Writeback: Clarifications, rejoinders, suggestions

This refers to a report titled, 8216;8216;Govt8217;s TB drugs fail Jharkhand test8217;8217;, dated August 4, 2003 which talked about Lu...

This refers to a report titled, 8216;8216;Govt8217;s TB drugs fail Jharkhand test8217;8217;, dated August 4, 2003 which talked about Lupin8217;s anti-TB drugs being declared substandard by a laboratory in Jharkhand. Being among the largest pharma companies in the country and a global leader in anti-TB drugs, we cannot take such accusations lightly.

We present to you the facts:

The same samples that have been reported below par on quality have been already checked by an authorised government laboratory, the Central Drug Laboratory in Kolkata. This is part of the standard operating procedure for drugs supplied to the government. The samples conformed to all required standards. Not only that, the internal analysis of stocks of the same drugs at the time of supply as happens with all our orders and subsequent to publishing of the news article establishes that our drugs comply with the required standards.

Among Indian companies, Lupin has one of the largest number of plants approved by the USFDA, UKMCA and WHO. We are supplying our formulations as well as bulk drugs to the most advanced markets such as the US and many other regulated markets. Without adhering to stringent quality control norms, our foray into the advanced markets would not have been possible.

Lupin is the world8217;s largest manufacturer of anti-TB drugs; over 40 years, we have helped millions of patients all over the world suffering from TB.

Lupin supplies drugs to some of the world8217;s most prominent pharmaceutical companies; in fact, most of our manufacturing capacities have been booked in advance by our international customers.

Lupin has not been informed of any such samples of our products being picked up for analysis by FDA authorities of Jharkhand. Neither have the reported results of the analysis of such a test, nor any government notification, been issued to Lupin as per the procedure laid down in the Indian Drugs and Cosmetics Act.

Not having the details of the reports at our command, we can only submit that drug quality and efficacy is not simply a function of manufacturing standards. Improper storage and handling can also result in damage to quality. Furthermore, quality testing laboratories must conform to international standards. Such laboratories must not only have proper equipment, they must have strict processes, and qualified and well-trained analysts.

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We are separately taking up the matter with the Jharkhand Drug Controller8217;s office. Senior members of our quality assurance team are getting in touch with them to ascertain facts of the case and get copies of the report to discuss the discrepancies between their findings and all other test reports from ours as well as other authorised government laboratories.

Anuradha Altekar
Head, Corporate Communications
Lupin Limited
Mumbai

Manoj Prasad replies: The newspaper just reported the ban imposed by the Jharkhand Drug Administration and what the State Drug Controller had to say about it.