NEW DELHI, JULY 2: The government today granted Ranbaxy Laboratories the final clearance to begin testing its new drugs on specially-reared animals. Today's clearance comes after a long-drawn battle industry has been having with government over the need to speedily clear such testing facilities. The validity of the licenses of most testing centers in the country runs out in December this year. With no testing permissible within the country, industry sources had been joking about their new Y2K problem -- all testing on new drug molecules would end by December, 1999!Today's clearance, from the ministry of social welfare, for Ranbaxy comes in the form of an approval for their in-house Ethics Committee which supervises testing on animals, as well as clearing the names of two independent directors on this. It will, however, still be a while before Ranbaxy, or any other pharmaceutical firm/laboratory can begin full-scale testing. Under the law they can buy animals only from animal farms which have beenregistered with the government -- no overseas suppliers have got licensed so far. And last week, the government ordered closure of one of the country's largest suppliers of such animals -- the Indian Council of Medical Research's National Centre for Laboratory Animal Sciences (NCLAS) -- since it was not registered with a special cell under the ministry of social welfare.
Last December, Maneka Gandhi, minister of state for welfare, had come up with new rules, whereby all testing facilities as well as locations where the animals were housed would have to adhere to certain standards and would have to be registered -- pharmaceutical industry sources say this is just a means to harass them since they are, in any case, all signatories to world conventions and meet these anyway. As part of this, all pharmaceutical firms/laboratories which wished to conduct tests on animals had to form their own Ethics Committees, and this committee in turn had to have nominees from a larger government-nominated committee calledCommittee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA).
For over six months, however, the CPCSEA did not nominate anyone to the Ethics Committee of any of the pharmaceutical firms that applied to it. This virtually brought testing and discovery of new molecules to a complete halt. While some like Ranbaxy were getting some testing done from government-owned labs that still had valid permissions, others such as Dr Reddy's Laboratories were even having their testing done abroad -- even Ranbaxy did some tesing in the US, but this hikes costs around 10 times, apart from being very time-consuming and tedious. Apart from the fact that it is more convenient for a pharmaceutical firm to conduct tests in a laboratory owned by it, several of the existing license holders don't have licenses for particular animals -- one of the new molecules Ranbaxy is working on, for instance, requires to be tested on laboratory-grown sheep, but no lab in India is licensed to do this so far.
Copyright© 1999 Indian Express Newspapers (Bombay) Ltd.