Manufacturing licence of ‘Insulin’ homeopathic tablets cancelled

The licence of ‘Insulin Tablets’, a homoeopathic proprietary medicine manufactured by a Rajasthan-based company, has been cancelled. This follows a complaint filed with the Prime Minister’s public grievance cell over violation of the Section 106 A(C) of the Drugs and Cosmetics Rules, 1945.

Kannur-based ophthalmologist and RTI activist K.V. Babu, who had filed the complaint on September 23, was informed on October 23 that Bhargava Phytolabs, the manufacturing company, had not submitted any application for the renewal of the licence. Quoting the State Drugs Controller, Rajasthan, the PMO also said that the licence stood cancelled.

Proprietary name

Dr. Babu had earlier filed a complaint on January 24 with the Drugs Controller General of India seeking action against the manufacturer under the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945. Section 106 A(C) of the Drugs and Cosmetics Rules, 1945, says that no homoeopathic medicine containing a single ingredient shall bear a proprietary name on its label. The particulars shall either be 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 Central Drugs Standard Control Organisation (CDSCO) sought a review of the licence in June and the Union Ayush Ministry found the labelling incorrect. “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. I approached the PM’s grievance cell as the State Drugs Controller of Rajasthan and the manufacturer refused to budge even after the CDSCO and the Union Ayush Ministry made their stand clear about the illegal labelling,” Dr. Babu said.

In their reply to the authorities, the manufacturer had said in May that the drug had been “licensed” by the Rajasthan State Drug Licensing Authority. The Ayush Ministry, however, found that the manufacturer was labelling the product 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 had also 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 to avoid confusion and misleading information in public interest.