What’s the news?

• The Indian government recently directed all pharmaceutical companies in the country to implement the revised Good Manufacturing Practices (GMP) to bring their processes in line with global standards.

Central Idea

• The improved standards aim to address critical issues, including alleged contamination incidents in India-manufactured products, deficiencies in quality control measures, and a of adherence to global guidelines. By ensuring adherence to the revised GMP, India aims to enhance the quality of medicines available in both domestic and global markets.

About Good Manufacturing Practices (GMP)

• GMP is a set of guidelines and quality management principles that ensure pharmaceutical products, as well as other products in the food and healthcare industries, are consistently produced and controlled to meet quality standards appropriate for their intended use.
• GMP covers all aspects of the manufacturing process, including the premises, equipment, personnel, materials, production, quality control, documentation, and storage of finished products.

The Need for Improved Standards

• Alignment with Global Standards: Implementing the new GMP norms will align the Indian pharmaceutical industry with global standards, ensuring that the country’s products meet the expectations of international regulators and consumers.
• Contamination Incidents: Numerous incidents of contamination in India-manufactured syrups, eye-drops, and eye ointments have been reported in other countries, leading to tragic consequences. These incidents have emphasized the need for stricter quality control measures.
• Identified Deficiencies: A risk-based inspection of manufacturing units revealed several deficiencies, such as the lack of testing incoming raw materials, inadequate product quality review, absence of quality failure investigation, infrastructure issues, and the absence of qualified professionals.

Importance of Implementing Revised GMP

• Standardized Processes: The improved standards will ensure that pharmaceutical companies follow standardized processes and quality control measures, thus enhancing the quality of medicines manufactured and sold both in India and globally.
• Recommendations from Chitan Shivir: The implementation of the revised GMP was one of the suggested measures during a Chitan Shivir following the contamination incidents. The stakeholders also recommended the creation of a country-wide IT platform to promote uniformity in licensing and inspection processes across states.

Benefits of the Revised GMP Implementation

• Boosting Regulatory Confidence: Uniform quality standards across the industry will instill confidence in regulators from other countries, potentially reducing the need for repeated inspections.
• Improving Domestic Market Quality: The implementation of revised GMP will enhance the quality of medicines supplied within India, benefitting consumers and public health.

Major Changes in the Revised GMP Guidelines

• Pharmaceutical Quality System: The new guidelines introduce a pharmaceutical quality system to ensure consistent product quality and a thorough investigation of deviations or defects.
• Quality Risk Management: Companies will be required to conduct risk assessments and implement preventive actions to manage quality risks effectively.
• Product Quality Review: Regular quality reviews of all products will be mandated to verify the consistency of quality and processes.
• Validation of Equipment: Pharmaceutical companies will have to validate equipment to ensure the accuracy and reliability of production processes.
• GMP-related Computerized Systems: The guidelines emphasize the use of computerized systems for GMP-related processes to prevent data tampering and unauthorized access.
• Additional Product Requirements: The new schedule M lists requirements for biological products, agents with radioactive ingredients, plant-derived products, and investigational products for clinical trials.

Way forward

• Urgent Implementation: Pharmaceutical companies must immediately initiate the implementation of the revised Good Manufacturing Practices (GMP) guidelines. Larger companies have six months, and smaller companies have a year to comply.
• Investment in Upgradation: Prioritize investments in facility upgradation, modern equipment, and IT systems to meet the new GMP standards.
• Employee Training and Awareness: Conduct extensive training programs for all employees to educate them about the revised GMP guidelines and their importance.
• Quality Control Enhancement: Strengthen quality control processes and invest in advanced testing equipment and laboratories to ensure product integrity and safety.
• Effective Documentation Systems: Implement robust documentation systems to maintain comprehensive records of manufacturing processes, quality checks, and deviations.
• Continuous Monitoring and Auditing: Regularly monitor manufacturing processes and conduct internal audits to assess GMP compliance.

