Rumblings about the quality of India-sourced generics get louder

A not-too-quiet campaign over the business practices of Indian generics manufacturers and the Indian government’s stance on intellectual property is getting louder. The American Enterprise Institute (AEI), a Washington-based think tank, held a meeting at the Capitol on Feb. 26, showcasing physicians who are critical of the quality of generic drugs they had been prescribing. A few weeks prior, FDA Commissioner Margaret Hamburg had toured pharma facilities in that country and met with government and industry officials; in her diplomatically worded blog post on the trip, she noted that industry representatives said that “they were challenged by our heightened inspectional activities.”

Dr. Preston Mason, member of the Cardiovascular Div. at Brigham and Women’s Hospital in Boston and Harvard Medical School, has been examining the quality of atorvastatin (generic Lipitor) available in the US and spoke at the AEI event. “All the generic Lipitor samples we tested and that contained impurities/contaminants were made by many different Indian companies from locations throughout the country,” he said. The current situation for Indian companies certainly isn’t helped by yet another recall of Ranbaxy-sourced atorvastatin (the company has had quality control issues ever since it began selling the product), announced in early February, or an FDA warning letter sent around the same time to USV Ltd., a Mumbai-based drug manufacturer, for laboratory quality controls so shoddy that they raise concern for “all the data generated by [the] firm.”

Dr. Roger Bate, visiting scholar at AEI (and known to Pharmaceutical Commerce readers for his book, “Phake: The Deadly World of Falsified and Substandard Medicine) paints a picture of a recalcitrant Indian pharmaceutical community that uses high-level debates about intellectual property rights to mask gaping weaknesses in the country’s internal regulation of the industry. And while the number of FDA inspectors has risen in the aftermath of the passage of the Generic Drug User Fee Act (GDUFA), Indian officials requested of Hamburg, during her recent visit, to provide advance notice of manufacturing facility inspections and to have inspectors of the Central Drugs Standard Control Organization “shadow” the FDA inspectors. CDSCO has been implicated in numerous bribery and corruption scandals, according to Bate.

Bate and other members of his “Searching for Safety” group suggest that long term, FDA should adopt an international policy similar to that of the Federal Aviation Administration, which routinely downgrades countries whose commercial air practices are deficient, thereby restricting their access to US airspace.

GPhA reaction

Generics are, of course, manufactured around the world, including inside the US, and inspection requirements for all manufacturers have risen in recent years. (Coincidentally, FDA had a record number of recalls issued under its guidance in the past year.) But if adulterated products continue to flow out of India, it will paint the entire industry with that brush, just at a time when the US healthcare system is enjoying the cost savings of the record number of new generics coming onto the market.

In a statement to Pharmaceutical Commerce, Ralph Neas, president of the Generic Pharmaceutical Assn., says:

“While GPhA does not have direct business in India, many of the GPhA member companies do. As the industry expands global operations, it is more important than ever for … FDA, the leading U.S. expert in public health and pharmaceutical safety and science, to work with its international counterparts in India and across the world. Part of GDUFA is global inspection parity. FDA leadership, insight and expertise can be a valued resource particularly in emerging markets. More can be done so that patients and consumers, regardless of geography, know that when they receive generic medicines that they are receiving the same medicine with the same active ingredients at lower cost.”

Generally speaking, a pharma company that obtains active pharmaceutical ingredients from a foreign manufacturer is ultimately responsible for the quality of the finished product sold in the US, so the product quality is attributable to that company. But for finished generics—provided that an FDA inspector hasn’t intervened—the product can go directly from the nominally approved foreign manufacturer to US pharmacy stockrooms. FDA may ultimately get a handle on its desire for a reliable, internationalized system of drug quality inspection and control—but should the rest of the pharma distribution industry wait until that happens?