Key Regulatory Acts and Compliance in Indian Pharmacy Law

Posted on Oct 31, 2025 in Other university degrees and diplomas

The Pharmacy Act, 1948

The main purpose of the Pharmacy Act of 1948 is to regulate the profession and practice of pharmacy in India. It was enacted on March 4, 1948.

Objectives of the Pharmacy Act, 1948

  • To make better provisions for regulating the profession and practice of pharmacy.
  • To raise the status of the “Profession of Pharmacy” in India.
  • To constitute the “Pharmacy Council of India” for setting new standards in pharmacy education.
  • To regulate pharmacy institutions, especially “Diploma in Pharmacy,” through education regulations and the registration of pharmacists.

Consequences of Practicing Without a License

Practicing without a license under the Pharmacy Act shall be punishable with imprisonment for a term which may extend to six months, or with a fine not exceeding one thousand rupees, or with both.

Difference Between State and Joint State Pharmacy Councils

The councils regulate the profession of pharmacy and maintain the register of pharmacists:

  • State Pharmacy Council: Constituted by each state government to regulate pharmacy within its boundaries. Functions include maintaining a register of pharmacists, monitoring professional activities, and ensuring quality of drug dispensing. Its scope operates within the defined boundaries of the individual state.
  • Joint State Pharmacy Council: Established through an agreement between two or more states. Its regulatory scope extends across the multiple states involved, sharing resources and regulations.

The Drugs and Cosmetics Act, 1940

Enforcement and Administration

The Central Drugs Standard Control Organisation (CDSCO) is the main authority responsible for enforcing the Drugs and Cosmetics Act of 1940 in India.

The Drug Technical Advisory Board (DTAB) is constituted by the Central Government to advise the Central and State Governments on technical matters arising out of the administration of this Act.

Composition of the Drug Technical Advisory Board (DTAB)

DTAB consists of 18 members: 8 ex-officio, 5 nominated, and 5 elected members. The ex-officio members include:

  1. Director General of Health Services (Chairman)
  2. Drug Controller of India
  3. Director, Central Drug Laboratory, Kolkata
  4. Director, Central Research Institute, Kasauli
  5. Director, Indian Veterinary Research Institute, Izatnagar
  6. President, Pharmacy Council of India
  7. President, Medical Council of India
  8. Director, Central Drug Research Institute, Lucknow

Drug Schedules and Regulation

  • Schedule H Drugs: Prescription medications that require a registered medical practitioner’s prescription for sale under the Indian Drugs and Cosmetics Rules, 1945.
  • Schedule X Drugs: Highly controlled substances, including: Amobarbital, Amphetamine, Barbital, Cyclobarbital, Dexamphetamine, and Ethchlorvynol.
  • Schedule C & C1: Prescribes the list of biological and other special products.

Penalties for Selling Adulterated Drugs

Consequences for importing, manufacturing, or selling adulterated or spurious drugs under the Drugs and Cosmetics Act include imprisonment up to three years and/or a fine of up to 5,000 rupees.

Qualification of Drug Inspectors

For appointment as Drug Inspectors, a person must have a degree in Pharmacy, Pharmaceutical Science, or Medicine with specialization in Clinical Pharmacology or Microbiology from an Indian University.

For the inspection of the manufacture of substances in Schedule C, the appointed Drug Inspectors must have:

  • At least 18 months experience in the manufacture of at least one of the substances specified in Schedule C.
  • At least 18 months experience in the testing of at least one of the substances in Schedule C in an approved testing laboratory.
  • Gained experience of not less than three years in the inspection of firms manufacturing any of the substances in Schedule C during the tenure of their service as Drug Inspectors.

Narcotic Drugs and Psychotropic Substances (NDPS) Act

Substances Regulated Under the NDPS Act

The substances regulated include:

  • Narcotic Drugs: Coca leaf, cannabis (hemp), opium, and poppy straw.
  • Psychotropic Substances: Any natural or synthetic material or any salt or preparation protected by the Psychotropic Substances Convention of 1971.

The Poisons Act, 1919

The Poisons Act of 1919 in India regulates the import, possession, and sale of poisons.

Regulation and Authority

  • The State Government has the authority to regulate the sale and possession of poison.
  • The State Government has the power to make rules regarding the possession of any specified poison in local areas where such poison can be used for murders or for poisoning cattle, and in local areas where such occurrences are very frequent.
  • Import of specified poison is allowed only under and in accordance with the conditions of a license; the Central Government may regulate the grant of such licenses.

