News / Health

Indian Drug Industry Attracts Greater US Scrutiny Over Safety Concerns

FILE - Indian scientists work inside a laboratory of the Research and Development Centre of Natco Pharma Ltd., in Hyderabad, India.
FILE - Indian scientists work inside a laboratory of the Research and Development Centre of Natco Pharma Ltd., in Hyderabad, India.
Anjana Pasricha
— As the Indian drug industry comes under greater scrutiny for quality lapses, U.S. regulators have called for better compliance with production standards. India is a huge supplier of prescription drugs to the U.S.
 
Concerns about the quality of medicines exported by India came to the forefront last year after a leading Indian drug company, Ranbaxy, pleaded guilty to falsifying clinical data and distributing adulterated medicines in the U.S.
 
The U.S. Food and Drug Administration (FDA) has banned drug imports from Ranbaxy’s Indian plants and some drugs from another company, Wockhardt.
 
As U.S. FDA commissioner Margaret Hamburg wrapped up a nine-day visit to India this week, she stressed the need for India’s drug industry to ensure that the medicines it exports are safe. 
 
Although the concerns have been triggered by a handful of companies, it has affected the image of the Indian pharmaceutical industry. India’s industry has boomed on the back of the low cost drugs it makes and exports to both developing and developed countries. In total, Indian drug exports are worth about $15 billion.    
 
The secretary general of the Indian Pharmaceutical Alliance, D.G. Shah, said drug companies are taking steps to comply with U.S. standards.  
  
“We are sensitizing organizations and CEO’s themselves have to be alert about the culture change they have to bring in organizations. Jointly with U.S. FDA we will organize seminars in India where Indian companies will be exposed to standards and requirements, how to achieve those,” said Shah.   
 
The U.S. FDA's Hamburg has called on Indian regulators to join the U.S. in ensuring more rigorous oversight of drug manufacturing facilities. Hamburg said the industry plays an important role in the global marketplace.
 
For its part, the U.S. will increase the number of FDA inspectors in India from 11 to 19 as it intensifies inspections of drug factories. India also plans to increase its staff of inspectors from 1,500 to 5,000 over the next five years.
 
However, Shah said, while some problems have been identified by the U.S. regulator, most Indian drug manufacturing facilities are world class. He said the issue should not be blown out of proportion.   
 
“We need to put our house in order first and this is something which is being addressed. Media should not be alarmist about what happens to one or two companies out of 300 companies which are exporting to U.S.,” said Shah.
 
Even as fingers are pointed at a lax approach to quality control by some drug-makers in India, the U.S. concerns are likely to serve as a wake-up call.
 
Some 40 percent of prescription and over the counter drugs sold in the United States come from India. Most of them are cheaper versions of medicines whose patents have expired.

You May Like

EU Court Fines Poland for Hosting CIA 'Black Sites'

Ruling is first time a court has acknowledged suspects were held and tortured at the sites, under US program launched following the 9/11 terrorist attacks More

Migrant Issues Close to Home Spur Groups to Take Action

Groups placing water, food in the desert, or aiding detainees after release, have one common goal: no more deaths of migrants crossing illegally into the US More

Video At AIDS Conference, Prevention Pill Stirs Excitement

Truveda shows promise, spurring debate over access and other approaches More

Featured Videos

Your JavaScript is turned off or you have an old version of Adobe's Flash Player. Get the latest Flash player.
Israel Targets Gaza Supply Tunnelsi
X
July 24, 2014 4:42 AM
The Israeli military has launched a ground operation in Gaza to destroy the myriad tunnels that may have been used to smuggle weapons to Hamas. VOA's Zlatica Hoke reports that could mean more hardship for the people of Gaza, who obtain some of their essential supplies through these underground passages
Video

Video Israel Targets Gaza Supply Tunnels

The Israeli military has launched a ground operation in Gaza to destroy the myriad tunnels that may have been used to smuggle weapons to Hamas. VOA's Zlatica Hoke reports that could mean more hardship for the people of Gaza, who obtain some of their essential supplies through these underground passages
Video

Video MH17's 'Black Boxes' Could Reveal Crash Details

The government of Malaysia now has custody of the cockpit voice and flight data recorders from Malaysia Airlines Flight 17, which was hit by a missile over Ukraine before crashing last week. As VOA's Carolyn Presutti reports, the so-called black boxes may hold information about the final minutes of the flight.
Video

Video Living in the Shadows Panel Discussion

Following a screening of the new VOA documentary, "AIDS - Living in the Shadows," at the World AIDS conference in Melbourne, a panel discussed the film and how to combat the stigma associated with HIV/AIDS.
Video

Video IAEA: Iran Turns its Enriched Uranium Into Less Harmful Form

Iran has converted its stockpiles of enriched uranium into a less dangerous form that is more difficult to use for nuclear weapons, according to the United Nations’ Atomic Energy Agency. The move complies with an interim deal reached with Western powers on Iran's nuclear program last year, in exchange for easing of sanctions. Henry Ridgwell reports for VOA from London.
Video

Video Relic of Saint Draws Catholics Worried About Immigration Issue

A Roman Catholic saint who is a figure of devotion for those crossing the border into the United States is attracting believers concerned about the plight of undocumented immigrants. Mike O'Sullivan reports from Los Angeles, where a relic of Saint Toribio has drawn thousands to local churches.
Video

Video US Awards Medal of Honor for Heroics in Bloodiest of Afghan Battles

U.S. combat troops are withdrawing from Afghanistan, on pace to leave the country by the end of this year. But on Monday, U.S. President Barack Obama took time to honor a soldier whose actions while under fire in Afghanistan earned him the Medal of Honor. VOA's Jeff Seldin has more from the Pentagon.
Video

Video Ukraine Rebels Surrender MH17 Black Boxes

After days of negotiations, a senior separatist leader handed over two black boxes from an airliner downed over eastern Ukraine to Malaysian experts early Tuesday. While on Monday, the U.N. Security Council unanimously demanded that armed groups controlling the crash site allow safe and unrestricted access to the wreckage.
Video

Video In Cambodia, HIV Diagnosis Brings Deadly Shame

Although HIV/AIDS is now a treatable condition, a positive diagnosis is still a life altering experience. In Cambodia, people living with HIV are often disowned by friends, family and the community. This humiliation can be unbearable. We bring you one Cambodian woman’s struggle to overcome a life tragedy and her own HIV positive diagnosis.

AppleAndroid