/

/

How to get CDSCO NOC for vaccines?

By Team Metacorp on September 30, 2022

How to get CDSCO NOC for vaccines?

Arrange a Callback

How to get CDSCO NOC for vaccines?

CDSCO NOC for vaccines

Introduction

The production of vaccines and its technologies and facilities in India has developed greatly. Today, the Indian vaccines are providing benefits to the Indian as well as the International market. During the clinical trial, it might not be possible to detect all the harmful effects of the product. Therefore, it is vital to assess the safety concerns of the drugs after the drug is marketed to reduce the health risk.
To evaluate and minimise the serious issues caused due to use or exposure of drugs, Pharmacovigilance Programme of India (PvPI), a division of the Central Drug Standards Control Organization (CDSCO), and the Expanded Programme on Immunization (EPI), Ministry of Health and Family Welfare, plays an important role in dealing with the issues.

About Pharmacovigilance Division (Human Vaccine)

The Pharmacovigilance division at CDSCO coordinates with the Immunization Division, Ministry of Health and Family Welfare, and NCC-PvPI (IPC-Gzb.) and attends meetings with stakeholders as per the need. The department also collects Serious Adverse Events (SAE) or adverse events which are reported by IPC and Immunization Division. Further, it is reviewed by an expert committee to take necessary action.

The Functions of the Vaccine Division of CDSCO:

The department is responsible for the grant of NOC to issue Form 29 to manufacture drugs for test or analysis of vaccines.
It approves clinical trial of the proposed drugs.
It grants authorization to market the drugs.
The depart is also responsible for providing Import License, Test License and Registration Certificate in Form 11.
Further, the department approves Form 28-D Licensing which is for vaccines under the scheme of CLAA.
It grants permission for Export NOC under Rule 37.
The department approves post-approval changes.

For more details, click METACORP

What is Recall?

If any reported drug is deficient in quality and safety then a recall step is taken to remove the distribution of drugs from the market. Recall action is also taken if drugs are prohibited under Drugs & Cosmetics Act. This also includes drugs the license for which are suspended.
In the Drugs & Cosmetics Act & Rules, Para 27 & 28 of Schedule M contains provisions for recalls of products, complaints and harmful reactions. The Drugs & Cosmetics Act & Rules also have necessary conditions to grant licenses for the recall of defective products. This rule is for all drugs, vaccines and biological. Manufacturers, distributors, importers, retailers and stockists must follow the guidelines. The Drugs Control Authorities of Central or State can use the process to take action in order to prevent any harmful cause of drugs on human beings and animals.

Classification of Recall

The Recall is classified into the following classes:

Class I

Class I involves a condition in which drug use or exposure causes serious health issues or death. It also includes banned drugs mentioned under 26A of the Drugs and Cosmetics Act 1940.

Class II

Class II is a condition in which the use or exposure to any drugs causes temporary health consequences.

Class III

Class III condition includes situations in which the use or exposure of a product causes no health consequences.

Documents for NOC for manufacturing of Test Batches for test and analysis under Form-29 (Vaccines and r-DNA products)

1. A cover letter should state the purpose of the application.
2. Provide names or names of the drugs.
3. Biosafety level and source of MSL/WSL.
4. Complete details of the site.
5. Site plan where the drugs will be manufactured.
6. Existing names of drugs manufactured at the proposed site, if any.
7. Manufacturing license details along with product permission.
8. The date, purpose and compliance status of the previous joint inspection of the site.
9. Process Flow Chart.
10. List of testing facilities and equipment to be used.
11. If there is a transfer of any technology mention the same.
12. Details such as name qualification and experience of the personnel who has taken responsibility to manufacture and test trial batches.
13. Declaration from the applicant.

If you wish to get more information on the CDSCO vaccines certification, click HERE

To discuss a project

End to End Certification Services – How we do it

01

Enquiry by the Applicant

Once any prospect makes a query for any service, a dedicated service manager is allotted to every query.This ensures personalized and focused service for each prospect.

02

Document Collection

We collect required documents from the customer, prepare other declarations/affidavits and submit online/offline application along with Govt. fee submission

03

Certificate issuance

Once the Govt. fee is submitted, we continuously monitor it and provide regular updates to the applicant. We also submit any document deficiency raised by the Authority.

Free initial consultation on legal aspects of daily business activity

To discuss a project

Project Callback

Our few valuable clients

partnerLogo

partnerLogo

partnerLogo

partnerLogo

partnerLogo

partnerLogo

partnerLogo

partnerLogo

partnerLogo

partnerLogo

View All Clients

Why Choose Metacorp

10 + years

Pollution Board Consulting

1000 +

CTE CTO Certificates issued

180+

EIA-EC Certificates issued

5+ years

CDSCO Consulting for medical device import

700 +

CGWA / HWRA NOCs

800 +

CPCB EPR certificates issued for Plastic, battery, electronics

1000 +

MOEF NOCs for HW import

300 +

DGFT Licenses for import of restricted items

Why Metacorp

About Metacorp

We are the pioneers in offering environmental consulting services to our patrons, giving us the first mover advantage & keeping us ahead of our competitors.

Very experienced in filing, monitoring & issuance of CDSCO Certificates, Drugs Licensing, Environmental Impact Assessment, AERB certificates, Pollution Control Board CTE & CTO, Waste Management Authorization from State Pollution Control Boards, Fertilizers & Insecticides Licensing

Very strong and experienced sales & documentation teams.
Very experienced liaison managers with offices in multiple locations across India
Extensive experience in end to end project certifications management
An acute understanding of the real challenges faced by our patrons and innovative solutions for compliance ready organizations.
Business ready for onboarding multiple customers with varied certification requirements
100+ existing channel partners ready to contribute for finding efficient environment certifications for our esteemed patrons.

Whatsapp Metacorp