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Wednesday, April 25, 2012
Lack of non-human primates testing facility hits pharma companies hard
Apr 26, 2012 HYDERABAD: Chinese non-human primates are hitting biomedical research activity in India hard. But stringent guidelines of the Drugs Controller General of India (DCGI) on the use of non-human primates (NHPs) in biomedical research are forcing pharmaceutical companies to head for China and other Asian countries for drug testing. This issue was discussed at the two-day national symposium on 'Laboratory animal science in the new millennium - challenges and solutions' organised by the National Centre for Laboratory Animal Sciences (NCLAS) and Laboratory Animal Science Association of India ( LASAI) at the National Institute of Nutrition (NIN) here. NCLAS scientist P Suresh, who presented a paper on the issue, revealed that according to an international study, of the total 651 studies carried out using non-human primates, only 54 were conducted in India and the rest were all performed in China, Japan, Indonesia, South Korea, Taiwan, Singapore, Philippines, Thailand, Vietnam, Malaysia, Hong Kong, Myanmar and Israel. In India, there are no primate facilities that can conform to the stringent stipulations of DCGI and the proposed facilities in Hyderabad and Mumbai have also not taken off as the government has not released funds as yet. Suresh said that it was estimated that even the Indian industry was spending approximately Rs 60 lakh to Rs 90 lakh for one product testing. Experiments on NHPs in Indian laboratories practically do not exist and currently there are also no state-of-the-art registered suppliers or breeders to provide the required quality non-human primates. Researchers and the pharma industry are also finding it difficult to conduct trials. A possible solution is to develop primate facilities to facilitate future research in the country and also to encourage investments from the government and also private sector to set up facilities for making available genetically and microbiologically defined large animals, he said. According to scientists, the genetic proximity of NHPs to humans make them good models for specific diseases. In India, the major challenge is to develop Aids vaccine. The Simian Acquired Immunodeficiency Syndrome (Saids) susceptibility of primates (especially of Indian origin Macaca mulatta) provides an ideal model for development of Aids vaccine. While the issue of non-human primates was debated in the national symposium, scientists raised several other issues too. Rishendra Verma, joint director, Centre for Animal Diseases Research and Diagnosis (Cadrad), Indian Veterinary Research Institute, Izatnagar, who spoke on `Animal experimentation - current scenario and future prospects,' said there should be more focus on `re-use' and `rehabilitation' of laboratory animals. S K Rath, scientist from Central Drug Research Institute (CDRI) Lucknow, explained the efforts being made by scientists from different places in the country to find alternatives to animal models. Federation of Indian Animal Protection Organisations (FIAPO) coordinator, animal experimentation, Alokparna Sengupta said it was important to find alternatives to use of laboratory animals in drug testing. She said FIAPO would not resort to protests or activism to promote its cause, but would like to work with scientists to shift to alternatives, some of which were already available.
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