Pharmacy Act 1948, MTP Act 1955 & NDPS Act 1985
This unit covers three separate Acts. The Pharmacy Act 1948 — the law that defines the pharmacy profession in India, establishes the Pharmacy Council of India (PCI), and regulates pharmacist registration. The Medicinal and Toilet Preparation (Excise Duties) Act 1955 — governing manufacture and sale of preparations containing alcohol/narcotics. The NDPS Act 1985 — India’s primary legislation for controlling narcotic drugs and psychotropic substances, with some of the harshest penalties in Indian law.
Syllabus & Topics
- 1Pharmacy Act 1948 – Objectives: (1) Regulate the profession of pharmacy. (2) Constitute the Pharmacy Council of India (PCI) and State Pharmacy Councils. (3) Prescribe minimum educational standards for pharmacy qualification. (4) Maintain a register of qualified pharmacists. (5) Ensure only registered pharmacists practice pharmacy.
- 2Pharmacy Act – Key Definitions: ‘Pharmacist’ = person whose name is entered in the register of pharmacists (Section 2(f)). ‘Pharmacy’ is not explicitly defined in the Act but understood as the practice of preparing, compounding, and dispensing drugs. ‘Registered Pharmacist’ = pharmacist registered under the provisions of this Act with a State Pharmacy Council.
- 3Pharmacy Council of India (PCI) – Constitution: Constituted under Section 3. President elected from among members. Members: (1) Representatives from each State Council. (2) Members nominated by Central Government (pharmacy education experts, pharmacists from different sectors). (3) Members from universities. (4) Director General of Health Services (ex-officio). Term of office: 5 years.
- 4PCI – Functions: (1) Prescribe minimum standards of education for pharmacy qualification (Education Regulations – ER). (2) Approve pharmacy colleges and courses (D.Pharm, B.Pharm). (3) Inspect pharmacy institutions. (4) Maintain the Central Register of Pharmacists. (5) Advise Central/State Governments on pharmacy matters. (6) Withdraw recognition from substandard institutions.
- 5Education Regulations (ER): PCI prescribes subjects, course duration, examination standards, practical training requirements. D.Pharm: 2 years + 500 hours practical training. B.Pharm: 4 years. M.Pharm: 2 years. Pharm.D: 6 years (clinical pharmacy). Only PCI-approved institutions can award pharmacy qualifications that enable pharmacy practice.
- 6State & Joint State Pharmacy Councils: Constituted under Section 19. Functions: (1) Maintain the State Register of Pharmacists. (2) Issue registration certificates. (3) Remove names for misconduct. (4) Send copies of register to PCI for Central Register. Joint State Pharmacy Council: formed when two or more states agree to have a common council.
- 7Registration of Pharmacists (Section 31-35): Qualifications for registration: (1) D.Pharm or B.Pharm from PCI-approved institution. (2) Practical training completed. (3) Application to State Pharmacy Council. Name entered in State Register → eligible to practice pharmacy. Only registered pharmacists can compound, prepare, mix, or dispense medicines on prescription. Penalty for unregistered practice.
- 8Offences & Penalties – Pharmacy Act: Using the title ‘Pharmacist’ without registration: fine up to ₹1,000. Practicing pharmacy without registration: fine up to ₹1,000 for first offence, ₹2,000 for subsequent. Employing unregistered persons as pharmacists: fine up to ₹1,000.
- 9Medicinal & Toilet Preparation Act 1955 – Objectives: (1) Regulate manufacture and sale of medicinal preparations containing alcohol, narcotic drugs, or narcotic preparations. (2) Levy excise duties on such preparations. (3) Regulate export of alcoholic medicinal preparations. Applicable when preparations contain alcohol or narcotics in quantities exceeding prescribed limits.
- 10MTP Act – Key Provisions: Manufacture: ‘In bond’ (within bonded warehouse under govt supervision – excise duty paid only when removed for sale) or ‘Outside bond’ (in licensed premises – duty paid at manufacture). License required from Excise Commissioner. Ayurvedic, Homeopathic, and Patent/Proprietary preparations containing alcohol are covered. Export of alcoholic preparations requires separate license.
- 11NDPS Act 1985 – Objectives & Scope: (1) Consolidate and amend all existing laws relating to narcotic drugs and psychotropic substances. (2) Make stringent provisions for the control and regulation of operations relating to narcotic drugs and psychotropic substances. (3) Provide for forfeiture of property derived from illicit trafficking. (4) Implement India’s obligations under international UN Conventions.
