Delhi: After meeting with patients all day, Babu K V, an ophthalmologist in Kerala, retires early before waking up at three in the morning to send out RTI (Right To Information) applications on public health issues that concern him as a citizen and a doctor.
Babu, who lives and works in Kannur, told Article 14 that “RTI work” is “very tough”, with public information officers seemingly reluctant to give up information in the years since the Bharatiya Janata Party (BJP) came to power in May 2014, followed by time-consuming appeals to the appellate authority and the central information commission.
In the challenge that he mounted to stop Divya Pharmacy, a manufacturing unit owned by Patanjali Ayurved Limited in Haridwar, Uttarakhand, from publishing advertisements prohibited by the law in national dailies, Babu sent over 100 RTI applications and related communications to the Drugs Controller General of India (DGCI), the Ministry of Ayush, Ayurveda and Unani Services, Uttarakhand and the Press Council of India.
Patanjali, of which yoga guru Baba Ramdev is the face, is headed by Acharya Bal Krishna, a billionaire who owns most of the private company. Their meteoric rise was after the BJP came to power and Prime Minister Narendra Modi urged yoga and Ayurveda amid a rising tide of Hindu nationalism. While Ramdev told millions of his supporters to vote for Modi, the prime minister has publicly endorsed Patanjali. In May 2017, as Modi inaugurated the Patanjali research institute in Uttarakhand, Reuters reported the company had received more than $46 million in discounts for land acquisitions in states controlled by the BJP.
After a year of correspondence and the intervention of two members of Parliament, Karti Chidambaram and V Sivasadan, who raised the issue with the union ministry of Ayush, Babu was successful in stopping Divya Pharmacy from advertising medicines in contravention of section 3(d) of The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, which prohibits advertisements for 54 diseases listed in its schedule.
After acknowledging that publishing the advertisements violated the law, official communications show that the union Ayush ministry took a different view a few months later until Chidambaram wrote to the Ayush minister Sarbananda Sonowal.
Even though the advertisements stopped earlier this year, the state authorities in BJP-run Uttarakhand are yet to initiate any criminal proceedings against the manufacturing unit for violation of section 3(d) of the Act.
The first conviction under the Act is punishable by six months in prison, a fine, or both. The second conviction is punishable with one year, a fine, or both.
The norms of the Press Council of India, a statutory body, say, “Advertisements which offend the provisions of the Drugs and Magical Remedies (Objectionable Advertisement) Act as amended in 2002, or any other statute should be rejected.”
In response to a question from V. Sivadasan, a Rajya Sabha member hailing from Kannur, the Ayush ministry on 28 March 2023 said there were 53 “misleading advertisements” of drugs in the past eight months from Patanjali for BPgrit (18), Madhugrit (15), Eyegrit Gold (10), Thyrogrit (3) and Lipidom (7).
“Though my complaint was filed with the DCGI on 24 February 2022 itself, why was Patanjali allowed to violate the law 53 times? Who allowed them to violate it? What action will be taken now?” Babu said.
On why there was a prohibition from advertising for diseases listed in the 1954 Act, Babu said, “If people are resorting to self-medication after seeing advertisements, that could be disastrous, and that could be a major public health issue.”
‘I Feel Very Proud’
Babu, who has been practising as an ophthalmologist since 1992, said he began his activism in 2008, three years after the Right to Information Act, 2005, was passed, and just as he was getting comfortable using the internet.
That year, Babu complained to the Medical Council of India (MCI) (now the National Medical Commission (NMC) against the Indian Medical Association (IMA), which signed an Rs.2.25-crore deal with Pepsico for endorsing its products, because it was in violation of the MCI’s Code of Ethics Regulations, 2002. For the next eight years, Babu fought his expulsion by the IMA Kerala branch and the MCI, which, according to The Hindu, “instead of upholding the code of ethics had exempted the IMA from within the ambit of the ethics regulation and had turned against Babu and his wife Bindu for going to the press”.
The MCI, following the intervention of the Public Service Commission, dropped the case in 2016.
Babu said that he had relentlessly pursued the case because he was morally, ethically and legally right on every count; hence, no one had the right to harass him.
