[Ip-health] Bill Haddad/CIPLA statement on WHO prequalification

[James Love]

This from Bill Haddad.  jamie

-------- Original Message --------
Subject: 	Pse Post on the Various networks for me...bill haddad
Date: 	Wed, 16 Jun 2004 14:51:28 EDT
From: 	WFHADDAD@aol.com
To: 	james.love@cptech.org, mpalmedo@cptech.org

June 16, 2004

I was asked to post the following statement from Cipla concerning
the media report that two ARV products being withdrawn from the WHO
qualification list.

Cipla was unable to respond last night because the Hudson Institute
began to solicit media after corporate Cipla in Mumbai, India had closed
for the day.  Dr. Amar Lulla, Cipla's Managing Director has been
responding to NGOs and UN agencies about the status of the revalidation
of two ARV singles, Lamivudine (3TC) and zidovudine (AZT). *

Here are the facts:

Three years ago, in accordance with regulatory requirements, Cipla
submitted the two above mentioned products to a CRO (Contract Research
Organization) for investigation. The CRO report ... the bio study ...
indicated no problems when compared to the European versions of these
products. In the intervening years, several international regulatory
authorities visited the CRO and from what can be determine found their
procedures were in accordance with international requirements. The CRO
serviced a number of companies.

In a routine and intimate follow-up inquiry by WHO and Cipla, it was
discovered that the necessary back-up documentation at the CRO did not
meet accepted standards.

Cipla immediately and voluntarily withdrew the products and resubmitted
them to another CRO for investigation. In accordance with its
requirements and standards, WHO removed the two products from their
prequalification list until the new data is received and evaluated. This
information was published on the WHO web site leading to a number of
inquiries to Cipla which were expeditiously answered.

Independently, one of the two Cipla products, Lamivudine, using FDA
standards and requirements, was successfully evaluated against the brand
product marketed in the United States. Cipla asked for and received
permission to submit this information to WHO.

There has never been any question with regard to the quality of the two
products or Cipla's facilities.

Cipla conducts approximately thirty or more bioequivalence studies a
year in CROs in India and elsewhere in the world.

What follows  is /_not_/ offered in explanation of the current
situation but is noted to provide context:

"While bio studies are monitored at critical time points it is
physically impossible to check every detail either in India or anywhere
else in the world. The CRO in question is certified for GCP and GLP by
various international agencies. From time to time there are instances of
bioequivalence centers not meeting or being inadequate in their
documentation and record keeping. For example, last year a CRO in
Switzerland was found to be inadequate and a number of licenses for a
product were canceled in Europe. /_However, there is no denial that the
responsibility for a biostudy rests with the sponsor, in this case
Cipla."_/

Finally:

Cipla stands by the quality, safety and effectiveness of these two
products and is committed to completing the biostudies in the shortest
time possible and looks forward to having them restored to the WHO
qualification list. Those who doubt WHO's qualification procedures and
follow-through should take heart at this unfortunate development.*

As has been reported, these two WHO qualified products are available
from other sources so no lag in the supply chain exists.*

This clarification came from Dr. Amar Lulla, Managing Director of Cipla
who is available to interested media and other parties at
91-222-307-0385 (Cipla, Mumbai).

Thanks for listening.