Pharmaceutical Committees, Code of Ethics & IPR
The concluding unit covers: (1) Historical pharmaceutical committees that shaped India’s drug legislation — the Drugs Enquiry Committee, Bhore Committee, Hathi Committee, and Mudaliar Committee. (2) The Code of Pharmaceutical Ethics — the professional and moral standards every pharmacist must uphold. (3) The Medical Termination of Pregnancy Act. (4) The Right to Information Act. (5) An introduction to Intellectual Property Rights (IPR) — Patents, Trademarks, and Copyrights in the pharmaceutical context.
Syllabus & Topics
- 1Pharmaceutical Legislation – Brief Review: Before independence, India had no comprehensive drug regulation. Several committees were constituted to study the problem and recommend legislation. These committees’ recommendations led to the enactment of the D&C Act 1940, Pharmacy Act 1948, and subsequent pharmaceutical laws.
- 2Drugs Enquiry Committee (Chopra Committee, 1930): Chaired by Col. R.N. Chopra. First committee to study the state of drug manufacture and sale in India. Key recommendations: (1) Enact central legislation for drug control (→ led to D&C Act 1940). (2) Establish drug testing laboratories. (3) License drug manufacturers. (4) Register pharmacists. (5) Standardize drugs according to pharmacopoeias.
- 3Health Survey and Development Committee (Bhore Committee, 1946): Chaired by Sir Joseph Bhore. Comprehensive review of health services in India (not just drugs). Key recommendations: (1) Three-tier healthcare system (Primary Health Centers, District Hospitals, Regional Hospitals). (2) Integration of preventive and curative healthcare. (3) Training of health workers including pharmacists. Laid the foundation for public health planning in independent India.
- 4Hathi Committee (1975): Committee on Drugs and Pharmaceutical Industry. Chaired by Jaisukhlal Hathi. Key recommendations: (1) Self-sufficiency in drug production. (2) Quality drugs at reasonable prices. (3) Generic prescribing should be mandatory. (4) Ban irrational drug combinations. (5) Strengthen drug regulatory machinery. (6) Indian Drug Pharmacopoeia should be developed. Led to the Drug Policy 1978 and formation of NPPA.
- 5Mudaliar Committee (1962): Health Survey and Planning Committee. Chaired by Dr. A.L. Mudaliar. Key recommendations: (1) Strengthening primary health infrastructure. (2) Priority for prevention and rural health. (3) More health manpower training. (4) Integration of family planning with general health services. Influenced subsequent Five Year Plans on health investment.
- 6Code of Pharmaceutical Ethics – Definition: A set of professional and moral standards governing the conduct and behavior of pharmacists. Not legally binding like Acts, but a moral obligation. Violation can lead to disciplinary action by the Pharmacy Council (including removal from register). Ensures public trust in the pharmacy profession.
- 7Pharmacist in Relation to His Job: (1) Maintain professional competence through continuous learning. (2) Ensure accuracy in dispensing — verify every prescription. (3) Maintain cleanliness of pharmacy. (4) Never substitute a drug without prescriber’s consent. (5) Never dispense substandard or expired drugs. (6) Maintain patient confidentiality. (7) Provide proper drug information and counseling.
- 8Pharmacist in Relation to Trade: (1) Fair pricing — do not overcharge. (2) Do not sell adulterated or spurious drugs. (3) Do not advertise in a misleading manner. (4) Do not offer secret commissions or incentives to prescribers (unethical). (5) Maintain fair competition with fellow pharmacists. (6) Do not sell drugs without proper license.
- 9Pharmacist in Relation to Medical Profession: (1) Respect the prescriber’s professional judgment. (2) Do not diagnose or prescribe (scope limited to dispensing). (3) Refer patients to qualified medical practitioners when needed. (4) Cooperate with physicians for patient’s benefit. (5) Do not interfere with the physician-patient relationship. (6) Communicate drug interactions/contraindications to the prescriber when detected.
- 10Pharmacist in Relation to His Profession: (1) Uphold the dignity and honor of the profession. (2) Do not engage in practices that bring disrepute. (3) Participate in professional organizations. (4) Contribute to professional knowledge and education. (5) Mentor junior pharmacists. (6) Report unethical conduct of colleagues to the Council. Pharmacist’s Oath: Similar to the Hippocratic oath — ‘I shall uphold the laws and standards governing pharmacy…’ (taken at the time of registration).
- 11Medical Termination of Pregnancy (MTP) Act 1971 (Amended 2021): Legalizes abortion under specific conditions. Pre-2021: Up to 12 weeks (one doctor’s opinion), 12-20 weeks (two doctors). Post-2021 Amendment: Up to 20 weeks (one doctor), 20-24 weeks (two doctors, only for special categories — rape, minors, change in marital status, etc.). No upper limit if substantial fetal abnormalities diagnosed by Medical Board. Privacy: Name and details of the woman NOT to be revealed.
