Government revokes nod to test new vaccines on stray dogs

Government revokes nod to test new vaccines on stray dogs

Subject: Polity

Section: National Organisation

Context:

A government committee tasked with animal welfare and protection has  withdrawn a 2022 circular that allowed stray dogs to be used in vaccine trials.

About CPCSEA

• The Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA) is a statutory body formed by the Act of the Indian Parliament under the Prevention of Cruelty to Animals Act 1960. 
• Formed in 1964, it was revived in 1998, under the committed chairpersonship of Maneka Gandhi. In the last two years, the CPCSEA has bettered the life of the animals in laboratories across India.
• This committee is composed of members of the scientific community, regulatory authorities and animal activists.
• The CPCSEA functions with a brilliant network of volunteers who liaise with the laboratories.
• For the first time in India: over 665 laboratories are registered with the CPCSEA; Institutional Animal Ethics Committees (IAECs) are constituted in every laboratory, which are only empowered to approve research project proposals that use rats, mice, guinea-pigs or rabbits.
• Every project that uses canines, ovines, bovines or non-human primates can only be conducted if approved by the panel of scientific experts constituted for this purpose; guidelines on laboratory animal care and practice have been formulated and enforced; a protocol for the production of immunobiologicals from equines has been formulated and ratified by the Supreme Court of India.
• The CPCSEA has been deliberating on alternatives and working out modalities to introduce alternatives in basic/regulatory research and education, in keeping with the international arena; the CPCSEA, to date, has rehabilitated and homed over 300 dogs, 150 equines, 200 non-human primates and several cattle, cats, birds, rabbits and mice; the CPCSEA proactively trains and guides scientific and non-scientific personnel on issues of alternatives and laboratory animal welfare; and the CPCSEA has fought legal issues on laboratory animal care and use and have had verdicts that favoured alternatives and animal welfare.

What are the Key Emerging Alternative Testing Methods?

• Organoids: Organoids are three-dimensional cellular structures that emulate specific organs of the body. These miniature organs, developed from human cells or stem cells, provide a more accurate representation of human physiology, enabling researchers to study drug interactions in a human context.
• Organs-on-Chip: Organs-on-chip are small devices lined with human cells, mimicking the blood flow and cellular interactions within the body. These chips replicate key physiological aspects and allow researchers to analyze tissue-tissue interactions and chemical signals, providing a platform for more accurate drug testing.
• 3D Bioprinting: 3D bioprinting technology enables the creation of complex human tissues and organs using patient-specific cells. This advancement allows for the development of personalized drug testing approaches, catering to individual variations in biology.

What is the Regulatory Mechanism of Clinical Trials in India?

The major legislations that govern clinical trials in India are: Drugs and Cosmetics Act, 1940, Medical Council of India Act, 1956 and Central Council for Indian Medicine Act, 1970, Guidelines for Exchange of Biological Material (MOH order, 1997).

Prerequisites of conducting a clinical trial in India are:

• Permission from the Drugs Controller General, India (DCGI).
• Approval from the Ethics Committee established under Drugs and Cosmetics Rules.
• Mandatory registration on the ICMR maintained website.