Quick recap

NDA (Nishith Desai Associates) discussed the regulations surrounding pharmaceutical advertising and promotion, emphasizing the importance of understanding all applicable laws and regulations to guide the development of promotional materials. Speakers highlighted various laws and regulations that govern this practice, including the Consumer Protection Act, the Advertising Standards Council of India (ASCI) Code, the Drug and Cosmetics Act, the Drugs and Magic Remedies Act (DMRA), the Food Safety and Standards Act (FSSAI), Uniform Code of Pharmaceutical Marketing Practices and industry codes. NDA also discussed the amendments proposed to the DMRA and the ASCI Code. They also emphasized the significance of compliance with various laws and regulations related to marketing and advertising in the pharmaceutical industry, and highlighting the potential penalties for non-compliance.

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Summary

 Pharmaceutical Advertising Regulations Discussed

NDA discussed the regulations surrounding pharmaceutical advertising and promotion. They highlighted that while direct-to-consumer advertising is not prohibited, it is heavily regulated. NDA outlined various laws and regulations that govern this practice, including the Consumer Protection Act, the Advertising Standards Council of India (ASCI) Code, the Drug and Cosmetics Act, the Drugs and Magic Remedies Act (DMRA), the Food Safety and Standards Act (FSSAI), Uniform Code of Pharmaceutical Marketing Practices (UCPMP) and industry codes. They emphasized the importance of understanding all applicable laws and regulations to guide the development of promotional materials. NDA also mentioned potential future changes to these laws, such as the proposed amendments to the DMRA and the ASCI Code.

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Consumer Protection Act and Advertising Standards

NDA discussed the Consumer Protection Act and its guidelines, emphasizing the importance of honesty and truthfulness in advertisements. They highlighted that the pharmaceutical industry, in particular, needs to be mindful of the act’s provisions and ensure that all information they provide to consumers is current and substantiated. NDA also outlined the rights of consumers under the act and the potential consequences for companies that violate its guidelines. They then moved on to the Advertising Standards Council of India’s (ASCI) code, explaining that while it’s not binding, the industry generally adheres to it due to ASCI’s influence. NDA concluded by discussing the application of the ASCI code to television ads, where statutory penalties can be imposed for non-compliance.Towards the end, NDA mentioned the ASCI influencer guidelines and the importance of disclosure and appropriate qualifications for influencers.

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Pharmaceutical Advertising Guidelines Explained

NDA discussed the guidelines and regulations related to pharmaceutical products and functional foods. They highlighted that the Drugs and Cosmetics Act and Rules are the main legislations governing the pharmaceutical industry, with specific restrictions on advertising prescription drugs and certain health conditions. NDA also explained the Drugs and Magic Remedies Act, which prohibits the advertisement of medicinal products for the treatment, cure, or prevention of any scheduled disorder. They clarified that these restrictions only apply to B2C marketing, not HCP marketing. NDA also mentioned that the DMRA is currently being amended, but the new act will not differ significantly from the current one. NDA also discussed the UCPMP imposes restrictions on B2C marketing and is followed by the industry as a best practice.

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Case Laws and Food Laws in Advertising Regulations

NDA discussed the importance of case laws in guiding principles for lawyers and highlighted key takeaways from these case laws. They emphasized that the product should not promote self-medication and should not offend decency and morality. NDA also stressed the importance of examining each advertisement closely, considering various factors such as the mode of advertising, the type of product, and the company’s ultimate goal. They then moved on to discuss food laws, outlining the regulations for marketing and promotional activities. NDA stressed the need for truthful, meaningful, non-misleading claims, and the need for consumers to be equipped with full information about the product. They also highlighted the importance of companies having data on their products’ performance and complying with all license requirements.

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UCPMP and Pharmaceutical Marketing Practices

NDA discussed the UCPMP and its role in the pharmaceutical industry. They explained that while the UCPMP is voluntary, it is typically followed as a best practice due to potential reputational and tax implications. NDA also noted the possibility of the UCPMP becoming a binding code in the future. They outlined the UCPMP’s requirements, including the marketing of only approved drugs in India, necessity of substantiations of claims made, restrictions on specific use of words, and the prohibition of the use of healthcare professionals in advertising. NDA then discussed the enforcement of the UCPMP through industry associations and the potential consequences for non-compliance. They also touched on the influence of membership in various associations and the development of company-specific standard operating procedures with respect to marketing.