Offenses and Penalties in the Poisons Act, 1919

Offenses include:

  • Unlawful possession for sale and sale of poison.
  • Importation without a license of any poison the importation of which is for the time being restricted by the Central Government.

Definition of Possession

Possession refers to the act of having control over or owning something. In legal terms, possession can refer to physical possession of an object (such as property or a weapon) or to constructive possession, which means that an individual has control or authority over something, even if they do not physically have it in their possession.

Animal Welfare Legislation

The Prevention of Cruelty to Animals Act, 1960

This Act was passed in 1960 and defines offenses and penalties for animal cruelty (amended in 1990).

Primary Objectives of the Act
  • To prevent unnecessary pain and suffering on animals.
  • To amend existing laws related to animal cruelty.
Offenses and Penalties

Offenses include:

  • Killing, poisoning, maiming, or rendering an animal useless.
  • Performing “phooka” or “doom dev” on a cow or other milch animal.
  • Failing to exercise due care and supervision to prevent cruelty against animals.

Penalties include:

  • A fine of up to ₹50 for a first offense under the 1990 Act.
  • A fine of up to ₹100 and/or up to 3 months in jail for a second or subsequent offense within 3 years under the 1990 Act.
  • A fine of up to ₹1,000 and/or up to 2 years in jail for performing “phooka” or “doom dev” on an animal.
  • Forfeiture of the animal to the government.
  • Prohibition of the convicted person from having custody of any animal.

CPCSEA (Committee for the Purpose of Control and Supervision of Experiments on Animals)

Objectives of CPCSEA
  • To promote animal welfare generally.
  • To prevent the infliction of unnecessary pain or suffering on animals, as well as to prevent cruelty to animals.
  • To provide guidelines for housing, care, breeding, and maintenance sources of experimental animals, and acceptable experimental procedures for anesthesia and euthanasia.
  • The goal of these guidelines is to promote the humane care of animals used in biomedical and behavioral research and testing.

Other Key Regulatory Frameworks in India

Drug Price Control Order (DPCO) and NLEM

  • The primary objective of the Drug Price Control Order (DPCO) 2013 is to ensure the availability of essential and life-saving medicines at affordable prices for the general public.
  • The full form of NLEM is the National List of Essential Medicines.
  • A ceiling price for a drug is a government-imposed maximum price limit on a specific drug, typically for those under price control.

CDSCO and IPC Functions

  • The full form of FSSAI is the Food Safety and Standards Authority of India.
  • The full form of IPC is the Indian Pharmacopoeia Commission.
  • The Central Drugs Standard Control Organisation (CDSCO) and the Indian Pharmacopoeia Commission (IPC) have a strong collaborative relationship, particularly in the context of the Pharmacovigilance Programme of India.
Functions of CDSCO
  • Approving new drugs.
  • Overseeing clinical trials.
  • Regulating the import of drugs.
  • Setting standards for drugs, cosmetics, and medical devices.

Clinical Establishments and Blood Banks

  • The Clinical Establishments Act provides for the registration and regulation of clinical establishments in the country with a view to prescribing basic minimum standards of facilities and services.
  • A blood bank definition: A blood bank is a facility that collects, processes, stores, and distributes blood and blood components for transfusion.
  • Blood banks in India are regulated under the purview of the Drug Controller General of India (DCGI) and State Drug Controllers (DCs).

Enactment Dates of Key Acts

  • The Drugs and Magic Remedies (Objectionable Advertisements) Act was enacted on April 30, 1954.
  • The Medical Termination of Pregnancy (MTP) Act in India was enacted in 1971.

Quality Standards and Classification Systems

  • Difference between cGMP and GMP: GMP (Good Manufacturing Practice) provides a general framework for ensuring quality, while cGMP (Current Good Manufacturing Practice) requires manufacturers to use the latest technologies and standards to meet quality requirements.
  • Good Regulatory Practices (GRP): GRP are internationally recognized processes and procedures used to improve the quality and effectiveness of regulations, especially in areas like trade, health, and safety.
  • Biopharmaceutical Classification System (BCS): The purpose of BCS is to characterize drugs for which products of those drugs may be eligible for a biowaiver of in vivo bioequivalence studies.