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CDSCO Eases Regulations For Bioavailability And Bioequivalence Studies Due To Covid-19 Outbreak

CDSCO or Central Drugs Standard Control Organization has clarified that validity of registration of BA/BE study centers will remain valid if the renewal application has been made 90 days before the expiry. The registration will remain in force till the further order has been passed by the required authority.

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CDSCO Eases Regulations For Bioavailability And Bioequivalence Studies Due To Covid-19 Outbreak

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  1. CDSCO Eases Regulations For Bioavailability And Bioequivalence Studies Due To Covid-19 Outbreak Bioavailability and Bioequivalence studies are done in a healthy human volunteer in a study center. This study center needs a clinical pharmacology unit along with a Bio analytical laboratory that is approved by CDSCO as per schedule, Indian GCP, Li of Drugs. At present approval for Bioavailability and Bioequivalence studies is offered by CDSCO after proper inspection for about one year. Then after completion of one year again the approval is renewed after proper assessment of enactment by doing a site inspection. All BA/BE centers have been directed and registered under Rule 44 of NDCT rules 2019 for conductance of BA/BE study of novel drugs in the country. Before these recent changes, the approval for conducting these studies was granted for a period of three years. Rather than an yearly inspection. But because of the ongoing pandemic COVID-19 outbreak and DCGI receiving several representations stakeholders asking to extend the registration validity of the from several Contact No: +91 7672005050 Email: contact@cliniexperts.com

  2. BA/BE study centers. It was needed specifically for those whose registration validity was getting over by August 2020. So, CDSCO or Central Drugs Standard Control Organization has clarified that validity of registration of BA/BE study centers will remain valid if the renewal application has been made 90 days before the expiry. The registration will remain in force till the further order has been passed by the required authority. For facilitating the ease of business, in agreement with the Ministry of Health and Family Welfare and required consultation with all stakeholders, it was decided that the validity period of the BA/BE study center along with the Bio analytical laboratory will be extended from at least one year to about three years. But the following conditions have to be satisfied: Contact No: +91 7672005050 Email: contact@cliniexperts.com

  3. ●There will be periodic supervision audits on the site. ●All important changes made in the site during the time the registration is valid must be informed to CDSCO. ●The complete report of the Audit of WHO/ international regulatory authority must be submitted to CDSCO after obtaining reports. BA/BE study center must apply for renewal 4 months before the expiry of the approval. Contact No: +91 7672005050 Email: contact@cliniexperts.com

  4. As per the circular by CDSCO for extension of validity of BA/BE study centers the renewal application must be applied in Form CT-08 along with required fees as well as documents and the registration will remain valid till any further notice is issued. CDSCO has also requested all these centers for submission of stability studies data according to NDCT rules 2019. Go to read more information:Drug License Registration Process Contact No: +91 7672005050 Email: contact@cliniexperts.com

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