Conclusion

• The Indian government’s initiative to implement the revised GMP is a commendable step towards bringing the country’s pharmaceutical industry up to global standards. The successful implementation of these improved standards will undoubtedly elevate India’s status in the global pharmaceutical arena

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What’s the news?

• In a recent development, the ICMR and the Ministry of Ayush have agreed to enhance cooperation in health research related to integrated medicine.

Central idea

• The recent push to integrate AYUSH medicinal systems into mainstream health care to achieve universal health coverage and decolonize medicine is a commendable pluralistic approach. However, this endeavor must prioritize safety and efficacy standards for every participating system. Unfortunately, Homeopathy falls short of meeting these essential criteria.

What is an integrated system of medicine?

• An integrated system of medicine refers to an approach that combines elements from different healthcare systems or modalities, such as conventional medicine and traditional, complementary, or alternative medicine, with the goal of providing comprehensive and patient-centered care.

What Is Homeopathy?

• Homeopathy is a system of alternative medicine founded in the late 18th century by Samuel Heinemann, a German physician.
• Homeopathy is a medical system based on the belief that the body can cure itself. Those who practice it use tiny amounts of natural substances like plants and minerals. They believe these stimulate the healing process.
• This is based on the idea that a substance that causes symptoms in a healthy individual can stimulate the body’s natural healing response to overcome similar symptoms in an ill person.

Key principles of Homeopathy

• The Law of Similar: Homeopathy follows the principle that a substance that produces symptoms in a healthy person can be used to treat similar symptoms in a sick person.
• Minimum Dose: Homeopathic remedies are prepared through a process of dilution and potentization, which involves repeatedly diluting the original substance and shaking it vigorously. The belief is that this process enhances the remedy’s healing properties while minimizing any potential toxicity.
• Individualization: Homeopathy treats each person as a unique individual and tailors the treatment to address their specific symptoms and overall constitution.
• Totality of Symptoms: Rather than focusing solely on a specific disease or isolated symptoms, homeopathy takes into account the totality of a person’s physical, mental, and emotional symptoms to find an appropriate remedy.

Concerns over the efficacy and safety of Homeopathy

• Weak Evidence: The evidence supporting the efficacy of homeopathy is considered weak. The Nuremberg Salt Test (1835), a well-conducted double-blind randomized controlled trial, discredited homeopathy, attributing its claimed effects to imagination, self-deception, or potential fraud.
• Inconsistent Systematic Reviews: Multiple systematic reviews and meta-analyses have consistently shown that homeopathic treatments lack clinically significant effects across various ailments, population groups, study types, and treatment regimes.
• Unregistered Trials: Researchers found that more than half of the 193 homeopathic trials conducted in the last two decades were not registered. Surprisingly, unregistered trials showed some evidence of efficacy, while registered trials did not, casting doubt on the validity and reliability of the evidence.
• Lack of confidence: The World Health Organization (WHO) has issued warnings against using homeopathy for serious conditions such as HIV, tuberculosis, malaria, and infant flu and diarrhea. This indicates a lack of confidence in its effectiveness in treating such illnesses.
• Ineffectiveness for Serious Conditions: Evidence suggests that homeopathy may not work effectively in treating cancers and may not help reduce the adverse effects of cancer treatments.
• Potential Delay in Effective Treatment: One of the safety concerns related to homeopathy is its potential to delay the application of evidence-based clinical care for serious or life-threatening conditions. This delay can have detrimental effects on patients’ health outcomes.

Arguments in favor of Homeopathy

• Historical Usage: Supporters of homeopathy often highlight its long historical usage and widespread popularity, arguing that its effectiveness is demonstrated by its continued use over the centuries.
• Individualization of Treatment: Homeopathy emphasizes individualized treatment, tailoring remedies to address a person’s unique symptoms and overall constitution. This personalized approach is believed to be beneficial for patients who may not respond well to standardized treatments.
• Minimal Side Effects: Homeopathic remedies are highly diluted, which proponents claim minimizes side effects and makes them safe for use, even in sensitive patient populations.
• Holistic Approach: Advocates assert that homeopathy takes a holistic view of health, considering not only physical symptoms but also mental and emotional aspects of a person’s well-being.
• Anecdotal Testimonials: Supporters of homeopathy often provide anecdotal testimonials from patients who claim to have experienced positive outcomes from using homeopathic remedies. Supporters of homeopathy often cite testimonials from famous figures like Gandhi and Tagore to bolster its credibility.

