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DTAB recommends to do away with toxicity studies for intravenous infusions and injectables
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Gireesh Babu, New Delhi
October 16 , 2024
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In line with the Centre's efforts to reduce the use of animals in research, especially in drug testing, the central drug regulatory authority may look at removing the need for sub-acute animal toxicity studies for intravenous infusions and injectables, if they meet certain other requirements.
The proposal to omit the requirement from the New Drugs and Clinical Trials (NDCT) Rules, 2019, was discussed by experts in a recent Drugs Technical Advisory Board (DTAB) meeting. The meeting, held on August 14, agreed with the proposal, which would help the government to take the proposed amendment forward.
During the meeting, the Board was apprised that the sub-rule 4.2 of rule 4 under Table 2 of Second Schedule of New Drugs & Clinical Trials Rules, 2019 specifies that the applicant shall submit the sub-acute animal toxicity study data for intravenous infusions and injection to the Central Licensing Authority (CLA).
In order to reduce the animal usage and minimize sacrifices during drug testing procedures, it was proposed to waive off toxicity studies for intravenous infusions and injectables, by proving the qualitative and quantitative composition similarity with the reference listed drug which has previously been approved in the country or in other countries.
On the basis of this, it was proposed to delete sub-para 4.2 of para 4 under Table 2 of Second Schedule of NDCT Rules, 2019, that is the sub-acute animal toxicity studies for intravenous infusions and injectables.
The Table 2 of Second Schedule pertains to grant of permission to import or manufacture a new drug already approved in the country. It details the data required to be submitted by an applicant for the purpose, including a brief description of the drug and the therapeutic class, chemical and pharmaceutical information of the drug, marketing information, and special studies conducted with approval of the CLA including bioavailability or bioequivalence and comparative dissolution studies for oral dosage forms.
"The Board further noted that sub-acute animal toxicity studies are not required in such formulations in case the qualitative and quantitative composition similarity with the reference listed drug is established," said the minutes of the DTAB meeting.
It may be noted that as per earlier reports, the Central government has already implemented certain amendments in the NDCT Rules in 2023, to reduce the use of animals in research, especially in drug testing.
This was to promote use of technologies such as 3D organoids, organs-on-chip, advanced computational methods, among others, with the researchers in their tests related to safety and efficacy of new drugs.
The move received applause from the animal lovers including People for the Ethical Treatment of Animals (PETA) India, a major animal rights organisation working against the cruelty to animals, especially during experiments in laboratories and other industries.
It said that the amendment in 2023 focuses on animal-free research methods like computer simulations and cell-based studies, which offer an accurate picture of human biology, ultimately leading to safer and more effective drugs. The amendment also mandates stricter guidelines for the use of animals in experiments, and aligns India with international best practices for transitioning away from animal use.
This would help in scientific advancements, and development of safer and more effective drugs reducing dependence on unreliable animal models, it added.
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