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= Regulatory Information and Facilitation Center (RIFC) = The Regulatory Information and Facilitation Center (RIFC) is a joint initiative of the Venture Center and BIRAC under the BIRAC Regional Bio-Innovation Center (BRBC) program.

The RIFC aims to assist bio-entrepreneurs in planning, seeking and securing regulatory approvals. The RIFC plans to achieve this by providing information in an entrepreneur-friendly manner, providing access to experts and regulators, providing access to practical insights from other entrepreneurs, providing services and organizing relevant and useful events.

Introduction:
Regulatory approvals in India for Pharma, Agro, food & related products involves obtaining multiple licenses from multiple licensing authorities such as CDSCO, APEDA, FSSAI, etc.

India: The Central Drugs Standard Control Organization (CDSCO) is the national regulatory body for Indian pharmaceuticals and medical devices, and serves parallel function to the European Medicines Agency of the European Union, the PMDA of Japan, the Food and Drug Administration of the United States and the Medicines and Healthcare products Regulatory Agency of the United Kingdom.

Within the CDSCO, the Drug Controller General of India (DCGI) regulates pharmaceuticals and medical devices, under the gamut of Ministry of Health and Family Welfare. The DCGI is advised by the Drug Technical Advisory Board (DTAB) and the Drug Consultative Committee (DCC). CDSCO has six zonal offices, four sub-zonal offices, 13 port offices and seven laboratories under its control (organization chart). Regulatory control over the import of drugs, approval of new drugs and clinical trials, meetings of Drugs Consultative Committee (DCC) and Drugs Technical Advisory Board (DTAB), approval of certain licenses as Central License Approving Authority is exercised by the CDSCO headquarters.

Though the CDSCO has a good track record with the World Health Organization, it has also been accused of past collusion with independent medical experts and pharmaceutical companies.

European Union: The European Medicines Agency (EMA) is a decentralized agency of the European Union (EU) responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU. EMA is governed by an independent Management Board. Its day-to-day operations are carried out by the EMA staff, based in London, overseen by EMA's Executive Director. EMA is a networking organisation whose activities involve thousands of experts from across Europe. These experts carry out the work of EMA's scientific committees.

United States of America: The Food and Drug Administration (FDA or USFDA) is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counterpharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.

Index:


 * By product / service Categories


 * Medical Devices
 * o  Drug & Cosmetics
 * o  Agro Products
 * o  Food & Nutrition
 * o  Biologicals
 * o  Other products

·        By regions / jurisdictions

o  India

o  US

o  EU

·        By Laws (Agency / Dept/ Ministry)

o  CDSCO

o  APEDA

o  FSSAI