CDL Demands Post-Approval For Changes In Human Vaccines

Summary: Post approval of vaccines has been made mandatory for manufacturers/importers of drugs to ensure proper compliance with medical device regulation in India.

As viruses and diseases have started to evolve, the drugs and medicines used to counter them also require certain changes to tackle this effect. Such changes will now require a post-approval from Central Drug Laboratory, Kasauli. 

It involves offering data for supporting any change which could be considered enough to facilitate a determination of the effect of the change on the quality of the approved vaccine. As it mainly relates to the safety and effective use of the product. Once the changes are approved, the applicant can apply all such approved changes to the vaccine. However, these changes must also be reported to CDSCO under the required categories.

As per the new obligation, it is compulsory to file a new vaccine manufacturing license in case of any changes made after obtaining the approval for a vaccine from CDSCO.

As per the latest guidance that is issued by the drug regulator, every applicant of a vaccine who makes some alteration after the approval process must apply for new drug authorization. If in case this alteration makes the product a novel drug according to the definition under the rule 122E of the Drugs and Cosmetics Rules.

If there is any change made to the manufacturing place, the license holder should apply for extra product permission to the respective state licensing authorities along with the zonal offices and the sub zonal offices. They are also required to apply for permission from the Central Licensing Approval Authority as per the rules set by the Drug & Cosmetics Act and respective rules.

The applicants must also file for an additional manufacturing license for any moderate changes by giving a clear statement of all alteration about every procedural, quantitative and qualitative alteration in a tabular form.

Along with all this, the applicants are also responsible for submitting clear statements and proofs on how the alterations will affect the quality, validation, animal toxicity, stability along with the safety and efficiency of the product.

These upgrades for post-approval will enhance the credibility of the approval process and help the authorities keep a tab on any unnecessary modifications to drugs. Moreover, this will also ensure that consumers receive properly tested and high quality vaccines which will be absolutely free from any adulteration or false-effects.