13 March 2024

Govt releases guidelines to curb unethical pharma sector practices

GS-2: Issues Relating to Development and Management of Social Sector/Services relating to Health, Education, Human Resources

The Department of Pharmaceuticals issued the Uniform Code for Pharmaceutical Marketing Practices (UCPMP) 2024 to prevent unethical practices by pharmaceutical companies.

Uniform Code for Pharmaceutical Marketing Practices (UCPMP) 2024

• Ethical Promotion: UCPMP emphasizes ethical marketing practices, ensuring that pharmaceutical companies promote their products responsibly and transparently. A drug can only be promoted after obtaining marketing approval, and the term ‘safe’ cannot be used without qualification.

• Guidelines on Gifts and Benefits: The code sets clear guidelines regarding the provision of gifts, incentives, and benefits to healthcare practitioners, aiming to prevent undue influence on prescription patterns. Free drug samples should not be supplied to individuals who are not qualified to prescribe such products. It prohibits healthcare professionals from accepting gifts from pharma companies or agents, including paid vacations, unless attending conferences, seminars, or workshops where the speaker is participating in Continuing Medical Education (CME) or Continuing Professional Development (CPD) programmes.

• Regulated Claims and Comparisons: Pharma companies must base claims about drug effectiveness on up-to-date evidence. Comparisons between drugs must be factual and fair, without disparaging competitors. Promotional materials must provide accurate information and adhere to standards of good taste.

• Transparency in Relationships: It promotes transparency in relationships between pharmaceutical companies and healthcare professionals, requiring disclosure of any financial or non-financial arrangements. Brand names of products of other companies must not be used in comparison unless the prior consent of the companies concerned has been obtained. UCPMP specifies that the use of the words "safe" and "new" for drugs must comply with specific rules outlined within the code.

• Professional Conduct of Medical Representatives (MRs): Standards are set for MRs, prohibiting the use of inducements to gain access to healthcare professionals. Companies are responsible for ensuring compliance with these standards among their employees.

• Adherence to Regulatory Standards: UCPMP ensures adherence to regulatory standards and compliance with all relevant laws and regulations governing the pharmaceutical industry.

• Complaint Mechanism: The code establishes mechanisms for monitoring and enforcing compliance, with penalties for violations to deter unethical practices effectively. Various pharmaceutical associations have been instructed to set up an “Ethics Committee for Pharma Marketing Practices” to handle complaints.

• Educational Initiatives: It encourages educational initiatives that provide accurate and unbiased information about pharmaceutical products to healthcare professionals and the public. Under the guidelines, companies may provide informational and educational material such as books and clinical treatment guidelines, valued at not more than Rs 1,000 per item.

• Patient Safety: UCPMP prioritizes patient safety by discouraging misleading or exaggerated claims about pharmaceutical products and promoting responsible advertising practices.

• Industry Accountability: Pharmaceutical companies are held accountable for their marketing activities, promoting integrity and trust within the industry.

• Regular Updates and Revisions: The code is subject to regular updates and revisions to adapt to evolving industry standards and address emerging challenges effectively.

• Collaborative Approach: It fosters collaboration between government agencies, industry stakeholders, and healthcare professionals to uphold ethical standards and ensure the welfare of patients.

Challenges faced by the Indian pharma sector concerning unethical practices within the sector

• Counterfeit Drugs and Supply Chain Integrity: Unethical manufacturers may produce and distribute substandard or fake medications, jeopardizing patient safety and eroding trust in the pharmaceutical industry. Thus, ensuring the integrity of the pharmaceutical supply chain, from manufacturing to distribution, is a complex challenge, particularly in a country as vast as India.

• Bribery and Corruption: Instances of bribery and corruption within the pharmaceutical sector can undermine fair competition, distort pricing practices, and compromise regulatory processes. Bribery may influence drug approvals, inspections, and procurement decisions, leading to unethical practices and suboptimal outcomes.

• Off-label Promotion: Some pharmaceutical companies engage in off-label promotion, where drugs are marketed for uses not approved by regulatory authorities. This practice can mislead healthcare professionals and patients, potentially leading to inappropriate prescribing and adverse health effects.

• Kickbacks and Incentives: Offering kickbacks, incentives, or inducements to healthcare professionals for prescribing specific medications is unethical and may violate regulatory guidelines. Such practices prioritize sales over patient welfare and can contribute to overprescribing or inappropriate medication use.

