CDSCO panel asks Hetero to resubmit Bioequivalence protocol for Trelagliptin Succinate tablet

Published On 2020-12-30 13:42 GMT   |   Update On 2020-12-30 13:42 GMT
Advertisement

New Delhi: Noting that the protocol was not scientifically designed and the safety of the study subjects was not taken care of, the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) has directed Hetero to submit a well-designed Bioequivalence (BE) protocol for Trelagliptin Succinate tablet to CDSCO for further review by the panel.

This came after the drugmaker presented the proposal for Trelagliptin Succinate 50/100 mg tablet along with the BE protocol before the committee. BE or Bioequivalence of a drug product is achieved if its extent and rate of absorption are not statistically significantly different from those of the reference product when administered at the same molar dose.

The said formulation, Trelaliptin Succinate is a potent, orally active, and highly selective DPP-4 inhibitor. It helps in controlling the blood glucose levels. It works by inhibiting DPP-4 selectively and continually. DPP-4 is an enzyme responsible for inactivating the glucagon-like peptide-1 and glucagon-dependent insulinotropic polypeptide. This way, it helps in regulating blood glucose.

The CDSCO Committee, during its 72nd meeting held on 16.12.2020, thoroughly examined all the proposals related to Endocrinology and Metabolism and made some recommendations as well. They minutely scrutinized the proposal regarding the Trelapliptin Succinate tablets made by Hetero.

While reviewing the proposal made by the firm, the committee observed that the proposal lacked proper scientific design. It opined that the firm should make a resubmission regarding the matter with a well-designed protocol. It noted;

"The committee noted that the protocol was not scientifically designed and the safety of the study subjects was not taken care of and therefore protocol presented by the firm was not acceptable in the present form."

After detailed deliberation, the committee recommended that the firm should submit a well-designed protocol to CDSCO for further review by the committee.

Hetero has a presence in over 126 countries and is engaged in the development, manufacturing, and marketing of high-quality Chemical and Biologic Drugs across diverse therapeutic areas with 36 manufacturing facilities located worldwide.

Read also: CDSCO Mandates License For Import, Manufacture Of Nebulizers, BP Monitoring Devices, Digital Thermometers, Glucometer

Tags:    

Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.

NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.

Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .

Similar News