WASHINGTON (TIP): US regulators are not targeting India, despite a series of import restrictions on drugs from the major US trading partner, the Food and Drug Administration chief said Friday, February 23. FDA Commissioner Margaret Hamburg briefed reporters after her first official trip to India, where she met with government and industry leaders earlier this month.
India is the second largest US supplier of prescription and over-the-counter drugs, and its big pharma companies Ranbaxy and Wockhardt have been hit with multiple US import suspensions due to safety concerns. “We are not targeting Indian countries. We are undertaking our required regulatory activities,” Hamburg said. “When products are sold in the United States for use by American citizens, then those products have to meet our standards.” Hamburg said the FDA has ramped up inspections at Indian drug plants as part of a global effort to improve safety.
The agency has 12 staff members in India, and plans to expand to 19, she added, describing the nation as “particularly important” to US food and drug trade. “The fact that we have increased our presence in India is true but it reflects the fact that India is a very significant and growing player in the US marketplace with respect to both pharmaceutical products and food.” While in New Delhi, Hamburg and Indian health secretary Keshav Desiraju signed their first statement of intent to cooperate in the field of medical products.
Hamburg described as “encouraging” her conversations with senior representatives during her eight-day trip to India, the United States’ third largest trading partner. At the start of Hamburg’s visit, Health Minister Ghulam Nabi Azad said India’s lower-cost medicines should not be viewed as “cheap and spurious.” India’s generics industry is a major supplier of lifesaving drugs, including antiretrovirals for HIV, to the United States and over 200 other nations. Many lower-income countries rely on the generics produced by Indian plants as a key source for affordable medicine.
But Ranbaxy, one of India’s biggest drugmakers, has been hit repeatedly with FDA import suspensions, most recently in January, when a fourth manufacturing plant was cited for violations from expected “good manufacturing practice.” Roger Bate, an expert at the American Enterprise Institute, said the problem lies with India’s national regulatory body for pharmaceuticals, the Central Drugs Standard Control Organization. “I believe the Indian generics companies can make the products well, but it is the lack of oversight,” Bate told AFP, describing CDSCO as “corrupt.” “India does not take drug regulatory matters seriously.”
The FDA issued earlier its first-ever ban on tobacco products on four varieties of hand-rolled cigarettes called bidis by an Indian company headquartered in Illinois, Jash International. Just days after FDA commissioner Margaret Hamburg returned from India, agency officials announced that four bidi brands made by Jash International – Sutra Bidis Red, Sutra Bidis Menthol, Sutra Bidis Red Cone and Sutra Bidis Menthol Cone – may no longer be domestically sold, distributed or imported.
The bidis were banned not because of any imminent danger – although it is well-known that all tobacco products are dangerous – but because Jash failed to provide ingredient information that is mandatory under new rules. In a conference call on Friday, not specifically related to the bidi issue, commissioner Hamburg denied the FDA was targeting Indian companies, but said the United States has a strict quality control regime for all products being imported into America.
”When products are sold in the United States for use by American citizens, then those products have to meet our regulatory standards and requirements and we inspect those facilities in other countries as well,” she told reporters after her first official trip to India, where FDA action against Indiabased pharmaceutical companies have been the focus of attention. But US efforts to stamp out bidi imports and smoking in America has a history going back some two decades when the Indian mini-cigarette started to become a fad among youth after hippies had first lit them up in the sixties. A 2002 survey showed close to 3% of American male high school students had tried bidis, which, because they were largely unregulated, were easier for the youth to access – particularly after the US cracked down on sale of cigarettes to the under-aged.
Over the last decade, bidis also began to appear in various all-American, candy-like flavors: chocolate, vanilla and strawberry, adding newer flavors such as grape, cinnamon, watermelon, menthol, black licorice, wild cherry, and mandarin orange, as the craze caught on. No accurate figures are available about the extent of bidi imports from India but estimates by an international trade group in the 1990s put import from India at 448 million pieces valued at less than $5 million. The Clinton administration tried to ban import of beedis around that time after a CBS 60 Minutes program showed child labor in the industry that employs an estimated 3 million people in India. But it was never fully carried through.
The health and economic cost of smoking is something that has seized developed countries even as developing countries continue to get sucked into western-inspired tobacco consumption that is far more lethal and pervasive than bidi imports to America. A 2010 WHO study estimated that smoking in developed countries will amount to 29% of world tobacco consumption (down from 34% in 1998), while developing countries’ share, now said to be growing at around 3% every year, will be 71%. Some six million people die every year from tobacco-related illness – 80% of them in low-income countries. Last year, the United States also raised concern about high rates of contaminants, including salmonella, in Indian spices.