The Union health ministry henceforth will not insist on repeat pre-clinical or toxicity studies on animals for permission for a new drug or clinical trial if authentic data on animal toxicology has been submitted with the technical data.
The health ministry's action in this regard comes in the backdrop of the fact that the Union minister for women and child development Maneka Gandhi had written to the Union minister of health and family welfare regarding pre-clinical/toxicity studies on animals under Schedule Y of the Drugs and Cosmetics Rules, 1945.
In her letter, the minister stated that India being signatory of OECD (Organization for Economic Cooperation and Development) Council Act related to mutual acceptance of data is under obligation to respect the data generated by other country regarding pre-clinical/toxicity studies and therefore there is no need for CDSCO to undertake further studies.
The molecules of interest have been those that are approved by multiple regulatory agencies and have been through many animal studies which have been made available on sites and published in scientific journals. Under the current regulations of item 4, Appendix-I of Schedule Y of Drugs and Cosmetics Act, 1940, additional tests on animals are then ordered.
As the issue was related to pre-clinical or toxicity studies on animals under Appendix I and Appendix III of Schedule Y, the matter was placed before the Investigational New drug (IND) Committee of the Union health ministry.
The committee in its meeting held on August 6, 2015 deliberated and agreed with the statement mentioning that, for drugs approved in other countries where complete toxicological data generated in GLP certified laboratory and in alignment with the requirements prescribed under Drugs and Cosmetics Act, 1940 and Rules, 1945 (Schedule Y), further toxicity study may not be required if complete data as per prescribed requirements is submitted during application for new drug approval.
It may also be explored, in line with international practices, to encourage the use of other alternative methods than animal studies, wherever such robust validated methods are available for small or large animals, the IND committee further recommended.
The IND committee recommendations were then sent to the Drugs Technical Advisory Board (DTAB), the highest authority under the Union health ministry on technical matters.
The issue came up for discussion in the DTAB meeting held on August 18, 2015. After deliberations, the DTAB agreed to the recommendations of the IND committee and further recommended that under item 4, Appendix I of Schedule Y, it may be mentioned that if authentic data on animal toxicology as per requirements of annexure III has been submitted with the technical data, then repeat animal testing for permission for a new drug or clinical trial is not necessary.