‘Insulin’ homoeopathic tablets under CDSCO lens

The Central Drugs Standard Control Organisation (CDSCO) has sought a review of the licence given to ‘Insulin tablets’, a homoeopathic medicine. Action could be initiated against its Rajasthan-based manufacturers under the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945, for incorrect labelling.

Rajeev Singh Raghuvanshi, Drugs Controller General of India (DCGI), issued a directive for the purpose on June 19 to Rajaram Sharma, Drugs Controller, Government of Rajasthan. It is based on a complaint filed by Kannur-based ophthalmologist and RTI activist K.V. Babu, also a central working committee member of the Indian Medical Association.

In a mail to the DCGI on January 24, Dr. Babu had pointed out that the labelling on the tablets was confusing and patients might stop the use of real insulin and switch over to them as they were more convenient to get. Subsequently, the DCGI found the labelling violating Section 106A(C) of the Drugs and Cosmetics Rules, 1945, which says no homoeopathic medicine containing a single ingredient shall bear a proprietary name on its label. The particulars shall be either printed or written in indelible ink and shall appear in a conspicuous manner on the label of the innermost container of any homoeopathic medicine and on every other covering in which the container is packed. The matter was forwarded to the Union Ayush Ministry on February 13, and later to the Rajasthan State authorities on March 11.

However, Bhargava Phytolabs, the manufacturers, said in its reply on May 3 that it was a drug licensed by the Rajasthan State Licensing Authority (SLA). Dr. Babu contended that the issue was not whether it was licensed or not, but if the labelling was allowed erroneously by the SLA. It was their responsibility to rectify it. The Ayush Ministry again wrote to the Rajasthan authorities on June 19 seeking action.

Later, the Ministry found that the manufacturer was labelling the product ‘Insulin tablets’ as a brand name and indicating its composition saying “Each tablet of 400 mg contains Insulin 6x”. Insulin 6x is a single ingredient drug in this case and writing ‘Insulin tablets’ on the label imitating it as a proprietary name was in violation of the Drugs and Cosmetics Rules, 1945. The Ministry noted that the manufacturer may be directed to prominently label the product as “Insulin Homoeopathic trituration tablets” with appropriate potency for which it has obtained licence instead of using “Insulin tablets” as a proprietary name so as to avoid confusion and misleading information in public interest.