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Misleading Advertisements in Medicine poses a serious health hazard Review of Uniform Code for Pharma Marketing practices is urgent

Date:

By Dr Arun Mitra

The Patanjli has been in the news not just for advertising its products and misleading claims in the media but also for criticising modern scientific medicine. This went on to the extent that the Hon'ble Supreme Court had to reprimand the Patanjli on 21st November 2023, for continuing to publish misleading claims and advertisements against modern system of medicine. A petition was filed by the Indian Medical Association (IMA) challenging Patanjli's outbursts. The Hon'ble Supreme Court warned the Patanjli to stop Misleading Advertisements, or will have to pay Rs 1 Crore Cost On Every Product Claiming False Cure.

 

Misleading claims has become the rule by the Patanjli. During the peak of COVID-19 it came out with Coronil as the cure for COVID-19. Astonishingly the then union Minister Dr Harsh Vardhan, an ENT Surgeon trained in modern medicine, promoted the product which had no scientific evidence to prove its utility. But this gave strength to Baba Ramdev to make unproven claims.

 

This is a serious matter as the medicines are used to get rid of the disease. We cannot let the human body fall prey to any unproven non-evidence based substance. Therefore there has to be proper regulation over drugs of any type and of any system of medicine.

 

In addition to the modern scientific medicine (Allopathy), several other systems of medicine being practiced simultaneously in our country include Ayurveda, Hoemeopathy, Yunani, Siddha, Yoga, Naturopathy, Accupuncture, Accupressure, Magnetotherapy, some ancient belief systems like ‘Jharra', Witch Hunting, Tantra Mantra, Hymn reciting, use of gaumutra, cow dung and prayers to please and seek blessing of the super natural powers for cure. Whatever may be the complexities involved, it is essential to regulate all these systems and ensure that health of the people is protected and promoted.

 

While the modern medicine has a better regulatory mechanism, other systems need to evolve the regulation which is more effective than the existing. To regulate the marketing practices in modern medicine, a Uniform Code of Pharmaceutical Marketing Practices (UCPMP) was designed by the Department of Pharmaceuticals, Ministry of Chemical and Fertilizers, Government of in 2012. It was prepared based on the comments/inputs received from various stakeholders on the draft UCPMP.

 

The code has set certain rules for the promotion of the drugs. It prohibits promotion prior to receipt of the marketing approval by the competent authority and mandates that information about drugs must be up-to-date, verifiable and accurately reflect current knowledge or responsible opinion. The Information about drugs must be accurate, balanced, fair, objective, and must not mislead either directly or by implication and it must be capable of substantiation. Claims for the usefulness of a drug must be based on an up-to-date evaluation of all the evidence and safety must not be used without qualification. It must not be stated categorically that a medicine has no side effects, toxic hazards or risk of addiction. Comparisons of drugs must be factual, fair and capable of substantiation. In presenting a comparison, care must be taken to ensure that it does not mislead by distortion, by undue emphasis, omission or in any other way. It must give recommended dosage, method of use and where not obvious, method of administration; adverse reactions, warnings and precautions for use and relevant contraindications of the product.

 

It was said that is a voluntary code of Marketing Practices for Indian Pharmaceutical Industry for the present and its implementation will be reviewed after a period of six months from the date of its issue. If found that it has not been implemented effectively by the Pharma Associations/Companies, the Government may consider making it a statutory code. Unfortunately even though the UCPMP was made effective in December 2014 with a promise to review it and make it statutory code after six months. But nothing seems to have moved forward.

 

A similar code should be made compulsory and mandatory for any system of healthcare being practiced in the country and should be implemented effectively.

 

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. Central Government notified amendment of the Drugs & Cosmetics Rules, 1945 on 24th December, 2018 to insert Rule 170 specifically for controlling inappropriate advertisements of Ayurvedic, Siddha and Unani medicines.

 

As a result of monitoring by Advertising Standards Council of India (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.

 

Rule 170 was meant to prohibit advertisement of Ayurvedic, Siddha and Unani drugs without the ad being cleared by the licensing authority of the state where the manufacturer of the medicine is located or where the corporate office is located, in case the manufacturing is happening in more than one state.

 

The rule 170 was withdrawn after the association of manufacturers of Ayurvedic medicines had given a representation in April 2023 seeking the repeal of Rule 170. The meeting of the Ayurveda, Siddha, Unani Drugs Technical Advisory Board (ASUDTAB) held on May 25, recommended the omission of Rule 170, which was inserted into the Drugs and Cosmetics Rules, 1945 in December 2018. This has been challenged by various saying that this revocation of the article adversely affects the health of the people and gives alibi to the manufacturers to market their product without any effective check.

 

It is high time that the UCPMP is reviewed and made statutory. Health of the people can not be left to suffer at the hands of misleading and false claims. Effective regulation for all the systems being practiced for healthcare delivery has to be ensured. (IPA Service)

Northlines
Northlines
The Northlines is an independent source on the Web for news, facts and figures relating to Jammu, Kashmir and Ladakh and its neighbourhood.

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