- 12NDPS Act – Key Definitions: ‘Narcotic Drug’ = coca leaf, cannabis, opium, poppy straw, and includes all manufactured drugs. ‘Psychotropic Substance’ = any substance listed in the Schedule to the Act (Amphetamines, LSD, Barbiturates, etc.). ‘Cannabis’ includes charas (resin), ganja (flowering tops), and any mixture.
- 13NDPS Act – Authorities & Committees: Narcotics Commissioner (appointed by Central Government). Narcotics & Psychotropic Consultative Committee: advises the government on supply for medical/scientific purposes vs prevention of abuse. National Fund for Control of Drug Abuse: receives fines, penalties, and donations for de-addiction and rehabilitation programs.
- 14NDPS Act – Prohibition & Control: No person shall cultivate coca plant/opium poppy/cannabis without license. No manufacture, purchase, sale, transport, import, or export of narcotic drugs/psychotropic substances without authorization. Licensed opium cultivation: only in notified areas (MP, Rajasthan, UP) under strict government control. Government monopoly on opium purchase.
- 15NDPS Act – Offences & Penalties: Possession of small quantity: imprisonment up to 1 year or fine up to ₹10,000 or both. Commercial quantity: imprisonment 10-20 years + fine ₹1-2 lakh. Trafficking (production, manufacture, sale for commercial purposes): 10-20 years rigorous imprisonment + fine ₹1-2 lakh. Repeat offence of commercial quantity: death penalty possible. Financing trafficking: 10-20 years + ₹1-2 lakh fine. Abetment and attempt also punishable.
Learning Objectives
Exam Prep Questions
Q1. What Is the Difference Between PCI and State Pharmacy Council?
Pharmacy Council of India is the central regulatory authority established under the Pharmacy Act 1948. It prescribes minimum educational standards for pharmacy education, approves pharmacy colleges, and maintains the Central Register of pharmacists across India. In contrast, a State Pharmacy Council operates at the state level. It registers pharmacists practicing within the state, maintains the State Register of Pharmacists, and can remove names in cases of professional misconduct. Thus, the PCI sets national policies and standards, while State Pharmacy Councils handle registration and regulatory activities within their respective states.
Q2. Can Someone With a B.Sc in Chemistry Work as a Pharmacist?
No. According to the Pharmacy Act 1948, only individuals who have completed a pharmacy qualification such as Diploma in Pharmacy or Bachelor of Pharmacy from a PCI-approved institution, completed the required practical training, and have their name entered in the State Register of Pharmacists can legally practice pharmacy. This includes activities such as compounding, dispensing, or selling prescription medicines. A person with only a B.Sc in Chemistry is not legally permitted to perform these duties.
Q3. What Is “In Bond” Manufacture Under the MTP Act?
Under the Medicinal and Toilet Preparations (Excise Duties) Act 1955, “in bond” manufacture refers to the production of medicinal preparations containing alcohol within a bonded warehouse that is supervised by excise authorities. The finished products remain inside the bonded premises until they are officially removed for sale. Excise duty on the alcohol content is paid only at the time the product is removed from the warehouse. This system allows the government to strictly monitor alcohol usage in medicinal products and prevent diversion for non-medical purposes.
Q4. What Are the Penalties for Drug Trafficking Under the NDPS Act?
The Narcotic Drugs and Psychotropic Substances Act 1985 prescribes strict punishments for drug trafficking. For offences involving commercial quantities of narcotic drugs or psychotropic substances, the punishment includes rigorous imprisonment for 10 to 20 years along with a fine ranging from ₹1 lakh to ₹2 lakh or more as determined by the court. In cases of repeat offences involving commercial quantities, the law allows the possibility of the death penalty. Financing illicit drug trafficking or harboring offenders is also punishable with similar penalties. The Act also criminalizes attempts, conspiracy, and abetment related to drug trafficking.
Q5. Is Cannabis Legal in India?
Under the Narcotic Drugs and Psychotropic Substances Act 1985, cannabis products such as charas (cannabis resin) and ganja (flowering tops of the cannabis plant) are illegal. However, bhang, which consists of the leaves and seeds of the cannabis plant without the flowering tops, is not specifically prohibited in the Act. Its regulation is therefore controlled by individual state governments, and some states allow licensed sale of bhang. In recent years, certain states have also permitted cultivation of industrial hemp varieties with low tetrahydrocannabinol (THC) content for use in fiber and seed oil production.