Ayurveda Unani and Siddha (AUS)companies had a free ground on advertisements till now. Hair grow, power booster, Himalayan rare herbs etc. etc. were making the rounds and majority of the customers lured into that. December 21 and 24, 2018 rang danger siren to the ears of AUS companies, as the AYUSH department has notified the Drugs and Cosmetics (Eleventh Amendment) Rules, 2018 and published on 24th in the official gazette. (1)
What this amendment for? AUS companies no longer will be able to give advertisements, blanket ban?
This is a reaction of the department and the government to the increased number of misleading advertisements making rounds in the market. The advertisements are become more luring than educating the customer or patients. Magical claims are sometimes made by the companies. In earlier years also the department have made some steps to curb the misleading advertisements but the numbers only increased. The signing of Memorandum of Understanding with Advertising Standards Council of India (ASCI), which is self-regulatory authority for the advertisement industry, was one of such step. (2)
ASCI and Grievances Against Misleading Advertisements (GAMA) portal of Department of Consumer Affairs have reported 804 cases of misleading claims or advertisements of herbal or AYUSH products and services. This data relates to April 2015 till January 2018. (3)
Drugs and Cosmetics (Eleventh Amendment) Rules, 2018
- The amendment adds Rule 170(1) to the D&C Rules. This new rule prohibits a manufacturer or agent from publishing any advertisement relating to the use of AUS drugs for diagnosis, cure, mitigation, treatment or prevent any disease, disorder syndrome or condition (4)
- If any manufacturer or agent want to give any advertisements for AUS drugs for a purpose other than that is mentioned above, they have to apply to the State Licencing Authority (SLA) for the Unique Identification Number(UIN). This condition is precedent, means the UIN need to be obtained before the advertisement is made.
- The application for UIN is not auto approved, it can be rejected if it is exaggerating, contains false claims, creates false impression, false claims, testimonials by government officials or celebrities with or without photo. Even existing advertisements need to get fresh UIN number.
To regulate the import, manufacture, distribution, sale, package and labelling of drugs including AYUSH drugs and cosmetics there is Drugs and Cosmetics Act 1940 (D&C Act) and Drugs and Cosmetics Rules 1945 (D&C Rules). There is more relevant Act and Rules, that is Drugs and Magic Remedies (objectionable Advertisements) ACT 1954 (DMROA Act) and Drugs and Magic Remedies (Objectionable Advertisements) Rules 1955. With regard to ASCI, it is only a self-regulatory authority, which looks on this aspect and its orders are self-regulatory in nature.
The amendment to Drugs and Cosmetics Rules in 2018 by adding new Rule 170(1) is a great step for protecting consumer interests, but is it proper? Can it create legal confusion in execution?
The D&C Act and DMROA Act are two different acts. Section 33N of the D&C Act says that the Central Government, after consulting or after getting recommendation from the board can make rules for the purpose of giving effect to the provisions of Chapter IVA of the Act. This chapter deals with import, manufacture, sale and distribution of drugs and cosmetics including AUS drugs. This chapter does not deal with the advertisement aspect of medicines.
Section 2(b) of DMROA Act covers AUS drugs also with other drugs as well Section 3 of the Act lays down a prohibition against advertisements of certain drugs of certain diseases.
This sections have clear cut provisions for the prohibition of advertising for drugs that claim treatment for certain diseases, and will of course apply to AUS drugs also. Section 3 of the DMROA Act also states that in the case AUS drugs, before making any rules by the Central Government, the Drugs Technical Advisory Board must be consulted, and also, person with special or practical knowledge with AUS drugs.
Whether the new amendment is overlapping existing provisions ?
So when the D&C Act doesn’t clearly have provisions for powers to prohibit advertisements on drugs, DMROA Act contains clear provisions. So making a rule or amendment to prohibit advertisements on drugs in D&C Act lacks logic. This might have been made on DMROA Act itself, which is enacted for the specific purpose.
There is one more point, we need to consider here. Where this new rule looking for a blanket ban on AUS drugs advertisement, there are no such prohibition for allopathic drugs. It is very interesting to note that in 2016 and 2018 more than 900 allopathic drugs were prohibited or banned as the regular or continuous usage can give negative results. In such cases, this rule denies a level playing ground for AUS drugs with allopathic drugs. This is going to be a big challenge for AUS drugs and companies to face.
Without questioning the need of the rule, as regulations helps to give more clarity, a blanket ban on some sectors and not on competitive sectors will not help the industries to survive. Of course the companies which manufacture AUS drugs definitely will find the wordings to overcome the effect of the same but overlapping and blanket ban may have been avoided and made specific.