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 has been exploring the possibility of introducing a voluntary product certification scheme for selected AYUSH products to enhance consumer confidence. The matter was discussed in a series of meetings taken by the Secretary (AYUSH) beginning 24 Dec 2008 and the Quality Council of India (QCI) offered to develop a concept paper on the subject.
The Scheme is based on a criteria for certification. It has two levels:
a. Ayush Standard Mark which is based on compliance to the domestic regulatory requirements
b. Ayush Premium Mark which is based on GMP requirements based on WHO Guidelines and product requirements with flexibility to certify against any overseas regulation provided these are stricter than the former criteria.
Under this scheme, each manufacturing unit would obtain a certification from a approved certification body (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.
STEP I Planning for Product Certification
STEP II Preparation
STEP III Self assessment
STEP IV Select a Certification Body
STEP V Registration and Evaluation by a Certification Body
STEP VI Follow up and Corrective actions
STEP VII Certification decision
STEP VIII Issue of a Certificate by Certification Body
STEP IX Agreement for usage of Ayush Certification Mark(s)
STEP X Maintaining Certification
Using the Ayush Certification Mark(s)
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