Even as the efforts to frame regulations for nanomedicines are stuck for years without any headway, the Department of Pharmaceuticals (DoP) now wants a National Pharmaceutical Nanotechnology Centre, to be set up preferably at the NIPER-Kolkota.
A proposal worth Rs.50 crore has already been forwarded to the Planning Commission for approval in this regard. The centre would work on development of nanomaterials, new drug delivery systems based on nanotechnology, medical devices, nano-toxicology and regulatory aspects concerning nano drugs and devices, sources said.
“Pharmaceutical nanotechnology’ involves use of nanomaterials for emerging industries like medical devices industry and for new innovative drug delivery systems, diagnostic, imaging and biosensor equipments, etc. Medical devices industry is growing at 30 per cent per annum. Accordingly, there is a need to develop indigenous product development capacity in the field of nano-technology. It is accordingly proposed to set up a National Centre for Pharmaceutical Nanotechnology at NIPER Kolkata,” according to the proposal.
Sources said it was in a way an attempt to revive the attempt to frame regulations for the nanomedicines as the earlier efforts launched way back in 2006 could not make progress so far. The NIPER, Mohali had been entrusted to the task of framing guidelines on the nano-based drugs, as it had a dedicated Centre for Pharmaceutical Nanotechnology.
With no such pioneering regulations existing in any countries and most of the nations including United States still trying to frame regulatory framework in view of its growing significance, NIPER could not go beyond a couple of workshops and compiling the inputs so far.
“Things are at preliminary stage. We have to scientifically test about the nanomaterials used in drug developing, besides finding out the toxicology effects and standardisations. Even the companies are not fully ready with the data to be supplied as inputs in this regard,” according to the sources in the NIPER.
Nanotechnology is fast emerging as a powerful platform technology for developing modern drugs with several companies getting into various stages of research worldwide. A few Indian companies are also into the task. Dabur Pharma has already developed a nanotechnogy-based chemotherapy agent Nanoxel, a novel drug delivery system for the widely used anti-cancer drug Paclitaxel. Dabur is working on at least seven other nano-based drugs. Large pharmaceutical companies like Dr Reddy's and Nicholas Piramal are also into research in nano drugs. All India Institute of Medical Sciences (AIIMS) is already conducting a clinical study to evaluate a new nanotechnology based Drug-Eluting Stent for opening of narrowed arteries of the heart.