BIOLOGICAL MEDICAL PRODUCT ALLERGIC, GENE, RECOMBINANT PROTEIN IN INDIA COMPERISION WITH EUROPE

Ashok Kumar P.*, Darshan R., Mohammed Shabaz Ahmed MS, Toufeeq Chowdry, Parmeshwar Biradar and Khalandar M.

ABSTRACT

The Beginning of new era The Biological Medical product in treatment Allergy disease biological product omalizumab, daclizumab. Specific medical product antihistamine [montelukast sodium] According European Directive product containing intact allergens chemically modified allergens. These products are developed and investigated in clinical trials in this article we compendious clinical efficacy, product specificity. Gene theraphy is a new and fast growing field of medicine and allowed the development of therapies for disease the gene theraphy products are recombinant of nucleic acid the gene theraphy must be authorized through centralized procedure. Methods of gene therapy, Advanced therapy medical product. Recombinant protein produced by recombinant r – DNA technology. The term r-DNA technology introduced by American Botanist Paul Burg the first recombinant biological product is insulin produced by E. coli Specific biological product Insulin, Growth hormone, Thrombolytic drug.

Keywords: E COLI, CDSCO, FDA, DCGI, CTD, IMPD.