THE CONTEXT: Recently, the Supreme Court restrained Patanjali Ayurved Ltd from issuing misleading advertisements on medical efficacy of its products and issued contempt notices to the company for violating an earlier undertaking given in November, 2023. The apex court also pulled up the Centre for inaction against Patanjali’s “misleading and false” advertisements that claim to cure different diseases.
MORE ON THE NEWS:
- In November 2023, the Supreme Court had given directions to Patanjali Ayurveda to stop publishing misleading advertisements.
- But, to establish its credibility, the company issued a press release reporting that it has conducted preclinical and clinical trials on a database of more than one crore people, to test the efficacy of its products.
- Recently in February 2024, the matter came up again before the apex court, which resented at the continued issue of advertisements despite having been given an assurance.
ISSUES:
- Ethical issue: The misleading advertisement violates the trust of consumers and undermines the integrity of the business. The controversy highlights vulnerability of the consumer, who assumes that some regulatory body would have checked that nothing unsafe, hazardous, or ineffective is sold as medicine.
- Violation of legislations: There is violation of legislation acting for drug regulation, the Indian Medical Association (IMA) claimed that Patanjali’s advertisement titled “MISCONCEPTIONS SPREAD BY ALLOPATHY”. It was in direct violation of the Drugs & Other Magical Remedies Act, 1954 (DOMA), and the Consumer Protection Act, 2019 (CPA).
- Adverse health impact: Unverified products can have negative effect on health of consumers. In the case of such drugs (of which Ayurveda constitutes more than 75%), there is greater danger, because the consumer assumes all products are natural and consequently safe.
- Misleading advertisements: There is a range of misleading advertisements for treating and curing any number of conditions displayed in newspapers, and the electronic media, consumers. These advertisements have increased the cases for self-medication because of its claims of efficacious treatment and cure of intractable diseases.
- Inactions of government and regulatory bodies: Even as the claims are made with growing impunity, no visible action seems to have been taken by the state governments to whom the Ministry of Ayush has sent hundreds of complaints. The regulatory watchdog, Advertising Standards Council of India, has too failed to take effective cognisance or to set guidelines.
- Inadequate legislations: There is lack of adequate legislation related to the regulation of such drugs and advertisement. For example, the provisions of DMR Act is, different, limited and specific as it was enacted to control misleading claims and advertisements involving medicinal substances and products. Whether the products have been licensed or not, whether they are evidence-based or otherwise, whether R&D has been done, goes beyond the ambit of DMR.
WHAT IS MISLEADING ADVERTISEMENT?
- Under the Consumer Protection Act, 2019, misleading advertisement in relation to any product or service is defined as an advertisement, which:
- Falsely describes such product or service; or
- Gives a false guarantee to, or is likely to mislead the consumers as to the nature, substance, quantity or quality of such product or service; or
- Conveys an express or implied representation which, if made by the manufacturer or seller or service provider thereof, would constitute an unfair trade practice; or
- Deliberately conceals important information.
- Misleading advertisements were not specifically covered by the law before the Consumer Protection Act of 2019.
LEGAL ARGUMENT AGAINST PATANJALI’S ACTIONS
- Drugs & Other Magical Remedies Act, 1954 (DOMA): Under Section 4 of the DOMA, there is a prohibition against publishing misleading advertisements relating to a drug. Publishing a misleading advertisement under the DOMA is punishable with upto six months imprisonment, and/or a fine for the first offence. On the second offence, the period of imprisonment can extend to one year.
- Consumer Protection Act, 2019: Section 2(28) of the Consumer Protection Act, 2019 deals with the ‘misleading advertisement’. Section 89 of the CPA contains more stringent punishments for false or misleading advertisements. First time violations may invite penalties up to Rs 10 lakh and imprisonment for a term which may extend to two years. Subsequent violations may attract penalties up to Rs 50 lakh and imprisonment for a term which may extend to five years. The CPA also provides the definition for a misleading advertisement.
It includes advertisements which: give a false description of the product or service, partakes in unfair trade practices, deliberately conceals important information, or is likely to mislead the consumer about the nature, substance, quantity or quality of the product or service.
- Violation of MoU signed by the Ministry of AYUSH and the Advertising Standards Council of India: The IMA has also highlighted the MoU signed by the Ministry of AYUSH and the Advertising Standards Council of India in January 2017 has been violated. AYUSH agreed to identify misleading advertisements that may be in violation of the DOMA and send complaints to the Council for review.
- Drugs and Magic Remedies (Objectionable Advertisements) Act 1954 (DMR): Advertising drugs purported to treat or cure certain diseases is prohibited under DMR which applies to all systems of medicine. Promoting drugs intended for the treatment and cure of 54 specific medical conditions, which include cancer, diabetes, heart disease and blood pressure, is explicitly barred.
- The Drugs and Cosmetics (D&C) Act, 1940: Under the act, a new Chapter IV A was introduced in 1964 for ASU medicine. The difference between classical medicine and patent and proprietary medicine is explained there. Classical ASU medicine refers to drugs that are manufactured strictly in accordance with the authoritative ancient texts (granthas or samhitas) listed under the D&C Act. Patent and Proprietary (P&P) medicine refers to manufacture of ASU drugs by modifying the classical recipe and introducing new combinations.
THE WAY FORWARD:
- Unified structure: The country needs a unified structure and system for regulating and administering the licensing, manufacture, sale, safety monitoring and drug advertising of ASU drugs when sold across states in inter-state commerce. This will instil not just oversight of safety but will bring greater ownership among new consumers worried about quality and claims.
- Scientific Evidence:Before making any claims about a product, businesses should ensure that they are backed by scientific evidence.
- Transparency: Businesses should be transparent about their products and services. This includes providing accurate information about product specifications, prices, and customer testimonials.
- Regulatory approval: There is a need to amend Drugs and Magic Remedy Act so that Ayurvedic medicines sold through misleading advertisements can be stopped.
- Strengthening Law Enforcement: Strengthening the implementation of the NDPS Act and PITNDPS Act by providing adequate resources, training and modern equipment to law enforcement agencies. It can be done by creating a more robust surveillance and intelligence gathering system to effectively curb drug trafficking along with improving coordination between agencies.
- Enhancing Preventive Measures: There is a need for enhancing preventive measures by increasing the availability of affordable treatment and rehabilitation facilities for drug addicts. It can be done by scaling up awareness campaigns to educate people about the dangers of drug abuse and the importance of seeking help.
THE CONCLUSION:
The Indian pharmaceutical industry currently faces issue of quality and regulatory challenges that can potentially restrict the projected growth of the industry. There is a need to solve the problems of standards and rules for drug regulation quickly and effectively for prioritizing patient safety and ensuring the delivery of quality medicines.
UPSC PREVIOUS YEAR QUESTION
Q. India’s proximity to the two of the world’s biggest illicit opium-growing states has enhanced her internal security concerns. Explain the linkages between drug trafficking and other illicit activities such as gunrunning, money laundering and human trafficking. What counter-measures should be taken to prevent the same? (2018)
MAINS PRACTICE QUESTION
Q. Analyse the consequences of misleading advertisement of Indian pharma products with respect to the interest of consumers? What steps can be taken to improve the quality and safety of Indian pharma products?
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