CPCSEA, Animal Ethics, Poisons Act, FSSAI, and DPCO Regulations

Posted on Mar 19, 2025 in Other university degrees and diplomas

CPCSEA and Animal Welfare

The Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA) has the following objectives:

  • Promote animal welfare.
  • Prevent unnecessary pain, suffering, and cruelty to animals.
  • Provide guidelines for housing, care, breeding, maintenance, and sourcing of experimental animals.
  • Establish 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.

Definition of Experiment: An experiment is any project involving the use of animals for acquiring knowledge of a biological, psychological, ethological, physical, or chemical nature. This includes using animals to produce reagents and products (e.g., antigens and antibodies), routine diagnostics, testing activities, and establishing transgenic stocks, for the purpose of saving or prolonging life, alleviating suffering, or combating any disease in humans or animals.

The Prevention of Cruelty to Animals Act (1960 and 1990)

This act defines offenses and penalties for animal cruelty:

Offenses

  • 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

  • A fine of up to ₹50 for a first offense (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 (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.

Institutional Animal Ethics Committee (IAEC)

An Institutional Animal Ethics Committee (IAEC) is a body recognized and registered by the committee for controlling and supervising experiments on animals performed in an establishment. It is constituted and operated according to procedures specified by the committee.

IAEC Objectives

  • Contribute to the effective functioning of the IAEC.
  • Ensure experiments are performed with due care and humanity.

IAEC Composition

Every IAEC shall include:

  • A biological scientist.
  • Two scientists from different biological disciplines.
  • A veterinarian (when animals are involved).
  • The scientist in charge of the animal facility.
  • A scientist from outside the institution.
  • A non-scientific, socially aware member.
  • A representative or nominee of the committee.
  • A specialist may be co-opted for projects using hazardous agents (e.g., radioactive substances, microorganisms).

Breeding and Stocking of Animals

  • Animal breeding is a branch of animal science that addresses the evaluation of the genetic value of livestock.
  • Selecting animals with superior Estimated Breeding Values (EBVs) in growth rate, egg, meat, milk, or wool production, or other desirable traits, has revolutionized livestock production worldwide.

Performance of Experiments

Performing experiments on animals is lawful for the purpose of advancing knowledge and discovering new ways to save lives or combat diseases in humans, animals, or plants.

Records

Every establishment and IAEC must maintain records of animals under their control and custody. They must furnish information as required by the committee in the specified format. All laboratories must report the exact number and species of animals as per the committee’s format.

Poisons Act, 1919

Objectives

  • Regulate the sale and possession of poisons to prevent illegal use.
  • Ensure certain poisons are labeled and sold only by licensed dealers to protect the public.

Definitions

  • Poison: Any substance that, if used or applied in a certain way, is likely to cause death, injury, or damage to health.
  • The act refers to the Pharmacy and Poisons Act 1933 and the Poisons List. Non-medical poisons are divided into two lists:
    • List One: Substances sold only by a registered pharmacist.
    • List Two: Substances sold by a registered pharmacist or a licensed retailer.

Possession for Sale

Possession refers to having control over or owning something. This can be physical possession or constructive possession (control or authority without physical possession).

Possession of Any Poison

The State Government can make rules regarding the possession of any specified poison in areas where it is used for murder or poisoning cattle, especially where such occurrences are frequent.

Import of Poisons

Import of specified poisons is allowed only under a license, and the central government regulates the granting of such licenses.

Offenses & Penalties

  • Unlawful possession for sale and sale of poison.
  • Importation of restricted poison without a license.

FSSAI (Food Safety and Standards Authority of India) Act and Rules

The Food Safety and Standards Authority of India (FSSAI) Act, 2006, and its rules provide the legal framework for food safety and standards in India. The Act establishes the FSSAI as the central regulatory authority responsible for setting science-based standards for food and regulating its manufacture, storage, distribution, sale, and import to ensure safety and fitness for human consumption.

Key regulations include:

  • Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations, 2011.
  • Food Safety and Standards (Packaging and Labeling) Regulations, 2011.
  • Food Safety and Standards (Prohibition and Restrictions on Sales) Regulations, 2011.

Food Supplements

Food supplements are concentrated sources of nutrients or other substances with a nutritional or physiological effect, intended to supplement the normal diet. They are typically marketed as capsules, tablets, powders, soft gels, gels, drops, liquids, or bars.

Manufacture of Food Supplements

  1. Good Manufacturing Practices (GMP): Manufacturers must comply with GMP standards.
  2. Raw Material Sourcing: High-quality raw materials from reputable suppliers are required.
  3. Production Processes: Strict processes must ensure a clean and hygienic environment.
  4. Testing and Quality Control: Regular testing is essential.
  5. Packaging and Labeling: Compliance with regulations is mandatory.

Storage, Sale, and Labeling of Food Supplements

  1. Storage: A clean, hygienic environment with proper temperature and humidity controls is required.
  2. Sale: Only registered food business operators (FBOs) can sell food supplements, complying with labeling and packaging requirements.
  3. Labeling: Labels must include the manufacturer’s name and address, product name, ingredients, recommended daily dose, and appropriate warning/caution statements, complying with the Food Safety and Standards (Labeling and Display) Regulations, 2011.

National List of Essential Medicines (NLEM)

The NLEM is a list of essential medicines considered necessary for meeting the basic health needs of the population. It is a comprehensive list of drugs and medicines essential for public health, updated periodically. The Ministry of Health and Family Welfare, Government of India, prepares and maintains the NLEM, based on the WHO’s Model List of Essential Medicines. The list is reviewed and updated every two years.

wevpStcBbMHawAAAABJRU5ErkJggg==

Drugs Price Control Order (DPCO) – 2013

Objective

  1. Fix maximum prices of essential and life-saving drugs to ensure affordability.
  2. Regulate prices of bulk drugs and formulations specified in the NLEM.
  3. Monitor prices of decontrolled drugs to prevent excessive pricing.

Difference Between Sale and Retail Price of Drugs

Sale Prices of Bulk Drugs

  • The sale price of bulk drugs is crucial as it determines the cost of raw materials for formulations.
  • Influenced by supply and demand, production costs, government regulations, and market competition.
  • In India, regulated by the DPCO 2013. The National Pharmaceutical Pricing Authority (NPPA) fixes and revises prices.
  • The NPPA considers manufacturing cost, market price trends, and the wholesale price index.

Retail Price of Formulations

  • The retail price is what a consumer pays for a finished dosage form (e.g., tablet, capsule, syrup).
  • Influenced by raw material costs, production costs, marketing, distribution, and regulations.
  • In India, regulated by the DPCO 2013. The NPPA fixes and revises maximum prices.