DCGI, India to set up own labs to test new drugs

NEW DELHI: India’s top drug regulator Drug Controller General of India (DCGI) has identified six labs to test new drugs before launching them in the
market. It is now looking at public-private-partnership (PPP) models to build infrastructure and better testing facilities in order to keep a vigil on the quality of drugs. Currently, the drug regulator gives marketing approval to new drugs based on the evaluation of the clinical trial data submitted by them. Testing of new drugs by a government agency will give more quality assurance to the consumer. “We have identified six government labs that can be used for testing new drugs. Now, we are in talks with some private labs for tie-ups to develop the infrastructure of these labs, so that they can be used for testing new drugs,” a health ministry official said. DCGI is also planning to test spurious drug samples, collected from the market, in the labs. “Drug inspectors have collected around 24,600 samples of spurious drugs from across the country. However, only 30-40% of the collected samples could be tested due to lack of manpower and facility. A PPP model would allow private laboratories to bring in more manpower and upgradation of facilities in these labs,” the official said. The government is looking at a revenue-sharing model with private labs to upgrade the labs. While the government will fund the projects, the private companies will bring in manpower and expertise, he added. According to official estimate, there is a substantial increase in the number of new drug applications received by the drug regulator annually. While DCGI received only around 1,200 application for new drugs in 2005, it received 1,600 applications in 2007 and 1,750 in 2008. In 2009, the drug regulator has received 920 applications for new drugs within the first six months. “While the number of applications has gone up, monitoring the quality of drugs in the market is a challenge that we have to face,” the official said.