Clinical investigators are unhappy over the ban by the Supreme Court on clinical trials till a mechanism is put in place to monitor them.
“It is rather unfortunate,” said State secretary of the Indian Medical Association A.V. Jayakrishnan.
He blamed the government for not presenting the case properly in the court. Dr. Jayakrishnan said though technically large numbers have died during clinical trials, most of the patients who had died were in terminal stages of cancer. Of the entire lot of clinical trials in the country, a major chunk is for cancer research.
“The government said they can’t monitor the trials and that is inefficiency,” he said. The government has also said about setting up an authority to monitor the clinical trials, which is welcome indeed. But till then, clinical trials in various stages are going to suffer.
The ban would also directly affect the drug manufacturers in the country who were producing newer drugs to meet the challenges of modern medicine, said Dr. Jayakrishnan.
The multi-national companies won’t be affected as clinical trials would only be affected in India, he said. Besides, the drugs for trials that come in as part of global trials are already in the fourth phase of the trial.
Noted oncologist Dr. V. P. Gangadharan told The Hindu that clinical trials are one of the important steps in medical development. “Traffic rules are to make the vehicles fall in line, but you don’t ban the traffic to ensure that none is breaking rules,” he said. Likewise, rules have to effectively bring in good clinical practice, he added.
Cancer treatment being one of the most vibrant in medical research, there are cases where patients who can afford to travel abroad go for clinical trials there, said Dr. Gangadharan, indicating the case of a patient with rectal carcinoma. “Clinical trial is suggested only when a physician has nothing else to offer as treatment,” he said.
The institutional ethics committee had to be made responsible for following the ethics and making available periodic reports to scrutiny, said Dr. Jayakrishnan.
Cardiologist S. Harikrishnan, secretary of the Cardiological Society of India, Kerala chapter, said it was essential that new drugs come in for treatment and clinical trials was an essential phase in drug development. “The Indian population is reaping the benefits of clinical trials held in humans elsewhere in the world. And as part of mankind, cannot stay away from being part of it,” he said.
“Regulations need to be strict,” said Dr. Harikrishnan. “In a country where there are a lot of underpriviledged people who can be easily influenced by money, the government has to ensure that regulations are in place and that they are followed too,” he said.
Compared to the contributions of the US, Germany and China, India is nowhere in drug development, said Dr. Harikrishnan. “It takes about 15-18 years to develop a drug. To keep the country away from such a scientific process is not healthy at all,” said Dr. Harikrishnan.