- 12Right to Information Act 2005 (RTI): Provides citizens the right to access information from public authorities. Applicable to pharmaceutical regulation: citizens can request information about drug approvals, clinical trial data, licensing decisions, Drug Inspector reports, drug quality test results. Response required within 30 days. First appeal to Appellate Authority; second appeal to State/Central Information Commission. Certain information exempted: national security, trade secrets.
- 13Intellectual Property Rights (IPR) – Introduction: IPR = legal rights given to creators/inventors to protect their innovations. Types relevant to pharma: (1) Patents (inventions — new drugs, processes, formulations). (2) Trademarks (brand names — Crocin, Dolo). (3) Copyrights (drug literature, package inserts). (4) Trade Secrets (undisclosed formulations). (5) Geographical Indications (Darjeeling Tea). Governed by international agreements: TRIPS (Trade-Related Aspects of Intellectual Property Rights) under WTO.
- 14Patents in Pharma: Indian Patents Act 1970 (Amended 2005 to comply with TRIPS). Product patent protection for drugs (20 years from filing date). Before 2005: India only had process patents (allowed generic companies to manufacture same drug by different process → India became ‘pharmacy of the developing world’). Section 3(d): Bars patents for new forms/derivatives of known substances unless significantly enhanced efficacy → prevents ‘evergreening.’ Compulsory licensing: government can grant license to manufacture patented drug in public health emergencies (e.g., Natco vs Bayer for Sorafenib).
- 15Trademarks & Other IPR: Trademarks protect brand names, logos, and packaging (Trade Mark Act, 1999). Registration: 10 years, renewable indefinitely. ® = registered, ™ = applied for. GI (Geographical Indications of Goods Act, 1999): protects products associated with specific geographic origin. Data Exclusivity: protection of clinical trial data from use by competitors (not yet fully implemented in India). Trade Secrets: protect undisclosed formulations and manufacturing processes.
Learning Objectives
Exam Prep Questions
Q1. What Was the Most Significant Recommendation of the Hathi Committee?
The Hathi Committee recommended that doctors should prescribe medicines using their generic names rather than brand names. This was intended to encourage competition among pharmaceutical companies, reduce medicine costs, and promote rational drug therapy. The committee also recommended banning irrational fixed-dose combinations and improving regulation of the pharmaceutical industry. Its recommendations strongly influenced the Drug Policy 1978 and later contributed to the establishment of the National Pharmaceutical Pricing Authority for drug price control.
Q2. What Is Section 3(d) of the Indian Patents Act?
Section 3(d) of the Indian Patents Act states that the discovery of a new form of a known substance—such as a salt, ester, polymorph, metabolite, or derivative—is not patentable unless it demonstrates significantly enhanced therapeutic efficacy. This rule prevents pharmaceutical “evergreening,” where companies attempt to extend patent monopolies by making minor modifications to existing drugs. The importance of Section 3(d) was reinforced in the landmark Novartis AG v. Union of India concerning the cancer drug Imatinib (marketed as Glivec).
Q3. What Is Compulsory Licensing?
Compulsory Licensing allows a government to permit another manufacturer to produce a patented drug without the patent holder’s consent. This can occur during national emergencies, when a drug is unaffordable or unavailable, or when the patent is not being worked effectively in the country. India’s first compulsory license was granted in 2012 to Natco Pharma for manufacturing Sorafenib (brand name Nexavar) originally patented by Bayer, drastically reducing its price and improving patient access.
Q4. Can a Pharmacist Prescribe Medicines?
No. According to the Pharmacy Act 1948 and the Code of Pharmaceutical Ethics, pharmacists are responsible for compounding, preparing, and dispensing medicines prescribed by registered medical practitioners. Diagnosing diseases and prescribing drugs is legally restricted to qualified medical professionals such as MBBS or BDS doctors. However, pharmacists may counsel patients on the correct use of medicines, recommend appropriate over-the-counter drugs, and alert physicians about possible drug interactions or prescription errors.
Q5. What Information Can Citizens Obtain About Drugs Through RTI?
Under the Right to Information Act 2005, citizens can request information from authorities such as the Central Drugs Standard Control Organization or State Drug Controllers. Accessible information may include clinical trial approvals, reasons for drug approvals or rejections, drug quality testing reports, inspection reports by drug inspectors, lists of licensed pharmacies, and details of banned or recalled medicines. Information related to drug pricing decisions by the National Pharmaceutical Pricing Authority can also be requested. However, certain commercially sensitive or confidential information may be exempt under Section 8(1)(d) of the RTI Act.