Objectionable Advertisements: Salient features of DMROA Act, 1954: Part-II

Last Updated on March 26, 2026 by The Health Master

Objectionable Advertisements: Salient features of DMROA Act, 1954

Continue from: Part-1 

Challenges facing the regulation:

Outdated provisions and Lack of Adaptability

The introduction of the internet and other digital media including AI has substantially changed how advertising is done. Legal experts contend that the DMROA Act is out-of-date and unable to adequately regulate internet advertising activities because it has not kept up with these developments.

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The complicated claims made by contemporary pharmaceutical goods are not addressed by the Act. Legal experts assert that the DMROA Act does not fully account for the sophisticated health claims that have resulted from advances in medical knowledge, making it difficult to judge the veracity of these claims.

Limited Scope and Incompatibility with Global Standards

The DMROA Act primarily focuses on ads; it does not include other forms of promotion, such as sponsorships, influencer marketing, or product placement. The statute, according to academics, is unsuccessful at preventing all sorts of deceptive marketing because of its narrow reach. Disparities can also be seen when comparing local laws to international ones.

In this light it is important to do a Comparative Analysis with International Standards:

Here are some of the International Regulations and Standards on Advertisement of Drugs and Remedies

World Health Organization (WHO) Guidelines

The WHO’s recommendations place a strong emphasis on the necessity of accurate, fair, and truthful advertising. They emphasize the necessity for trustworthy information for customers, particularly when it comes to the efficiency and security of medications and treatments.

In keeping with WHO recommendations, information about potential dangers and adverse effects of promoted goods should be openly disclosed. These recommendations are made to protect the public’s health and encourage wise decision-making.

International Conference of Drug Regulatory Authorities (ICDRA)

Resolutions and recommendations from the ICDRA provide a framework for cooperation among regulatory bodies on a worldwide scale. Here, the emphasis is on mutual recognition of approvals and establishing global standardization.

Collaboration at ICDRA facilitates the sharing of knowledge, skills, and best practices, fostering a unified approach to drug advertising laws. Countries may promote global pharmaceutical cooperation by following the ICDRA’s suggestions.

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

The promotion and dissemination of medication information is explicitly covered in ICH recommendations. These rules are essential for making sure that marketing communications, including advertising, present accurate and impartial information.

The need of avoiding advertising materials that could be deceptive is emphasized in ICH standards. The emphasis is on upholding a high level of ethical behaviour and making sure that consumers and healthcare professionals are given accurate information regarding medications.

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How DMROA Act Aligns or Differs from International Standards

Alignment with International Standards

DMROA Act mandates that ads cannot be deceptive or fraudulent, in line with international norms. To guarantee that customers have access to correct information about the items being advertised, it necessitates transparency with regard to the content.

The Act frequently reflects WHO recommendations about the need on-exaggerated advertising, aligning itself with the global focus on ethical advertising practices.

Divergence from International Standards

Despite similarities in a number of areas, DMROA Act’s implementation and enforcement may be different from those of international standards. A deceptive advertising may be defined differently or the consequences for breaking the law may differ.

Furthermore, DMROA Act could have particular provisions that are not directly comparable to international norms, resulting in distinctive regulatory procedures in the country setting.

Implications of Compliance or Non-Compliance with International Standards

Implications of Compliance

Pharma firms are more credible when they adhere to international norms. Such compliance shows a dedication to moral behaviour and promotes confidence between patients and medical personnel.

It is simpler for businesses that follow international standards to join international partnerships, penetrate new markets, and take part in international bids and trade agreements. Compliance creates a favourable public perception, which may improve sales and market share since consumers are more confident.

Implications of Non-Compliance

Non-compliance harms a business’ reputation and causes a decline in customer, medical, and regulatory authority confidence. The financial stability of a corporation may be affected by fines and penalties imposed by regulatory organizations for infractions.

If there are repeated infractions, there may even be product bans or market restrictions. Trade obstacles that hinder the impacted firm from entering specific foreign markets might result from non-compliance. This restriction may seriously impede international growth and economic growth.

