US ban on Ranbaxy; Indian drugs regulator orders quality check at manufacturing facilities

US ban on Ranbaxy; Indian drugs regulator orders quality check at manufacturing facilities

New Delhi (ISJ): India's drugs regulator, Drug Controller General of India (DCGI) on Tuesday (Jan 28) asked state drug controllers to notify import alert and restrictions imposed on domestic drug manufacturers by regulatory bodies abroad. The move comes in the wake of ban on drugs manufactured by Ranbaxy Laboratories at its Tosana unit in Punjab by US Food and Drug Administration on January 23.

"?in spite of warning/prohibition issued by various international Regulatory Authorities like USFDA, MHRA etc. to the Indian manufacturers, this office has not received any such information from you," said Dr. G.N. Singh, Drugs Controller General of India, in a communication to state drug controllers. USFDA, which carried out an inspection at the Toansa manufacturing facility of Ranbaxy earlier in January, 2014 found violation of the Federal Food, Drug and Cosmetic Act or FDA regulations, including current good manufacturing practice (CGMP) requirements. USFDA mandates CGMP requirements as the primary regulatory safeguard over drug manufacturing to ensure quality. "The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug products," said a media release by USFDA on January 23, 2014. "We are taking swift action to prevent substandard quality products from reaching U.S. consumers," said Carol Bennett, acting director of the Office of Compliance in the FDA?s Center for Drug Evaluation and Research. USFDA has asked Ranbaxy to hire a third-party expert to thoroughly inspect the Toansa facility and certify that the facility and its methods and controls are adequate to ensure continuous compliance with CGMP. Until then, Ranbaxy will not be able to export drugs to US market. Ranbaxy, in the meanwhile, apologised to its stakeholders for suspension of shipments. "This development is clearly unacceptable and an appropriate management action will be taken upon completion of the internal investigation," said Arun Sawhney, CEO and Managing Director of Ranbaxy in a statement on January 24, 2014 DCGI mandates state drug regulators to notify to it restrictions or alerts issued by any regulatory body abroad in respect of drugs manufactured and exported from India. Terming non-compliance of its directives "serious in nature," the central drug regulator has asked State Licensing Authorities to inspect manufacturing facilities "to verify compliance of provisions of Drugs & Cosmetics Act and Rules thereunder specially with respect to GMP so that products manufactured comply with the prescribed Standards." The DCGI has however, not imposed on any restrictions on distribution and sale of Ranbaxy products in the domestic market, as Indian and US quality standards for drugs differ.


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