New Delhi: A ban has been proposed on advertisements for products in the Indian traditional medicine category, by the Union Government’s Ministry of Ayush. The government has invited stakeholder opinions on the decision by May 12,2016 for comments .
As per the April 4, 2016 guideline, the ministry plans to put a restriction on advertisements on products/drugs related to Ayurveda, Yoga, Naturapathy, Unani, Siddha and Homeopathy. The draft notification clearly indicates that manufacturers who fall under this category should abstain from participating in publicity of this kind.However, the Ministry may allow advertisement of drugs as per contents noted or recorded by the state licensing authority or drugs controller reports Pharma Biz.
The ministry aims to disallow publicity material suggesting use of particular drugs for diagnosis, cure, mitigation treatment or prevention of any disease or disorder .The diseases covered under this restriction are -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 others.
All information related to advertisements to be prepared for Ayush products need to be submitted to the state licensing authority on form 26E4, along with an application fee of Rs. 1000 and supportive documentation, for each advertisement. If the manufacturer resides in more than one state, the application for the advertisement has to come in from all the states, where the manufacturer’s corporate offices exist.
The rejection of the applicant’s form can come in on the basis of vulgarity,obscenity, giving of false impression about the true character of AYUSH or making a misleading or exaggerated claim about the effectiveness of the said drug.
The state licensing authority has the right to appoint a panel of experts to decide on the fate of a manufacturers application and the disposal of it; which has to happen within 30 days from the date of submission. The licensing authority has the right to issue a unique identity number to the chosen advertisement.
The applicant is supposed to furnish whatever information is asked for by the licensing authority; in failing to do so he or she may run the risk of being rejected; the acceptance or rejection would be conveyed to him on form 26ES. However, the acceptance of an advertisement on the part of the state licensing authority would be recorded on Form E5 and will carry validity till the date the license happens to be valid.
The industry could also stand up to the state licensing authorities decision pertaining to an advertisement by appealing to the central government . The decision of the centre, however will be final. The AYUSH officers can also be instructed to keep a close watch on advertisements brought out by manufacturers in the print, electronic and audio visual mediums and report objectionable issues to the central government after every three months.
Reviewing drafts of advertisements, experts were of the view that special awareness for data review and wording of claims on labels and advertisements needed to be built, which they felt was a massive exercise in itself. The government has given 35 days for the stakeholders to submit their opinions.