Pharmaceutical Regulatory Affairs: Open Access

Department of Pharmaceutical Sciences, Maharshi Dayanand University, Rohtak, Haryana, India

Publications

• Review Article   
  Regulatory Scenario of Pharmaceuticals during COVID-19 Pandemic in India
  Author(s): Sonia Tanwar and Anshuman Panchal*
  
  In India, CDSCO controls all the activities related to importing, exporting, manufacturing, warehousing, and selling drugs, biologics, and medical devices. The CDSCO's intention to expedite the evaluation and licensing of a COVID-19 vaccine was announced in the Vaccine Notice, which was released at the start of the pandemic. After getting authorization from the CDSCO, the hospitals/medical institutions may import or produce the unapproved medicine as long as the unapproved drug is undergoing Phase-III clinical trials in India or elsewhere. CDSCO issued a notice regarding the launch of the online platform for adverse event reporting of medicines through the SUGAM portal. Under extraordinary circumstances, the CDSCO may only modify the eligibility criteria for importing drugs with a shorter shelf life if they have not passed their expiration date. Manufacturers of medical devices ar.. Read More»
  

  Abstract PDF