Bad Medicine: Global Concerns Rise Over India's Mounting Drug Quality Problems

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Reported by Annette Kreuger, Industrial Info Resources (Sugar Land, Texas)--It has become evident over the past few years that India is determined to become a major player in the drug manufacturing industry. In terms of APIs (active pharmaceutical ingredients, which is the part of the drug that makes it effective) and generics, the country has been on an upward trajectory of growth. Coupled with the news of yet another production plant under construction, India is garnering increasing attention regarding the quality of those drug products, or the lack thereof.

What consumers in North America and Europe may not understand is that the prescription drug they take in their home country may have its origins in India. An estimated 80% of APIs for drugs sold in the U.S. are now produced in India or China. India was reaching for $25 billion in drug exports by 2014. Enjoying growth rates of 25% in 2012-13, the country's growth has been curbed as product recalls mount. In addition to APIs, generics have been one of the leading factors in the country's rapid success.

The most stunning news out of India's drug manufacturing industry was the $500 million fine slapped by the U.S. Department of Justice on one of its biggest drug makers, Ranbaxy Laboratories (Guragon, India), in May 2013. Majority-owned by Japan's Daiichi Sankyo since 2008, the company pled guilty to multiple cGMP (current good manufacturing practices) violations, false claims, fraudulent testing records and adulterated drugs.

The five felony counts focused on the generic drugs manufactured at Ranbaxy's plants in Paonta Sahib and Dewas, India. The drug products in question include the generic version of board spectrum antibiotic ciprofloxacin (Cipro) and gabapentin, used to treat epilepsy.

Earlier this month, the U.K. drug regulator Medicines and Healthcare Products Regulatory Agency (MHRA) issued a recall on Wockhardt Limited's (Maharashtra, India) entire line of generic prescription products. The 16 drugs at issue included generic versions of treatments for high blood pressure, diabetes, epilepsy, depression, schizophrenia, Parkinson's disease, dementia in Alzheimer's patients, and thyroid conditions.

Sourced out of the company's injectables and solid dosages plant in Waluj, the drug manufacturing deficiencies were uncovered during a March 2013 inspection. MHRA did not extend the "precautionary" recall to the patient level of having to return the drugs, but asked that all existing retail stock in the U.K. be pulled off the shelves.

Wockehardt's woes increased as the U.S. Food and Drug Administration (FDA) extended its existing import ban on its products from the Waluj plant. In its warning letter dated July 18, the FDA said it might withhold approvals for any new launches Wockhardt was planning for the U.S. until the company addressed its concerns about the Waluj plant. The FDA also recommended Wockhardt hire independent auditors to review its operations at Waluj, and asked the company to detail its plan for an upgrade. The agency stated Wockhardt had "repeatedly delayed, denied, limited inspections" or refused to permit FDA inspections.

Global demand for the low-cost copycat generics is growing with no end in sight. That demand goes far beyond the so-called "Pharmerging" countries that have been slower to institute health care programs than first thought. It specifically includes mature markets such as Europe and North America, which receive the bulk of the Indian exports.

For decades, domestic consumers have been relatively comfortable in feeling that they could take a drug prescribed by their doctor and, weird side effects non-withstanding, it would cure or ease whatever malady for which it was designed. A few had a vague understanding that the FDA monitored everything to make sure the drug was produced correctly and in the right dosage. In theory, that is still true in the case of products sourced domestically.

Unfortunately, the beleaguered and short-staffed FDA has found it difficult to investigate all of the manufacturing plants in North America. Fortunately, there are high standards already in place, including procedures and quality assurance programs. The understanding is that an inspector can show up at anytime, anyplace. The last thing the majority of these North American operations, including the Big Pharma players, desire is to put out bad drugs. With a transparent news force, beyond the obvious health dangers, the bad press is bad business.

As the danger over tainted or subpar drugs grows in scope, the complaints over India's unbridled growth no longer remains in the realm of "sour grapes" by Big Pharma over lost profits as drugs have gone off patent. As "Obamacare" moves closer to reality and with it, the chance to offer more citizens access to prescription drugs, the last thing anyone wants is to place those same citizens at risk. These fears spurred the Obama administration and members of Congress late last month to urge India to curb its generic medication industry and enact more uniform guidelines.

In respect to India, it reportedly would take the FDA well over a decade to inspect all of the existing plants, not even factoring in the lack of a true count of how many plants actually exist. Unlike domestic standards, which feature unannounced inspections, foreign drug makers receive ample notice thanks to various agreements in place.

A large number of the Indian drug plants have never been inspected, saving the owners huge sums in cleanup and other compliance costs--an important reason that so many drug manufacturing plants closed in the U.S. If Indian companies are forced to play by the same rules, or for some reason refuse to, it is a fair bet to say there will be a resurgence in domestic manufacturing of APIs and generics.

Industrial Info Resources (IIR), with global headquarters in Sugar Land, Texas, and eight offices outside of North America, is the leading provider of global market intelligence specializing in the industrial process, heavy manufacturing and energy markets. Industrial Info's quality-assurance philosophy, the Living Forward Reporting Principle™, provides up-to-the-minute intelligence on what's happening now, while constantly keeping track of future opportunities.