The FDA has banned four Ranbaxy Laboratories plants in 5 years, imposed a consent decree on the company and extracted guilty pleas and $500 million in penalties for selling subpar products. But according to Indian media reports, in the last 7 years the Drug Controller General of India (DCGI) has made only three inspections of Ranbaxy facilities and found little to worry about. Responses by Indian industry leaders illustrate the difference in attitude about the difference in standards.
The DCGI has decided to send a team to the Ranbaxy API plant in Toansa that the FDA banned last week. But former Pfizer ($PFE) employee and pharma entrepreneur Praful Akeli told the Indian Express that the fact that Ranbaxy facilities have failed to meet FDA standards does not necessarily mean the company's drugs are ineffective. "The DCGI standards are lower but can we as a nation invest on each facility at par with USFDA standards?" he asked rhetorically. "The almost doubling of costs is something we need to factor in."
The FDA imposed the import alert last week after an inspection earlier this month found ongoing problems. Particularly troubling, the FDA said, was that workers at the plant had been retesting products that failed analytics until they got the results that were needed, overwriting the old results in its database. Proper analysis procedures were not followed, and equipment was not properly calibrated, inspectors said. On the sanitation side, they found broken windows in a laboratory that was filled with flies.
Narendra Saini, general secretary of the Indian Medical Association, told the The Economic Times the group would like the DCGI to upgrade its standards, asking for more documentation on processes and doing surprise inspections at plants. The group asked the drug regulator for assurances that Ranbaxy's products are safe and effective. But Saini also said the group understands "that different countries have different parameters to judge quality of drugs." He pointed out that some other countries, like the U.K. and Australia, have not taken the same actions as the FDA.
Regulators in the U.K. and Europe, like the U.S., have banned products from several plants owned by India's Wockhardt, facilities that the Indian regulator has not penalized.
The latest FDA action has spurred the Indian regulator to take another look at Ranbaxy. Drug Controller General G. N. Singh told the Indian Express it is awaiting a response from Ranbaxy about the FDA action but also intends to do its own appraisal of the Toansa plant. "We will be sending a team of officials to inspect the plant to test the product," Singh told the Indian Express. "If there are any violations, we will take action."