Babu said that in 2009, when the then health minister of the UPA (United Progressive Alliance) government, Anbumani Ramadoss, closed down three public sector units manufacturing many life-saving vaccines, his RTIs exposed a vaccine shortage in the country and were used by the NGOs in the Supreme Court.
“When something is unscientific or unethical, I have to question it. It is not easy, but my mental makeup is that I have to do it,” he said. “Now, age is not on my side. This work needs more effort, but I have more experience and expertise.”
On his most recent intervention, which stopped the advertisements of Patanjali’s Divya Pharmacy, Babu said, “I feel very proud knowing that citizens can make a difference. My winning is a message that we can use existing avenues to fight the powerful even when difficult. Sometimes it can be hard, but it can work.”
‘Time Is Very Important’
In the years since the BJP came to power, Babu said it was getting harder and harder to get information without filing appeals.
“In any fight using the RTI, time is very important. If you go to the CIC, it may take one or two years. At that time, it may no longer help in a court battle,” he said. “Most of the time, the PIOs (public information officers) will find a way not to share the document. The appellate authority provides documents after losing 30 to 40 precious days.”
On why it was important to file RTI applications in the present case, even though it was clear from the 1954 Act that the advertisements for diseases in the schedule were prohibited, Babu said the RTIs allow the applicant to monitor the movement of the complaint and the notings officials make in the file.
“If I didn't use RTI, they would still be sitting on my complaint,” said Babu. “The earlier file notings of the Ayush ministry absolutely agreed with my view that the advertisements were in violation of The Drugs and Magic Remedies (Objectionable Advertisements) Act and action had to be taken, even though there was a u-turn later on.”
Babu said he first saw an advertisement from Divya Pharmacy on Twitter for eye drops effective for glaucoma and cataract (advertising for which is banned under the Act) in November 2019 and was bothered by it. In the following months, two of his patients with glaucoma dropped off to use Ayurvedic eye drops (a different company) and returned after almost a year in a worse condition.
Babu left a comment on the advertisement on Twitter two years later, in March 2021, calling it misleading and tagging the Advertising Standards Council of India, an independent, voluntary self-regulatory organisation.
A year later, in 2022, Babu was incensed when he saw advertisements from Divya Pharmacy appearing in the national dailies and decided to do something about it.
Babu recalled that on 21 February, he saw an advertisement published in the Hindu for Lipidom, which said it “helps in reducing cholesterol level in a week thereby protecting you from heart problems, blood pressure, stroke etc.”.
Babu sent an email on 24 February to the DCGI about the advertisement.
“The list of diseases and medical conditions mentioned in the schedule to the law include “heart diseases” (no 26) and “high or low blood pressure (no 27),” the email said.
Babu said his complaint was forwarded to the Ayush ministry on 16 March.
On 15 April, the Ayush ministry wrote to the director of Ayurvedic and Unani Services, Uttarakhand, concerning the products Lipidom, Livogrit & Livamrit, and Madhunashini & Madhugrit, saying that “the matter may be examined for withdrawal of advertisements which is contravening” the 1954 Act and the Drugs and Cosmetics Act and Rules, 1940. The ministry said the state licensing authority (SLA) “is advised to take necessary action in this regard, and an action taken report may be kindly submitted to the ministry”.
The letter was copied to Acharya Balakrishna, the co-founder and managing director of Patanjali Ayurved, for compliance.
On 26 April, the Ayurvedic and Unani Services wrote to Divya Pharmacy regarding the “contravention of the provisions of the Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954 and Rules 1955 and Drugs and Cosmetics Act 1940 and Rules 1945 concerning the product Lipidom, Livogrit and Livamrit.
On 7 May, Divya Pharmacy replied to the Ayurvedic and Unani Services, saying that “the undersigned has immediately stopped publication of the impugned advertisements”.
“That should have been the end of the matter. But they started advertising again after a gap of two months or so,” said Babu. “All the newspapers were flooded.”
Divya Pharmacy did not respond to Article 14’s query about why they started advertising again.
