New Delhi: In a move that will allow greater transparency in human clinical trials conducted in India, the registration of all such trials will be made mandatory starting in June. The trials will be registered on the Clinical Trials Registry-India (CTRI) website.
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Through the registry, information on all clinical trials taking place across the country in all areas pertaining to health—new drugs, treatments, therapies, surgical procedures and new medical devices—will become publicly available for the first time. ICMR’s National Institute of Medical Statistics set up the CTRI website.
“Until now, clinical trials were being registered on the website of the Indian Council of Medical Research (ICMR) voluntarily. From January, it was made advisory. But by June, we will make it mandatory,” said Surinder Singh, drugs controller general of India (DCGI), whose office functions under the health ministry.
After DCGI hands out pre-registration approvals, the trial sponsor will have to provide on CTRI key information, including the nature of the clinical testing and the funding source, and name an ethics committee that will oversee the process before enrolling the first patient.
The move has also been approved by the Drugs Technical Advisory Board (DTAB), the highest drug advisory body in India, and will be notified once the minutes of the DTAB meeting are approved, he said.
The move to make the process of clinical trials more transparent follows concerns triggered by the death of 49 babies enrolled in clinical trials at the All India Institute of Medical Sciences (AIIMS) in New Delhi between January 2006-June 2008. More recently, in October, an infant died after being enrolled in a trial sponsored by Wyeth Pharmaceutical Ltd and monitored by clinical research organization (CRO) GVK Biosciences Pvt. Ltd.
Meanwhile, an increasing number of clinical trials are being outsourced to India by drug companies based overseas. A March 2008 report by the Planning Commission estimated the value of clinical trials outsourced to India at around $300 million (Rs1,485 crore today), having increased by 65% from 2006.
According to a December 2008 report by the task force of the ministry of commerce and industry, India is emerging as a highly attractive location for multinational drug companies to conduct research and development (R&D), particularly clinical trials.
“The consumption potential offered by more than one billion inhabitants, rising affluent customers and the changing lifestyles offer huge potential domestically for the sector,” the report said.
As part of the move to regulate the manner in which clinical trials are conducted in India, several changes have also been proposed in the Drugs and Cosmetics Act, 1940.
The regulatory changes include the introduction of a new schedule—Schedule Y1— in the Act along with a new set of rules.
The new schedule will call for the registration of all contract CROs so that they follow a uniform, harmonized law throughout the country. The draft guidelines for the registration of CROs have been framed and gone through DTAB. The minutes of the DTAB meeting are yet to be approved.
“Once they get approved, these draft guidelines will be put up on the Web and we will invite comments and observations from other stakeholders. Then we will take it through another round of DTAB and get it notified,” said Singh. He explained that the proposal was taken up “because more and more clinical trials are being undertaken and a number of CROs are involved in it”.
No penal provisions
Still, there are concerns over the lack of any related penal provisions in the country. DCGI suspended Wyeth’s advanced vaccine clinical trial related to pneumonia and meningitis after the October death of the infant, who should not have been included in the trial in line with a so-called exclusion criteria of the protocol. An audit had later found that the trial violated protocol, standard operating procedure and good clinical practices norms mandatory in the country.
In the absence of penal provisions, DCGI was only able to ask the two companies to comply with the clinical trial guidelines. “We will soon re-audit the companies and if everything is clear, allow the trial to be restarted,” said a senior official at DCGI’s office, who didn’t want to be named.
The baby deaths in the clinical trials at AIIMS and the more recent incident also focused attention on the conduct of CROs as well as ethical committees at the centres and hospitals where the trials are conducted.
“Many CROs are targeting tier II cities. Are they trained? We need 5,000 trained investigators. Some investigators have 20 trials under their belt,” said a senior executive at a leading CRO, who didn’t want to be named. “Who conducts the actual trial then? This affects the quality of the trial. Even the ethics committees of hospitals need to be looked into.”
India currently has 150 investigators—the personnel who conduct and oversee the trials—registered with the US Food and Drug Administration.
“India is getting into R&D sector, but in clinical trials, you don’t treat it as a marketplace because you test on people,” said Sri Mosur, chief executive and president of Jubilant Biosys Ltd. “Good talent will drive growth of industry here. And though regulations are delayed, there is serious consideration to bring changes.” (The promoters of HT Media Ltd, which publishes Mint, and promoters of Jubilant Biosys are closely related. The firms have no promoter cross-holdings.)
Mosur added that multinational firms still prefer not to hand over a complete trial to a CRO because clinical trials on humans is a sensitive issue. “If you see the industry, there isn’t a very impacting CRO that has evolved. It is still developing,” he said. “The most risk-averse group in the entire pharma industry is the clinical research group. So, the MNCs are extraordinarily thorough.”