• Data Manipulation and Misrepresentation: Unethical practices may involve manipulating or misrepresenting clinical trial data to exaggerate the efficacy or safety of pharmaceutical products. This can mislead regulatory authorities, healthcare providers, and patients, leading to misguided treatment decisions and compromised patient outcomes.

• Price Fixing and Cartelization: Collusive practices such as price fixing and cartelization among pharmaceutical companies can artificially inflate drug prices, limiting access to essential medications for patients. These unethical practices harm consumers and undermine the principles of fair competition in the pharmaceutical market.

• Inadequate Pharmacovigilance: Failure to report adverse drug reactions (ADRs) or withholding safety information about pharmaceutical products constitutes unethical behaviour. Inadequate pharmacovigilance practices can delay the identification of potential risks associated with medications, compromising patient safety.

• Conflict of Interest: Conflicts of interest may arise when pharmaceutical companies exert undue influence on healthcare professionals, researchers, or regulatory authorities. Financial relationships, gifts, or sponsorships from pharmaceutical companies can compromise the objectivity and independence of decision-makers, leading to biased practices and decisions.

• Patent Evergreening and Abuse: Some pharmaceutical companies engage in patent evergreening strategies to extend their market exclusivity for drugs, often through minor modifications or patent litigation. This practice can delay generic competition, limit access to affordable medications, and perpetuate monopolistic practices in the industry.

• Lack of Transparency in Clinical Trials: Unethical practices may involve withholding or selectively reporting clinical trial data to favourably influence regulatory decisions or mislead healthcare professionals and patients. Lack of transparency in clinical trials undermines scientific integrity, patient trust, and informed decision-making in healthcare.

Other Challenges faced by Indian pharmaceutical sector

• Regulatory Compliance: The pharmaceutical industry operates within a stringent regulatory framework. Compliance with regulations from various authorities like the Central Drugs Standard Control Organization (CDSCO) and the World Health Organization (WHO) poses challenges due to evolving standards and requirements.

• Intellectual Property Rights (IPR) Issues: India's patent laws have been a point of contention, particularly regarding generic drug production and patent infringement cases. Balancing the interests of domestic pharmaceutical companies with international patent holders remains a challenge.

• Quality Control and Standardization: Ensuring consistent quality across the manufacturing process is crucial for pharmaceutical companies. Challenges arise in maintaining quality standards, especially in the context of complex supply chains and the need for adherence to Good Manufacturing Practices (GMP).

• Rising Costs of Research and Development (R&D): Developing new drugs entails significant R&D expenditures. Indian pharmaceutical companies face challenges in financing extensive R&D efforts, especially for innovative drug discovery, which often requires substantial investments in technology and talent.

• Market Access and Pricing Pressures: Accessing global markets while navigating pricing pressures is a significant challenge for Indian pharmaceutical companies. Negotiating pricing agreements, overcoming trade barriers, and adapting to diverse regulatory environments demand strategic acumen and flexibility.

• Competition from International Players: The Indian pharmaceutical market faces stiff competition from multinational pharmaceutical companies with significant resources and established market presence. Competing on a global scale requires Indian firms to innovate, differentiate their offerings, and enhance operational efficiency.

• Talent Acquisition and Retention: The pharmaceutical industry relies heavily on skilled professionals across various domains, including research, manufacturing, and regulatory affairs. Attracting and retaining top talent amidst competition from other industries and global markets is a persistent challenge.

• Access to Capital and Financing: Despite the sector's growth potential, accessing capital for expansion, modernization, and R&D can be challenging, particularly for small and medium-sized enterprises (SMEs). Ensuring adequate financing options and facilitating investment in the sector is essential for its sustained growth.

• Healthcare Infrastructure and Distribution Challenges: India's healthcare infrastructure, particularly in rural areas, faces significant gaps in accessibility and quality. Ensuring the effective distribution of pharmaceutical products, including temperature-sensitive drugs and vaccines, poses logistical challenges.

• Dependency on Active Pharmaceutical Ingredients (APIs) Imports: India heavily relies on imports for crucial raw materials, particularly APIs. Vulnerability to disruptions in the global supply chain, geopolitical tensions, and quality control issues in imported raw materials can impact the domestic pharmaceutical industry's operations.

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