NOC withdrawn - WHO Prequalification Unit (WHO-PQT) informs DCGI and others

3 August, 2023

The WHO Prequalification Unit (WHO-PQT) would like to inform Drugs Controller General of India (DCGI) and, national regulatory Authorities, procurement agencies and other stakeholders that the Notice of Concern (NOC), issued 9 November 2022 to Accutest Research Laboratories (I) Pvt. Ltd., the Clinical Unit of Unit I located at A-31, M.I.D.C, T.T.C Industrial Area, Khairane, Navi Mumbai, 400709, Maharashtra, India by WHO-PQT, has been withdrawn, removed from the WHO Prequalification Unit website and archived. The NOC was originally issued after an inspection performed on 30 May - 3 June 2022, during which several critical and major non-conformities were identified. In response, WHO-PQT requested the applicants of the affected products to thoroughly review the impact of these findings and take appropriate actions to ensure their compliance with GMP/GLP/GCP/ISO standards.

The review process has been successfully concluded, encompassing data and reports derived from recent studies conducted by the CRO. Notably, the studies include ARL/22/087 for CV 020: Ritonavir 100 mg + Nirmatrelvir 300 mg Film-coated tablets and ARL/20/027 for MA193: Sulfadoxine 500 mg and Pyrimethamine 25 mg Tablets. These submissions have been evaluated and have been determined to adhere to the mandated standards of WHO GCP/GLP/BE guidelines. The assessment of data from these studies supports the new products, effectively addressing concerns that had previously been raised in the Notice of Concern.

World Health Organization