Explainer / Drugs & magic remedies Act

The AYUSH ministry has asked yoga guru Ramdev’s Patanjali Ayurved Ltd  to provide “at the earliest” details of composition and research undertaken prior to the launch of the medicines it claimed are for the treatment of COVID-19, and advised the firm to stop advertising them until the “issue” is examined.

Ramdev’s herbal medicine company Patanjali Ayurved has launched ‘Coronil tablet and Swasari vati’ medicines claiming they can cure the highly contagious disease within seven days.  

However, the AYUSH ministry said that the facts of the claim and details of the stated scientific study are not known to it.  

The licensing authority of Uttarakhand government has been requested to provide copies of licence and product approval details of the Ayurvedic medicines being claimed for the treatment of coronavirus infection, the ministry said in its statement.

It said such advertisements of drugs including ayurvedic medicines are “regulated under the provisions of Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 and Rules thereunder and the directives issued by the central government in the wake of COVID-19 outbreak”.

Drugs and Magic Remedies Act

Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 and Rules thereunder encompass the provisions for prohibition of misleading advertisements and exaggerated claims of drugs and medicinal substances including AYUSH medicines and for the penalty to be imposed on the defaulters.  

According to the Act, ‘magic remedy’ includes a talisman, mantra, kavacha, and any other charm of any kind which is alleged to possess miraculous powers for or in the diagnosis, cure, mitigation, treatment or prevention of any disease in human beings or animals or for affecting or influencing in any way the structure or any organic function of the body of human beings or animals. 

No person or company will take part in advertisements which give false impressions or make a false claim for the drug or mislead the people, it said. Whoever contravenes any of the provisions of this Act shall be punishable with imprisonment which may extend to six months and fine. 

In February 2020, the health ministry proposed to amend the Act. According to the draft, the first conviction will attract imprisonment which may extend to two years and a fine of Rs 10 lakh. It also has added 24 new conditions to the existing 54 for which remedies cannot be advertised.

Tackling misleading advertisements

The central government notified amendment of the Drugs & Cosmetics Rules, 1945 in 2018 to insert Rule 170 specifically for controlling inappropriate advertisements of ayurvedic, siddha and unani medicines. 

Considering the emerging situation of misleading advertisements, the ministry of AYUSH signed MoU with Advertising Standards Council of India (ASCI) for two years to undertake monitoring of AYUSH-related advertisements in the print and television media and bring the cases of contravention of legal provisions to the notice of the state regulatory authorities for necessary action.  

Similarly, the department of consumers affairs has set up an online system called GAMA (Grievances Against Misleading Advertisements) portal for registering public complaints of misleading advertisements of various commodities including AYUSH medicines and allied products.

As a result of monitoring by ASCI, 732 cases of misleading advertisements of AYUSH were reported in 2017-18 and 497 cases in 2018-19. Out of which 456 cases of violation of Drugs & Magic Remedies Act, 1954 in 2017-18 and 203 cases in 2018-19 have been escalated to the state regulators for taking necessary action in accordance with legal provisions. 

In order to check the veracity of misleading advertisements of AYUSH medicines, state/UT governments are empowered to enforce the legal provisions under Drugs & Cosmetics Act, 1940, Drugs & Magic Remedies (Objectionable Advertisements) Act, 1954 and rules thereunder.

Pharmacovigilance centres 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 centres have reported 1,127 cases of misleading advertisements of AYUSH from August 2018 to March 2019.

ASCI flags 50 ad campaigns offering COVID-19 cure

The Advertising Standards Council of India (ASCI) said it has found 50 campaigns by ayurveda and homeopathic drug makers offering cure for COVID-19 in April alone, and had flagged them to the Union government for action.

The advertisements were across media platforms and were found to be violating ministry of AYUSH order dated April 1, 2020, prohibiting publicity and advertisement of AYUSH-related claims, the self-regulatory body said in a statement.

The body also made public the list of the 50 companies which were found to have advertised about COVID-19 cure or prevention in April.

Apart from this, the ASCI said it also flagged 91 cases of potential violation of Drugs and Magic Remedies regulations to the AYUSH ministry. The list had companies making a slew of claims including curing diabetes, cancer, sexual problems, lifestyle ailments like blood pressure and hypertension.

Advertising Standards Council of India

The Advertising Standards Council of India (ASCI) is a self-regulatory voluntary organisation established in 1985. It is committed to the cause of self-regulation in advertising, ensuring the protection of the interests of consumers. 

ASCI is not a government body. It was formed with the support of all four sectors connected with advertising — advertisers, advertising agencies, media (including broadcasters and the press) and others like PR agencies, market research companies, etc.

ASCI’s main goal is to maintain and enhance the public confidence in advertising.

ASCI processes the complaints received through this portal as per ASCI Code, based on an MoU signed with the department of consumer affairs. If a complaint is upheld, ASCI takes up the complaint with the company/agency concerned either for withdrawal or modification of the advertisement. In case of non-compliance of its orders, ASCI forwards the complaints to the regulators concerned for taking appropriate action.

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