India’s pharmaceutical sector is governed by several landmark legislations designed to ensure public health, regulate the profession of pharmacy, and prevent misuse of narcotic drugs. Unit 3 provides an in-depth look at three major acts: the Pharmacy Act, 1948, the Medicinal and Toilet Preparations Act, 1955, and the Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985. This news-style article highlights their objectives, administrative structures, regulatory provisions, and penalties.
Download UNIT 3 – Key Pharmaceutical Legislations in India Notes
Get simplified revision notes for this unit:
⬇️
Download Unit 3 Notes PDF
Pharmacy Act, 1948 — Regulating the Pharmacy Profession in India
Objectives and Definitions
The Pharmacy Act was enacted to regulate the practice of pharmacy, ensure professional standards, and establish pharmacy education guidelines in India. Key definitions include pharmacist, registered pharmacist, and pharmacy institution, ensuring clarity in professional responsibilities.
Pharmacy Council of India (PCI): Constitution and Functions
The PCI is the apex statutory body created under the Act. Its constitution includes:
Central government nominees
University representatives
Registered pharmacists
Medical and pharmaceutical experts
Its major functions include:
Prescribing Education Regulations (ER) for D.Pharm and B.Pharm courses
Approving pharmacy institutions
Maintaining uniform educational standards across the country
PCI plays a pivotal role in shaping pharmacy practice and curriculum development.
State and Joint State Pharmacy Councils
Each state establishes a State Pharmacy Council (SPC), while smaller states may form Joint State Councils. These bodies are responsible for:
Registration of pharmacists
Renewal and maintenance of pharmacy registers
Monitoring professional conduct
Their constitution includes elected pharmacists, nominated members, and state government representatives.
Registration of Pharmacists
To be a registered pharmacist, individuals must meet educational and training requirements set by PCI. Registration ensures that only qualified professionals dispense medicines, thereby safeguarding patient safety.
Offences and Penalties
Practicing pharmacy without registration, falsely claiming to be a pharmacist, or violating council regulations may result in:
Fines
Suspension or removal from the register
Legal action
These safeguards uphold ethical and professional pharmacy practice.
Medicinal and Toilet Preparations Act, 1955 — Regulating Alcoholic Preparations
Objectives and Definitions
This Act regulates duty (taxation) and licensing related to medicinal, toilet, and cosmetic preparations containing alcohol, narcotics, or other controlled substances. Definitions include toilet preparation, medicinal preparation, bonded laboratory, and manufacture.
Licensing Provisions
Manufacturers must obtain licenses specifying:
Type of preparation
Manufacturing location
Quantity limits
Bonding requirements
Authorities ensure that alcohol and narcotics used in formulations are properly accounted for and not diverted for illegal use.
Manufacture: In-Bond and Outside-Bond
In-Bond Manufacture: The manufacturer uses alcohol stored under excise supervision. Duty is payable only when the final product is removed from the bond.
Outside-Bond Manufacture: Alcohol is procured after payment of duty, and manufacturing occurs without continuous excise supervision.
Export of Alcoholic Preparations
Manufacturers exporting alcoholic formulations must comply with customs and excise procedures to prevent unlawful diversion.
Ayurvedic, Homeopathic, Patent & Proprietary Preparations
Special licensing provisions apply to traditional systems of medicine and patent preparations. These ensure product quality while acknowledging unique manufacturing methods used in traditional formulations.
Offences and Penalties
Violations such as illegal manufacture, diversion of alcohol, tampering with excise seals, or unlicensed production can lead to:
Heavy fines
Imprisonment
Cancellation of licenses
These penalties maintain transparency and accountability in alcohol-based pharmaceutical manufacturing.
Narcotic Drugs and Psychotropic Substances Act, 1985 — India’s Anti-Drug Abuse Framework
Objectives and Definitions
The NDPS Act aims to:
Prevent misuse of narcotic drugs and psychotropic substances
Control and regulate their production, sale, and distribution
Support medical and scientific use while preventing abuse
Key definitions include narcotic drug, psychotropic substance, controlled substance, and illicit traffic.
Authorities and Officers Under the Act
The Act empowers several authorities, including:
The Central Narcotics Bureau
Narcotics Commissioners
Excise officers
Customs and police authorities
These officers monitor compliance, investigate offences, and seize illegal substances.
Narcotic & Psychotropic Consultative Committee
This committee advises the government on:
Controlled substances
Necessary amendments
International narcotics conventions
Strategies for drug abuse prevention
It ensures India’s drug control policies align with global standards.
National Fund for Controlling Drug Abuse
The fund supports:
Drug de-addiction programs
Public awareness campaigns
Rehabilitation centres
Training for enforcement officers
This strengthens national efforts to combat addiction.
Prohibition, Control, and Regulation
The Act strictly regulates:
Production, possession, sale, and transportation of narcotics
Manufacture of psychotropic substances
Import, export, and trans-shipment
Only licensed medical and scientific institutions may produce or handle such substances.
Opium Poppy Cultivation and Poppy Straw Production
Cultivation of opium poppy is allowed only under government license. Farmers must follow strict quotas and deliver all produce to government agencies to prevent diversion for illegal drug production.
Manufacture, Sale, and Export of Opium
Only authorized factories may process opium for medical use (e.g., morphine). Export is strictly controlled to prevent international trafficking.
Offences and Penalties
Penalties vary by quantity and type of substance involved. They may include:
Long-term imprisonment
High fines
Forfeiture of property
Enhanced punishment for repeat offenders
These stringent penalties reflect the seriousness with which India combats drug abuse and trafficking.