🏭 Siddha's Quality Leap: The Mandatory March to GMP Certification
Category: Integrative Healthcare |
🛡️ Introduction: Industry Present Situation
With growing demand nationally and internationally for herbal and traditional medicines, [translate:Siddha] is positioned as a unique, time-tested system from India. [translate:Good Manufacturing Practice] (GMP) is a set of minimum standards ensuring consistent quality and control for drug production, mandated under Schedule T of the Drugs & Cosmetics Rules, 1945.
Compliance with GMP is mandatory for all Ayurvedic, Siddha, and Unani drug manufacturers for sale, while practitioners making medicines for personal patients are mostly exempt. The industry is formalizing, with small and traditional units facing infrastructure and cost challenges. The government actively promotes certification and quality upgrades.
🔬 Trend and Scope of Siddha Research and Medical Colleges
GMP focus drives research toward standardization, pharmacognosy, and chemical analysis to ensure purity and contamination-free raw materials. Research validates [translate:Suddhi] (purification) processes and safety of [translate:Rasa] (herbo-mineral) drugs, essential for compliance.
Siddha medical colleges play a dual role: training qualified technical staff and supporting QC through labs or partnerships, assisting smaller producers in GMP compliance.
✅ Current and Future Opportunities
GMP certification, especially WHO-GMP/CoPP, opens export markets in culturally relevant regions like Southeast Asia and the Middle East. The e-Aushadhi platform simplifies licensing with perpetual licenses renewed every five years given GMP validation.
Technological upgrades including HPLC/GC analysis and automation provide scale and quality consistency. Pharmaceutical clusters with shared testing and effluent treatment can reduce costs for small units.
🤝 Government and CSR Support
The AYUSH Oushadhi Gunvatta Evam Uttpadan Samvardhan Yojana (AOGUSY) scheme offers financial support for pharmacy modernization and drug testing facilities. Regulatory strengthening and skilled human resource training are ongoing. CSR can fund infrastructure, SOP development, and technical consultancy for MSMEs.
🔬 Case Study: Small-Scale Unit Transition
A family-run Siddha unit overcame space and setup constraints with state grants and investments in modular facilities and professional staffing. They implemented rigorous documentation and quality protocols, passing audits for GMP certification. This enabled market expansion including government contracts.
🏭 Key GMP Requirements for Siddha Units (Schedule T)
- Infrastructure: Separate areas for raw materials, manufacturing, packaging, QC; minimum 150 sq.ft QC lab.
- Personnel: Qualified staff including chemists, botanists, and Siddha graduates oversee production and QC.
- Documentation: SOPs and Batch Manufacturing Records (BMRs) track every production step and test.
- Hygiene & Equipment: Proper sanitation and calibrated equipment designed for contamination control.
⭐ Conclusion
Adhering to GMP regulations via Schedule T is crucial for Siddha medicines’ credibility, safety, and growth. Supported by government schemes and technology, GMP-certified units will elevate Siddha as a globally trusted pharmaceutical system, delivering its ancient wisdom with scientific rigor and integrity.