Delhi: The Government of India has taken several measures to strengthen the quality assurance, regulatory compliance and consumer safety framework for AYUSH products, including medicines sold through digital commerce platforms.
The initiatives focus on ensuring that Ayurvedic, Siddha, Sowa-Rigpa, Unani and Homoeopathic (ASU&H) drugs meet prescribed safety and quality standards before reaching consumers.
The information was provided by Union Minister of State (Independent Charge) for Ayush, Prataprao Jadhav, in a written reply in the Rajya Sabha.
AYUSH Drugs Regulated Under Drugs and Cosmetics Act
AYUSH medicines are regulated under the Drugs & Cosmetics Act, 1940 and Drugs Rules, 1945, which contain specific provisions for Ayurvedic, Siddha, Sowa-Rigpa, Unani and Homoeopathic drugs.
Manufacturers are required to comply with several mandatory conditions, including:
- Obtaining a valid licence for manufacturing drugs for sale.
- Providing proof of safety and effectiveness.
- Following Good Manufacturing Practices (GMP).
- Meeting quality standards prescribed in respective pharmacopoeias.
For Ayurvedic, Siddha, Sowa-Rigpa and Unani medicines, manufacturers must comply with GMP requirements under Schedule T, while Homeopathic drug manufacturers must follow standards under Schedule M-I of the Drugs Rules, 1945.
Regular Testing and Action Against Substandard AYUSH Medicines
Drug Inspectors appointed by state and Union Territory authorities regularly collect samples of AYUSH medicines from manufacturing units and retail outlets.
These samples are sent to authorised Drug Testing Laboratories for quality checks.
If any medicine is found to be “Not of Standard Quality”, authorities take necessary action, including:
- Stopping the sale of the product.
- Removing non-compliant medicines from the market.
- Initiating legal action under the Drugs and Cosmetics Act and related rules.
AYUSH Regulatory Wing Created Under CDSCO
To strengthen monitoring and regulatory systems, an AYUSH vertical has been established within the Central Drugs Standard Control Organization (CDSCO).
The initiative aims to improve oversight of AYUSH medicines and ensure compliance with safety and quality requirements.
The CDSCO also issues WHO Certificate of Pharmaceutical Product (WHO-CoPP) to AYUSH medicines that comply with global quality standards.
Drug inspectors working under the AYUSH vertical conduct joint inspections of manufacturing facilities along with state and Union Territory drug authorities to verify compliance.
AYUSH Standard and Premium Quality Marks Through QCI
The Government has implemented a quality certification system through the Quality Council of India (QCI) for AYUSH medicines.
Under this scheme, manufacturers can receive:
- AYUSH Standard Mark – Based on compliance with domestic quality standards.
- AYUSH Premium Mark – Based on compliance with international quality requirements.
The certification process involves third-party evaluation of product quality and manufacturing practices.
AOGUSY Scheme Supports Quality Manufacturing and Testing
The Ministry of Ayush is implementing the Central Sector Scheme Ayush Oushadhi Gunavatta Evam Uttpadan Samvardhan Yojana (AOGUSY) to improve the overall AYUSH drug ecosystem.
The scheme focuses on:
- Standardisation of AYUSH medicines.
- Quality manufacturing practices.
- Analytical testing facilities.
- Strengthening regulatory systems.
- Safety monitoring.
- Controlling misleading advertisements.
Under AOGUSY, financial support is provided to government and private AYUSH manufacturers, including MSMEs, for upgrading:
- AYUSH pharmacies to achieve higher standards such as WHO-GMP.
- Drug Testing Laboratories to meet NABL accreditation standards.
Pharmacovigilance Network Monitors AYUSH Drug Safety
The Pharmacovigilance Programme for ASU&H drugs operates under the AOGUSY scheme through a nationwide three-tier network.
The network includes:
- 1 National Pharmacovigilance Coordination Centre (NPvCC)
- 5 Intermediary Pharmacovigilance Centres (IPvCs)
- 97 Peripheral Pharmacovigilance Centres (PPvCs)
The system monitors suspected adverse drug reactions and ensures better safety surveillance of AYUSH medicines.
Ayush Suraksha Portal Tracks Misleading Advertisements and Drug Reactions
The Ministry of Ayush has launched the Ayush Suraksha Portal for real-time reporting and monitoring of:
- Misleading advertisements related to AYUSH products.
- Suspected adverse drug reactions.
The Coordinator of the National Pharmacovigilance Coordination Centre at the All India Institute of Ayurveda has also been appointed as the nodal officer under the Information Technology Act, 2000.
The officer can issue notices to digital platforms regarding misleading or objectionable AYUSH drug advertisements.
E-Commerce Platforms Advised to Follow Prescription Rules
The Central Consumer Protection Authority (CCPA) has issued an advisory to e-commerce companies regarding the online sale of Ayurvedic, Siddha and Unani medicines containing ingredients listed under Schedule E(1) of the Drugs Rules, 1945.
E-commerce platforms have been advised to allow the sale of such medicines only after users upload a valid prescription from a registered:
- Ayurveda practitioner
- Siddha medical practitioner
- Unani medical practitioner
This step aims to improve consumer protection in online medicine sales.
Ayush Quality Mark Initiative to Boost Consumer Trust and Global Competitiveness
The Ministry of Ayush has launched the Ayush Quality Mark (AQM) initiative through the Ayush Export Promotion Council (AYUSHEXCIL).
Under this framework, AYUSH products receive quality certification after verification of valid approvals and certifications issued by authorised government agencies.
These include:
- GMP certification
- WHO-GMP certification
- AYUSH Premium Mark
- Other recognised quality certifications
The initiative aims to:
- Increase consumer confidence.
- Improve quality assurance.
- Enhance the credibility of Indian AYUSH products.
- Strengthen global competitiveness of AYUSH exports.
Government Promotes Verified Information About AYUSH Products
The Ministry of Ayush is also working to spread verified and evidence-based information about AYUSH systems and products.
Information is shared through:
- Official advisories
- Websites
- Social media platforms
- Public notices
- Research publications
- Journals
- Awareness programmes
- Print and electronic media
Research councils and national institutes under the Ministry of Ayush conduct Information, Education and Communication (IEC) activities to promote awareness about safe and effective use of AYUSH products.
India Builds Stronger Digital and Regulatory Framework for AYUSH Sector
Through stricter regulation, quality certification, digital monitoring and consumer awareness initiatives, the government aims to create a reliable ecosystem for AYUSH medicines.
The measures are expected to improve safety standards, strengthen public confidence and support the growth of India’s traditional medicine sector in both domestic and international markets.
