New Delhi (ISJ): India on Monday (Feb 03) termed ‘politics and business interests’ behind the US ban on Ranbaxy drugs. Union Health Minister Ghulam Nabi Azad told Indian Science Journal, India is a victim of cartalisation by developed nations. “There are several reasons behind this ban, I don’t want to dwell on it,” commented Azad when asked about the recent ban on Ranbaxy Laboratories by US Food and Drugs Administration, USFDA.
“There is politics and business interest of multi-national companies, who find it difficult to take on competition from Indian companies.” USFDA had banned drugs manufactured by Ranbaxy at its Tosana unit in Punjab for ‘violation’ of the Federal Food, Drug and Cosmetics Act or FDA regulations including current good manufacturing practice (CGMP) requirements. “The developed countries lay down such strict parameters to bar manufactures from developing countries from global competition,” said the Indian minister, without naming any country in particular. The U.S. Food and Drug Administration on January 23, 2014 prohibited Ranbaxy Laboratories from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug products. “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. Ghulam Nabi Azad however, discounted the possibility of any ban on drugs manufactured by Ranbaxy, saying “We have to keep in mind our national interests. We have no plan to ban these drugs, if it adhere to our standard quality parameters.” He said, investigations carried out after the US ban has found Ranbaxy adhere to all quality parameters laid down by Indian drug regulator. Following the ban, India’s drugs regulator, Drug Controller General of India (DCGI) had asked state drug controllers to notify import alert and restrictions imposed on domestic drug manufacturers by regulatory bodies abroad. 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.” USFDA had 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 and said in a statement an appropriate management action will be taken upon completion of the internal investigation.
