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.

Read More

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.

Read More
knowledge-service-img

Regulation/Guidelines

Ethics Committee Guidance Amid COVID-19 Pandemic In India

Ethics preparedness is the capability of the public health system to protect and have the ability to quickly respond to by having in place an ethical framework that would build trust and guide measures to recover from health emergencies. ICMR Bioethics unit, NCDIR, Bengaluru, along with COVID19 National Ethics Committee (CoNEC), released a guidance document regarding the ethical conduct of clinical research in India.

Read More
knowledge-service-img

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.

Read More

Regulation/Guidelines

What Are The Benefits Of Having A Wholesale Drug License In Form 20B & 21B?

A wholesale drug license in Form 20B / 21B has numerous benefits for wholesalers despite the strict rules and regulations of CDSCO and SLA. Since wholesale drug license has a Indian reorganization, so it opens up endless possibilities for businesses.

Regulation/Guidelines

CDSCO Provides Guidelines For Approval Of COVID-19 Vaccines For Restricted Use In An Emergency Situation In India And For The Import Of Vaccine By The Private Sector

The Government of India has laid out guidelines for the Restricted use of vaccines in Emergency situations. The guidelines also allow the ready-to-use vaccine to be fully utilized from 1st May.

Call Now