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Regulation/Guidelines

CDSCO Notified Information On Convalescent Plasma In COVID-19

A growing number of research centres, hospitals are investigating antibody testing and blood-plasma therapy as a way to fight the new coronavirus in sick patients. People who survive an infectious disease like COVID-19 are left with antibody-rich blood plasma or convalescent plasma made to fight off the virus. Researchers are predicting convalescent plasma can be a lifeline for corona virus-infected individuals. The Ministry of Health and Family Welfare, Government of India on 27th June 2020, came out with CLINICAL MANAGEMENT PROTOCOL: COVID-19 Version 4.

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News

Self-Assessment/Audit of Unit for GMP/GLP Compliance

The Indian government has brought about some major changes with regards to the rules and regulations governing the manufacturing to enhance the quality of products used in the healthcare industry. As India being a major market for the healthcare-related products and its services, these modifications to the existing regulations are […]

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Regulation/Guidelines

Marketing Authorization of Biological Products in India

What are Biological Products? Biological products are used for diagnosis, prevention, treatment and cure of diseases and certain medical conditions and are regulated by the Food and Drug Administration of India. They can be classified in varied categories and consist of complex molecules that are produced through biotechnological techniques in […]

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Insight

Draft Guidelines on Similar Biologics, 2016

Medicinal products which are mainly composed of living tissues or cells are called Biologics

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Regulation/Guidelines

RCGM And CDSCO Recommends Fast Track Processing Of Recombinant Vaccines Applications For COVID-19

The Central Drugs Standard Control Organisation (CDSCO) and Review Committee on Genetic Manipulation (RCGM) recommend the rapid processing of recombinant vaccine development during COVID-19 pandemic under Rapid response Regulatory Framework. All the applications will be screened depending on the proper data and population.

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Insight

NDAC/MDAC/SEC

In order to strengthen the scientific review and approval of new drugs/devices, the ministry has appointed 12 New Drug Advisory Committee’s (NDAC), Subject Expert Committees (SEC) and 7 Medical Device Advisory Committee’s (MDAC) to advise the CDSCO in making their decisions on approval of new drugs and global clinical trials.

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Regulation/Guidelines

Release of Consignments of Vaccines and In-vitro Diagnostics in COVID-19 Pandemic

CDSCO released the notification for release of vaccines, IVDs and blood products (sampled 100% testing) from the ports after reviewing the documents, protocol, and certificate of release batch by the manufacturer and past satisfactory history of the product.

Regulation/Guidelines

CDSCO Announced Clinical Trials Conduct Rules During COVID-19 Outbreak

This guidance document covers the actions that sponsors of ongoing clinical trials affected by the present pandemic should take to ensure the integrity of the research studies and interpretation of study results while safeguarding the safety of clinical trial participants as a priority

Regulation/Guidelines

New Regulatory Guidance to Facilitate Drug & Vaccine Approval for COVID-19

The SARS-CoV-2 virus started in December 2019 and then spread at an alarming rate, mainly to China, Italy, the USA, Iran, Japan, and South Korea and even India. There is no drug or vaccine yet approved by the FDA for COVID-19. Presently, there is not any evidence from randomized clinical […]

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