📜 Indian Pharmacy Law & Statutory Regulations (12 Statutes)

The Pharmacy Act, 1948 (Act No. 8 of 1948) (1948 (Enacted 4 March 1948))

An Act to regulate the profession and practice of pharmacy across India by constituting the Pharmacy Council of India (Central Council) and State Pharmacy Councils, prescribing minimum uniform educational standards (Education Regulations), and maintaining statutory registers of qualified pharmacists.

The Drugs and Cosmetics Act, 1940 (Act No. 23 of 1940) & The Drugs Rules, 1945 (Act: 1940 (10 April 1940) • Rules: 1945)

An Act to regulate the import, manufacture, distribution, and sale of drugs and cosmetics in India to ensure that no substandard, misbranded, adulterated, or spurious medicine reaches patients.

The Pharmacy Practice Regulations, 2015 (2015 (Notified by PCI in Official Gazette on 15 January 2015 under Sections 10 & 18 of the Pharmacy Act, 1948))

Establishes the statutory Code of Pharmacy Ethics, duties of Registered Pharmacists toward patients, prescription review and patient counselling standards, continuing pharmacy education (CPE), and dress code / professional identification across community and hospital pharmacies in India.

The Drugs Rules, 1945 (1945)

Operational rules framed under Sections 6, 12, 33, and 33N of the Drugs and Cosmetics Act, 1940 governing import licences, retail/wholesale sale licences (Part VI), manufacturing licences (Part VII), labelling (Part IX), and Schedules A to X.

The Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985 (Act No. 61 of 1985) (1985 (Enacted 16 September 1985))

Consolidates and amends the law relating to narcotic drugs (opium, morphine, heroin, codeine, coca derivatives, cannabis) and psychotropic substances, while regulating Essential Narcotic Drugs (ENDs — Morphine, Fentanyl, Methadone, Codeine, Hydrocodone, Oxycodone) for medical pain and palliative care.

The Drugs (Prices Control) Order (DPCO), 2013 (Issued under Section 3 of the Essential Commodities Act, 1955) (2013 (15 May 2013))

Empowers the National Pharmaceutical Pricing Authority (NPPA) to fix market-based Ceiling Prices for Scheduled Formulations listed in Schedule I (aligned with NLEM 2022) and cap annual price increases of non-scheduled formulations at ≤10% per annum.

The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 (Act No. 21 of 1954) (1954)

Prohibits advertisements of drugs and magic remedies (kavacha, talisman, mantra) claiming to procure miscarriage, improve sexual potency, correct menstrual disorders, or cure any of the 54 diseases/conditions specified in the Schedule to the Act.

The Medical Devices Rules, 2017 (2017 (Effective 1 January 2018))

Introduces risk-based classification and licensing for medical devices and in-vitro diagnostics (IVDs) in India under the Drugs and Cosmetics Act, 1940.

The New Drugs and Clinical Trials (NDCT) Rules, 2019 (2019 (Notified 19 March 2019))

Supersedes Part XA and Schedule Y of the Drugs Rules, 1945 to govern clinical trials, bioequivalence/bioavailability (BA/BE) studies, Ethics Committee registration, biomedical and health research, compassionate use, and compensation for trial-related injury or death.

The Cosmetics Rules, 2020 (2020 (Notified 15 December 2020))

Separates cosmetic regulatory provisions from the Drugs Rules, 1945, establishing dedicated import registration, manufacturing licensing, GMP (Eighth Schedule), labelling, and prohibition of animal testing on cosmetics.

The Poisons Act, 1919 (Act No. 12 of 1919) (1919 (3 September 1919))

Regulates the importation, possession, and sale of scheduled poisons across India, empowering Central Government to regulate import and State Governments to regulate possession for sale and retail/wholesale poison registers.

The Bio-Medical Waste Management Rules, 2016 (Amended 2018) under the Environment (Protection) Act, 1986 (2016 (Notified 28 March 2016; Amended 2018))

Mandates four-colour source segregation, barcoding, pretreatment, and safe disposal of hospital, laboratory, and pharmaceutical biomedical waste, including expired or discarded cytotoxic and antibiotic medicines.