(IN) New Pharma Regime - Animal Rights in question?

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Rishi Dev (CFAR) [rishidev.cfar]

Friday, 6. März 2009 15:10

New Pharma Regime - Animal rights in question?

 

 

 

smita joshi

 

5 Mar 2009

 

NEW DELHI: Drug makers in the country will get a new regulatory regime that

is more friendly for investing heavily into high-risk research, testing

experimental drugs on animals, protecting the costly research data shared

with the regulators and everything needed to lead them to the global league

of drug inventors.

 

A proposal from the department of pharmaceuticals now being considered by

Prime Minister Manmohan Singh seeks to make comprehensive changes in the

laws governing research funding, drug discovery, clinical trials and

approvals at different stages so that Indian drug makers re-orient

themselves from successful copiers of costly multinational brands to owners

of scientific breakthroughs.

 

Regulatory reforms is attached to the pharmaceutical research funding plan

of Rs 10,000 crore ($2 bn) every year that chemicals minister Ram Vilas

Paswan announced a week ago before the model code of conduct for political

parties and candidates kicked in on March 2.

 

The department has already interviewed 50 top executives of drug makers such

as Ranbaxy, Biocon, Wockhardt, Pfizer, Wyeth and F Hoffmann La Roche and

identified the bottlenecks that hold drug firms from inventing new drugs.

" Our idea is to fill in the missing links in drug discovery, starting from

identifying the disease to inventing drugs and securing patent rights. This

offers the population a chance to have new cutting edge drugs at more

reasonable prices than today. Now only 35% of the population have access to

healthcare, mostly from private doctors and hospitals. About 80% their total

health spending is on medicines, " a senior official of the department of

pharmaceuticals said, quoting WHO figures.

 

The areas for reforms and financial support include import, maintenance and

use of animals for clinical trials, an area where tough restrictions are in

place because of opposition from animal activists and NGOs.

 

For example, beagle dogs, used to test new drugs because they are docile and

manageable for scientists, are imported from Thailand at a price for Rs

20,000 per animal. One animal cannot be subjected to more than five clinical

trials and it has to be ensured that it survives and leads a good life after

the tests, the official said. It is also very difficult to get regulatory

clearances to set up large animal houses for testing new drugs. The

state-run Central Drug Research Institute, which has the facility, is booked

for many years to come, the official added.

 

The plan also proposes to fix the porous government offices so that the

costly clinical data generated by drug makers and shared with regulators do

not get leaked to rival companies. While data theft will be prevented, the

government will not allow inventors to extend their monopoly over their drug

beyond the 20 year patent term by claiming exclusive rights once the patent

has expired.

 

Faster approvals for various stages of animal and human experiments and

marketing is another reform planned. Specific regulatory changes will be

identified in a detailed project report to be prepared within six months

after the Prime Minister clears the project, said an official.