Date : 22/06/2023

Relevance: GS Paper 3; Pharmaceutical Industry

Main Points: Central Drugs Standard Control Organization (CDSCO), Drugs and Cosmetics Act of 1940, Quality and Safety

Context-

• India holds a significant position in the global pharmaceutical market as one of the largest producers and exporters of generic drugs, catering to approximately 20% of global demand.
• The country also ranks among the top 12 destinations for biotechnology globally and third in the Asia Pacific region, with its biotechnology industry surpassing USD 80.12 billion in 2022, marking a 14% growth from the previous year.

Positive Contributions and Concerns:

• India's pharmaceutical industry has played a crucial role in improving healthcare outcomes and enhancing access to affordable medicines, particularly in developing nations.
• However, the industry has faced allegations and incidents of producing substandard, contaminated, or harmful drugs, leading to adverse effects and even deaths among patients in various countries such as Sri Lanka, Gambia, Uzbekistan, and the United States.

Potential Causes of Inadequate Safety Standards:

Lack of Adequate Regulation and Enforcement:

• Outdated and inadequate legislation: India's drug regulation is governed by the Drugs and Cosmetics Act of 1940, which does not address the complexities of the modern pharma market adequately.
• Incomplete coverage: The Act fails to encompass essential aspects such as clinical trials, bioequivalence studies, and good manufacturing practices necessary for ensuring drug quality and safety.
• Weak enforcement: The enforcement of the Act is fragmented, involving multiple authorities at the central and state levels, with overlapping jurisdictions and responsibilities.

Inadequate Resources:

• Shortage of manpower, infrastructure, funds, and technology hampers effective inspections, testing, monitoring, and surveillance of drug manufacturing units and products.

Lack of Transparency and Accountability:

• Limited information disclosure: India's drug regulator, the Central Drugs Standard Control Organization (CDSCO), does not provide comprehensive information about its activities, processes, outcomes, etc., to the public or the media.
• Absence of evaluation mechanisms: There is no established method to assess the performance and impact of the regulator in curbing substandard or spurious drugs.
• Potential influence and conflicts: Allegations of corruption, collusion, and conflicts of interest among certain CDSCO officials and pharma companies raise concerns about the impartiality and independence of the regulator.

Lack of Awareness and Compliance among Pharma Companies:

• Non-adherence to standards and norms: Some pharma companies neglect prescribed guidelines for manufacturing, testing, labeling, packaging, storing, and distributing drugs.
• Unethical practices: Certain companies resort to substandard or counterfeit raw materials, adulteration, dilution, data manipulation, etc., compromising quality and safety to reduce costs or increase profits.
• Limited knowledge of regulatory requirements: Some companies lack awareness and understanding of regulatory guidelines for different markets or countries.
• Inadequate quality control systems: Companies may lack robust mechanisms to detect and prevent errors or defects in their products.

Consequences of Ineffective Regulations:

• Harm to Public Health: Poor drug quality and safety can cause infections, allergies, organ damage, poisoning, etc., among patients, leading to treatment failure, drug resistance, complications, or even deaths. Patients with chronic or life-threatening diseases like HIV/AIDS, tuberculosis, malaria, cancer, etc., are particularly vulnerable.
• Erosion of Public Trust: Ineffective regulation undermines trust and confidence in Indian pharmaceutical products among patients and healthcare providers.

Harm to Economic Growth:

• Substandard products harm the reputation and competitiveness of India's pharma industry globally, resulting in a loss of market share, revenue, and profits.
• Bans, recalls, or rejections by foreign regulators or customers can have a detrimental impact, leading to a decline in foreign exchange earnings, employment opportunities, and investments in the sector.
• Violations of international laws or norms can expose the industry to legal liabilities or penalties.

Harm to International Relations: Poor quality and safety of Indian pharma products can tarnish India's image and credibility as a responsible partner in global health initiatives, potentially straining international relations.

Harm to International Cooperation: Inadequate regulation can hinder India's collaboration with other countries or organizations in addressing global health challenges, such as pandemics and epidemics.

Proposed Solutions:

Amending the Drugs and Cosmetics Act, 1940:

• Updating the legal framework to address the complexities and challenges of the modern pharma sector.
• Incorporating clear and uniform standards and norms for different categories of drugs and markets.

Streamlining and Rationalizing the Drug Regulatory Structure and Functions:

• Establishing a single, central authority with adequate powers, resources, expertise, and autonomy to regulate the entire pharma sector effectively.
• Ensuring robust enforcement and compliance with drug laws and norms.

Fostering a Culture of Quality and Safety In the Pharma Industry:

• Providing incentives, recognition, support, and guidance to the industry for adhering to standards and norms and producing high-quality drugs.
• Encouraging voluntary self-regulation and promoting quality certification schemes.

Conclusion:

Addressing the challenges faced by India's pharmaceutical industry in terms of quality and safety standards is crucial to protect public health, restoring trust, fostering economic growth, maintaining good international relations, and facilitating global cooperation. By updating regulations, streamlining the regulatory structure, and fostering a culture of quality and safety, India can ensure that its pharma industry continues to make a positive impact on global healthcare.

Source: The Hindu