E-DRUG: Are Indian Companies selling Poor Quality Drugs in Africa? (5)
The recent topic discussed in E-drug about the quality of drugs exported by
Indian drug companies in Africa has now been covered by this week's Lancet.
Copied as fair use below for easy reference.
Indian generic drugs debate heats up
Lancet Vol 384; p.1334; Oct 11, 2014
India has strongly objected to the findings of new research that raises
questions about the quality of drugs manufactured in the country and
exported abroad. Sanjeet Bagcchi reports.
Findings from a new investigation have raised questions over the quality of
generic drugs manufactured in India and distributed for selling in Africa.
According to the study, generic drugs sold in Africa by some Indian drug
manufacturers are of substandard quality compared with the same drugs that
the companies distribute for selling in India and non-African countries.
The paper hasn't specified the name of any pharmaceutical company. The
Indian Government, however, has strongly objected to the findings, calling
the paper an 'irresponsible report'�.
Roger Bate from the American Enterprise Institute, Washington, DC, USA, and
coworkers assessed 1470 samples of antibiotic and tuberculosis drugs
claiming to be manufactured in India. The samples, as the researchers
noted, were collected (and tested for quality) from five Indian cities and
17 low-to-middle-income countries. 'We find that a significantly higher
fraction of these Indian-made drugs are of poorer quality if they were
purchased from Africa than from India or from non-African mid-income
countries such as China, Brazil, Turkey, Thailand and Russia', wrote the
'Although this paper has focused on Indian produced medicines, India is by
no means the only large exporter of drugs. Further research into the drug
quality of Chinese and other export countries would be useful to understand
how widespread the problem may be'�, they continued.
'Developing countries, particularly African ones using Indian medicines,
need to be more cautious', said one of the researchers, Amir Attaran,
University of Ottawa, Common Law Section, Ottawa, Canada. 'Tests by several
groups show that Indian medicines fail quality tests unacceptably often'�,
he told The Lancet. Attaran recommended that a wholesale replacement of
drug laws and regulatory institutions must be done in India.
Concerns about the safety and quality of generic drugs manufactured in
India'a major exporter of generic drugs to the USA and other countries, came
into focus in June this year, when the US Food and Drug Administration
(FDA) and UK Medicines and Healthcare Products Regulatory Agency (MHRA)
issued two recalls of often used drugs, 13 560 bottles of antihypertensive
metoprolol succinate were recalled by the FDA on June 19 (after a failed
dissolution test), and batches of antibiotic clarithromycin were recalled
by the MHRA (owing to possible impurities) on June 18. Last week, Health
Canada moved to ban the import of all drugs and drug ingredients from three
factories in India.
The research paper by Bate and coworkers, however, has sparked a backlash
in India. The India Brand Equity Foundation (IBEF), a trust established by
the Government of India's Department of Commerce at the Ministry of
Commerce and Industry, pointed out, 'It seems that the effort is to tarnish
the image of the Indian pharma industry, which it has painstakingly
developed over the years and is often recognised as 'Pharmacy of the
According to IBEF, 'The study has not been reviewed by any of the authors'
peers as is the gold standard in serious academic publishing. The study
cites anecdotal evidence and hearsay, quoted earlier in the authors' other
publications, as facts with established academic provenance.'
“Realising the serious damage that such an irresponsible report is trying
to make, the pharma industry has asked the Government of India to initiate
legal proceedings against all concerned”, IBEF added.
Attaran condemned the reaction: 'Academics publish research that irks
governments all the time, but no serious democracy ever sues them for it.
Not even North Korea or Russia stoops to that sort of thing.'
D G Shah, secretary general of Indian Pharmaceutical Alliance, an industry
body of 20 research-based Indian pharmaceutical companies, said, 'The
research paper] tarnishes the image of the Indian pharmaceutical industry.
It would be to the advantage of our adversaries as they can then sell more
expensive drugs to the poor countries.'
According to Shah, the steps India should take to address any concerns
include strengthening of regulatory infrastructure, regulatory capacity
building, and initiatives to curb unauthorised or merchant exports to
ensure stricter control of exported medicines.
Suerie Moon from the John F Kennedy School of Government, Harvard Kennedy
School, MA, USA, told The Lancet, 'As the authors [of the research paper]
themselves note, based on this study one cannot draw conclusions of the
intention or practices of the Indian generic industry as a whole. One could
reasonably conclude, however, that the quality of medicines available in
the market in both India and the sampled countries in Africa (which are not
named [in the research paper]) continue to be a concern and merit further
attention and research.'
Syed Rizwanuddin Ahmad, MD, MPH, FISPE, FCP
Consultant with Special Interest to Strengthen National Medicines
Regulatory Authorities in Resource-limited Countries
Formerly (1998-2013) with the U.S. Food and Drug Administration
Assistant Professor (adjunct), Georgetown University School of Medicine,
Washington, DC, USA