Ongoing proceedings against Patanjali

KV Babu, an ophthalmologist from Kannur came upon an advertisement in 2019 by Patanjali which claimed that their eye drops could cure glaucoma. He also noticed that few of his patients chose to use the drops to self-medicate and returned to him in a year when the disease had worsened. Babu noted that the misleading advertisements continued especially regarding diseases specifically debarred in section 3 of the Drugs and Magic Remedies Act 1954.

On February 24, 2022, he wrote a complaint to the Drugs Controller General of India, which forwarded the complaint to the AYUSH ministry on March 16 that year. On April 15, the ministry wrote to the director of Ayurvedic and Unani Services, Uttarakhand, concerning the products Lipidom, Livogrit, Livamrit, Madhunashini and Madhugrit and instructed them to take appropriate action under the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 and the Drugs and Cosmetics Act and Rules, 1940.

The SLA wrote to Divya Pharmacy (the manufacturer of the drugs) regarding the five drugs being in violation of the law. Divya Pharmacy in its reply on May 7, 2022, said it would stop the publication of the impugned advertisements, however, it noted that no action could be taken under Rule 170 of the Drugs and Cosmetics Rules, 1945 as the same had been stayed by the Bombay high court on February 2, 2019.

Rule 170 was introduced on December 24, 2018. According to a press release issued by the AYUSH ministry, the amendment was made “specifically for controlling inappropriate advertisements of Ayurvedic, Siddha and Unani medicines.” The Rule prohibited manufacturers of Ayurvedic, Siddha and Unani drugs from publishing advertisements of any drug for the use of diagnosis, cure, mitigation, treatment or prevention of any disease, disorder, syndrome or condition. It also mandated the manufacturers to secure a Unique Identification Number from the State Licensing Authority prior to the publication of any advertisement. However, within months, many alternate medicine companies moved the courts and were successful in securing a stay on the rule. A stay was granted both by the Delhi HC as well as the Bombay HC in 2019.

Not just the rule, but another law altogether

However, the Kerala doctor said that he had not complained against Patanjali under Rule 170, but had sought action under the Drugs and Magic Remedies (Objectionable Advertisements) Act 1954. On November 9, 2022, the Uttarakhand Ayurvedic and Unani Services Licensing Authority (UAUSLA) asked Divya Pharmacy to stop the production of these five products and asked the company to submit its reply with amended formulation sheets and label claims in advertisements within a week. It also asked the company to remove all advertisements of these drugs from the media.

Both Baba Ramdev and Acharya Balakrishnan condemned this move, claiming it was an attempt to tarnish the tradition of Ayurvedic medicine by “ignorant, insensitive, incompetent licensing officers.” Patanjali threatened legal action against the state. Within 48 hours of the notice, the SLA relented and the licence officer noted that the ban was erroneous and the company may continue production.

Subsequently, all RTI replies cited action could not be taken as Rule 170 of the Drugs and Cosmetics Act and Rules, had been stayed.

MPs take up the matter

Babu sought the assistance of Congress MP Karti Chidambaram who complained to the AYUSH ministry. The MP in his complaint noted that the Pharmacovigilance Centres for Ayurveda, Siddha, Unani and Homeopathy Drugs set up in different parts of the country had reported 18,812 misleading advertisements between 2018 and 2021. The ministry in its response said, “The State Licensing Authority (SLA) has been directed in light of the Drugs and Magical Remedies (Objectionable Advertisements) Act, 1954, and rules thereunder.”

Despite clear instructions no action was taken, in response to a question raised in the Parliament by Kannur MP V. Sivadasan, the Ayush ministry stated that the offending advertisements had been withdrawn but nothing further was done.

Further, on August 29, 2023, the ministry of AYUSH wrote to all state/UT licensing authorities and drug controllers of AYUSH informing them that a notification for the omission of Rule 170 was to be finalised and in the meantime, all the state authorities should refrain from taking any action under Rule 170.

On January 24, 2024, the Prime Minister’s Office also directed the Ayush ministry to take appropriate action, following which the ministry directed the Uttarakhand SLA “to examine the matter and take the necessary action as deemed appropriate “

However, as is evident from the Supreme Court exchange, no action was initiated against Patanjali.

Previous case against Patanjali

This is not the first time that Patanjali has run into trouble because of their misleading advertisements and claims belittling other manufacturers or streams of medicine. In 2019, the Delhi high court directed Patanjali to alter their advertisement for Chyawanprash, as the same was found to be disparaging the goodwill and reputation of Dabur Chayawanprash.

In a suit filed by the Resident Doctors Association of AIIMS, Rishikesh in 2021, Baba Ramdev and Patanjali were accused of not only disparaging allopathy but also preventing the Covid-19 vaccine drives. The suit also sought clarification from the company that Coronil was not a cure for Covid 19, as they claimed. Similar to the apology tendered before the Supreme Court in February, the clarification filed by the company in 2022 was also not accepted by the court, which noted that the clarification sounded more like a disclaimer. The bench remarked, “You gave the public two impressions. One is that allopathic doctors don't have a cure, they are themselves dying of the disease. Two, that coronil itself is a treatment and cure.”

Similar to their response to a ban by the SLA, the company claimed that the litigation was motivated to tarnish the reputation of Ayurveda. The court was quick to point out that the aim of the proceedings was not to undermine Ayurveda but to prevent misleading advertisements. The suit is pending adjudication.

Interestingly, the Drugs and Magic Remedies Act was challenged soon after it was passed in 1954 as being in violation of Article 19(1)(a), 19(1)(f)&(g), 14, 21 and 31 of the Constitution in the case, Hamdard Dawakhana (Wakf) Lal Kuan, Delhi v. Union of India. The Supreme Court however noted that commercial advertisements which have an element of trade or commerce and advertising an individual’s personal business is not part of freedom of speech. The court noted that the act sought to prevent unethical advertisements and physical harm caused by self-medication and thus, was not unconstitutional.

In a country like India, where medicines are easily sold without prescriptions, there is a need for strict regulation of advertisements to prevent the harm of self-medication. The lack of action on the part of the Central government and the state authorities shows that public health is only taken seriously on the threat of action.

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.