Principal Investigator Must Be Psychiatry-Trained, MADRS-Certified: CDSCO Panel Asks Exemed to Revise Bupropion-Dextromethorphan PMS Study
New Delhi: After reviewing the active post-marketing surveillance (PMS) protocol for Bupropion Hydrochloride (As Extended Release) IP 105 mg plus Dextromethorphan Hydrobromide IP 45 mg film-coated bilayer tablet, the Subject Expert Committee (SEC) functioning under the Central Drugs Standard Control Organisation (CDSCO) has opined to Exemed Pharmaceuticals that the principal investigator must be trained in psychiatry.
Further, it added that all the PIs/raters should be trained and certified to use MADRS (Montgomery–Åsberg Depression Rating Scale) for this study.
This came after Exemed Pharmaceuticals presented the Active PMS protocol before the committee, as per the condition mentioned in Form CT-23 dated 16.05.2024.
The drug combination Bupropion and Dextromethorphan is a medication used to treat Major Depressive Disorder (MDD) in adults.
Dextromethorphan hydrobromide can block specific signals in the brain that are often overactive in people with depression. By doing this, it may help calm the brain down and improve mood. It also activates certain brain receptors that help regulate mood and protect the brain. This can help balance the chemicals in your brain that affect how you feel. Bupropion increases the levels of certain chemicals in the brain, specifically dopamine and norepinephrine. These chemicals are involved in mood regulation, and by increasing their levels, bupropion can help improve mood and feelings of well-being.
At the recent SEC meeting for neurology and psychiatry, the expert panel reviewed the active post-marketing surveillance (PMS) protocol for Bupropion Hydrochloride (As Extended Release) IP 105 mg plus Dextromethorphan Hydrobromide IP 45 mg film-coated bilayer tablet.
After detailed deliberation, the committee opined that:
1. The principal investigator must be trained in psychiatry.
2. All the PIs/raters should be trained and certified to use MADRS for this study.
Accordingly, the expert panel suggested that the revised Active PMS protocol should be submitted to CDSCO for review. Further, after approval from CDSCO the firm should submit an Active PMS report for further review by the committee.