Way forward: Key areas that India needs to focus on regarding Homeopathy

• Evidence-Based Medicine: India needs to prioritize evidence-based medicine across all healthcare systems, including homeopathy. Rigorous research, clinical trials, and systematic reviews should be conducted to evaluate the efficacy and safety of homoeopathic treatments.
• Integration and Pluralism: India should adopt a balanced approach to healthcare by integrating various medicinal systems, including allopatry and AYUSH, while ensuring that only evidence-based and effective practices are incorporated into mainstream healthcare.
• Regulatory Oversight: Strengthen regulatory bodies to oversee the practice of homeopathy and ensure adherence to quality standards and ethical guidelines. This will help maintain patient safety and foster trust in the healthcare system.
• Education and Awareness: Promote education and awareness among healthcare professionals and the public about the strengths and limitations of homeopathy. Informed decision-making and patient choice should be encouraged based on scientific evidence.
• Holistic Health Approach: Emphasize a holistic approach to healthcare that considers not only physical symptoms but also mental, emotional, and social aspects of health. This approach should be integrated into all medical systems, including homeopathy.
• Continuous Improvement: Continuously review and update the integration of homeopathy and other medical systems based on emerging evidence and changing healthcare needs. This iterative approach will lead to a more responsive and effective healthcare system.

Conclusion

• For India’s path towards universal health care, an evidence-based and ethics-driven medicine approach should be embraced, ensuring that only safe and effective treatments are integrated into mainstream healthcare practices.

Also read:

World Ayurveda Congress: Aligning traditional medicine with modern medicines

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What’s the news?

• A new amendment bill introduced by the Centre in the Lok Sabha has sparked a debate on the autonomy of the Indian Institutes of Management (IIMs). The bill proposes to make the President of India the Visitor to IIMs with powers to audit their functioning, order probes, and appoint as well as remove directors.

Central idea

• In 2017, the Parliament passed the IIM Act, significantly expanding the autonomy of IIMs and giving them greater control over their affairs. One crucial provision mandated an independent review of the institutes every three years, with the report to be made public. However, after six years, only a few IIMs have complied with this requirement, leading the government to table the IIM (Amendment) Bill in 2023.

The proposed provisions in the Bill

• Creation of the Post of Visitor: The Bill proposes the creation of the post of Visitor, who will be the President of India. The Visitor will play a crucial role in overseeing the functioning of the IIMs and ensuring proper governance.
• Appointment Powers: The Visitor will have the authority to appoint the chairperson of the Board of Governors (BoG) of the IIMs. This move grants the President of India a significant say in the leadership of the institutes.
• Involvement in Director Appointments: The Bill empowers the Visitor to have a say in the appointment process for directors of IIMs. The Visitor will have representation on the selection committee for the appointment of directors, allowing them to influence the choice of institute heads.
• Review and Inquiry Initiation: The Visitor will have the power to initiate reviews or inquiries into the affairs of any IIM. This provision allows for greater oversight and scrutiny of the institutes’ functioning.
• Director Removal: The Visitor will be granted the authority to remove a director of an IIM if deemed necessary. This move gives the President the power to take action against directors who may not be performing their duties effectively or who are involved in any misconduct.

