Abstract
REGULATORY AND BUSINESS ASPECTS OF NEW HERBAL DRUG DEVELOPMENT IN INDIA: A CASE STUDY ON ANTIOXIDANTS FOR PAIN MANAGEMENT
Anju Verma1, Shreya Gupta1, Snigdha Rathour1, Pankaj Kumar Sonar2*
1. Department of Pharmaceutical Sciences and Technology, Madan Mohan Malaviya University of Technology, Gorakhpur-273016, Uttar Pradesh, India
2. Government Pharmacy College, B.R.D. Medical College Campus, Gorakhpur-273013, Uttar Pradesh, India
Abstract
Herbal and Ayurvedic medicines, deeply rooted in India’s traditional healthcare systems, are increasingly recognized worldwide as safer and cost-effective alternatives to synthetic drugs. Chronic pain affects nearly 30% of the global adult population, posing significant health and economic challenges. This study evaluates the regulatory framework, therapeutic potential, and market barriers associated with herbal medicines for pain management in India. A comprehensive review of literature from the Drugs and Cosmetics Act, 1940, Ministry of AYUSH, Central Drugs Standard Control Organization (CDSCO), World Health Organization (WHO), and European Medicines Agency (EMA) was conducted. Additionally, stakeholder interviews, consumer surveys, and selected case studies were analyzed to assess regulatory compliance and market readiness. Findings indicate that bioactive compounds such as curcumin and boswellic acids possess strong antioxidant and anti-inflammatory properties, making them effective for chronic pain management with improved safety profiles. However, challenges including inadequate Good Manufacturing Practice (GMP) compliance, limited standardization, and weak regulatory enforcement persist. To enhance global competitiveness, streamlined regulations, strengthened quality control, increased research investment, and international market expansion are recommended. Integrating traditional knowledge with scientific validation is essential for positioning India as a global leader in herbal therapeutics.
Keyword: Herbal drugs, Antioxidants, Pain management, Ayurveda, Regulatory framework, Market analysis, Consumer preferences
Article Information
| Article Type |
Research Article |
| Journal Name |
Global Journal of Pharmaceutical and Scientific Research
|
| ISSN |
3108-0103 |
| Volume |
Volume-2 |
| Issue |
Issue-1, January-2026 |
| Corresponding Author |
Anju Verma1, Shreya Gupta1, Snigdha Rathour1, Pankaj Kumar Sonar2* |
| Address |
1. Department of Pharmaceutical Sciences and Technology, Madan Mohan Malaviya University of Technology, Gorakhpur-273016, Uttar Pradesh, India
2. Government Pharmacy College, B.R.D. Medical College Campus, Gorakhpur-273013, Uttar Pradesh, India |
| Received |
24 Dec, 2025 |
| Revised |
15 Jan, 2026 |
| Accepted |
28 Jan, 2026 |
| Published |
31 Jan, 2026 |
| Pages |
26-37 |