The pharma industry has urged that the requirement of conducting toxicity studies should be mandated only for Investigational New Drugs (INDs) not approved anywhere in the world. Considering the molecules approved internationally, the requirement should be waived off on its well established safety and availability in the market.
As per the Gazette Notification No. GSR 559(E) dated July 17, 2015, the health ministry has proposed draft rules elaborating the requirements for conducting the systemic toxicity studies for 'oral parenteral or transdermal' products for obtaining clinical trial or new drug approval in the country. But the draft does not specify whether the requirements are for the molecules already approved in India, for the molecules not approved in India, but approved in other countries or for the INDs not approved anywhere in the world.
The IDMA has suggested to waive off the requirement considering the extensive toxicity studies performed internationally with molecules for obtaining approval from international regulatory authorities and availability of the same in public domain. Indian manufacturers are also using the same approved and well accepted raw materials, solvents and excipients used in other pharmaceutical drug products for manufacture of drug products. By using the same approved/accepted raw materials, solvents and excipeints, the end product may not be toxic.
The association also suggests that the requirement of performing toxicity studies in non-rodent species can be employed only for INDs. Alternatively, rabbit which is a lower phylogenetic species as against the traditionally recommended species like dog or monkey can be considered a preferred non-rodent species that can be employed in toxicological studies. For conducting toxicity study in animals in India, approval from CPCSEA (Committee for the Purpose of Control and Supervision of Experiments on Animals), New Delhi has to be obtained after obtaining approval from IAEC (Institute of Animal Ethics Committee). Approval from CPCSEA, New Delhi is approximately taking 4-6 months of time which delays the timeline for conducting toxicity study and ultimately introduction of the product in market.
Performing animal studies for the molecules having extensive toxicity study data in public domain, bring in the question of unnecessary exposure of animals and it also creates additional burden to the pharmaceutical industry in terms of cost and delayed timeline for introducing several drug products for life threatening diseases to serve the needy patients in the country.
In the minutes of 70th meeting of Drugs Technical Advisory Board (DTAB), the committee recommended that under item 4, appendix 1 of Schedule Y, of Drug and Cosmetics Rules, 1945 it may be mentioned that if authentic data on animal toxicology as per requirements of annexure III has been submitted within the technical data, then repeat animal testing for permission of a new drug or clinical trial is not necessary.
DTAB committee also agreed that for the drugs approved in other counties where complete toxicological data generated in GLP certified laboratory and in alignment with the requirements prescribed under Drugs and Cosmetics 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.