The Ayush ministry’s response on 26 September to Babu’s RTI application of 27 August said that no information had been received from the licensing authority in Uttarakhand after the ministry wrote to them on 22 September about advertisements for Lipidom, Livogrit and Livamrit being in contravention of the 1954 and 1940 laws, requesting them to expedite the matter.
“It was going on. The advertisements were coming again and again and again. Nothing was happening. The state licensing authority would issue a notice to Divya Pharmacy,” said Babu. “They started saying there is a stay on rule 170, so no action will be taken.”
Hiding Behind Rule 170
On 24 December 2018, the central government notified the amendment of the Drugs & Cosmetics Rules, 1940 to insert Rule 170 for controlling inappropriate advertisements of Ayurvedic, Siddha and Unani medicines, but the Bombay High Court stayed it in February 2019 following a petition by the Ayurvedic Drug Manufacturers Association of which Divya Pharmacy is a member.
Babu said there was no reason to invoke Rule 170 because not only was it sub judice, but his complaint was covered under section 4(d) of The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, and that was sufficient to make Divya Pharmacy’s advertisements an actionable offence.
On 9 November, the licensing authority in Uttarakhand ordered Divya Pharmacy to stop the production of BPgrit, Madhugrit, Thyrogrit, Lipidom and Eyegrit Gold tablets due to the “repeated contravention” of both laws and remove all advertising of these products. The authorities asked for the submission of amended formulation sheets and label claims of these drugs and said that production only be restarted after amended sheets and labels were ratified by them.
Acharya Balkrishna tweeted that “the anti-Ayurveda drug mafia has conspired against Divya Pharmacy, but we will not allow this to succeed”.
On 12 November 2022, the state licensing authority revoked its ban.
Babu said he never asked for a ban on the production of the drugs, only their advertisements.
The response from the Ayush ministry on 22 November 2022 to his RTI application of 29 October 2022, referring to Rule 170, said that “the matter is under sub judice and pending” before the Bombay High Court, “and the necessary action may be taken subject to the final decision of the court”.
“That was a U-turn,” said Babu. “In April and September, they said action could be taken under Act (1954), but in November, they said it was not possible. That was a U-turn on their part. Why?”
The Ayush Ministry did not respond to Article 14’s query about why they seemingly changed their position but referred to the letter they sent three months later in February 2023, following MP Karti Chidambaram’s intervention, telling the state licensing authority that while Rule 170 was sub-judice, the matter should be looked at under the 1954 Act.
After the “shocking reply” from the Ayush ministry in November, Babu said that he reached out to Kirti Chidambaram, the member of Parliament from Sivaganga, Tamil Nadu, who sent a letter to the union Ayush minister Sarbananda Sonowal on 23 November 2023, informing him about the ministry erroneously invoking rule 170.
“I would like to bring to your attention the misleading advertisements by Patanjali Ayurved where it markets its medicines as an instant cure for several diseases.”
“It is strange that the State Licensing Authority invoked Rule 170 when its application has been stayed by the Hon’ble Bombay High Court vide its order dated 17 February 2019, directing the Union Government not to take any coercive action against members of petitioner’s association, in this case Divya Pharmacy which is a member of Ayurvedic Drug Manufacturers Association (petitioner).
“Why did the Uttarakhand Ayurvedic and Unani Services Licensing Authority send a notice to Patanjali Ayurved under a rule that is currently sub judice and will not stand the test of legal scrutiny?”
“Patanjali Ayurved continues to publish false claims in the name of science. As per a news report, on 10 July 2022, the company published an advertisement in leading newspapers calling out ‘misconceptions spread by allopathy’. Only 5 out of 17 drugs listed in this advertisement had undergone clinical trials. Of this, only one trial had been completed. Out of the 117 clinical trials listed by Patanjali Ayurved on the clinical trials registry India portal, 93 trials have either not started or are incomplete. The company published an advertisement in a leading daily as latest as 14 November 2022.”
“Further, it has been more than three years since the Hon’ble Bombay High Court ordered a stay on the application of Rule 170 of the Drugs and Cosmetics Rule, 1945. A well-intentioned provision, this Rule would have provided a stringent regulatory check for misleading and inappropriate advertisements of Ayurvedic, Siddha or Unani drugs. Does this Union Government not intend to vacate this stay to stop the menace of pseudoscience in the country.”
