Union government’s ministry of Ayurveda, Yoga, Naturopathy, Unani, Siddha and Homoeopathy(Ayush) has issued a draft notification related to ban on advertisements for products from the Indian traditional medicine category. The government has sought comments and suggestions from the stake holders within 35 days which is by May 12, 2016.

In a draft guidelines issued on April 4, 2016, the ministry has prohibited advertisements of Ayurveda, Yoga, Naturopathy, Unani, Siddha and Homoeopathy. Manufacturers under this category should refrain from taking part in publicity of such products, as per the draft notification.

The publicity material which suggests use of particular drugs for diagnosis, cure, mitigation treatment or prevention of any disease or disorder are banned. These include appendicitis, baldness, greying of hair, blindness, cancer or tumour reduction, cataract, change of fetal sex, chikungunya, dengue, fairness, diabetes, deafness, Parkinson’s disease, schizophrenia, hepatitis B and C, gangrene, mental retardation and various others.

The manufacturer of Ayush drugs may advertise the drug as per the contents noted or recorded by the state licensing authority or drugs controller.

The application for making the advertisements of any Ayush products needs to be submitted to the state licensing authority in Form 26 E4 specifying claims such as textural references, rationale from the authoritative books scientific evidences regarding safety, efficacy and quality of the drug. The application fee of Rs. 1,000 per advertisement  needs to be deposited along with Form 26 E4 and other supporting documents.

If the Ayush manufacturer is located in more than one state, the application for the advertisement should be submitted to the licensing authority of the state where the corporate offices of the company are located.

Application of the advertisements can be rejected if the contents directly or indirectly tantamount to vulgarity or obscenity or gives a false impression about the true character of Ayush or make a misleading or exaggerated claim about the effectiveness of the said drug.

The state licensing authority can appoint a panel of experts for disposal within 30 days from the date of receipt of the application and may allot a unique identity number to the intended advertisement.

The Ayush applicant must furnish the required information to the licensing authority when called, failing which the application could be rejected. The state licensing authority on being satisfied with the application can convey the approval or rejection with reasons in Form 26 ES. The advertisement recorded by the state licensing authority in Form E5 will be valid till the date of license validity.

The industry could also file an appeal before the central government against the orders of the state licensing authority under sub-rule 8. However, the decision of the central government will be final.

State governments could also notify in the official gazette for Ayush officers to monitor the surveillance of advertisements in print, electronic, internet and audio visual media. They will need to maintain a register, make appropriate entries including those found inappropriate and provide the data to the central government on the quarterly basis.

Commenting on the draft, experts sector said, “This is nothing but a reinstatement of a procedure, much more legally through a notification. Before the department of Ayush was set up such clearances of ads used to happen in Nirman Bhavan which houses the ministry of health. While the move puts legal structure for this process, Ayush licensing authority needs to be taken on their competency to review the claim support. Till this happens, there would be problems in this procedure being implemented.”

Gathering a general opinion across the industry, it is learnt that special awareness for data review and wording of claims on labels and advertisements needs to be built, which is a massive exercise.