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

Cambodia Seeks Official UN Maps for Vietnam Border

Notice of request comes as 2 countries open border talks Tuesday after a clash last month More

From South Africa to Vietnam, Cyclists Deliver Message Against Rhino Horns

Appalled by poaching they saw firsthand, sisters embark on tour to raise awareness in countries where rhino horn products are in demand More

Uber Wants Johannesburg Police Protection

Request follows recent protests outside ride-hailing service's Johannesburg office More

Featured Videos

Your JavaScript is turned off or you have an old version of Adobe's Flash Player. Get the latest Flash player.
Getting it Done Beyond a Nuclear Deali
X
July 07, 2015 12:02 PM
If a nuclear deal is reached between Iran and world powers in Vienna, it will be a highly technical road map to be used to monitor nuclear activity in Iran for years to come to ensure Tehran does not make nuclear weapons. Equally as complicated will be dismantling international sanctions that were originally intended to be ironclad. VOA’s Heather Murdock talks to experts about the key challenges any deal will present.
Video

Video Getting it Done Beyond a Nuclear Deal

If a nuclear deal is reached between Iran and world powers in Vienna, it will be a highly technical road map to be used to monitor nuclear activity in Iran for years to come to ensure Tehran does not make nuclear weapons. Equally as complicated will be dismantling international sanctions that were originally intended to be ironclad. VOA’s Heather Murdock talks to experts about the key challenges any deal will present.
Video

Video Rice Farmers Frustrated As Drought Grips Thailand

A severe drought in Thailand is limiting the growing season of the country’s important rice crop. Farmers are blaming the government for not doing more to protect a key export. Steve Sandford reports from Chiang Mai, Thailand.
Video

Video Making Music, Fleeing Bombs: New Film on Sudan’s Internal Refugees

In 2012, Sudanese filmmaker Hajooj Kuka went to make a documentary among civil war refugees in Sudan’s Blue Nile and Nuba Mountains region. What he found surprised him: music was helping to save people from bombing raids by their own government. VOA’s Carolyn Weaver has more.
Video

Video 'From This Day Forward' Reveals Difficult Journey of Transgender Parent

In her documentary, "From This Day Forward", filmmaker Sharon Shattuck reveals the personal journey of her transgender father, as he told his family that he always felt he was a woman inside and decided to live as one. VOA’s Penelope Poulou has more.
Video

Video Floodwaters Threaten Iconic American Home

The Farnsworth House in the Midwest State of Illinois is one of the most iconic homes in America. Thousands of tourists visit the site every year. Its location near a river inspired the design of the house, but, as VOA’s Kane Farabaugh reports, that very location is now threatening the existence of this National Historic Landmark.
Video

Video Olympics Construction Scars Sacred Korean Mountain

Environmentalists in South Korea are protesting a Winter Olympics construction project to build a ski slope through a 500-year-old protected forest. Brian Padden reports that although there is strong national support for hosting the 2018 Pyeongchang Winter Olympics, there are growing public concerns over the costs and possible ecological damage at the revered mountain.
Video

Video Xenophobia Victims in South Africa Flee Violence, Then Return

Many Malawians fled South Africa early this year after xenophobic attacks on African immigrants. But many quickly found life was no better at home and have returned to South Africa – often illegally and without jobs, and facing the tough task of having to start over. Lameck Masina and Anita Powell file from Johannesburg.
Video

Video Family of American Marine Calls for Release From Iranian Prison

As the crowd of journalists covering the Iran talks swells, so too do the opportunities for media coverage.  Hoping to catch the attention of high-level diplomats, the family of American-Iranian marine Amir Hekmati is in Vienna, pleading for his release from an Iranian prison after nearly 4 years.  VOA’s Heather Murdock reports from Vienna.
Video

Video UK Holds Terror Drill as MPs Mull Tunisia Response

After pledging a tough response to last Friday’s terror attack in Tunisia, which came just days before the 10th anniversary of the bomb attacks on London’s transport network, British security services are shifting their focus to overseas counter-terror operations. VOA's Henry Ridgwell has more.
Video

Video Obama on Cuba: This is What Change Looks Like

President Barack Obama says the United States will soon reopen its embassy in Cuba for the first time since 1961, ending a half-century of isolation. VOA White House correspondent Luis Ramirez reports.
Video

Video Hate Groups Spread Influence Via Internet

Hate groups of various kinds are using the Internet for propaganda and recruitment, and a Jewish human rights organization that monitors these groups, the Simon Wiesenthal Center, says their influence is growing. The messages are different, but the calls to hatred or violence are similar. VOA's Mike O’Sullivan reports.
Video

Video Blind Somali Journalist Defies Odds in Mogadishu

Despite improving security in the last few years, Somalia remains one of the most dangerous countries to be a journalist – even more so for someone who cannot see. Abdulaziz Billow has the story of journalist Abdifatah Hassan Kalgacal, who has been reporting from the Somali capital for the last decade despite being blind.

VOA Blogs