Posted: November 24, 2006

India developing regulatory guidelines for nanotechnology drugs

(Nanowerk News) NIPER, the Indian National Institute of Pharmaceutical Education and Research, is planning to take up the ambitious task of developing regulatory guidelines for approving nanotechnology based drugs. The attempt would be to come out with standard parameters to test nanotoxicity in nano based drug delivery systems. The move turns significant in the wake of increasing R&D by Indian companies to develop nanodrugs.
NIPER had recently opened a dedicated Centre for Pharmaceutical Nanotechnology for carrying out nano based drug delivery research. The centre would help NIPER generate more basic data on nanotoxicology. The significance of NIPER move could be understood when one realizes that USFDA organized a major workshop for the first time on October 19 to deliberate on the nanodrug regulatory guidelines.
According to Dr P Rama Rao, director, NIPER, "nanotoxicology is a new subject for drug researchers all over the world. Every regulator is thinking of framing guidelines. We should also initiate research in this area and collect more basic data. As a preparatory step, we intend to look for toxicity in certain type of nanoparticles. Since research findings show that they may have toxic contents because of their surface properties, such a study will be of immense help to the regulatory authorities," he said.
NIPER had also organized two major workshops on the topic recently. NIPER had started research in nanotechnology for drug delivery in 2003. Its research programmes have attracted funds from several National and international funding agencies such as the Third World Academy of Science, Italy, Royal Society of Chemistry, London Department of Science and Technology, Govt of India and Department of Biotechnology, India. It was after realizing the potential of its research efforts, Ministry of Science and Technology decided to assist NIPER in setting up a centre for pharmaceutical nanotechnology.
Source: (Joe C. Mathew)