Issues with the Current Governance

• Lack of Accountability: The current governance structure in IIMs lacks adequate accountability due to the significant autonomy granted by the 2017 IIM Act. This has led to a governance vacuum with limited checks and balances on directors’ actions, potentially resulting in mismanagement.
• Absence of Norms on Key Matters: The IIM Act’s failure to establish clear norms on crucial matters, such as the appointment of key positions, has led to a lack of transparency and objectivity in decision-making.
• Turmoil and Protests: Some IIMs have experienced internal turmoil and protests against administrative decisions, indicating a disconnect between management and stakeholders.
• For instance, at IIM Ahmedabad, faculty and alumni protested against changes to the institute’s logo and the decision to demolish architecturally significant structures on the campus.
• Rising MBA Course Fees: An additional concern with the current governance is the relentless rise in the fee for MBA courses, which is not necessarily related to the actual costs of the course.
• Unresponsive to Queries and Suggestions: There have been reports that some IIMs have been unresponsive to queries and suggestions from various stakeholders, including the government.
• Uneven Governance Practices: The level of governance and accountability might vary across different IIMs. Some of the lower-ranked IIMs have been accused of operating as petty tyrannies, with directors holding unchecked power.

Importance of Government Control

• Ensuring Accountability: Government control is crucial to ensuring accountability in the functioning of educational institutions, including the Indian Institutes of Management (IIMs). It helps prevent misuse of power, financial irregularities, and a lack of transparency.
• Preserving the Public Interest: As public institutions, IIMs have a responsibility to serve the public interest. Government control ensures that the institutes remain focused on their core mission of providing quality education and contributing to socio-economic development.
• Academic Integrity: Government oversight safeguards academic integrity by promoting fairness in faculty appointments, curriculum design, and research activities.
• Addressing Societal Needs: Government involvement allows IIMs to align their objectives with societal demands, producing graduates with relevant skills to address the country’s evolving challenges.
• Equitable Access and Affordability: Government control promotes inclusivity by implementing policies that ensure equal access to quality education, irrespective of socio-economic backgrounds.
• Quality Assurance: Government oversight allows the establishment of quality assurance mechanisms, ensuring that the IIMs maintain their reputation as world-class institutions adhering to global standards.

Concerns Regarding the IIM Amendment Bill 2023

• Potential Government Control: Critics and some directors of IIMs are concerned about increased government control over the institutions through the designation of the President of India as the Visitor with powers to appoint and remove directors.
• Autonomy Erosion: The bill has raised fears that it may undermine the autonomy granted to IIMs in 2017, potentially leading to a dilution of their independence and decision-making authority.
• Lack of Stakeholder Involvement: Stakeholders, including directors of IIMs, are apprehensive about insufficient consultation during the bill’s drafting, which they believe could impact the institutes’ governance.
• Apprehensions About the Independent Board Model: Critics argue that the existing independent board model governing B-schools has been successful globally and could continue to be effective in India without introducing a Visitor.
• Potential for Ideological Influence: The critiques allege that the bill may be used to enforce ideological conformity, raising concerns about the Visitor’s influence over the institutes’ academic pursuits.
• Impact on Institutional Reputation: Uncertainty surrounding the bill could affect IIMs’ reputation, leading stakeholders to question their stability and governance.

Way Forward

• Inclusive Consultation: The government should engage in inclusive consultations with IIMs, education experts, policymakers, and stakeholders to address concerns and ensure broad consensus on the bill’s provisions.
• Amendment Refinements: Based on feedback received during consultations, the government should consider refining the bill’s provisions to strike an appropriate balance between accountability and autonomy.
• Codifying Norms: Clear norms and guidelines should be incorporated into the bill to provide a framework for responsible governance while allowing flexibility in decision-making.
• Promote Transparency: The bill should emphasize transparency in decision-making processes and overall governance to build trust among stakeholders.
• Continuous Evaluation: Implementing a system of continuous evaluation and feedback will help gauge the effectiveness of the bill’s provisions.
• Focus on Quality Education: The primary focus should remain on maintaining and improving the quality of education in IIMs while fostering greater accountability.

Conclusion

• The Bill reflects the government’s efforts to restore accountability and democratic oversight in the IIM system. Striking the right balance between autonomy and accountability is vital to maintaining the IIMs’ esteemed position in the Indian education landscape.

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