Team of senior officers from Central Drugs Standard Control Organization (CDSCO) and Food & Drug Control Authority, Gujarat was on a surveillance visit at Accuprec Research Labs Pvt. Ltd. on 5th and 6th October, 2017 for audit purpose. The team included Dr. Prajesh Prajapati, Vishnubhai Patel, Arvindbhai Zala and Ketan Panchal.During the Two-day visit, the team inspected various facilities and checked the testing equipments as well as staff skills. They expressed satisfaction about the work going on in the CRO.
The Central Drugs Standard Control Organization (CDSCO) is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act. CDSCO has six zonal offices, four sub-zonal offices, 13 port offices and seven laboratories under its control.
Major functions of CDSCO: 1. Regulatory control over the import of drugs, approval of new drugs and clinical trials, meetings of Drugs Consultative Committee (DCC) and Drugs Technical Advisory Board (DTAB), approval of certain licences as Central Licence Approving Authority is exercised by the CDSCO hqrs.
Under the Drug and Cosmetics Act, the regulation of manufacture, sale and distribution of Drugs is primarily the concern of the State authorities while the Central Authorities are responsible for approval of New Drugs, Clinical Trials in the country, laying down the standards for Drugs, control over the quality of imported Drugs, coordination of the activities of State Drug Control Organisations and providing expert advice with a view of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act. Drug Controller General of India is responsible for approval of licenses of specified categories of Drugs such as blood and blood products, I. V. Fluids, Vaccine and Sera.