Major hurdles 'cleared' for clinical trials in India: Experts
The recent amendment brought to the compensation guidelines in carrying out clinical trials in the country has cleared "major hurdles" for testing of new drugs, especially for those diseases for which cure is not yet available in India, experts Thursday claimed.
New Delhi: The recent amendment brought to the compensation guidelines in carrying out clinical trials in the country has cleared "major hurdles" for testing of new drugs, especially for those diseases for which cure is not yet available in India, experts Thursday claimed.
"The government brought in amendment to the clinical trials guidelines in December 2014 and it has come into effect from June this year.
"And, the revised regulations are balanced and have addressed various issues, because of which sponsors have earlier been either not participating in or withdrawing from trials," President, Indian Society for Clinical Research (ISCR), Suneela Thatte said.
She added that the new regulations also seek to streamline the 'institutional ethical committee' to make sure the trials are carried out in the safest way.
"The guidelines earlier were as blanket that for any injury suffered by the patient (trial subject) the medical management had to be provided to him or her, irrespective of its causality. This was one of the factors that was keeping sponsors away. Now with the amendment, the compensation would be awarded commensurate with the severity of the injury," Thatte said.
She was speaking at a press conference called at the AIIMS here, where few doctors and a patient, who have been associated with conduct of clinical trials, also participated.
Y K Gupta, professor and head of department of pharmacology at AIIMS and executive council member, ISCR, said, there were some trials in the past, which "went wrong" and since then the government has taken "correctional measures" in the regulations.
"Compensation guidelines are balanced and ensure safety of patients, and the compensation offered would be based on the severity of the injury if any sustained by the patient during the course of the trial.
"All institutional ethical committees for the trials have to be accredited and no trial can be conducted without the informed consent of a patient," Gupta said.
He said that the amendment has added the provision of "recording and archiving" the interaction with the patient for future references.
Thatte said, "some of the sponsors (individual, company etc) over the period have been unwilling to participate, because of unpredictability in review process of their application to begin trials."
"The process takes long time and now the amendment to the rules seek to bring in more predictable review timeline, steps which will encourage sponsors to participate in the trials," she said.
"We therefore have cleared major hurdles in making clinical trial in India more streamlined and there are only operational challenges now, like the right number of trials, etc," she added.
A schoolteacher who suffers from multiple sclerosis, and relatives of two patients who both suffer from Rett Syndrome, shared their agonising experience of suffering these diseases, while looking for an affordable cure for them in the country.
Rett Syndrome is a rare genetic postnatal neurological disorder of the grey matter of the brain that almost exclusively affects females but has also been found in male patients.
Samir Sethi, President of Indian Rett Syndrome Foundation, said, "My daughter suffers from this debilitating disease and we want to find a cure for her. We only hope clinical trials will offer some hope for people like my daughter."
Gupta of AIIMS said, "While patients must know that clinical trials offer possible hope but not the only hope in case of such diseases."
He further said that for companies agreeing to enter into clinical trials in India or any other country, "they have to ensure that later after the drug is developed, it must be made available to the country at affordable rates."
"Also, genetic make differs from one county to another, so if cures of diseases suffered by people here is to be found, the trial must be conducted in India only," he added.
All clinical trials being undertaken in India has to be registered first with the Clinical Trials Registry-India (CTR) that falls under the aegis of the Indian Council of Medical Research (ICMR).
ICSR is a non-profit association of clinical research professionals that aims to build awareness on the issue and facilitate its growth in the country while while evolving the highest standards of quality and ethics.