The Central Drugs Standard Control Organization (CDSCO) has contacted 283 drugmakers including Abbott, GlaxoSmithKline and Pfizer about its review of their fixed-dose combination (FDC) products. The review looked at the safety and efficacy of FDCs sold without approval at the national level.
CDSCO and a FDC-focused expert committee conducted the review to assess whether applications filed by companies supported the continued sale of certain products, despite them never having been approved by the Drug Controller General of India (DCGI). In each case, the reviewers have issued either a no objection certificate for the continued manufacturing and marketing of the FDC, a show cause notice or a letter requesting the running of a Phase IV trial.
The notice released publicly by CDSCO lists the companies that have been the subject of review and how many letters they have received, but lacks details of the FDCs assessed and the conclusions reached by the regulator. The notice illustrates the scale of the task undertaken by CDSCO. With the review covering 283 companies, some of which are subject to many assessments, CDSCO sent out close to 1,000 letters detailing its findings.
Publication of the letters moves CDSCO a step closer to its long-standing goal of rationalizing the FDC market in India. In the past, companies introduced FDCs without first securing approval from DCGI. This led to FDCs with questionable safety and therapeutic rationale being available in India. CDSCO wrote to manufacturers in January 2013 seeking data to support the continued use of their FDCs. The letters sent out this week are the result of reviews of data received following that request.
Downloads: CDSCO Alert, Other
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