US ban on Ranbaxy: Centre blames politics, business interests
The union government on Monday termed "politics and business interests" behind the US ban on drugs manufactured by Ranbaxy. Union health minister Ghulam Nabi Azad said India was a victim of cartalisation by developed nations.Updated: Feb 03, 2014 20:29 IST
The union government on Monday termed "politics and business interests" behind the US ban on drugs manufactured by Ranbaxy. Union health minister Ghulam Nabi Azad said India was a victim of cartalisation by developed nations.
"There are several reasons behind this ban, I don't want to dwell on it," Azad was quoted by the Indian Science Journal website as saying when asked about the recent ban on Ranbaxy Laboratories by the United States Food and Drugs Administration (USFDA).
He further said: "There is politics and business interests of multi-national companies, which find it difficult to take on competition from Indian companies."
The USFDA had banned drugs manufactured by Ranbaxy at its Toansa unit in Nawanshahr (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 manufacturers from developing countries from global competition," said Azad, without naming any country.
The USFDA had on January 23 prohibited Ranbaxy Laboratories from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa for FDA-regulated drug products.
"We are taking swift action to prevent substandard quality products from reaching US consumers," said Carol Bennett, acting director of the office of compliance in the FDA's Centre for Drug Evaluation and Research.
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 these adhere to our standard quality parameters."
He said investigations carried out after the USFDA ban had found Ranbaxy adhering to all quality parameters laid down by the Indian drug regulator.
Following the ban, India's drugs regulator, the Drug Controller General of India (DCGI), had asked state drug controllers to notify the import alert and restrictions imposed on domestic drug manufacturers by regulatory bodies abroad.
The 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 and Cosmetics Act and Rules thereunder specially with respect to the CGMP so that products manufactured comply with the prescribed standards."
The 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 were adequate to ensure continuous compliance with the CGMP. Until then, Ranbaxy will not be able to export drugs to the US market.
Ranbaxy, in the meantime, apologised to its stakeholders for the suspension of shipments and said in a statement that an appropriate management action would be taken upon the completion of the internal investigation.