New Drug Discovery and Development

 

•In the past most drugs have been discovered either by identifying the active ingredient from traditional remedies or by serendipitous discovery.

•But now diseases are controlled at molecular and physiological level as shape of an molecule at atomic level is well understood.

•Information of Human Genome.

Registration: 

•The Ministry of health & Family Welfare and the Ministry of Chemicals & Fertilizers have major role in regulation of IPM.

•NDA must be submitted to DCGI.

•Phase III study reported to CDL, Kolkata

•Package inserted approved by DCA, India

•Marketing approval from FDA, CDSCO.

  

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