[REG-11] Pharmaceutical Ethics, Pharmacist Oath, Good Pharmacy Practice (GPP), Digital Health (ABDM) & Intellectual Property (Indian Patents Act 1970 Sec 3(d))

REG-11 • 12. Pharmaceutical Jurisprudence & Indian Pharmacy Law

Learning Objectives

Apply the Pharmaceutical Code of Ethics (Pharmacy Council of India — pharmacist in relation to job, trade, medical profession, and profession) and the Pharmacist's Oath.; Explain the Indian Patents Act 1970 (2005 Product Patent Amendment, 20-year term from filing date, **Section 3(d) anti-evergreening clause**, and **Compulsory Licensing under Section 84**).; Integrate Good Pharmacy Practice (GPP — IPA/CDSCO/WHO), Telemedicine & e-Pharmacy rules, and Ayushman Bharat Digital Mission (ABDM).

Chapter Overview & Core Explanation

Professional pharmacy ethics and India's landmark patent laws balance rewarding genuine scientific innovation with a moral and legal duty to keep life-saving medicines affordable and accessible to every patient.

Key Exam & Clinical Takeaways

• Section 3(d) of the Indian Patents Act 1970 prevents 'evergreening' by requiring proof of enhanced **therapeutic efficacy** (not merely improved physicochemical flowability or stability) for new salts or polymorphs of known drugs.
• A Compulsory Licence under Section 84 of the Indian Patents Act 1970 can be applied for after the expiration of **3 years** from the date of grant of a patent.

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