Wants to promote global standards, weed out unethical practices in sector.
The central government is planning to mandate biometric identification for clinical trial volunteers in the country to bring in global standards and to weed out unethical practices in the industry, which is less than a decade old.
Clinical trials are essentially research studies to test the safety and efficacy of a new drug by administering it on healthy human volunteers and patients. Unlike other forms of identification, biometric identification — which relies on the unique physical characteristics of a person, like the iris of the eye or a fingerprint — is almost impossible to fudge.
The Ministry of Health and Family Welfare plans to ask all clinical research organisations (CROs) to enforce biometric identification for the volunteers they recruit for their clinical trials, according to officials at the ministry. Data from the trials will then have to be made available for scrutiny by regulators, civil society groups and the clinical trial industry, they said.
“The move will bring transparency into the conduct of clinical trials. Those who feel Indians are being used as guinea pigs can actually get access to genuine data on the volunteers and their socio-economic backgrounds, and can then arrive at informed decisions,” the officials added.
The biometric system, which is present in developed countries, will also help the Indian clinical research industry generate more credible data and ensure better care for the human volunteers.
Since the system can identify any unethical practice — such as participating in more than one clinical trial at a time, or non-observance of the mandatory gap that is required to be maintained between two trials — the outcome will be better, officials feel.
The biometrics system proposal is among a series of measures being undertaken by the government to make clinical trials more accountable in the country. To begin with, the health ministry will insert a new rule to make registration of CROs and clinical trials mandatory.
This could also pave the way for allowing in India first-time-trial-on-humans — referred to as Phase-I clinical trails — for new drugs developed outside the country, sources said. Currently, India does not allow Phase-I clinical trials on Indians unless human-trials have already been conducted in the developed world.
Though data is hard to come by, according to an Indian Brand Equity Foundation report, Indian drug discovery and development outsourcing market — which includes clinical services — is projected to grow at 50 per cent to reach $900 million (over Rs 4,100 crore) in 2009.
Arn Bhatt, president of Clininvent, one of the leading CROs, said the country has over 100 CROs and, of this, about 30-40 are focused on conducting bio-equivalence and bio-availability studies. “Trials conducted by multinationals in India are in accordance with the Organisation of Pharmaceutical Producers of India’s (OPPI) code of ethics and conform to the International Conference on Harmonisation Guideline for Good Clinical Practice,” said Gireesh Telang, chairman of OPPI’s medical committee and managing director of Roche India.
At present, an informed consent of the patient or the volunteer is adequate for recruitment for a trial, which is monitored by Principal Investigators, an independent ethics committee, and the Drugs Controller General of India. However, exact statistics and data on participants in a trial are not currently available with authorities.
Typically, a drug is tested on a group of 20-80 people in Phase-I of a clinical trial, between 100-300 people in Phase-II and 1,000-3,000 patients in Phase-III. “In India, drug trials can be 50 per cent cheaper than in developed countries,” said Suresh Menon, chief scientific officer of Novartis India.
According to a McKinsey report, employee costs of a lab technician in India are only 6 per cent of that in the US, and 8 per cent in the case of a quality control scientist.
At least 700-800 such clinical studies are held in India. According to rough industry estimates, multinational companies accounted for 440 trials in the country in 2008, which is much lower than trials in competing countries like Korea (740) and China (670).
Of the 440 trials, about 70 trials were for new drugs for diabetes, 67 for oncology and 18 for hypertension, said Sadhna Joglekar, executive director, GlaxoSmithkline Pharmaceuticals.
The government is also in the process of framing guidelines for the formation of ethics committees. While the guidelines will be advisory in nature in the initial stages, it will be incorporated into a law soon, officials said.