The biotech companies in the country are demanding to the central government to shift the powers for approvals for experimental animals, also referred to as lab animals, from the union ministry of environments and forests to the union health ministry, as they feel that only the experts in the ministry of health can comprehend the importance of the animal studies in development of a drug.

The Association of Biotechnology Led Entrepreneurs (ABLE), the umbrella organisation of biotech companies, will soon initiate a dialogue with the government of India in this regard, said Kiran Mazumdar-Shaw, chairperson Vision Group on Biotechnology, government of Karnataka and chairman and managing director Biocon Limited.

There is big difference between the laboratory animals and those in the wild. Now for those animals used for drug experiments require clearances from a panel of experts at the ministry of health who comprehend the importance of these studies. Therefore, all clearances of these experimental animals used to test drugs should now come under the purview of ministry of health and should no longer be with the ministry of environment and forests. The latter should only continue to focus on ensuring the welfare of wild animals, she said on the sidelines of the 13th curtain raiser of the Bangalore India Bio.

Following a media query on experimental animals clearances, Shaw pointed out there was no exact information available with the animal activists who are blowing up the issue out of proposition. Instead they should comprehend that without these experiments, drug research and development had no future.

The lab animals are imported and there was a need for the government to handle the approvals with responsibility and ascertain view of industry stakeholders. Therefore, we as representatives of the biotechnology industry through ABLE would now engage with the government to comprehend the serious issues associated with experimental animal clearances and take a stand where they could move the approvals from the ministry of environment and forests to ministry of health. The move would benefit companies undertaking animal research and the next phase of study is human studies, said Shaw.

Moving on the clinical trials, Shaw said that the human studies are indispensable for the development of drugs to treat patients who have no access to advanced drugs to control conditions like for instance cancer. Therefore industry wanted transparency and an ethical accountable system for the conduct of human studies. This is where technology is important. Right now data disclosure about clinical trials is mired.

“Now ABLE is going to work with the government insisting on putting up all data about the human studies conducted in the country in a website. For instance, more often, the volunteer or patient who has enrolled for a clinical trial succumbs to a road accident then the hospital or pharma company engaged in the study is accused of death caused by the drug. This is where  we will need to provide every bit of detail of the clinical trials. There is also need to clarify and declare the reason for fatality. Going forward, every person would only benefit from the outcome of a clinical trial as it is the only path to newer and efficacious drugs to treat some of the dreaded diseases,” she pointed out.

It is high time we arrive on a balanced view about experimental animals and human studies. Largely, clinical trials are conducted ethically in India but there are few errant players who need to be dealt with punitive measures. The government will now need to take a responsible move and act with maturity to take prudent decisions on this as India is no doubt a hub for clinical trials for many global players, said Shaw.