CDSCO Releases Regulatory Guidance For Post-Approval Changes In Biological Products

The post-approval changes are those changes that are made to the biological products that have already obtained approval. It also offers necessary data supporting a change that could be considered sufficient to determine the effect of the change on the overall quality of the approved product because it related to the safe, efficient and proper use of all biological products. Once the product is approved and the applicant wants to make some changes, he/she can do it but with prior notification of all changes to CDSCO under required categories. According to the new amendment done by Central Drugs Standard Control Organization or CDSCO, it is compulsory to file for a new biological or manufacturing license for all-natural products if there are any post-approval alterations. The CDSCO should be intimated if there is any chance for the biologicals, no matter how small the change is. Recent regulatory guidance was published by the drug regulator where the applicants of all biological products who make an alteration in their development after getting approval must apply for a novel drug authorization. This is if the alteration made makes the product a novel drug according to the definition under the Drugs and Cosmetics Act and Rules made thereunder. Suppose there is a change in the manufacturing unit. In that case, the licensee will have to apply for extra product permission to the required state licensing authorities along with the zonal offices and sub-zonal offices and the central licensing approval authority. It is according to the Drugs and Cosmetics Act and Rules requirement in addition to the required fees as per daily procedures. All of the applicants must file for a new biological application if there are significant quality changes. Furthermore, one has to file for an additional manufacturing license for modest-quality changes with strong alteration statements about the quantitative, procedural, and qualitative alterations in a comparative table format. Similarly, the applicants should also submit formal statements and proofs about the impact of the change of quality, stability, animal toxicity, validation, and clinical status of the product. Suppose any waiver is expected or is assumed in any kind of physicochemical characterization studies, validation studies, and stability studies, along with pre-clinical and clinical studies. In that case, it must be acceptable most precisely that proves the equivalence. It is clarified in the amended guidelines.