Survey and Case Study of Traditional Herbs of Jalgaon District and Regulatory Aspects of Herbal Formulations as Per D and C Act

Abstract

The present study focuses on a survey and case study of traditional medicinal herbs used in Jalgaon District, Maharashtra, and examines the regulatory aspects of herbal formulations under the Drugs and Cosmetics Act, 1940. Jalgaon district is rich in biodiversity and traditional knowledge, where local communities extensively use herbal plants for primary healthcare. Common medicinal plants such as Azadirachta indica (Neem), Ocimum sanctum (Tulsi), Withania somnifera (Ashwagandha), and Aloe vera are traditionally used for treating infections, inflammation, stress, and skin disorders, reflecting the deep-rooted ethnomedicinal practices of the region. The study also highlights the regulatory framework governing herbal formulations in India. Herbal medicines are regulated under the Ayurveda, Unani, and Siddha (ASU) systems by the Ministry of AYUSH. The Drugs and Cosmetics Act, 1940 and Rules, 1945 provide guidelines for licensing, manufacturing, labelling, quality control, and marketing of herbal drugs. As per Schedule T of the Act, manufacturers must comply with Good Manufacturing Practices (GMP) to ensure quality and safety. Herbal formulations are categorized into classical formulations based on authoritative Ayurvedic texts, and patent or proprietary medicines, which require scientific validation and regulatory approval. Furthermore, the Act enforces standards for raw materials, mandates proper labelling, and ensures safety and efficacy through regulatory monitoring. This study emphasizes the importance of integrating traditional herbal knowledge with modern scientific validation and regulatory compliance to promote safe, effective, and standardized herbal medicines. It also highlights the need for documentation and conservation of medicinal plants in Jalgaon district.

Introduction

It highlights that tribal and rural communities commonly use medicinal plants such as neem, tulsi, aloe vera, and shatavari to treat everyday ailments. These remedies are prepared in various forms like powders, decoctions, and pastes. With rising global demand for herbal medicine, concerns about safety, quality, and efficacy have increased, making regulation essential.

In India, herbal drugs (including Ayurveda, Siddha, and Unani systems) are regulated under the Drugs and Cosmetics Act, 1940 and Rules, 1945, with guidelines for manufacturing, licensing, labeling, and Good Manufacturing Practices (GMP). Authorities like CDSCO and the Ministry of AYUSH oversee compliance. WHO guidelines also support standardization, safety, and scientific validation.

The text further explains classifications of herbal drugs, quality control measures, labeling requirements, and rules for import/export. It also identifies key challenges such as lack of standardization, adulteration, weak scientific validation, and regulatory complexity, while noting recent improvements like stricter GMP enforcement and initiatives such as AYUSH Mark.

Conclusion

The study highlights Jalgaon district’s rich traditional knowledge of medicinal herbs like Neem, Tulsi, Ashwagandha, and Aloe vera, which play a key role in primary healthcare. Despite widespread use, scientific validation, standardization, and proper documentation are needed to ensure safety and efficacy. Regulatory frameworks under the Drugs and Cosmetics Act and the Ministry of AYUSH support quality control and global acceptability. Integrating traditional knowledge with modern research, regulatory enforcement, and conservation efforts will promote sustainable use and wider acceptance of herbal medicine.

References

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Copyright

Copyright © 2026 Sanjana Tandekar, Mubeen Ahmad Mohammad Aarif, Ishak khan Saudagar, Jayash Choudhary. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.