P A FrancisWednesday, January 11, 2017, 08:00 Hrs  [IST]

A set of rules prohibiting misleading advertisements of Ayurveda, Siddha & Unani drugs is expected to be introduced in the country in the coming weeks by suitably amending the Drugs & Cosmetics Rules, 1945. The Union Ministry of Ayush in consultation with Ayurveda, Siddha and Unani Drugs Technical Advisory Board had already framed and notified draft rules for prohibition of misleading advertisements of these drugs in the Official Gazette April last year. As per the draft Rules, manufacturers are directed to refrain from taking part in publicity of such products. The publicity material which suggests use of particular drugs for diagnosis, cure, mitigation treatment or prevention of any disease or medical condition is disallowed. The manufacturer of products in these systems may advertise them as per the contents noted or recorded by the state licensing authority or drugs controller. Application for making the ads 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 with 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 ads should be submitted to the licensing authority of the state where the corporate offices of the company are located. Application for the ads can be rejected if the contents directly or indirectly tantamount to vulgarity or obscenity or gives a false impression about the true character of the product or make a misleading or exaggerated claim about the effectiveness of the drug. State governments can notify in the official gazette for Ayush officers to monitor the surveillance of ads in print, electronic, internet and audio visual media. They also have to maintain a register, make appropriate entries including those found inappropriate and provide the data to the Central government on a quarterly basis.

Over the years, the number of companies selling ayurvedic and traditional medicines through commercial advertisements in media claiming to cure any diseases without scientific evidence or clinical trials has increased tremendously. The practice of conducting clinical trials before launching of a new Ayush drug does not exist now and drug authorities in the country do not have any credible proof of efficacy and safety of these products. In a situation like this, advertising of products with false and exaggerated claims can definitely endanger lives of millions of poor and illiterate people in country. At present, complaints regarding misleading content of the ads of ayurvedic medicines received by the Ministry of Ayush forwarded to the concerned State Licensing Authorities with the direction to take necessary action in accordance with the provisions of Drugs & Magic Remedies Act and Drugs & Cosmetics Act. In quite a few cases, the state authorities reported to have taken actions against the offenders. But, many unscrupulous companies escape the provisions of the existing acts. A specific set of rules to curb the unethical practice of marketing Ayush products by way of advertising was thus long overdue. In fact, these rules should also have provisions to regulate ads in the social media and internet considering the growing reach of these two new communication channels.