Several pharma companies in the country lately are heading towards China and Indonesia for pre-clinical testing of drugs. This, because the country does not as yet have a national facility which provides monkeys and dogs for carrying out such of those trials that require large animals. The national facility was proposed to set up in Hyderabad in 2004 but is yet to materialise due to bureaucratic hurdles. Because of the delay, the cost of setting up the facility has got escalated.
The facility is to be set up by the National Institute of Nutrition (NIN) at Shamirpet on a 100-acre of land that was sanctioned by the Andhra Pradesh government free of cost. The land was given through the Andhra Pradesh Industrial Infrastructure Corporation ( APIIC) so that bio-technology companies and pharma companies can be benefited.Though the Andhra Pradesh government acted promptly and handed over the land, the Union ministry of health and technology and Union ministry of health had to be convinced by ICMR on several matters for funds to be sanctioned for the proposed centre.
The Indian Council of Medical Research (ICMR) is still pursuing the project proposal with the Centre. Official sources said that one big question that had to be answered was how the proposed animal resource facility would sustain itself. It was informed that in some of the private facilities which have large animals that are available in the country, pharma companies are having to wait for long periods to carry out their pre-clinical trials for drug testing. Moreover, several companies are also going abroad, especially to Indonesia and China, which have such facilities, being offered for more affordable rates.In addition, because of lapse of time, the project proposals had to be reevaluated and now the project is estimated to cost Rs 400 crore.
Earlier, the national resource facility proposed as a private-public partnership venture but now the plan is to get it fully funded by the Centre itself. Sources said, since all the questions that have been raised were answered, the planning commission was now expected to sanction funds for the project.
In the large animal facility, there would be provision for pharma companies to carry out drug trials on rhesus monkeys and beagle dogs. While the monkeys can be caught in the forests in the nearby districts of Hyderabad, the proposal is to import beagle dogs from Germany. "The plan is to allow pharma companies to conduct their pre-clinical trials at the national facility itself following all the stipulated rules for such experiments," NIN director B Sesikeran told this reporter.Rules stipulate that as far as possible, clinical trials have to be conducted on small animals like mice, rats and rabbits. However, since some drugs will have to be tested on large animals, the animal resource facility was planned.
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