[e-drug] Are Indian Companies selling Poor Quality Drugs in Africa?

e-drug
1

E-DRUG: Are Indian Companies selling Poor Quality Drugs in Africa?
----------------------------------------------------------------------------------------

Dear E-druggers,

According to findings from a recent study some Indian generic drug
companies are exporting lower quality drugs including TB drugs in Africa
compared to the quality of the same drugs they sell at home and non-African
countries. If true, this report is alarming to say the least and calls for
increased action and efforts to strengthen the regulatory systems in
resource-limited countries. I have copied the abstract of the study at the
end of this note.

Best wishes,

Rizwan
--------------------------

*Poor Quality Drugs and Global Trade: A Pilot Study*

Abstract:
Experts claim that some Indian drug manufacturers cut corners and make
substandard drugs for markets with non-existent, under-developed or
emerging regulatory oversight, notably Africa. This paper assesses the
quality of 1470 antibiotic and tuberculosis drug samples that claim to be
made in India and were sold in Africa, India, and five mid-income
non-African countries. We find that 10.9% of those products fail a basic
assessment of active pharmaceutical ingredients (API), and the majority of
the failures are substandard (7%) as they contain some correct API but the
amount of API is under-dosed. The distribution of these substandard
products is not random: they are more likely to be found as unregistered
products in Africa than in India or non-African countries. Since this
finding is robust for manufacturer-drug fixed effects, one likely
explanation is that Indian pharmaceutical firms and/or their export
intermediaries do indeed differentiate drug quality according to the
destination of consumption.

Bate, Roger and Jin, Ginger Zhe and Mathur, Aparna and Attaran, Amir, Poor
Quality Drugs and Global Trade: A Pilot Study (September 2014). NBER
Working Paper No. w20469. Available at SSRN:http://ssrn.com/abstract=2492979

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
Email: drugsafetyconsultant@gmail.com
www.drugsafetyconsultant.com

2

E-Drug: Are Indian Companies selling Poor Quality Drugs in Africa? (3/4)
----------------------------------------------------------------------------------------------
[Message and response posted together]

Dear e-druggers,

Do you think this study report could be a step in a war of propaganda against generics?
Just asking, no affirmation is implied.

Olena Wagner
Olena Wagner <Olena.Wagner@theglobalfund.org>

Dear E-druggers,

Olena has a valid argument and as I stated in my first posting, "If true, this report is alarming to say the least and calls for increased action and efforts to strengthen the regulatory systems in resource-limited countries."
Because a large number of international donor groups and governments depend on the Indian pharmaceutical industry as a source to provide low-cost generics to the public health programs around the world, as a first step a detailed critique of the study is warranted.

The full report is needed with the full disclosure on the methodology, source of the samples; and how and who did the analyses and where; who funded the study; did the funders have any input on the study design and findings before being released; did the authors have any conflict of interest, etc.

There is no question that Indian pharmaceutical industry is very advanced and have played a significant part in providing access to cheap essential medicines in resource-limited countries. However, it is also true that news about Indian companies exporting poor quality drugs overseas including in Africa is not new.

The oversight of Indian pharmaceutical industry is lax - there are not many trained drug inspectors to do the necessary and timely inspections, a fact that even the Indian government has recognized. There was recent report that the Indian government were hiring several thousand drug inspectors. And in the recent past, the U.S. FDA has sanctioned a number of Indian companies for their manufacturing lapses.

Thank you again Olena for your posting.

Best wishes,

Rizwan

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
Email: drugsafetyconsultant@gmail.com
www.drugsafetyconsultant.com

3

E-DRUG: Are Indian Companies selling Poor Quality Drugs in Africa? (2)
-------------------------------------------------------------------------------------------------

E-druggers,

Interesting article although I will solicit that further work be done on this.

The rate limiting point of every health care system when it comes to medicines is the strength of its Regulatory body which is something that can only be done by the people themselves and not wait for any intervention from the donors. Unless the people push for that, this all important part of our health system will be pushed further to the abyss as it is not easily seen as an achievement in politics!!!

Regards,

Jiru Bako
Crown Agents
"Bako, Jiru" <Jiru.Bako@ng.crownagents.com>