Guidance For Industry For Post-Approval Changes In Biological Products Quality Safety And Efficacy Documents

The Central Drugs Standard control organization, or CDSCO, has modified its guidance for the industry for post-approval changes in biological products quality safety and efficacy documents. It has eliminated the provisions of the automatic approval of all post-approval changes, thereby making it mandatory for all companies to file for fresh new drug or manufacturing licenses for all products with the regulator.

As per the recent guidance issued by the drug regulator under the Drugs and Cosmetics Act, all the applicants for biological products who make any change in their development after approval must apply for new drug permission if in case there are any changes as per rule 2 (w) of New Drugs and Clinical Trial Rules, 2019.

For any change in the manufacturing, premises must get approval for an already approved product, the respective licensee should apply for the extra product permission to the individual state licensing authorities along with the zonal office and the sub-zonal office. In addition, the licensee has to use central licensing approval authority according to the requirements by Drugs & Cosmetic Act and rules along with all required fees in a usual process.

In earlier times, when an applicant report changes post-approval, can consider the application for alteration was accepted by the Drug Controller General of India and is in compliance with regulatory process for import and export of drugs in India. When the regulator has not spoken out within 30 days after submission of application in case of some significant changes in quality and 15 days post quality changes.

As per the earlier guidance, the level -1 supplements are known as changes that have some of the substantial potential to have some adverse effects on the identity, quality, potency, and strength of the biological product as all these factors might relate to safety the effectiveness of the product. Level –II notifiable changes are those changes that have a modest potential to have a contrary effect on already stated characteristics of the biological product.

The companies have to apply for change with the support of complete documentation according to the earlier document. Because of the amendment, the previous provision has been omitted entirely, making it mandatory for all applicants to file for new drug applications if there are any quality changes and for filings like a different manufacturing license for some moderate quality changes. The applicant has to file for an additional manufacture license for some changes with a clear statement of change about the procedural, quantitative and qualitative changes in comparative table form.

In the same manner, the applicants have to submit clear statements and proof about all effects of all changes on quality, validation, animal toxicity, and the clinical status of the product. Suppose there is any need for a waiver in physiological characterization studies, validation studies, clinical studies, and pre-clinical studies. It will be justified precisely that proves the equivalence and clarifies the amended guideline.