Aug. 1 2023

Readiness assessment and certification of ART centres/clinics in accordance with the model-code of the Assisted Reproductive Technology Regulations, 2021

Ahead of the World IVF Day, Bharat Serums and Vaccines Limited (BSV) a leading biopharmaceutical company in India has roped in Bureau Veritas (India) Pvt. Ltd. (BVIL), a world leader in Audit and Certification Services - as part of the BSV ART Act Readiness Program. This program aims to assess 50+ IVF centres/clinics (in the first six months) in terms of readiness for inspection as per the model-code of Assisted Reproductive Technology Regulations, 2021 (the ART Act). Through an intensive survey, BVIL, will assess and then certify these centres with a Platinum, Gold and Silver rating depending on their level of readiness, ahead of the final inspection by the State authorities.

In accordance with the BSV ART Act IVF centres/clinics need to be inspected by State Boards to be registered as Level 1 / Level 2 Clinics & Surrogacy Clinics. ‘The ART Act Readiness Assessment Program of BSV’ assesses the current state of these centres against six critical parameters: infrastructure; people and competency management; communication; patient and process selection; data records and compliance monitoring and identifies the gaps/areas of improvement that the centres need to address to become a model-code as described in the Act. 

Speaking on this Vishwanath Swarup, COO- Domestic Operations, BSV, said “The Assisted Reproductive Technology Regulations (ART), 2021 aims at the regulation and supervision of ART clinics and banks, to prevent misuse and ensure adherence to safe and ethical practice of ART services. On the occasion of World IVF Day, as responsible leaders in IVF treatment, we are delighted to announce a first-of-its-kind initiative from BSV - ‘The ART Act Readiness Assessment Program’. This initiative endeavours to work with identified clinics to make them inspection-ready before supervision. The objective is to support the identified centres to enable them to improve their people, process, and compliance standards in accordance with the prevailing laws.” 

According to Dr. Rakesh Patel, Poojan IVF, Ahmedabad, “This is a welcome step for fertility clinics and centres who are awaiting inspection. This certification would be very useful in providing safe and ethical services to the needy infertile couples. The Platinum, Gold and Silver ratings will be a good indicator of where we could channelise our efforts and improve service levels of the clinics.”

Adding to this, Jagdheesh Manian, Director Certification, South Asia Region, BVIL, said, “We have a rich legacy of partnering with industry leaders and creating benchmark initiatives. 'The ART Act Readiness Assessment Program of BSV’ is one such industry initiative that aims to assess clinics/centres and support them in their journey of excellence in customer service. We believe that this certification will help streamline the service standards of all identified centres and ensure they comply with the ART Act.”