India’s pharmaceutical framework has evolved through decades of expert committee recommendations, regulatory reforms, and ethical codes designed to protect public health. Unit 5 highlights the historical committees that shaped drug policy, the ethical obligations of pharmacists, and major legislations such as the Medical Termination of Pregnancy (MTP) Act, the Right to Information (RTI) Act, and an introduction to Intellectual Property Rights (IPR). This news-style article brings together these diverse yet interconnected topics in a clear and engaging format.
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A Brief Review of Pharmaceutical Legislations in India
Introduction
Pharmaceutical legislations in India aim to ensure safe, effective, and quality-controlled medicines while regulating professional conduct and safeguarding patient rights. Over the years, several high-level committees have guided reforms that shaped the nation’s drug policy and healthcare landscape.
Influential Committees Shaping India’s Drug Regulatory Structure
Drugs Enquiry Committee (Chopra Committee), 1930
The Drugs Enquiry Committee was one of India’s earliest efforts to examine drug quality and regulation. It highlighted widespread adulteration, spurious medicines, and lack of standardization, recommending the establishment of legal controls that eventually led to the Drugs Act of 1940.
Its findings laid the foundation for modern drug regulation in India.
Health Survey and Development Committee (Bhore Committee), 1946
The Bhore Committee is considered a landmark in Indian public health planning. It recommended:
A comprehensive national health service
Strengthening of medical education
Establishment of primary health centres
Its emphasis on preventive care and integrated health systems continues to influence Indian healthcare policies today.
Hathi Committee, 1975
Formed to review the pharmaceutical industry, the Hathi Committee made strong recommendations for:
Price control of essential drugs
Encouraging domestic manufacturing
Reducing dependence on multinational companies
Its advocacy for self-reliance strengthened India’s public sector drug manufacturing and laid the groundwork for the Drug Price Control Orders (DPCO).
Mudaliar Committee, 1962
Established to improve healthcare delivery, the Mudaliar Committee recommended:
Strengthening primary healthcare infrastructure
Better training for healthcare workers
Improved coordination across health programmes
Its proposals bridged the gap between policy planning and practical implementation, particularly in rural healthcare.
Code of Pharmaceutical Ethics: Upholding Professional Integrity
Definition
The Code of Pharmaceutical Ethics, issued by the Pharmacy Council of India (PCI), outlines the moral and professional standards expected from pharmacists in their interactions with patients, healthcare providers, and society.
Pharmacist in Relation to His Job
Pharmacists must ensure accurate dispensing, maintain proper storage of drugs, and uphold patient confidentiality. They must not substitute medications without authorization and should always prioritize patient safety.
Pharmacist in Relation to Trade
Ethical trade practices are essential. Pharmacists must avoid misleading advertisements, selling substandard drugs, or engaging in unfair competition. They should maintain transparent transactions and avoid conflicts of interest.
Pharmacist in Relation to the Medical Profession
Pharmacists must maintain cooperative relationships with physicians and other healthcare professionals. They should respect prescriptions, offer correct drug information, and avoid criticism that may harm inter-professional trust.
Pharmacist in Relation to His Profession
Professionalism includes continuous learning, adherence to laws, and participation in community health programs. Pharmacists must contribute to public health education and promote rational drug use.
Pharmacist’s Oath
The Pharmacist’s Oath emphasizes:
Serving humanity
Maintaining professional conduct
Upholding the dignity of the pharmacy profession
Ensuring ethical interaction with patients and colleagues
It symbolizes a lifelong commitment to ethical pharmaceutical practice.
Medical Termination of Pregnancy (MTP) Act
Overview and Significance
The MTP Act, initially enacted in 1971 and amended in 2021, provides a legal framework for safe and regulated termination of pregnancy. It aims to reduce maternal mortality caused by unsafe abortions.
Key Provisions
Termination permitted up to 20 weeks with one registered medical practitioner (RMP) approval.
Up to 24 weeks allowed for special categories (survivors of rape, minors, etc.) with approval from two RMPs.
Protection of patient confidentiality is mandatory.
Medical Boards may approve termination beyond 24 weeks in cases of severe fetal abnormalities.
The Act balances reproductive rights with medical safety.
Right to Information (RTI) Act, 2005
Purpose and Applications in Healthcare
The RTI Act empowers citizens to request information from public authorities, promoting transparency and accountability.
In the pharmaceutical sector, RTI supports:
Access to drug approval documents
Clarity on procurement and pricing policies
Transparency in regulatory decisions
It strengthens public trust in healthcare institutions.
Introduction to Intellectual Property Rights (IPR)
Understanding IPR
Intellectual Property Rights are legal protections granted for creations of the mind, including inventions, trademarks, copyrights, and industrial designs. In pharmaceuticals, the most relevant form of IPR is patents.
Importance in the Pharmaceutical Industry
IPR:
Encourages innovation by granting exclusive rights to inventors
Protects new drug molecules and manufacturing processes
Facilitates technology transfer and investment
Ensures global competitiveness
However, strict patent protection can increase drug prices, making the balance between innovation and public health a central policy challenge.