[REG-02] Pharmacy Act 1948, PCI Education Regulations (ER 2020), NDPS Act 1985, DPCO 2013 & NLEM 2022
REG-02 • 12. Pharmaceutical Jurisprudence & Indian Pharmacy LawLearning Objectives
Outline the constitution and functions of the Pharmacy Council of India (PCI), State Pharmacy Councils, Education Regulations (ER 2020), and First/Subsequent Registers under the Pharmacy Act 1948.; Detail the Narcotic Drugs and Psychotropic Substances (NDPS) Act 1985, Essential Narcotic Drugs (ENDs — 2014 Amendment for palliative care access to [6.10] Morphine and [6.11] Fentanyl), and commercial quantity penalties.; Apply the Drugs (Prices Control) Order (DPCO 2013) ceiling price formula under the Essential Commodities Act 1955, NPPA, and the National List of Essential Medicines (NLEM 2022 — 384 medicines).
Chapter Overview & Core Explanation
Beyond the Drugs and Cosmetics Act, Indian pharmacy is governed by laws that regulate who may practise as a Registered Pharmacist (Pharmacy Act 1948), prevent abuse of narcotic opioids while ensuring cancer pain relief (NDPS Act 1985), and cap retail prices of essential life-saving medicines (DPCO 2013 & NLEM 2022).
Key Exam & Clinical Takeaways
- Under DPCO 2013, the statutory retailer margin (M) factored into the ceiling price of NLEM Scheduled Formulations is 16%, and non-scheduled drugs cannot increase MRP by more than 10% in 12 months.
- The 2021 MTP Amendment Act extended the gestational limit from 20 weeks to 24 weeks (with two RMP opinions) for survivors of sexual assault, minors, and fetal anomalies.