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Healthcare Professional Facing Advertising

NDA discussed the legal regulations – UCPMP and the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 (MCI Code) and ethical considerations surrounding the promotion of products in the healthcare industry. They highlighted that healthcare professionals (HCPs) should not be incentivized to prescribe products, and that any material provided should be comprehensive and informative. NDA also explained the restrictions on HCPs from receiving gifts or Hospitality. Samples may be provided to HCPs subject to certain conditions under the UCPMP. They further discussed the implications of the upcoming NMC code, which could potentially prohibit any interaction between the industry and healthcare professionals. Lastly, NDA touched on digital engagement, emphasizing that the same ethical considerations apply to digital marketing as to physical marketing.

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Pharma Marketing Compliance: Laws, Penalties, and Tax Implications

NDA discussed the importance of compliance with various laws and regulations related to marketing and advertising in the pharmaceutical industry. They highlighted the potential penalties for non-compliance, including fines and statutory requirements. NDA also emphasized the tax implications of marketing expenditure under Indian tax laws. They noted that while the industry is worried about these tax implications, where specific deductions may not be allowed under the Income Tax Act for marketing practices non-compliant with applicable laws. They concluded by advising companies to structure their advertisements carefully, ensuring compliance with all applicable laws.

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Compliance in Communication: Significance and Risks

NDA stressed the importance of adhering to regulations to prevent financial, reputational, and litigation costs. Dr. Ashok, a global health and pharmaceutical industry leader, then led a Q&A session where they shared their views on the regulatory framework for medico marketing communications. He emphasized the importance of communication in product promotion and viewed regulatory frameworks as tools to ensure patient centricity and appropriate product use. Ashok also highlighted the potential risks of not adhering to these norms and stressed the need to consider all circumstances and conditions when developing and communicating about products.

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Product Information and Regulations Discussion

Ashok underscored the significance of providing detailed product information to healthcare professionals, which NDA confirmed as mandatory, including potential legal implications of copying a competitor’s product. NDA cautioned against making price comparisons with competitors and emphasized the importance of focusing on demonstrating value for money. The team also discussed the potential of using health economic studies in future discussions. Questions about restrictions on gifting, sampling, and promotional materials for doctors were raised by the participants, which NDA clarified is prohibited under current law. NDA highlighted the potential business losses and disciplinary action for doctors who do not comply with these regulations. NDA also discussed the guidelines for organizing events and awareness campaigns, emphasizing the need to avoid perceived incentives for doctors to prescribe certain products. They touched upon the restrictions regarding the provision of samples to healthcare professionals and the need for record-keeping and labeling requirements. NDA also discussed the guidelines for doctors’ endorsement of products, stating that doctors cannot endorse any product or have their photograph on promotional material. They also discussed the use of AI-generated images and stock images in promotional brand collateral. NDA also clarified the regulations and guidelines surrounding medical claims made by companies and the collection and use of health data.

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Healthcare Regulations and Ethics

The team discussed various regulations and ethical considerations in the healthcare sector. Ashok stressed the importance of respecting copyright and trademark laws, and involving different departments in communication processes. NDA highlighted the restrictions imposed by the Medical Council of India code on hospitality and promotional activities for doctors. They also clarified that companies are not restricted from providing promotional items however, the same should be legally compliant and confirm to the restrictions under applicable laws. The team also discussed the potential impact of the upcoming NMC code. Other topics discussed included the legality of surrogate marketing, the applicability of general and specific laws to herbal or Ayurvedic formulations, and the legality of having practicing doctors on a pharma company’s advisory board.

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Disclaimer: This summary has been generated by an artificial intelligence (AI). While efforts have been made to ensure accuracy, this summary should be regarded as AI-generated and may not fully capture nuanced details or interpretations present in the original content.