E-DRUG: Indian substandard products in Africa
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Dear E-druggers,
This post is about substandard Indian products and not others because India
is a major supplier for medicines in Africa. Please don't misunderstand the
purpose of this post.
I, or anybody else can’t ignore India’s important role in supplying Africa
with the affordable HIV/AIDS products, without which, more than 80% of
HIV/AIDS patients might not be able to have access to their doses. For such
kind of medicines, quality is mostly assured not only by the manufacturers,
but it is assured by the NGO or third party organization which normally
require manufacturing site inspection or a WHO prequalification. A quick
look at the prequalified medicines in WHO website, we can easily figure out
how important is the Indian generic versions of the life saving products. [
http://apps.who.int/prequal/query/ProductRegistry.aspx\]
How about other essential medicines like antibiotics, antivirals,
anthelmintics, anti-inflammatory drugs..etc? India still is a major
supplier for those drugs in Africa. These kind of medicines normally are
only subjects for approval by the national regulatory authority in the
respective country.
It’s been a while since I came across a pharmaceutical manufacturer in
India, Flamingo Pharmaceuticals, LTD. which has been accredited some
international approvals as in their website:
Flamingo products are qualitative therapeutics which is affordable to one
and all. The products manufactured at Flamingo confirm to national and
international quality standards of WHO-GMP, UK-MHRA / EU-GMP and various
other approvals
Flamingo Pharmaceuticals exports to many African countries like Sudan,
Kenya, Ethiopia, Madagascar, Uganda and others ( As mentioned in their
website). Few weeks ago, I read in the news about the ban of their products
in Uganda by the Uganda national drug authority due to failure to comply
with cGMP. Full story can be found in this link:
Having FP products banned in Uganda and not in many other African countries
where its products are marketed raises many fears about having substandard
products marketed in this region.
This case is not something new. No one can deny the doubts about the
quality of the Indian pharmaceuticals. A study was done to randomly check
substandard products in two regions in India. The following result was
found:
12% of all samples tested from Delhi failed either one or both tests, and
were substandard. 5% of all samples tested from Chennai failed either one
or both tests, and were substandard. Spatial heterogeneity between
pharmacies was observed, with some having more or less substandard drugs
(30% and 0% respectively), as was product heterogeneity, with some drugs
being more or less frequently substandard (12% and 7% respectively).
Full Study can be found in this link:
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2695555/
Not to forget the study was done on the Indian local market which the NMRA
controls but how about products for export and how about the products for
export to lowly regulated countries?
The basic analysis for such case of Flamingo Pharmaceuticals which I see as
a representative of many Indian products, is that cheap is cheap. No magic
can be done to produce quality product so much cheaper than the others and
still keep a profit, unless the product is subsidized by a third party like
a government or NGO. Although the cheap labour and the fact that India is a
major producer for chemicals and raw materials used in manufacturing of
pharmaceuticals, prices of medicines produced in India can’t reach 5 times
less than the same generic produced by another factory in India or another
country. Drug prices isn’t only built out of materials prices, there are
many other factors that contribute to the final price. Every good
manufacturing, storage, laboratory and transportation practice is a cost
which is usually built in the final price of the product. Be assured there
is no magical shortcut, it is a simple math, 1+1 can’t be still 1.
Back to analysing what usually happens with some of “so cheap” generic
manufacturers. A full complete product dossier is usually submitted with
quality samples to the strict NMRA with a ready to inspect manufacturing
site. Once the approval is granted, the violations starts. Violations are
usually made for reducing of costs and also can happen due to uncontrolled
human resources. These violations will eventually result in substandard
products. Examples are:
1- The use of cheap out of specification active ingredient, excipients
and/or packaging materials.
2-Skipping quality-critical manufacturing steps (dispensing/weighing,
washing or blowing of primary packing material..etc) which is done normally
to increase capacity of production and save cost of extra labor.
3- Repacking batches with allocating new batch NO. and new expiry date.
4- Skipping in process controls to save cost and speed up the production.
5- Skipping microbial testing and/or chemical assays.
6- Affecting the quality of he product by storage unapproved conditions
during warehousing or transportation.
7- And I hope I don’t misunderstood and flamed for this, cheap labour is not
good and good labour isn’t cheap. Simply a well trained, educated and
careful labour can’t be cheap, unless you compromise the quality of the
labour, you can’t get a cheap labour.
I personally know some countries that took very dramatic actions like not
allowing registering an Indian product ( Although it is not clearly
mentioned in their guidelines) in their market. Others add more strict
requirements to prove the quality of the finished products and only allows
the importing of products of high shortage in the local market and they
require the product to be freely sold in a highly regulated country like
US, Europe or Japan. Yes, honestly speaking they are stereotyping a lot
when it comes to Indian or Asian product in general. You can’t blame them
after all.
Although some African NMRA’s are getting stronger and adopting highly
regulated guidelines for approving medicines, there are still many
countries with very weak medicines regulatory policies, not to mention the
ports security and integrity in some African countries which allows not
only substandard products but also counterfeited products to enter the
country.
It is difficult to find an straight forward solution for such an issue. WHO
has issued Interventions for prevention and control of
substandard/spurious/falsely labelled/falsified and/or counterfeit medical
products in the WHO African Region, can be found in this link:
A few opinions I’d like to mention:
1- Creating and enforcing a unified registration systems between the
neighbouring countries shall minimize the existence and the releasing of out
of specification batches.
2- Enforcing a system of violation monitoring and control which puts in
effect a high scale of penalties from expensive fines to suspension,
cancellation or ban of a product or a company.
3- Enforcing a system of post marketing surveillance and drug quality
reporting system, which actually seemed to be the real problem behind the
existence of a substandard product in the market even though the product
has obtained an approval from the NMRA. It’s usually because of the
violation of the formulation or manufacturing approved process after the
approval has been granted.
4- Of course relying on a third party with high quality standards to pass
the Indian products into the country is not a suitable solution and it
won’t make any development for the NMRA staff but it is very important to
use documented evidences and history checks before approval of a certain
manufacturer to see if it has been suspended or rejected for a product and
reasons and actions taken.
I really appreciates if you have more opinions or inputs to share with me.
Thanks for reading.
Respectfully,
Ahmed Abdelwahab Rady
Kuala Lumpur,
Malaysia
03 SEPT 2012