What are the criteria for a new drug?

Introduction

• Whether the drug is safe and effective in its proposed use(s), and whether the benefits of the drug outweigh the risks.
• Whether the drug’s proposed labeling (package insert) is appropriate, and what it should contain.

What is Dcgi approval?

Drugs Controller General of India (DCGI) is the head of department of the Central Drugs Standard Control Organization of the Government of India responsible for approval of licences of specified categories of drugs such as blood and blood products, IV fluids, vaccines, and sera in India.

How do I get Dcgi approval?

Submit complete report of clinical trials as per the approved protocol from the individual investigator duly signed by him along with his observations/remarks on the drug. 2. Indicating the date of commencement and conclusion of the clinical trial at each center (in case the study is multi-centric).

What are CDSCO guidelines?

This guideline describes requirements for approval of clinical trials and new drugs and the procedure for review of technical dossiers of such applications by CDSCO under Rule 122 A, 122B, 122DA, 122DAA, 122E and Schedule-Y of Drugs and Cosmetics Rules.

What are the 4 phases of FDA approval?

Phases of Drug Development

• Phase I: Discovery & Development.
• Phase II: Preclinical Research.
• Phase III: Clinical Research.
• Phase IV: FDA Review.
• Phase V: FDA Post-Market Safety Monitoring.

What comes first IND or NDA?

The Investigational New Drug (IND) application falls into the first category, while the New Drug Application (NDA), Abbreviated New Drug Application (ANDA), and Biologics License Application (BLA) fall into the second category.

Who is the CEO of Dcgi?

CEO Jagadeesh Babu Rangisetty said the company has developed the highly complex peptide in a very short period of time, primarily due to its focus on prioritizing COVID related products over the last one year.

Which is the regulatory body for drugs in USA?

The FDA
The FDA is the main regulatory body that handles drug approval in the United States.

Who is current Dcgi?

Dr. Venugopal G Somani
Dr. Venugopal G Somani is the Drugs Controller General of India (DCGI) since July 2019.

What is Remdesivir use for?

What is remdesivir? Remdesivir is used to treat people with coronavirus disease 2019 (COVID-19) who are in a hospital. Remdesivir is approved for use in adults and children at least 12 years old who weigh at least 88 pounds (40 kilograms).

Which is nominated members in DTAB?

There are two members in the DTAB who are nominated by the DCGI. They are Karnataka drug controller Dr Jagashetty and Jammu & Kashmir drug controller Satish Gupta. K Chinnaswamy is the other member of the Board who was nominated by the PCI. The MCI has named Dr Dhorubajyat Bora as its nominee in the Board.

What is a BA BE study?

A bioequivalence study is usually carried out for generic drug product. The study evaluates clinical differences in the bioavailability of two distinct drugs. These studies are conducted to assess the efficacy of a new drug product which may have a few different excipients or inactive ingredients.

How big is the DCGI Post Approval Draft?

The 38-page draft (including 2 Appendices) entitled “Post-approval Changes to Drug Substances” has been completed as part of the commitment to the reauthorization of the Generic Drug User Fee Amendments (GDUFA II).

Are there any new drug approvals for 2021?

Below is a listing of new molecular entities and new therapeutic biological products approved by CDER in 2021. This listing does not contain vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products, or other products approved in 2021 by the Center for Biologics Evaluation and Research.

When to consult FDA for post approval guidance?

As per the US FDA guidelines, manufacturers of active pharmaceutical ingredients (APIs) who want to make changes to the drug substance (DS) manufacturing process during an application’s post-approval period should consult US FDA (Food and Drug Administration) new draft guidance released on September 10, 2018.

When did DCGI issue guidelines for bioavailability ( BA )?

The DCGI, in March 2005, had notified guidelines for bioavailability (BA) and BE studies specifying the instances where these studies are necessary to ensure safety and efficacy of the products.