Mr. Baburao Vikram, M.S. Pharm.

Founder & Managing Director – Pharexcel Consulting Private Limited

 

Mr. Baburao Vikram holds a Master of Science in Pharmacology & Toxicology from the prestigious National Institute of Pharmaceutical Education and Research (NIPER), Mohali. With over 22 years of diverse experience in the pharmaceutical and healthcare sectors, he brings deep expertise in clinical research, regulatory affairs, and quality systems.

 

His professional background spans the following:

 

• Clinical trial projects – from design and monitoring to execution and reporting

• Pre-clinical and toxicology studies

• Real-world evidence (RWE) and late-phase programs

• Drug safety and pharmacovigilance

• Cosmetic and medical device regulatory support, including CE marking documentation and technical file development

• Regulatory strategy and documentation for DCGI, USFDA, and EU submissions

• Authoring PDE (Permitted Daily Exposure) reports

• Quality and compliance audits, including credentials as a Lead Auditor for ISO 9001:2015 and Internal Auditor for ISO 13485

 

 

As the Founder and Managing Director of Pharexcel Consulting Private Limited, Mr. Vikram leads a multidisciplinary team providing end-to-end regulatory, clinical, and scientific consulting services to pharmaceutical, biotech, cosmetics, and medical device companies globally.

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Selected Publications:

 

 

1. Efficacy and Safety of Neemint Capsules in Gastrointestinal Disorders

    

   • This open-label clinical trial assessed the effectiveness of Neemint capsules, a polyherbal formulation containing neem and peppermint oils, in treating gastrointestinal disorders, including irritable bowel syndrome (IBS). The study reported significant improvements in symptom scores and quality of life among participants. 

    

2. Virulina® in COVID-19 Treatment

    

   • In a double-blind, placebo-controlled, randomized clinical trial, Dr. Vikram and colleagues evaluated the efficacy and safety of Virulina®, an herbal formulation, alongside standard treatment protocols for mild to moderate COVID-19 patients. The study found that 93.33% of patients treated with Virulina® tested negative for the virus compared to 53.33% in the placebo group. 

    

3. BC Caps for Abnormal Vaginal Discharge

    

   • This open-label pilot study investigated the use of BC caps, a neem seed oil-based intravaginal capsule, in women experiencing abnormal vaginal discharge due to microbial infections. The study reported a 100% microbiological cure rate and significant symptom improvement among participants. 

    

4. Intravenous Line Organizer (IVO) Trial and Others

    

   • Mr. Vikram co-authored a randomized clinical trial evaluating the performance and safety of an Intravenous Line Organizer (IVO) in a tertiary care hospital setting. The study aimed to assess the device’s impact on intravenous line management and patient safety.