Mumbai: India’s drug regulator is drawing up plans to allow international companies to conduct initial-stage drug trials in the country, a senior government official said on Wednesday.
The move by the Central Drugs Standard Control Organisation (CDSCO) is expected to increase contract research outsourcing business to India.
The country’s clinical research market was estimated at $200 million in 2007 and is expected to touch $500 million to $600 million by 2010, said KPMG in a report citing Cygnus Industry Insight January 2008.
Global drug firms are only allowed to conduct mid-stage or phase II and last stage or phase III trials in India.
However, Indian companies are allowed to conduct all stages of trials on drugs including the first stage, or phase I, and phase 0, the stage just before phase I where the drug is first tested on a few human beings.
“We have had two series of meetings with stakeholders,” said Surinder Singh, Drug Controller General (India). “There are certain areas that need to be addressed, but we can notify phase 0 and phase 1.”
The issues needing redressal include analysis of drugs, setting up stringent clinical trials monitoring systems, registering the organisation which conducts these trials - contract research organisations - and creating a databank of people who volunteer for these drug trials, Singh said on the sidelines of a pharmaceutical industry summit.
Global drug firms are increasingly outsourcing their drug discovery research to low-cost destinations such as India, as these firms reel under the onslaught of generic competition and rising drug development costs.
The CDSCO had also begun restructuring itself, setting up 10 divisions, and is in the process of recruiting 72 people, Singh said. “With rapid growth happening, especially in clinical research, we do not have the time,” Singh said.
“The bill will take time to be passed,” he added referring to the Central Drug Authority bill that awaits government clearance.
The CDSCO also plans to have a single-window approach for the pharmaceutical industry in India, he added. Currently, about half a dozen units look into various aspects of the sector with about five ministries having a say in the affairs of the industry.
The government also proposes to remove medical devices from being clubbed with drugs, Singh said.
CDSCO officers will also be sent to inspect manufacturing sites in other countries before the drugs can be imported to India to ensure quality standards, he added.