VOLUNTARY CERTIFICATION SCHEME FOR AYUSH PRODUCTS
Quality Council of India has been engaged for voluntary certification of quality of Ayurveda Siddha Unani (ASU) products. Through this scheme drug manufacturers are awarded quality seal to the products on the basis of third party evaluation of the quality, subject to fulfillment of the regulatory requirements. AYUSH Standard and AYUSH Premium Marks are awarded for products moving in domestic and international market respectively.
SCOPE OF CERTIFICATION
- Ayush Standard Mark which is based on compliance to the domestic regulatory requirements;
- Domestic regulation means regulatory requirements prescribed under the Drugs and Cosmetics Act, 1940 for AYUSH products.
- Contaminants for AYUSH Standard Mark should be within Permissible levels.
- Ayush Premium Mark which is based on either or both of the following options;
- Compliance to GMP Requirements based on WHO Guidelines and Levels of contaminants as given in Certification Criteria document.
- Compliance to regulatory requirements of any importing country provided they are more stringent than Option above.
Note
- The requirements of heavy metals shall not be applicable to Ayush products having raw materials of metallic origin provided they are intended for domestic market.
- For the time being this certification is available for Herbal products only.
CERTIFICATION CRITERIA
- For any manufacturer to qualify for Ayush Premium Mark certification, compliance to the domestic regulation and having in-house testing facilities is a prerequisite.
- The elements of the Certification process are:
- Evaluation of the manufacturing facility for manufacturing and hygiene processes and capability to manufacture Ayush products of a desired quality on a continuous basis.
- Evaluation of the quality of the Ayush product(s) for compliance to relevant certification criteria through testing of products sampled from the manufacturing facility and the market or any other source.
3. The Scheme is open to all manufacturing organizations that are legal entities in India.
4. The Department of Ayush itself is not involved in the certification of Ayush products. It is the owner of the Certification Scheme, Certification Criteria and the Certification Mark(s). Certification is operated by independent product certification bodies duly accredited by NABCB and/or recommended by QCI.
5. The process by which a manufacturing organization gains and maintains certification is summarized in the document “Steps for obtaining Certification for Ayush Products”.
6. The certification to the above mentioned criteria shall be carried out by the CBs duly accredited for the certification scheme as per ISO/IEC Guide 65, by NABCB and/or recommended by QCI.
CERTIFICATION PROCESS
- Registration of Application :- The prospective applicant organization manufacturing Ayush products shall apply to the Certification Body on the Application format prescribed by the CB, and provide as a minimum information on the name and address of applicant with contact details, proof of legal entity, location of manufacturing unit, products being manufactured, products and dosage form for which certification is being sought, relevant certification criteria against which certification is being sought, description of production processes, own installed/existing manufacturing and testing facilities, number and competence of manpower, and accessibility to external testing facilities, if required. The prospective applicant must confirm that the production facility has been in production for at least one year, and that five commercial batches of the products of dosage form for which certification is being sought, have been manufactured during the current licensed period.
Only applications found to be completely filled and supported with all documents sought shall be accepted. Registration shall be done within seven days of receipt of application or deficiencies communicated if observed.
- Initial Evaluation: – Initial evaluation shall be carried out by a competent evaluation team in one stage for the Ayush Standard Mark and two stages for the Ayush Premium Mark.
In the initial evaluation for Ayush Standard Mark, the certification body shall list the applicable domestic regulatory requirements, verify compliance to the certification.
During the Stage 1 Evaluation for Ayush Premium Mark, the certification body shall list the applicable regulatory requirements, check the applicant’s compliance to these requirements on a sampling basis, status of GMPs, availability of competent personnel and adequate equipment for production and testing, availability of production and test records, the validation records.
During the Stage 2 Evaluation for Ayush Premium Mark certification body shall draw at least one sample of the product from one or more dosage forms for factory testing for establishing its capability to test, and sample at least 25% of the products offered within the dosage form for independent testing.
An internal quality assurance protocol for controlling the quality of the Ayush product(s) during various stages of production up to its despatch based on the general Internal Quality Assurance Protocol given under this scheme shall be developed by the CB for each product/product group and given to the applicant.
- Grant of Certificate: – The certification Body shall grant certification after ensuring complete compliance to the Certification Criteria and certification scheme requirements. The certificate for product certification shall be for a maximum period of 3 years from the date of decision to grant the product certification.
- Surveillance: – Surveillance evaluations of the certified sites during the first certification cycle shall be carried out at a frequency of at least once in six months, ensuring that the gap between two surveillance evaluations does not exceed six months.
