Introduction: Central Drug Standard Control Organization
CDSCO (Central Drug Standard Control Organization) is a regulatory body under the ministry of health to look after the medical device industries and pharmaceutical products.
Table of Contents
- Introduction: Central Drug Standard Control Organization
- It's three Easy Steps Process
- Documents Required to Obtain an NOC From CDSCO for Manufacture of Drugs for the Purpose of Examination, Test and Analysis of Vaccines :
- Procedure for Manufacture of Drugs for the Purpose of Examination, Test and Analysis of Vaccines
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- In order to obtain NOC from CDSCO for the manufacture of drugs for the purpose of examination, test and analysis for biological products (vaccines & r-DNA products), guidelines have been stated by the organization and any applicant applying for such NOC must follow the procedure as stated by the government through CDSCO.
- No person or firm shall conduct manufacture of drugs for the purpose examination, test and analysis of vaccines without obtaining prior license from the License Authority and NOC from CDSCO.
- NOC from CDSCO is a must requirement for any firm applying for the License for manufacturing drug for the purpose of examination, test and analysis of vaccines. No license can be issued unless a NOC is obtained.
- A firm has to simultaneously apply with CDSCO for such NOC when applying for license with the concerned State Licensing Authority (SLA) under whose jurisdiction the manufacturing site lies, to obtain form 29.
- Form 29 is the license issued by SLA to a firm for manufacture of drug for examination, test and analysis of vaccines for which NOC from CDSCO is requisite.
- For the purpose of procuring NOC from CDSCO a firm is required to apply for issuance of NOC to CDSCO Head Quarters as well as concerned CDSCO Zonal Office along with requisite documents and undertaking.
- It ought to be applied by hard copy as well as soft copy
- Soft copy of requisite documents with undertaking and application must be sent to these zonal and head quarter via e-mail and hard copy to head quarter and concerned zonal/sub zonal offices.
It's three Easy Steps Process
- Connect with team Corpseed to discuss specific requirements for your business, most of our customers take 20 to 25 minutes to discuss their business needs and get instant solutions
- Once you discuss the requirement we will align a dedicated Account Manager to assist you with the entire process of getting license for manufacture of drugs for the purpose of examination, test and analysis of vaccines
- Once job is completed you will receive License Copy directly to your email ID and and at your door-step.
Documents Required to Obtain an NOC From CDSCO for Manufacture of Drugs for the Purpose of Examination, Test and Analysis of Vaccines :
- Covering Letter clearly mentioning the purpose of test license for Development/Preclinical studies/Clinical studies
- Name of Drug/Drugs
- Source of MSL/WSL with their Biosafety Level requirement.
- Details of the proposed site: New/Existing
- Site plan for manufacture of proposed drug.
- List of existing drugs manufactured in the proposed facility (with their BSL requirements), if any.
- Details of the manufacturing license (with product permissions) for the proposed site, if any.
- Details of previous joint inspection of the proposed site
- Compliance status. (Proposed site shall also include details of particular manufacturing Blocks which was inspected earlier along with the name(s) and type of product(s) produced in this particular manufacturing Block)
- Process Flow
- List of equipment and testing facility
- If technology transfer, details thereof
- Name, qualification experience of personal responsible for manufacturing and testing of trial batches
- Undertaking by applicant. These documents must be submitted with the desired application for purpose of procuring NOC.
Procedure for Manufacture of Drugs for the Purpose of Examination, Test and Analysis of Vaccines
- After scrutiny of documents No Objection Certificate will be issued by this directorate within 07 working day. If NOC is not issued within 07 working days, NOC will be deemed to be granted by the Central Drug Standard Control organization.
- State Licensing Authority (SLA) would issue the form 29 only after NOC and within 03 days working days from the date of receipt of NOC from CDSCO-HQ. It is only possible for a firm to continue with the process of obtaining license by way of form 29 after NOC from CDSCO.
- Such process includes joint inspection conducted based on risk based approach as per the criteria if the seed/strain falls under BSL III & IV or BSL I & II.
- All the information about the BSL of the microorganism/strains with supporting documents shall be submitted with the application.
- If seed/strain falls under BSL I & II, joint inspection may not be required, if manufacturing facility has already jointly inspected earlier. But it is mandatory to conduct inspection for all new facilities which have never been licensed/incorporated.
- NOC can be suspended/cancelled if a firm does not submit the Corrective and Preventive action along with documents within 30 days to CDSCO, HQ for review. And in case of unsatisfactory reply/compliance, form 29/NOC so granted may be cancelled/suspended.
- Targeted time line for grant of vaccine manufacturing license are set to be 30 working days from the date of submission of the application for scrutiny of the documents.
- If any deficiencies are found in the documents, notice of compliance are forwarded with tentative inspection date to the firm as well as State Licensing Authority and after conformation of date, inspection must be done.
- To conclude NOC from CDSCO is a must document required for a firm applying for the license to manufacture drug for the purpose of examination, test and analysis of vaccines.
- To procure such desired NOC, a firm must send all the required documents with undertaking to CDSCO, HQ and Zonal/Sub Zonal Office by way of hard copy as well as soft copy. Procedure for procuring NOC is not that difficult but must be done extreme caution as after scrutiny of documents CDSCO hold the right to reject any application and without such desired NOC it is impossible for a firm to procure License in form 29 from State Licensing Authority.
This portion of the site is for informational purposes only. The content is not legal advice. The statements and opinions are the expression of author, not corpseed, and have not been evaluated by corpseed for accuracy, completeness, or changes in the law.
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