Updated on 10 May 2013
India should adopt a regulatory process, which should have stringent yet extremely streamlined evaluation methodologies and protocols, thinks Dr Smita Singhania, consultant, Getz Pharma India and Natco Pharma India and director, Symbiosis School of Biomedical Sciences, Symbiosis International University, Pune, India. She says, "Every delay is costing the developers a significant amount of resources and consequently affecting their approval process in other countries either emerging or regulated." She also feels that as Indian developers gain hands on experience with biotherapeutics, the regulators must give them the adequate support by in depth discussions and making case by case expectations clear.
Mr Bhagirath Choudhary, national coordinator, International Service for the Acquisition of Agri-biotech Applications (ISAAA), India, while speaking on the prevalent condition of the Indan agri sector, says that, "The Indian policy makers have to feel the pulse of the farmers and allow them a choice without mandatory conditions for cultivation."
No matter what the present regulatory scenario in India, there is still hope at the end of the tunnel , as long as people like Dr Gyanendra Nath Singh, the Drug Controller General of India (DCGI), occupy decision making positions. Dr Singh thinks that it is the responsibility of drug regualtory and policy making bodies to take utmost care of patient safety, well being and rights.
Where do you think is the regulatory train heading in India? Do let us know about what you think, in the comments section below.