With a view to protect the interest of innocent patients, the state government has decided to tighten norms for clinical trials through new legislation.
With a view to protect the interest of innocent patients, the state government has decided to tighten norms for clinical trials through new legislation. A proposed law will make it mandatory for companies to provide health security and other welfare benefits to individuals subjected to clinical trials.
The state has appointed a two-member expert committee to study and frame guidelines to regulate and reorganise clinical trials and research projects in all the government and private medical hospitals and colleges.
Addressing the media, SA Ramdas, minister for medical education said, “We have appointed Dr AS Aravind, expert in research and Mahabaleshwaramaiah, retired physician and cardiologist of Victoria Hospital to the committee. The committee has to submit the report within two months.”
“After submission of report, we will have discussions with the chief minister, chief secretary and legal experts and bring new legislation to regulate clinical trials. New legislation will be streamlined with more stringent clauses for the welfare of those who are subjected to trials,” he said.
“Our state and country does not have any laws or guidelines to regulate these experiments. The doctors are being lured by pharmaceutical companies with various kinds of inducements. This is a bad trend. So to curb this it is essential to bring new legislation. At present, about 500 clinical trials are going on in India and out of which 100 are in Karnataka. In developed countries, trials are conducted as per stringent rules and regulations, but here they are doing it as they wish,” he said.
Ramdas said, “All the drug-manufacturing companies before releasing the drugs to open market, should conduct trials in three stages — epidemiology, observational study and drug trials. These will be conducted simultaneously at 150 centres across the world and all the data will be registered in clinical trial register mandatory. But in India, not many companies are maintaining this index. In foreign countries if any company wants subject any individual for clinical trials they will enter into an agreement assuring that the company will take care for their health security for the next 10 years., but here no uniform rules are in place and even standard operating procedures are not being followed.” he said.
Before clinical trials, the company has to get permission from human ethical committee. This is also not being followed in the state. So to streamline that and bring uniformity in trials and to fix role of patients, doctors, companies and institutions we have set up this committee, said the minister.
Fresh paramedical staff announced
According to the high court direction, the medical education department has announced a fresh provisional selection list of paramedical staff in Mysore and Hassan medical colleges, on Wednesday.
“Keeping all the observations of the high court in mind and going through the merit criteria, we have prepared a fresh provisional list and it has been announced in the colleges. Any one can file objections within 15 days and after considering objections we will announce final selection list,” said Ramdas.
After several irregularities in the staff selection for Mysore and Hassan medical colleges, the new list has been announced for the two colleges — 45 for Mysore and 307 for Hassan. The selection is purely on the basis of merit and those who have appointed earlier illegally their appointment will be cancelled, he said.
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