The Hindu Business Line : Transparency sought in drug trials on animals

Animal trials
To conduct animal trials in India, companies require approvals from the Committee for the Purpose of Control and Supervision of Experimentation on Animals (CPCSEA).

Mumbai March 26 A week ago, a cell-phone message did its rounds seeking homes for 32 beagle dogs imported into the country by drug-maker Ranbaxy for laboratory experimentation.

Ranbaxy did eventually release the beagles and engage with the Delhi-based organisation Friendicoes to re-home the dogs. But the incident has, again, raised concerns on the use of animals in laboratory experiments, with animal-welfare campaigners seeking transparency in how animal trial proposals are approved, the animals are treated and released.

In the recent release of beagles, for instance, confusion still prevails over whether trials had been done on the dogs. A Ranbaxy spokesperson told Business Line that no testing was done on the dogs and they were voluntarily put up for adoption. The history of the dog, along with a certificate from a veterinary doctor was given to the family adopting the dog. Ranbaxy has followed Government protocol, he said, adding that globally, it was mandatory that drugs be tested on animals before they are tried on humans for safety.

The spokesperson was unwilling to get into specifics on whether and when the dogs were imported from the US and why the dogs were with the drug-company, if not for testing.

An industry representative indicated that the dogs may have been released as the company may have abandoned or may not have got clearance for the project in which it was to use the beagles. A Health Ministry official adds, the dogs may have been old and so released.

Animal-rights campaigner Ms Maneka Gandhi, however, told this correspondent that Ranbaxy had in fact conducted trials on the beagles for a couple of years, after which they kept the dogs. The company had not disclosed drug-trial protocols used on the dogs, she said. In 1998, Ranbaxy has been in a similar situation, when it had to surrender beagle dogs imported for drug trials.

Animal trials are increasingly being out-sourced to India and other drug companies too were participating in them, she said. To conduct animal trials in India, companies require approvals from the Committee for the Purpose of Control and Supervision of Experimentation on Animals (CPCSEA).

Ms Gandhi alleged that the CPCSEA no longer had animal-welfare workers and it was becoming easier to get approvals to conduct animal trials in the country. Dr Chinny Krishna of Chennai's Blue Cross and former CPCSEA member echoes similar demands to have representation from animal welfare organisations on the CPCSEA, to make sure existing laws to protect animals are implemented.

The debate over animals used in research came to boil in 2002, with Ms Gandhi locking horns with the then Union Health Minister, Dr C.P. Thakur, on the subject. Approvals for experimentation, particularly on large animals such as primates, dogs and pigs, subsequently became more stringent.

Last month, however, the CPCSEA's sub-committee on large animals was disbanded. All clearances are now being directly handled by the CPCSEA, a Health Ministry official said.

A scientific-hand in a pharmaceutical company said animals are used in pharmacology studies to test how a drug works and in toxicology studies on safety. Indian drug companies should be encouraged to bring research into India, he said, or they would have to do their studies in China or Europe. International norms require companies to use only as many animals as it requires, he said. Companies should also be incentivised to explore alternative methods of trials that do not use animals, he recommended.

Animals on trial

Beagles are traditionally used as their metabolism is similar to humans, a Health Ministry official said. They are used in studies on hypertension and benign prostatic hyperplasia. Pigs are used in cardio-vascular studies, horses are used to test serums and monkeys are used in endocrinology studies, the official added.