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The Recent Ban On Advertising Of Ayurvedic, Unani And Siddha Drugs (ASU Drugs)

In the contemporary times of yore we perceive that, there has been inflation in the quantity of misleading advertisements that have taken place relating to the Ayurvedic, Unani and Siddha drugs (ASU Drugs). Therefore, the Government via The Ministry of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy (AYUSH) has amended the Drugs and Cosmetics (Eleventh Amendment) Rules, 2018 (Amendment) vide its notification G.S.R. 1230(E) on December 21, 2018. The amendment seeks to regulate the advertisements of ASU Drugs by curbing the misleading advertisements. In an endeavour to scrutinize the misleading advertisements that were taking place in media and print, there was a Memorandum of Understanding (MoU) signed by Ministry of AYUSH with the Advertising Standards Council of India (ASCI).
It’s been reported by the Grievances Against Misleading Advertisements (GAMA) and Advertising Standards Council of India (ASCI) that, there have been 804 cases relating to misleading advertisements of AYUSH products and services including Ayurvedic medicines between April, 2015 and January, 2018.
There are various Regulations that govern ASU Drugs in India. The Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945 regulate the import, manufacture, packaging, distribution, labelling and sale of drugs. The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 and the Drugs and Magic Remedies (Objectionable Advertisements) Rules, 1955 govern the regulation of advertisements for drugs (including ASU drugs).
The recent amendment to the Drugs and Cosmetics (Eleventh Amendment) Rules, 2018 intend to guard the consumer interests and regulate the AYUSH industry. The amendment added Rule 170(1), prohibiting a manufacturer or his agent from publishing and advertisement relating to the use of ASU drugs for mitigation, treatment or prevention of any disease, disorder, diagnosis, cure, syndrome or condition. The amendment mentions about the Unique Identification Number (UIN), which is required for advertising and ASU Drug for purposes other than that prohibited under the aforesaid rule i.e. Rule 170(1). One needs to apply to the State Licensing Authority (SLA) for the UIN within a period of three months from the date of notification of this Amendment. The SLA has power to suspend and cancel manufacturing licences if the directions are not followed.
The Amendment mentions about the grounds on which application for advertisements can be rejected. This includes, misleading claims about the effectiveness of the concerned ASU Drugs; depiction of testimonials or photographs of government officials or celebrities; appearance of inaccuracy about the real nature of the ASU Drug; vulgar content; if that drug or medicine is referred and used for capacity of performance of both male and female organs or to enhance the height etc; reference to the government or an autonomous organisation of the government. The Amendment also mentions that if the advertisements don’t fall within these grounds, then they need to apply for the UIN before April 21, 2019.
There are a lot of issues relating to this Amendment.  Firstly, the Amendment lacks in clarity and is not justified because, as according to the Rule 170 the applicant has to submit the data a second time which has been already submitted to the regulator while applying for a manufacture, sale or import licence under the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945. Secondly, in Section 33N of the Drugs and Cosmetics Act, 1940 Central Government has powers to make rules for with the intention to give effect to the provisions of the Chapter IVA of the Act, which deals with the regulation of import, manufacture, sale and distribution of drugs and cosmetics (including ASU drugs). Therefore, we see that advertisement of the drugs is outside the purview of the said Act and even the rules, but, is a subject matter under the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954. Thirdly, the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 has provisions prohibiting advertisements of drugs (which apply to ASU drugs as well) so the question arises as to why there is a need for an additional rule if this already exists. Fourthly, the Draft Rules that was submitted differed from the Final Rules. Fifthly, as the Amendment differentiates between allopathic drugs and ASU drugs without any basis, is violating the right to equality under Article 14 of the Constitution of India. It also violates Article 19(1)(a) as the amendment violates the right to freedom of commercial advertisements.
Let’s hope that this amendment doesn’t cause turmoil and disruptions in the ASU drug industry and the industries are more vigilant with their advertising and marketing strategies.




 Shristi Talukdar is currently in her 5th Year of B.A.LLB.(Hons) at National Law University and Judicial Academy, Assam. She has immense interest in the field of Intellectual Property Law.


In Content Picture Credit: DNA India


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