CDSCO regulator moves SC against Ranbaxy over lapses


Regulatory troubles mounted further for generic drugmaker Ranbaxy after central drug regulator found deficiencies at Ranbaxy’s facilities, reports CNBC-TV18’s Ashmit Kumar. The Central Drugs Standard Control Organization (CDSCO) has filed an affidavit in the Supreme Court based on its observations in June-July 2013 period. The regulator has also said Ranbaxy failed to take any action despite reminders to the company. The joint inspections with eight other regulators carried at six of Ranbaxy’s laboratories in Himachal Pradesh found discrepancies in testing, stability standards and expiry dates, among other standards. The plants that were inspected by the regulator are located in Dewas, Paonta Sahib, Baddi, Solan and Ponds. Subsequently, the CDSCO had apprised Ranbaxy of its findings and had sought clarifications from Ranbaxy on it. Also, it had also exchanged the findings with Himachal Pradesh’s state regulator. It is learnt that the last reminder to the state’s regulator was issued in June 2015 and there has been no action from the agency. CDSCO’s acknowledgment of lapses at Ranbaxy facilities aggravates problems for the drugmaker which has been pulled by the US Food and Drug Administration (USFDA) in the past. In 2013, Ranbaxy pleaded guilty to felony charges relating to drug safety and had agreed to pay USD500 million penalty in the case filed with the US Department of Justice.

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