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

Video Drug Use Rises in Afghanistan

Ninety percent of world’s heroin comes from Afghanistan More

Here's Your Chance to Live in a Deserted Shopping Mall

About one-third of the 1200 enclosed malls in the US are dead or dying. Here's what's being done with them. More

Video NASA: Big Antarctica Ice Shelf Is Disintegrating

US space agency’s new study indicates Larsen B shelf could break up in just a few years More

Featured Videos

Your JavaScript is turned off or you have an old version of Adobe's Flash Player. Get the latest Flash player.
Poverty, Ignorance Force Underage Girls Into Marriagei
X
May 21, 2015 4:14 AM
The recent marriage of a 17-year old Chechen girl to a local police chief who was 30 years older and already had a wife caused an outcry in Russia and beyond. The bride was reportedly forced to marry and her parents were intimidated into giving their consent. The union spotlighted yet again the plight of many underage girls in developing countries. Zlatica Hoke reports poverty, ignorance and fear are behind the practice, especially in Asia and Africa.
Video

Video Poverty, Ignorance Force Underage Girls Into Marriage

The recent marriage of a 17-year old Chechen girl to a local police chief who was 30 years older and already had a wife caused an outcry in Russia and beyond. The bride was reportedly forced to marry and her parents were intimidated into giving their consent. The union spotlighted yet again the plight of many underage girls in developing countries. Zlatica Hoke reports poverty, ignorance and fear are behind the practice, especially in Asia and Africa.
Video

Video South Korea Marks Gwangju Uprising Anniversary

South Korea this week marked the 35th anniversary of a protest that turned deadly. The Gwangju Uprising is credited with starting the country’s democratic revolution after it was violently quelled by South Korea’s former military rulers. But as Jason Strother reports, some observers worry that democracy has recently been eroded.
Video

Video California’s Water System Not Created To Handle Current Drought

The drought in California is moving into its fourth year. While the state's governor is mandating a reduction in urban water use, most of the water used in California is for agriculture. But both city dwellers and farmers are feeling the impact of the drought. Some experts say the state’s water system was not created to handle long periods of drought. Elizabeth Lee reports from Ventura County, an agricultural region just northwest of Los Angeles.
Video

Video How to Clone a Mammoth: The Science of De-Extinction

An international team of scientists has sequenced the complete genome of the woolly mammoth. Led by the Swedish Museum of Natural History in Stockholm, the work opens the door to recreate the huge herbivore, which last roamed the Earth 4,000 years ago. VOA’s Rosanne Skirble considers the science of de-extinction and its place on the planet
Video

Video Blind Boy Defines His Life with Music

Cole Moran was born blind. He also has cognitive delays and other birth defects. He has to learn everything by ear. Nevertheless, the 12-year-old has had an insatiable love for music since he was born. VOA’s June Soh introduces us to the young phenomenal harmonica player.
Video

Video Women to March for Peace Between Koreas

Prominent female activists from around the world plan to march through the demilitarized zone dividing North and South Korea to call for peace between the two neighbors, divided for more than 60 years. The event, taking place May 24, marks the International Women's Day for Peace and Disarmament and has been approved by both Koreas. Zlatica Hoke has more.
Video

Video Drug Use Rises in Afghanistan Following Record High Poppy Crops

Afghanistan has seen record high poppy crops during the last few years - and the result has been an alarming rise in illegal drug use and addiction in the war-torn country. VOA's Ayesha Tanzeem has this report from Kabul.
Video

Video America’s Front Lawn Gets Overhaul

America’s front yard is getting a much-needed overhaul. Almost two kilometers of lawn stretch from the U.S. Capitol to the Washington Monument. But the expanse of grass known as the National Mall has taken a beating over the years. Now workers are in the middle of restoring the lush, green carpet that fronts some of Washington’s best-known sights. VOA’s Steve Baragona took a look.

VOA Blogs