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

Scotland Vote Raises Questions of International Law

Experts say self-determination, as defined and protected by international law, confined narrowly to independence movements in process of de-colonization More

Video Whaling Summit Votes to Uphold Ban on Japan Whale Hunt

Conservationists hail ruling as a victory, but Tokyo says it will submit revised plans for a whale hunt in 2015 More

Annual Military Exercise Takes on New Meaning for Ukraine Troops

Troops from 15 nations participating in annual event, 'Rapid Trident' in western Ukraine More

Featured Videos

Your JavaScript is turned off or you have an old version of Adobe's Flash Player. Get the latest Flash player.
Russian Economy Reeling After New Western Sanctionsi
X
September 18, 2014 2:28 AM
A new wave of Western sanctions is hitting Russia’s economy hard. State-owned energy firms continue to bleed profits and Russia’s national currency plunged to a new low this week after the U.S. and the European Union announced new sanctions to punish Russia's aggressive stance in eastern Ukraine. But as Mil Arcega reports, the sanctions could also prove costly for European and American companies.
Video

Video Russian Economy Reeling After New Western Sanctions

A new wave of Western sanctions is hitting Russia’s economy hard. State-owned energy firms continue to bleed profits and Russia’s national currency plunged to a new low this week after the U.S. and the European Union announced new sanctions to punish Russia's aggressive stance in eastern Ukraine. But as Mil Arcega reports, the sanctions could also prove costly for European and American companies.
Video

Video Belgian Researchers Discover Way to Block Cancer Metastasis

Cancer remains one of the deadliest diseases, despite many new methods to combat it. Modern medicine has treatments to prevent the growth of primary tumor cells. But most cancer deaths are caused by metastasis, the stage when primary tumor cells change and move to other parts of the body. A team of Belgian scientists says it has found a way to prevent that process. Zlatica Hoke has more.
Video

Video Mogadishu's Flood of Foreign Workers Leaves Somalis Out of Work

Unemployment and conflict has forced many young Somalians out of the country in search of a better life. But a newfound stability in the once-lawless nation has created hope — and jobs — which, some say, are too often being filled by foreigners. Abdulaziz Billow reports from Mogadishu.
Video

Video A Dinosaur Fit for Land and Water

Residents and tourists in Washington D.C. can now examine a life-size replica of an unusual dinosaur that lived almost a hundred million years ago in northern Africa. Scientists say studying the behemoth named Spinosaurus helps them better understand how some prehistoric animals adapted to life on land and in water. The Spinosaurus replica is on display at the National Geographic museum. VOA’s George Putic has more.
Video

Video Iraqi Kurdistan Church Helps Christian Children Cope find shelter in churches in the Kurdish capital, Irbil

In the past six weeks, tens of thousands of Iraqi Christians have been forced to flee their homes by Islamic State militants and find shelter in churches in the Kurdish capital, Irbil. Despite U.S. airstrikes in the region, the prospect of people returning home is still very low and concerns are starting to grow over the impact this is having on the displaced youth. Sebastian Meyer reports from Irbil on how one church is coping.
Video

Video NASA Picks Boeing, SpaceX to Carry Astronauts Into Space

The U.S. space agency, NASA, has chosen Boeing and SpaceX companies to build the next generation of spacecraft that will carry U.S. astronauts to the International Space Station by the year 2017. The deal with private industry enables NASA to end its dependence on Russia to send space crews into low Earth orbit and back. Zlatica Hoke has more.
Video

Video Future of Ukrainian Former President's Estate Uncertain

More than six months after Ukraine's former President Viktor Yanukovych fled revolution to Russia, authorities have yet to gain control of his palatial estate. Protesters occupy the grounds and opened it to tourists but they are also refusing to turn it over to the state. VOA's Daniel Schearf reports from Mezhigirya, just north of Kyiv.
Video

Video China Muslims Work to Change Perceptions After Knife Attacks

China says its has sentenced three men to death and one woman to life in prison for a deadly knife attack in March that left more than 30 dead and 140 injured. Beijing says Muslim militants from China's restive western region of Xinjiang carried out the attacks. Now, more than six months after the incident, residents in the city are still coping with the aftermath. VOA's Bill Ide has more from Kunming.


Carnage and mayhem are part of daily life in northern Nigeria, the result of a terror campaign by the Islamist group Boko Haram. Fears are growing that Nigeria’s government may not know how to counter it, and may be making things worse. More

AppleAndroid