Biopharma

As pharmaceutical sector is growing so fast, many companies are producing their products and selling throughout the world. So to control the Drug development, licensing, production of drugs and selling many regulatory agencies are established.  There are some international regulatory agencies are available like, ICH (International conference on harmonization), WHO (World health organization), PAHO (PAN Americal health organization), WIPO (World intellectual property organization), WTO (World trade organization). Apart from these many countries are develop their own regulatory body like, USFDA(USA), EMEA( European Union), CDSCO(India), MHRA(UK), TGA(Australia), Health Canada (Canada), ANVISA(Brazil), NMPA(China), MCC(South Africa), NAFDAC(Nigeria), PMDA(Japan), NMRA(Srilanka), KFDA(Korea) etc. Indian Drug Regaulatory Authority DCGI (Drug Controller General of India) - DCGI is the head of CDSCO in India.    CDSCO (Central Drug Standard Control Organization) - Headquarter:-

Clinical trials are set of tests in medical research and drug development that generates safety and efficiency data for health intervention in human beings. Clinical trials are the part of drug development process. Drug development include the steps like,  (1) Preclinical test,  (2) IND (investigation new drug) Application filling, Review and approval,  (3) Clinical Trials  (4) NDA (New drug application filling and approval),  (5) Post marketing. Applicant before going to clinical trials, one need to complete preclinical on Cell line and Animal, (in vivo/in vitro) test.  Main evaluation phases in preclinical test are, Pharmacodynamic, Pharmacokinetic, Toxicity profile, Safety and efficiency. After successful completion of preclinical tests, applicant has to file for IND approval. Once IND approval being done then clinical trial can start. CLINICAL TRIAL:-  Clinical trial have five phases from phases 0 to phase IV. Phase 0:-  In phase 0 study of drug at micro dosing (1/100 of the dose o