New York: Food and Drug Administration Commissioner Margaret Hamburg wrapped up an eight day trip to India aimed at keeping substandard drugs from entering the US. Hamburg and ministry officials signed a statement of intent to improve regulatory practice and improve drug safety and quality, but there are daunting obstacles.
To begin with India’s Central Drugs Standard Control Organization (CDSCO), the country’s drug regulator, has a staff of 323, barely 2 percent the size of the FDA's. Its authority is limited to new drugs, while it falls on state health departments to oversee the making of medicines that have been on the market at least four years.
“Study after study has shown that at least five percent of Indian medicines sold in India fail basic quality control tests,” reported Forbes.
Yet nothing is likely to change on the ground despite US pressure.
“If I have to follow US standards in inspecting facilities supplying to the Indian market,” G N Singh, India’s top drug regulator, said in a recent interview with Business Standard, “we will have to shut almost all of those.”
During the visit, Hamburg and ministry officials signed a non-binding framework agreement to achieve, among other things, "convergence in regulations in keeping with international standards." But the Drug Controller General of India G.N Singh soon told Reuters he sees scope for the CDSCO working with the FDA and improving regulatory practice, but the Indian regulator will follow its own quality standards.
“We don’t recognize and are not bound by what the US is doing and is inspecting. The FDA may regulate its country, but it can’t regulate India on how India has to behave or how to deliver,” said Singh.
The agreement provides for US and Indian regulators to inform each other before inspecting drugmakers' plants, so host-country inspectors can join as observers. Not everyone is convinced it is such a good idea.
“Instead of making serious commitments during Commissioner Hamburg’s visit, Indian officials instead asked FDA to provide advanced notice of manufacturing facility inspections and let them “shadow” FDA inspectors —presumably to learn from FDA how they can hold their own inspectors to the highest standards,” wrote Dinesh Thakur, Roger Bate and Amir Attaran in Forbes.
“This would be a mistake. By opening its playbook to India’s CDSCO — the US FDA may inadvertently make it easier for Indian companies to cheat, and to pass inspections as and when they happen, while conducting business as usual when they don’t. After all for Indian drug companies, even the most generous bribe would be far less expensive than failing an FDA inspection.”
The magazine’s assumptions are fair as a 78-page Indian parliamentary report found that officials in the CDSCO colluded with pharmaceutical firms to speed up medicine approvals. Just last month, India’s Central Bureau of Investigation caught a CDSCO Deputy Controller red-handed accepting bribes to renew the operating license of a blood bank.
India which is second only to Canada as a drug exporter to the US, where it supplies about 40 percent of generic and over-the-counter drugs, is coming under increased scrutiny by American regulators for safety lapses and falsified drug test results.
In recent months the FDA has banned the import of drugs and drug ingredients from leading Indian manufacturers including Ranbaxy and Wockhardt, citing quality concerns. The bans threaten the image and market share of India's $14 billion pharmaceuticals sector in the US.
Of course, there is grumbling in India that the US drug watchdog is “disproportionately targeting” Indian companies for enforcement actions. They say the recent FDA export bans of generic versions of popular medicines — like the acne drug Accutane, pain drug Neurontin and antibiotic Cipro — are moves to protect US domestic industry from cheaper imports.
“There are some people who take a very sinister view of the FDA inspections,” Keshav Desiraju, India’s former health secretary told the New York Times.
The New York Times noted that some of India’s drug factories are “world-class, virtually undistinguishable from their counterparts in the West.” But others suffer from serious quality control problems.
It’s because of this anomaly that the FDA is “blitzing Indian drug plants.” The FDA inspected 111 Indian plants last year, compared with 72 in 2010, the regulator's data shows. The number of inspections in China rose to 78 from 48.
The FDA is recruiting more inspectors in India as Hamburg pushes the need for quality in the wake of serial drug quality violations among Indian generic manufacturers. The FDA has received approval from the Indian government to add seven investigators in India. The FDA’s presence is growing from 12 to 19 American staff based in India. Indian drug makers will eventually have to invest in infrastructure and commit to high quality standards to ensure they get market access to America.
Updated Date: Feb 27, 2014 11:42 AM