Government strengthens quality assurance framework for AYUSH products sold online

NEW DELHI: The Government has strengthened the quality assurance and regulatory framework for AYUSH products, including those sold through digital commerce platforms, by introducing stricter certification, enhanced surveillance and consumer protection measures.

In a written reply in the Rajya Sabha, Union Minister of State (Independent Charge) for AYUSH Prataprao Jadhav said the Government has implemented multiple initiatives to ensure the safety, quality and regulatory compliance of Ayurvedic, Siddha, Sowa-Rigpa, Unani and Homoeopathy (ASSU&H) medicines.

Under the Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945, manufacturers of AYUSH medicines are required to obtain manufacturing licences, demonstrate safety and effectiveness, comply with prescribed Good Manufacturing Practices (GMP), and adhere to quality standards specified in the respective pharmacopoeias.

Drug Inspectors in States and Union Territories regularly collect medicine samples from manufacturing units and retail outlets for laboratory testing. If products are found to be “Not of Standard Quality”, authorities initiate legal action and prevent their sale in the market.

To further strengthen regulation, an AYUSH vertical has been established within the Central Drugs Standard Control Organization (CDSCO). The organisation also issues the World Health Organization Certificate of Pharmaceutical Product (WHO-CoPP) to AYUSH medicines that meet global quality standards. Joint inspections involving CDSCO and State drug inspectors are conducted regularly to ensure compliance with safety and quality norms.

The Government is also implementing a Quality Certification Scheme through the Quality Council of India, which awards the AYUSH Standard and AYUSH Premium marks to eligible products following independent third-party evaluation against domestic and international quality benchmarks.

To promote standardisation and strengthen manufacturing infrastructure, the Ministry of AYUSH is implementing the Central Sector Scheme, Ayush Oushadhi Gunavatta Evam Uttpadan Samvardhan Yojana (AOGUSY). The scheme provides financial support to government and private manufacturers, including MSMEs, for upgrading AYUSH pharmacies and drug testing laboratories to achieve higher standards such as WHO-GMP certification and NABL accreditation.

The scheme also supports a nationwide pharmacovigilance network comprising one National Pharmacovigilance Coordination Centre, five Intermediary Pharmacovigilance Centres and 97 Peripheral Pharmacovigilance Centres to monitor adverse drug reactions and improve patient safety.

The Ministry has launched the AYUSH Suraksha Portal for real-time reporting of suspected adverse drug reactions and misleading advertisements. The National Pharmacovigilance Coordination Centre at the All India Institute of Ayurveda has also been designated as the nodal authority under the Information Technology Act, 2000, to issue notices to digital intermediaries regarding objectionable or misleading advertisements related to AYUSH medicines.

To strengthen consumer protection in online sales, the Central Consumer Protection Authority (CCPA) has advised e-commerce platforms to allow the sale of Ayurvedic, Siddha and Unani medicines containing ingredients listed under Schedule E(1) of the Drugs Rules only after customers upload a valid prescription issued by a registered practitioner of the respective system of medicine.

The Ministry has also introduced the AYUSH Quality Mark initiative through the AYUSH Export Promotion Council (AYUSHEXCIL). The certification is granted after verification of statutory approvals and recognised quality certifications such as GMP, WHO-GMP and AYUSH Premium Mark. The initiative aims to enhance consumer confidence, improve product credibility and strengthen the global competitiveness of Indian AYUSH products.

The Government is also promoting evidence-based information on AYUSH systems through official websites, social media platforms, public advisories, research publications, outreach programmes and awareness campaigns conducted by the Ministry’s research councils and national institutes.