Cosmetic Regulation and Alternatives to Animal Experimentation in India

Mohammad A. Akbarsha

Mahatma Gandhi -

Doerenkamp Center for

Alternatives

Bharathidasan University,

Tiruchirappalli, India

National Center for

Alternatives to Animal

Experiments,

Bharathidasan University,

Tiruchirappalli, India

Central Drugs Standard Control Organization (CDSCO)

the Central Authority for discharging regulatory functions assigned to the Central Government under the Drugs and Cosmetics Act,1940 and Drugs and Cosmetics Rules, 1945 Headed by Drugs Controller General (India)

Bureau of Indian Standards(BIS) •BIS formulates National standards and carry out conformity assessment by operating the Product and Management System Certification Scheme •One of the activities of BIS is to lay down Standards for cosmetics in India

Legal Enactments to Regulate

Cosmetics

Drugs and

Cosmetics

Act, 1940

Drugs and

Cosmetics

Rules, 1945

made under

the Act

Safety Evaluation of Cosmetics

• Cosmetics products formulated as per the restrictions imposed by IS 4707 (Part 1 and 2 ) and the list of Cosmetics, Toiletry, Fragrance Association of America (CTFA), European Economic Community (EEC) and the guidelines of International Fragrance Association (IFRA) are likely to be safe and such products may not warrant any safety testing.

• Whereas products which contain novel ingredients which are not under the purview of the above documents shall require safety testing as per the guidelines provided in IS 4011

Animal tests used for cosmetics

• Skin irritation test and eye irritation test (Draize Tests in Rabbits) were removed from the Standard in 2007

• In February,2014, the IS 4011 was amended specifying that when there is a need for safety evaluation of cosmetic products to demonstrate absence of oral toxicity and/or oral mucosal irritation, the manufacturer shall submit the safety data based on alternative non-animal test methods to the concerned State Licensing Authorities for their consideration and approval

Safety Evaluation of Cosmetics

Approaches to Campaign

Research: Study existing science as well as regulatory framework

Public Awareness

Broadening the movement

Legislative campaign

11,000 consumers urge sales ban of animal-tested cosmetics in India

Humane Society International/India's Be Cruelty-Free petition was presented to Singh at his office in New Delhi.

Systematic approach makes it easy for a decision-maker to make hard decisions

Wednesday , August 24 , 2016

Two-year limit to phase out 'cruel' rabbit eye tests Our Special Correspondent

Rabbits in restraints in an animal-testing laboratory waiting for eye tests. New Delhi, Aug 23: A government panel has set a two-year deadline for India's drugs sector to phase out tests on rabbit eyes used in the evaluation of certain medicines but decried by animal rights activists as cruel and obsolete. The government's drug regulatory agency's Drug Technical Advisory Board (DTAB) has recommended a two-year phase-out period for the tests that involve exposing the eyes of laboratory rabbits to candidate medicines to determine whether they are safe for human use. The DTAB move, which is yet to be accepted and notified by the Union health ministry, follows representations to the government by animal protection activists seeking an immediate ban on the test and the use of alternatives that they say are equally or more reliable.

Animal testing on soaps and detergents banned in India: Considering the colossal death rates of animals during the manufacturing process of the household products, Union Minister, Maneka Gandhi along with the Indian Ministry of Health and Family Welfare has established the prohibition A circular under the Environment Ministry in this regard has been issued by the Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA) to People for the Ethical Treatment of Animals (PETA), through an RTI request. With this, the organisations aim to put a halt to animal testing for the household goods which are manufactured within the country

Published19 Apr, 2016

Handling of reconstructed 3D tissue models, in collaboration with Episkin Academy, France during

• June 24 - 27, 2013 – MGDC, Trichy • June 16-19, 2014 - University of Madras, Chennai • Jan 22,23, 2015 - IGIB, New Delhi • Nov 19, 20, 2015 - MGDC, Trichy