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Indian generic drug manufacturers in the spotlight
Editorial
Corbis
PTSD care, out of service
To read the IOM report see http://www.iom.edu/ Reports/2014/Treatment-forPosttraumatic-Stress-Disorderin-Military-and-VeteranPopulations-Final-Assessment/ Report-Brief-062014.aspx
2·6 million of the 22 million veterans in the USA served in Afghanistan and Iraq, and many suffer from serious and long-term physical and mental disabilities. Post-traumatic stress disorder (PTSD), a “signature” disability of the Afghanistan and Iraq conflicts, affects an estimated 7–20% of active service people and veterans. In 2012 alone, more than 500 000 veterans sought treatment for PTSD at Veterans Affairs (VA) facilities. With the heavy human cost and financial burden that PTSD places on the VA system, what is being done to ensure that veterans are receiving adequate and timely care? Not enough according to a highly critical report issued on June 20, 2014, by the Institute of Medicine (IOM). The assessment, Treatment for Posttraumatic Stress Disorder in Military and Veteran Populations, was commissioned by the Department of Defense (DoD) and VA to look at the treatment methods and programmes in place and to identify the efficacy and adequacy of those programmes. The result is a document that lambasts a chaotic and fragmented system. PTSD care
at the DoD is described as “local, ad hoc, incremental, and crisis-driven”, and although the VA fares somewhat better, it has failed to improve and expand programmes to meet the increasing burden. Under current organisational schemas, there is no coordination between DoD and VA efforts to establish best practices, nor a unified treatment and research strategy. In 2012, the DoD and VA spent about US$294 million and $3 billion, respectively, on PTSD care for service members and veterans. A bill passed by the Senate in May, 2014, would increase federal funding to the VA by another $50 billion, earmarked to add staff, facilities, and services. Without adopting recommendations such as those outlined by the IOM—setting comprehensive standards, developing patient monitoring and reporting systems, and measuring outcomes and performance— the financial investments in the DoD and VA are unlikely to produce results. As the demand for PTSD treatment surges, the need is urgent, the shortcomings obvious, and the obligation to veterans is clear. n The Lancet
Wladimir Bulgar/Science Photo Library
Indian generic drug manufacturers in the spotlight
See Comment Lancet 2014; published online June 27. http://dx.doi.org/10.1016/ S0140-6736(13)60845-4 For the enforcement report of Dr Reddy’s recall see http:// www.accessdata.fda.gov/scripts/ enforcement/enforce_rptProduct-Tabs. cfm?action=select&recall_ number=D-13812014&w=06182014&lang=eng For the report on class 2 medicines recall: clarithromycin see http://www.mhra.gov.uk/ Publications/Safetywarnings/ DrugAlerts/CON426899
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Concerns have arisen about safety and quality issues in the manufacture of pharmaceuticals in India, a major exporter of generic drugs to the USA and elsewhere. These concerns came into sharp focus last week when the US Food and Drug Administration (FDA) and UK Medicines and Healthcare Products Regulatory Agency (MHRA) issued two recalls of commonly taken drugs. On June 19, the FDA recalled 13 560 bottles of the antihypertensive drug, metoprolol succinate, from Dr Reddy’s laboratory after a failed dissolution test. On June 18, the MHRA reported the recall of batches of clarithromycin, an injectable antibiotic, owing to possible impurities from the India-based US generic pharmaceutical company, Mylan. India’s pharmaceutical industry has had remarkable growth since the early 1970s, when patents on drugs were abolished. In 1994, the World Trade Organization (WTO) negotiated trade-related aspects of intellectual property rights with the Indian Government, but it took until 2005 for the changes required by the WTO to be implemented. Patents were limited in some areas, unless they resulted in a drug with improved efficacy.
