office (PMO), quoting the Rajasthan State Drugs Controller, confirmed that the company’s license had been revoked.
Dr. Babu had previously filed a complaint with the Drugs Controller General of India (DCGI) on January 24, urging action against the company under the Drugs and Cosmetics Act of 1940 and the Drugs and Cosmetics Rules of 1945. Section 106 A(C) of these rules stipulates that no homeopathic medicine containing a single ingredient is permitted to carry a proprietary name on its label. Labels must clearly present information in indelible ink, and this must be displayed prominently on the innermost container and any packaging.
My concern was that a tablet being made available with the name insulin may confuse the patients, who may switch over from insulin injection to the tablets
Dr. K.V. Babu, The Activist
In June, the Central Drugs Standard Control Organisation (CDSCO) requested a review of the company’s license, and the Union Ministry of Ayush found issues with the product’s labeling. Dr. Babu explained that his concern was the potential for confusion, as patients might mistake these “Insulin Tablets” for a substitute for insulin injections, leading to uncontrolled diabetes, particularly in children. Despite intervention from the CDSCO and the Ayush Ministry, both the State Drugs Controller of Rajasthan and Bhargava Phytolabs initially refused to alter their labeling, prompting Dr. Babu to escalate the issue to the Prime Minister’s grievance cell.
The controversy centers on the use of the name “Insulin Tablets.” The manufacturer argued in May that their product had been "licensed" by the Rajasthan State Drug Licensing Authority. However, the Ayush Ministry found that the labeling of the product as “Insulin Tablets” violated the law, as it gave the impression that the tablets were a proprietary medicine, when in fact the product contained a single ingredient—Insulin 6x. This violation of the Drugs and Cosmetics Rules, 1945, was noted by authorities.
The Ayush Ministry stated that the manufacturer should clearly label the product as “Insulin Homoeopathic Trituration Tablets” with an appropriate potency, as licensed. This would prevent confusion and avoid misleading consumers, many of whom might assume the product was a direct substitute for insulin injections.
The Ministry found that labeling the product as ‘Insulin Tablets’ violated the law by imitating a proprietary name, misleading the public,
Ayush Ministry’s report.
Dr. Babu expressed concern that misleading labeling could pose serious health risks. He stated, “My concern was that a tablet being made available with the name insulin may confuse the patients, who may switch over from insulin injection to the tablets. This could lead to uncontrolled diabetes, especially in children.” His persistence in addressing the issue through formal complaints to both the CDSCO and the Prime Minister’s Office eventually led to the revocation of Bhargava Phytolabs’ license.
The decision to revoke the license underscores the importance of clear and accurate labeling for pharmaceutical products, particularly in the case of life-saving treatments such as insulin. Misleading labels can cause significant harm, especially when patients rely on them to manage chronic conditions like diabetes. The revocation of the license for “Insulin Tablets” serves as a cautionary tale for other manufacturers, highlighting the need to adhere strictly to regulatory guidelines and to avoid any labeling that might mislead the public.
Dr. Cyriac Abby Philips, MBBS, MD (Internal Medicine), DM (Hepatology and Transplant Medicine), tweeted that in India, a government known for its scientific progress initially granted a manufacturing license to a homeopathic company to produce and market oral insulin tablets. However, the license was later rescinded after medical professionals pointed out that oral insulin is not yet a viable treatment.
The Ministry’s decision also emphasizes the role of regulatory bodies in ensuring patient safety and public health by enforcing compliance with pharmaceutical labeling laws. Moving forward, the Ministry of Ayush has urged manufacturers to comply with the law and label products accurately, to prevent confusion and protect consumers from potential harm.
For now, Bhargava Phytolabs will have to cease the production and sale of “Insulin Tablets” until they meet regulatory requirements. The revocation of their license illustrates the seriousness of the issue and serves as a reminder of the consequences for violating drug regulations
(Input from various sources)
(Rehash/Yash Kamble/MSM)
