Quality standards for herbal and homeopathy medicines in India

The department of Ayush under the health ministry has introduced a voluntary quality certification scheme to ensure efficacy of herbal products based on the Indian systems of medicines including ayurveda, unani, siddha as well as medicines belonging to homeopathy, reports said.

The Department of Ayush (Ayurveda, Unani, Siddha and homeopathy) will be issuing quality standard certificates for herbal and homeopathic medicines for domestic use and export puposes.

Ayush has two types of certification schemes for manufacturing units engaged in production of ayurveda, unani, siddha and homeopathic medicines.

The Ayush Standard Mark will be issued as certification for manufactureres who meet the domestic regulatory requirements. These companies can sell thier products within the country.

While the Ayush Premium Mark is meant for the units that export their products and are in compliance with manufacturing practices international regulatory agencies such as those set by WHO, European Commission, USA and other countries.

Each manufacturing unit would obtain a certification from an approved CB which is accredited to appropriate international standards by the National Accreditation Board for Certification Bodies (NABCB) and will be under regular surveillance of the certification body.

Ayush has roped in the Quality Council of India (QCI) as policy setting body for the purpose. Third party organisations will act as as certification bodies (CB) to carry out evaluation and issue certificate to the manufacturing units of Ayurveda, Unani, Siddha and homeopathy (Ayush) products.

QCI together with department of Ayush worked out the modalities of the certification scheme.

Hyderabad-based Foodcert India (P) Ltd and Mumbai-based Bureau Veritas Certification (India) Pvt Ltd have been chosen as the approved certification bodies under the scheme.

More such CBs will be approved in the coming days, sources said.

CBs will conduct evaluation of the desiring units and certify the products in consultation with the QCI. CBs will also continue stringent monitoring of the AYUSH manufacturing units further.

Currently, the Ayush products are regulated under the Drugs and Cosmetics Act, 1940 by the Drugs Controller General of India through the State Governments.

The Department of Ayush and QCI formally signed the agreement to design the scheme around two years ago.

QCI will host the secretariat and the scheme will be overseen by a Multistakeholder Steering Committee (MSC) chaired by the secretary of Ayush.

A Technical Committee and a Certification Committee constituted by QCI will supported MSC.