FDA should follow Europe’s lead on Indian drug suspensions

Europe’s chief drug regulator recently took an unprecedented step and recommended suspending 700 generic drugs whose approvals were based on flawed – or forged – clinical studies conducted by GVK Bio, an Indian contract research organization. Sabine Julicher, the Head of Unit, Medicinal products said that “falsification of ECGs was performed by at least 10 different individuals over a period of five years, between
July 2008 and 2013."

U.S. Federal regulators should follow Europe’s lead and move to rescind market approval for these drugs while conducting their own investigation. In the past, when the US FDA discovered similar fraudulent behavior, it advised patients to continue to take drugs of questionable quality while restricting their further import into the country. This approach provides a fig leaf to the manufacturers in question; they use it to justify their business while the FDA gives them time to take corrective actions. Unfortunately, this approach hasn’t provided the results that the FDA had hoped for. A cursory review of the inspection results of manufacturing facilities in India continue to identify behavior that the FDA calls “data integrity”; in layman’s terms this means that the FDA found the manufacturers continue to try and cheat the agency to secure approvals to sell their products in the US.

This massive recall is just the latest reminder that India’s pharmaceutical industry still suffers from serious and systemic quality control problems. Over the last decade, this industry has rapidly expanded, breaking into new markets all over the world and evolving into the production of highly sophisticated biopharmaceutical agents that have historically been the exclusive province of Western drug companies.
But India’s regulatory framework hasn’t kept pace. Many of the drugs produced by generic manufacturers based in the country are dangerously low quality. Fifteen young women died and 70 were seriously taken ill in November 2014 for example, after receiving antibiotic medicines laced with rat poison after undergoing tubectomies in the state of Chhattisgarh.

Indian generic manufacturers are either struggling to master the relatively simple process of creating chemical drugs or willfully corner-cutting and failing to consistently supply the market with quality products.

At the same time, Indian manufacturers have begun to produce a class of advanced pharmaceuticals called “biologics.” Unlike chemical drugs, biologics are derived from living organisms. They’re significantly more complex than traditional medicines -- and often more effective or better targeted with fewer side-effects.

Accordingly, the biologic manufacturing process is extremely precise. Even minor missteps can compromise the safety and effectiveness of the final product.

These manufacturers may have the technical expertise and possibly enough of a research base, but they certainly do not have the regulatory framework required to responsibly manufacture biologics. It is notable that no Indian pharmaceutical company has yet produced a new chemical entity (a new drug) that has gone through a regulatory approval process at a reputable regulator like the US FDA.

American regulators need to become more proactive in addressing the risk from poor quality medicines manufactured overseas where oversight and quality control do not seem to be on par with what is typically expected of US manufacturing facilities. At the very least, those 700 generic products deemed unsafe by European authorities need to be critically examined whether they were also approved for sale in the US based on the fraudulent data that the European Regulator found.

National quality control authorities (like the US FDA) should be granted unencumbered access to Indian production facilities to investigate more flaws, since domestic officials in India seem to have been coopted by local producers, and appear uninterested in discovering flaws and inconsistencies in the research data submitted by Indian companies. It is ironic that foreign drug regulators like the US FDA, the UK MHRA and the European Regulator continue to find outright fraud with Indian manufacturers while the Indian drug regulator hasn’t found one single instance of fraudulent behavior with any of its manufacturers.

This regulatory intervention should be coupled with an organic market check. It is ironic that we know more about where our pet food comes from than we do about the medicines we take. Patients in the US need to be informed where their drugs are manufactured. In the event these medications do cause unexpected side effects, physicians and patients can note their origin and avoid them. This would create a financial incentive for the manufacturers to improve the quality of their product.

European regulators have met this mounting drug quality problem with aggressive action. American officials need to do likewise. Indian generic pharmaceutical industry has perpetually failed to meet basic quality and safety standards that are required to sell products in the
US. Its products are already putting American lives at risk. The FDA should prohibit companies with such fraudulent behavior to sell their products in the in the domestic market. And they should only be allowed back in if and when they’ve cleaned up their act.

Bate is a scholar at the American Enterprise Institute and the author of “Phake: The Deadly World of Falsified and Substandard
Medicines.” Thakur is the CEO of the Medassure Global Compliance Corporation.
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