Rudderless healthcare legislations

The campaign against false, unscientific, and inappropriate advertisements making dangerous claims of efficacy for Ayurvedic, Siddha and Unani medicines has been going on for years. During the Covid pandemic, the Indian Medical Association complained against a popular ayurvedic company for describing one of its products as the ‘first evidence-based medicine for Covid-19′. There was no scientific basis for this totally unsubstantiated claim. A Kerala based ophthalmologist, Dr K V  Baba, filed a complaint against five products advertised by the company Pharmacy, alleging ‘deceptive’ and ‘objectionable’ promotion of these products violating the Drugs and Magic Remedies (Objectionable Advertisements) Act 1954 Section 3D, and the Drugs and Cosmetics Act 1940 Rules 1945 106(1). 

The products listed in the complaint were advertised as treatments for conditions like glaucoma, cataract, thyroid disease, hypertension, and increased cholesterol –all having potentially devastating consequences. Dr Girish Jangpangni, the Ayurveda and Unani Licensing Officer, responded by stating that a letter had been issued to undertake due enquiry, and stop the advertisements and marketing of the products. He said that they had asked the company to submit additional documents to check for potential discrepancies in the claims made by the company on the labels of these products. Divya Pharmacy was asked to halt manufacturing these five products for the time being, and to submit new formulation sheets for fresh approval within one week. The advertising and marketing continue unchecked.

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The Drugs and Magic Remedies Act and the Rules, prohibit misleading advertisements and exaggerated claims of drugs and medicinal substances including AYUSH medicines and provide for penalty to be imposed on the defaulters.  Celebrities, manufacturers and service providers may be fined up to Rs 10 lakh and even face a jail term of two years for false or misleading advertisement. A misleading ad is defined as promotions across platforms that wrongly describe a product or service or gives a false guarantee, according to the terms of Consumer Protection Bill 2019 passed by Lok Sabha. It includes misleading the customers on the nature, substance, quantity or quality of a product or service or deliberately concealing important information. Even as strict action has been proposed against the advertiser for false advertisements, the media publicizing such ads escapes sanction.

The matter was discussed in the Lok Sabha in June 2019, where then Ayush Minister of state, Shripad Naik, replying to questions, stated that he reviled the number of incidents of misleading advertisements throughout the years. According to Naik, the ministry has inked a MoU with the Advertising Standards Council of India (ASCI) to monitor Ayush-related commercials for two years and bring infractions to the attention of state regulatory authorities for appropriate action. He revealed that, as a result of ASCI monitoring, 732 cases of misleading AYUSH advertisements were reported in 2017–18 and 497 cases in 2018–19. Of these, 456 cases of violations of the Drugs and Magic Remedies Act, reported in 2017–18, and 203 cases in 2018–19 had been escalated to state regulators for necessary action.  

The Department of Consumers Affairs had also set up an online portal called GAMA (Grievances Against Misleading Advertisements) for registering public complaints of misleading advertisements of various commodities. State/UT Governments are empowered to enforce the legal provisions under Drugs & Cosmetics Act, and Drugs & Magic Remedies Act; and directed to appoint Gazetted Officers under section 8 (1) of the Drugs and Magic Remedies Act, to enter, search any premises or examine or seize any record which contravenes any provisions of the Act related to the alleged misleading or improper advertisements.  States/UTs are reported to have appointed Gazetted Officers/Nodal Officers for this purpose and actions initiated against the cases of default.  Pharmacovigilance Centers for Ayurveda, Siddha, Unani and Homoeopathy Drugs set up in different parts of the country under the Central Scheme of Ministry of AYUSH are mandated to monitor and report misleading advertisements to the respective state authorities.  These pharmacovigilance centers have reported 1127 cases of misleading advertisements of AYUSH from August 2018 to March 2019. 

All these background details were incorporated into a notified amendment of the Drugs & Cosmetics Rules, 1945 on December 24, 2018 as Rule 170 specifically for controlling inappropriate advertisements of AYUSH medicines. In January 2019, this was challenged in the Delhi High Court.  An interim stay was granted which remained in place for four years. In a subsequent hearing, when challenged by several pharma companies making ayurvedic formulations, the government appeared to backtrack, even as Sarbananda Sonowal, Naik’s successor, claimed in Parliament, that ‘the protocol or guidelines are in force to restrict Ayush products of medicinal use with dubious claims and for selling certain medicines under medical supervision.’

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 The government’s counsel told Delhi HC that the matter would be placed before the Ayurvedic, Siddha and Unani Drugs Technical Advisory Board (ASUDTAB) for ‘reconsideration’, and accepted the litigants’ request. The petitions of Ayush stakeholders regarding Rule 170 are now placed before ASUDTAB for ‘reconsideration’. The implication being, that Rule 170 will be scrapped or somehow rendered impotent. The case was disposed stating that if the petitioners were aggrieved by the decision taken by ASUDTAB, they could challenge it in court. The goal post was not only shifted, but thrown away altogether. Scrap the law if its enforcement does not satisfy political expediencies. We have already seen how a minister facing allegations of sexual harassment, under POCSO, stated that a Sant Sammelan would be held in Ayodhya to consider amendments to the POCSO Act, ‘as it was being mis-used.’  

Quite apart from the obvious hypocrisy, don’t these false advertisements reek of rank medical negligence? 

(The writer is a founder member of VHAG 

and past president, 

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IMA Goa State Branch)

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