One of the difficulties is in the digital sphere, where ads use social media and internet platforms to reach a larger audience. Innovative approaches and global collaboration are needed for monitoring and regulating these platforms in order to successfully counteract potentially hazardous marketing.

In addition, regulatory agencies and lawmakers must continue to focus on issues like dealing with fraudulent claims, maintaining openness, and protecting vulnerable customers.

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The Roadmap Ahead

There have been suggestions to modify the DMROA Act to bring it into line with modern advertising practices in response to concerns. Advocates for complete improvements, such as clear definitions, updated rules, and a wider definition of promotional activities, include legal professionals and lawmakers.

To get opinions and views, regulatory organizations undertake conversations with industry stakeholders. Collaboration aims to fill knowledge gaps and provide rules that are useful, enforceable, and supportive of the expansion of the pharmaceutical industry.

The Ministry of Health and Family Welfare (MoHFW) initiated the Draft Drugs and Magic Remedies (Objectionable Advertisements) (Amendment) Bill, 2020, to update the archaic law to include modern media and stricter penalties.

Key Aspects of the Proposed Amendments:

• Expanded Definition of Advertisement: The amendment expands the definition to include electronic media, internet, websites, and social media, rather than just traditional print/audio-visual media.
• Increased List of Diseases: The draft proposes to expand the list of prohibited diseases and conditions from 54 to 78.
• Significantly Higher Penalties: The proposal seeks to enhance punishments to make the law a stronger deterrent:
  • First Conviction: Up to two years imprisonment and a fine of up to ₹10 lakh (presently six months imprisonment/fine).
  • Subsequent Convictions: Up to five years imprisonment and a fine of up to ₹50 lakh (presently one year imprisonment/fine).
• Inclusion of Medical Devices: The amendments align with 2020 notifications that treat medical devices as drugs, bringing devices under the purview of strict advertisement regulations.

Status and Challenges:

• Delayed Implementation: Despite recommendations from a 2018 parliamentary standing committee and subsequent interventions, there has been no substantial file movement on the amendments since late 2022.
• “Omission” Controversy: While the amendment is stalled, controversy arose in 2023 regarding a proposal to omit Rule 170 of the Drugs and Cosmetics Rules (which specifically regulated AYUSH ads) before the new DMROA amendments were in place, creating a regulatory void.
• Implementation Issues: Experts argue that for the amendments to be effective, CDSCO drug inspectors need to be empowered to take punitive action, which is currently lacking.

Possible suggestions to prohibit Drug & Magic Remedies misleading Advertisements

• There is need for self regulation in advertising therefore, the Advertising Standards Council of India (ASCI) should adopt a Code for Self Regulation which would ensure that advertisement should be such that there is no violation of the code of self regulation.
• It is necessary to identify the spots where the consumers are required to be cautioned in order to prevent them from being deceived by such advertisements. This could be done by way of advertising in buses, metro or railway platforms.
• Disciplinary action must be taken against doctors who advertise their services or against those who participate in advertisements for promoting a particular medicine, vitamin or drug.
• People should avoid self-medications via advertisements. A medicine that promises to relieve from ailments, such as joint pain etc should not be believed unless it is prescribed by a certified medical practitioner and awareness programs regarding the same should be run by the Government.
• To strengthen the DMROA Act, a member committee should be structured which may include drug controllers from different states, doctors and pharma association representatives.
• Corrective advertisements are also very essential and necessary in order to ensure that the impression created by a false or misleading advertisement is corrected through a series of advertisements.
• “Pre-clearance” (pre-vetting) or screening is another mode to avoid false and misleading ads. This involves evaluation of ads by self regulatory body before they are published or broadcast.
• It is necessary to provide severe punishment & mandatory jail term for advertising magic cures.
• Cine stars, celebrities and also influencers should caution against endorsing such misleading ads of magic remedies & drug products. There should be legal provisions to prosecute them as well.
• As major ayurvedic companies are being scanned for dubious claims promising magical remedies. For checking on Ayurvedic fake products, more number of ayurveda drug inspectors should be recruited in every state.
• Food and Drug Administration (FDA) should plan to pull the plug on television channels, social media channels, podacsts, etc that offer air time to promote medicines which guarantee to cure joint pain, impotency and weight reduction etc.