“Ethical violations of hum-an drug trial research will face severe punishments, which could amount to several years of rigorous imprisonment,” said Dr Vishwa Mohan Katoch, director general of the Indian Council of Medical Research and secretary of the Department of Health Research.
The national health research policy, which will be discussed in the next session of Parliament, will ensure that the paradigm of ethics is strengthened, by including the opinions of decision makers across medical, biomedical and agricultural aspects. “The ministry of science and technology will be the co-chair during the final decision making. The drafting that began in March 2011, will be enacted by June at the earliest,” said Dr Katoch.
Reacting to the allegations about human trials of the Human Papilloma Virus vaccine in Andhra Pradesh and Gujarat, Dr Katoch said that there was no malafide intention by those who conducted the trial, and that the ethical committee closely monitors the activities, and deliberates the means and ends of it. He also said that human trials continue to be permitted in India and that there is a need for close ethical monitoring. He added that the Drugs and Cosmetics Act will be amended to eliminate all loopholes, making it more stringent.
When asked whether Indian laws would ever catch up with the robust human trial laws of the West, Dr Katoch said, “Our laws have been the best in this regard. There’s no need to compare India with West-ern countries and a unique path for India should be laid for everyone to follow.” Dr Katoch also said, “Comparing Indian medical research to that done in other nations goes against the grain of our unique culture. We must also keep in mind the entire spectrum of medical needs in a vast country such as ours. To see our nation completely developed in this aspect, we need more investment.”