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.