The CSIR-Central Drug Research Institute (CDRI), Lucknow, was seventh in the chain of CSIR labs that were established in India right after independence India with an aim for technological independence of the Nation. CSIR-CDRI was broadly mandated with the task to revolutionise the pharmaceutical sector, which was almost non-existent at that time for accessibility and affordability of drugs. Today, CSIR-CDRI has evolved into a unique institution possessing end-to-end expertise in the domain of new drug development - its human resource and infrastructure today is second to none. Besides being the breeding ground of huge highly trained human resource for the drug development and manufacturing, out of 20 new drugs discovered, developed and approved in the post-independent India, 11 (8 synthetic + 3 phytopharmaceuticals) are contributions of CSIR-CDRI, Lucknow. These include Centchroman, Arteether, Centbucridine, Gugulipid, Bacosides Enriched Standardized Extract of Bacopa, etc. Centchroman (Ormeloxifene), a non-steroidal contraceptive with almost no toxicity, is now part of the National Family Program, whereas a-(3 Arteether (antimalarial) is included in the National Malaria Program.
The U.S. Food and Drug Administration has warned Liveyon Labs Inc. (Liveyon Labs) and Liveyon LLC, of Yorba Linda, California, and their presidents and chief executive officers, Roya Panah and John W. Kosolcharoen, for processing and distributing unapproved products derived from umbilical cord blood. They have also been warned regarding significant deviations from current good tissue practice (CGTP) and current good manufacturing practice (CGMP) requirements, including deficient donor eligibility practices, inadequate aseptic practices to prevent contamination and deficient environmental monitoring. These deviations create potential significant safety concerns that put patients at risk. The companies’ unapproved products derived from umbilical cord blood are PURE and PURE PRO.