As interpreted by Indian courts, these changes restrict international companies from extending monopolies on existing medicines, such as generic antiretroviral drugs. These cheap generic drugs have saved millions of lives in developing countries. In a Lancet Comment published online, Amir Attaran discusses failings in India’s system of drug regulation, including weak regulatory oversight and poor quality control by some drug manufacturers. Although India is known as the pharmacy of the developing world, the country’s reputation as a supplier of safe, affordable drugs is now in jeopardy. To restore the reputation of its pharmaceutical industry and protect global competitiveness, it is encouraging that India’s Government plans to spend about US$500 million over 5 years to strengthen pharmaceutical education and research, and to train its manufacturing workforce and state regulators. But more immediately, India’s Government needs to act quickly and decisively to address the quality and safety concerns of its medicines which are a lifeline to many worldwide. n The Lancet www.thelancet.com Vol 383 June 28, 2014
Corbis
PTSD care, out of service
To read the IOM report see http://www.iom.edu/ Reports/2014/Treatment-forPosttraumatic-Stress-Disorderin-Military-and-VeteranPopulations-Final-Assessment/ Report-Brief-062014.aspx
2·6 million of the 22 million veterans in the USA served in Afghanistan and Iraq, and many suffer from serious and long-term physical and mental disabilities. Post-traumatic stress disorder (PTSD), a “signature” disability of the Afghanistan and Iraq conflicts, affects an estimated 7–20% of active service people and veterans. In 2012 alone, more than 500 000 veterans sought treatment for PTSD at Veterans Affairs (VA) facilities. With the heavy human cost and financial burden that PTSD places on the VA system, what is being done to ensure that veterans are receiving adequate and timely care? Not enough according to a highly critical report issued on June 20, 2014, by the Institute of Medicine (IOM). The assessment, Treatment for Posttraumatic Stress Disorder in Military and Veteran Populations, was commissioned by the Department of Defense (DoD) and VA to look at the treatment methods and programmes in place and to identify the efficacy and adequacy of those programmes. The result is a document that lambasts a chaotic and fragmented system. PTSD care
at the DoD is described as “local, ad hoc, incremental, and crisis-driven”, and although the VA fares somewhat better, it has failed to improve and expand programmes to meet the increasing burden. Under current organisational schemas, there is no coordination between DoD and VA efforts to establish best practices, nor a unified treatment and research strategy. In 2012, the DoD and VA spent about US$294 million and $3 billion, respectively, on PTSD care for service members and veterans. A bill passed by the Senate in May, 2014, would increase federal funding to the VA by another $50 billion, earmarked to add staff, facilities, and services. Without adopting recommendations such as those outlined by the IOM—setting comprehensive standards, developing patient monitoring and reporting systems, and measuring outcomes and performance— the financial investments in the DoD and VA are unlikely to produce results. As the demand for PTSD treatment surges, the need is urgent, the shortcomings obvious, and the obligation to veterans is clear. n The Lancet
Wladimir Bulgar/Science Photo Library
Indian generic drug manufacturers in the spotlight
See Comment Lancet 2014; published online June 27. http://dx.doi.org/10.1016/ S0140-6736(13)60845-4 For the enforcement report of Dr Reddy’s recall see http:// www.accessdata.fda.gov/scripts/ enforcement/enforce_rptProduct-Tabs. cfm?action=select&recall_ number=D-13812014&w=06182014&lang=eng For the report on class 2 medicines recall: clarithromycin see http://www.mhra.gov.uk/ Publications/Safetywarnings/ DrugAlerts/CON426899
2186
Concerns have arisen about safety and quality issues in the manufacture of pharmaceuticals in India, a major exporter of generic drugs to the USA and elsewhere. These concerns came into sharp focus last week when the US Food and Drug Administration (FDA) and UK Medicines and Healthcare Products Regulatory Agency (MHRA) issued two recalls of commonly taken drugs. On June 19, the FDA recalled 13 560 bottles of the antihypertensive drug, metoprolol succinate, from Dr Reddy’s laboratory after a failed dissolution test. On June 18, the MHRA reported the recall of batches of clarithromycin, an injectable antibiotic, owing to possible impurities from the India-based US generic pharmaceutical company, Mylan. India’s pharmaceutical industry has had remarkable growth since the early 1970s, when patents on drugs were abolished. In 1994, the World Trade Organization (WTO) negotiated trade-related aspects of intellectual property rights with the Indian Government, but it took until 2005 for the changes required by the WTO to be implemented. Patents were limited in some areas, unless they resulted in a drug with improved efficacy.
As interpreted by Indian courts, these changes restrict international companies from extending monopolies on existing medicines, such as generic antiretroviral drugs. These cheap generic drugs have saved millions of lives in developing countries. In a Lancet Comment published online, Amir Attaran discusses failings in India’s system of drug regulation, including weak regulatory oversight and poor quality control by some drug manufacturers. Although India is known as the pharmacy of the developing world, the country’s reputation as a supplier of safe, affordable drugs is now in jeopardy. To restore the reputation of its pharmaceutical industry and protect global competitiveness, it is encouraging that India’s Government plans to spend about US$500 million over 5 years to strengthen pharmaceutical education and research, and to train its manufacturing workforce and state regulators. But more immediately, India’s Government needs to act quickly and decisively to address the quality and safety concerns of its medicines which are a lifeline to many worldwide. n The Lancet www.thelancet.com Vol 383 June 28, 2014