“In a written response to a question in the Rajya Sabha dated 22 March 2022, you had stated 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. With this mammoth rise in objectionable advertisements, it is the government’s responsibility to ensure that those peddling in pseudoscience are not allowed to bring disrepute to India’s sophisticated scientific community. Stringent measures must be taken against them before they cause any further harm to public health and safety.”
Babu wrote to the union Ayush minister on 1 December 2022, saying that the reply he received from the ministry on 22 November “was shocking, misinterpreting an unrelated law and the stay on it”.
On 10 December 2022, Babu wrote to the state licensing authority, Ayurvedic and Unani Services, on the “repeated violations of the provisions” of the law 1954 Act in relation to the advertisement carried in The Hindu on 21 February for Lipidom (heart problems and blood pressure 26 and 27 in the schedule), in Dainik Bhaskar on 14 November for Madhugrit (diabetes 9 in the schedule), in The Hindu on 9 October for Madhugrit, and in the Mathrubhumi for BPgrit on 8 October( blood pressure 27 in schedule).
“It is clear that Divya Pharmacy violated the provisions of DMR (OA) 1954 & the SLA is entrusted to enforce the legal provisions. I reiterate that there are no complaints from me under Rule 170 of drugs and cosmetic rules 1945, which is sub judice,” he wrote.
On 10 February 2023, the Ayush ministry wrote to the Ayurveda and Unani Services saying that while there was a challenge to rule 170 pending in Delhi and Bombay high courts, there was no such challenge to the 1954 Act, and to examine the matter under the latter.
On 14 February 2023, the union Ayush minister sent a reply to Chidambaram, which said the “matter has been examined” and “the State Licensing Authority, Uttarakhand has been directed to take appropriate action as deemed fit in the aforementioned matter in light of the Drugs and Magical Remedies (Objectionable Advertisements) Act, 1954, and rules thereunder”.
“This was the turning point,” said Babu. “This is what I was saying from day one onwards. My complaint was under the Drugs and Magic Remedies (Objectionable Advertisements) Act. I never invoked 170 in my complaint.”
Babu said the intervention of the lawmakers was essential.
“The joint action of the RTI and the lawmakers was behind the success,” he said. “They intervened at the right time, or it would have been dragging on even now.”
'That Is The Catch'
In Parliament, Rajya Sabha member from Kannur, V Sivadasan, asked “whether the Ministry has taken any legal action against Patanjali Ayurveda for their misleading advertisements in newspapers with false claims of medicinal value and treatment efficiency”.
In his reply on 28 March 2023, the Ayush minister did not specify legal action, replying instead that the “Ministry of Ayush had forwarded advertisements of Madhunashini, Madhugrit, Lipidom, Livogrit, Eyegrit Gold, Drishti Eyedrops and BPgrit to Ayurvedic & Unani Services, state of Uttarakhand for withdrawal of advertisement.”
Having stopped the advertisements, Babu is still pursuing his RTI application from 22 February 2023, where he asked Ayurveda and Unani Services, Uttarakhand, about the action taken after the Ayush ministry wrote to the state licensing authority about Divya Pharmacy’s advertisements being in contravention of the law.
Following a hearing on 21 April 2023, the state licensing authority issued an order, appointing a drug inspector to investigate the matter but did not set a deadline for the probe.
“That is the catch,” said Babu.
The Uttarakhand state licensing authority did not respond to Article 14’s query about any legal action against Divya Pharmacy.
The Ayush ministry said the state governments are authorised to enforce the legal provisions under the two Acts and rules.
Recalling that the Divya Pharmacy had communicated in May 2022 that it would stop advertising but then started again a few months later, Babu said, “There is a trust deficit.”
“There should be very clear communication between the licensing authority to Divya Pharmacy and Divya Pharmacy to the licensing authority that they will not advertise,” he said. “I have not seen anything like that.”
(Betwa Sharma is the managing editor of Article 14).
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