India Pharma Outlook Team | Wednesday, 26 July 2023
Bharat Serums and Vaccines Limited (BSV), a leading biopharmaceutical business in India, has enlisted the help of Bureau Veritas (India) Limited (BVIL), a global leader in audit and certification services, as part of its ART Act preparedness plan. In the first six months, the plan seeks to review 50+ IVF centers/clinics and assist them in implementing the provisions of the Assisted Reproductive Technology Regulations, 2021 (the ART Act), moving them towards higher compliance.
BVIL will analyse and then certify these centres with a platinum, gold, or silver rating based on their level of preparation, prior to the final inspection by state authorities, through a thorough survey. According to the BSV ART Act, IVF centers/clinics must be inspected by state boards before they may be registered as Level 1/Level 2 Clinics or Surrogacy Clinics. 'The ART Act readiness assessment programme of BSV' evaluates 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 must address in order to become model-code as described in the Act. 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 programme’.
This initiative endeavours to work with identified clinics and enable them to improve their people, process, and compliance standards in accordance with the prevailing laws.” "This is a welcome step for fertility clinics and centres that are awaiting inspection," says Dr. Rakesh Patel of Poojan IVF in Ahmedabad. This certification will be extremely beneficial in offering safe and ethical treatments to infertile couples in need. The platinum, gold, and silver ratings will be a useful indicator of where we may focus our efforts to improve clinic service standards." 'The ART Act readiness assessment programme of BSV' is one such industry initiative that aims to examine clinics/centers and support them on their journey to customer service excellence. We believe that this certification will assist in streamlining the service standards of all recognised locations and ensuring compliance with the ART Act."