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.
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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.
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.
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