On March 15, 2018, the Parliamentary Standing Committee on Health and Family Welfare, presented its 108th Report wherein, among other concerns, it had raised the issues pertaining to misleading advertisements. Critiquing the ‘laid back’ approach of the health and family welfare and Ayush ministries the Committee stated, “…the Ministry of Ayush should aggressively pursue the matter with the ministry of health and family welfare so that relevant provisions are incorporated in the legislation and enacted so as to prohibit misleading advertisements and strengthen the effective regulation of ASU&H drugs.

Subsequently, on December 21, 2018, the Ayush ministry issued a notification introducing Rule 170 under the Drugs and Cosmetics Rules 1945. The new Rule mandated that no manufacturer or their agent could advertise Ayurveda, Siddha or Unani (ASU) drugs for the use of diagnosis, cure, mitigation, treatment or prevention of any disease, disorder, syndrome or condition. It also mandated that for advertisements not disallowed, manufacturers must secure a Unique Identification number from the State Licensing Authority or Drug Controller.

Different manufacturers immediately approached the different high courts challenging the validity of the new Rule. The Delhi High Court was the first to stay the rule on January 15, 2019. Similarly, the Bombay High Court granted a stay on February 11, 2019, and the Kerala High Court granted a stay on April 29, 2019. Subsequently, the ministry appears to have constituted an expert committee under the Chairmanship of S.S. Savrikar, chairman, Pharmacopoeia Commission for Indian Medicine & Homeopathy, to consider the amendment pertaining to ASU drugs.

This committee recommended the omission of Rule 170 and the recommendation was placed before the Ayurveda, Siddha and Unani Drugs Technical Advisory Board (ASUDTAB), a statutory body under the Drugs and Cosmetics Act, 1940, on 15th March 2021. The ASUDTAB endorsed the omission of Rule 170. The Board also noted that amendments in the Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954 were also under consideration and suggestions had been provided with regard to the prevention of misleading advertisements.

The Ayush ministry then circulated the amended draft rules of the Drugs and Cosmetics Act, 1940, in 2021 wherein Rule 170 was omitted. However, in a subsequent meeting of the ASUDTAB on June 27, 2022, it was decided that it may not be appropriate to omit Rule 170 in anticipation of its inclusion in the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954. Thus, the Board concluded that the Omission of Rule 170 is not required.

On May 1, 2023, the Delhi High Court disposed of the challenge to Rule 170 on the statements of the counsels for the parties that the Rule as well as the connected Form 26E4 shall be re-examined and reconsidered by the ASUDTAB. Subsequently, the Technical Board met on May 25, 2023. In this meeting, it was noted that the recommendation not to omit Rule 170 was not correct as it amounted to negating the board's previous decision taken on March 15, 2021, based on the report of an expert committee.

Based on the recommendations in this meeting, the Ayush ministry, issued a formal letter on August 23, 2023, directing the different State/UTs licensing authorities not to initiate/take any action under Rule 170 of the Drugs & Cosmetics Rules, 1945. The letter mentioned that a formal notification omitting Rule 170 would take time.

In October 2023, in response to an RTI query asking for the reason for the omission of Rule 170, the Ayush ministry is said to have replied by stating, ‘decision for the omission of Rule 170 was a conscious decision, considering a policy of the government to promote ease of doing business.” The reply also stated that the Pharmacovigilance programme of Ayush had been strengthened to curb misleading advertisements.

Despite the assurances, the Patanjali contempt case revealed the complete lack of action with regard to misleading advertisements. One of the reasons for inaction was the stay on Rule 170.

On April 23, 2024, the Supreme Court decided to examine misleading advertisements closely and said the issue was not limited to just ASU drugs but also FMCGs/Pharmaceutical Companies. During this hearing, the Court also asked the Union government to explain how it issued a letter staying the implementation of Rule 170 on mere recommendations of a body when the Rule was not legally deleted or omitted.

The Union government tried to defend the letter by stating that the final gazette notification would take time, and with an intent to avoid confusion and prevent litigations, the letter had been issued for the time being. The apex Court rejected the explanation and noted that an administrative instruction cannot put on hold a rule which is enforceable in law. The Additional Solicitor General assured the Court that the letter dated August 29, 2023, would be withdrawn.

However, on July 1 this year, the Ayush ministry published a notification officially omitting Rule 170. This notification has been stayed by the Supreme Court.

The Court is presently, looking into the issue of misleading advertisements as a whole and has impleaded the Advertising Standards Council of India, Central Consumer Protection Authority, the consumer affairs ministry, ministry of electronics and information technology, ministry of information and broadcasting among others.

Internet and smartphones have expanded the reach of advertisements. In a country like India where most medicines are available without a prescription, the need for greater regulation in the advertising, distribution and sale of drugs is essential. Ease of business cannot be at the cost of public health.

Parijata Bharadwaj, a lawyer and researcher based in New Delhi, co-founded the Jagdalpur Legal Aid Group that offered legal services to adivasis in Chhattisgarh. The views expressed are personal.