The article ignores several facts which would be important considerations in the Role of Indian Generics.
For one, in the opening section on Background, the article states that the ARV provision has been of "quality assured medicines". In the WHO Prequalification Programme, it only states that the drugs are of "an acceptable quality", yet offers no definition of this statement. Since this is one attribute of drug regulation, WHO further states in every edition of Prequalification that the drugs are "not warranted for safety and/or efficacy if used in the treatment of HIV/AIDS".
Secondly, the article proports that all Indian manufactured ARVs are generic products when in fact many are copies with no regulatory approvals.
In May 2004, WHO had to de-list 18 of the ARVs on its Prequalification Programme. In a public statement, it commented that the reason for doing this was because they lacked proof of bioequivalency to the reference product.
At this point, the US FDA stepped in and offere to any manufacturer, of any ARV, that wished to submit its files the opportunity to have them classified as true generics. Since most were from Indian manufacturers, the FDA had to offer the patent holders the right to lodge a legal challenge. None did so.
As of December 2007, only 2 ARVs on WHO's Prequalification Programme had been certified as true generics by the FDA out of the 162 different products listed. Another 19 had been granted "tentative approval by the FDA".
As of October 2009, the FDA announced that 100 ARVs or OIs had been granted status as true generics.
The remaining ARVs or OIs on WHO's Prequalification Programme that are not offered directly by patent holders are copy drugs. By definition of stringent regulatory authorities, these are substandard drugs.
Lastly, there is no Indian manufacturer that has produced an innovative or patentable ARV or OI. While India may dominate the ARV market, it does so with the intellectual property of others.
As one of the co-authors, UNITAID might well have stated that while it procures ARVs and OIs that have only been approved by WHO, it then remits to WHO a commission for each drug purchased. Further, while these drugs are approved by WHO, its sole metric is GMP--a certificate which it issues. This is a manufacturing standard rather than a product standard.
These facts would have mitigated the statement that "the analyses quantify and confirm the exceptional role that India has played in providing quality ARVs to people with HIV/AIDS". When the ARVs or OIs have not been approved by a regulatory authority, they violate the UN Universal Declaration on Human Rights and its provision for informed consent with patients.
Sincerely, Jeremiah Norris Director Center for Science in Public Policy Hudson Institute Washington, DC
Competing interests
None declared
Response to comment posted by Jeremiah Norris
Mirjam Eckert, World Health Organization
28 October 2010
We are sorry to see yet another muddled and misinformed statement by the Hudson Institute. We wonder how a Center for Science in Public Policy can ignore the most basic requirement for science: to verify the facts. For example, generic medicines legally registered and produced in India according to Indian patent law and regulations, are not copy drugs but legal products in their own right. The statement that they would become 'true generics' by FDA approval is misformed.
While UNITAID has contracted WHO to assist in its quality assurance programme for all medicines procured with UNITAID funds, there is no volume-related commission which would create a conflict of interest. Jeremiah Norris should check his facts before making such unfounded accusations against WHO or its public interest partners.
Dr Hans V. Hogerzeil Director Essential Medicines and Pharmaceutical Policies World Health Organization
Article Ignores Several Facts
4 October 2010
The article ignores several facts which would be important considerations in the Role of Indian Generics.
For one, in the opening section on Background, the article states that the ARV provision has been of "quality assured medicines". In the WHO Prequalification Programme, it only states that the drugs are of "an acceptable quality", yet offers no definition of this statement. Since this is one attribute of drug regulation, WHO further states in every edition of Prequalification that the drugs are "not warranted for safety and/or efficacy if used in the treatment of HIV/AIDS".
Secondly, the article proports that all Indian manufactured ARVs are generic products when in fact many are copies with no regulatory approvals.
In May 2004, WHO had to de-list 18 of the ARVs on its Prequalification Programme. In a public statement, it commented that the reason for doing this was because they lacked proof of bioequivalency to the reference product.
At this point, the US FDA stepped in and offere to any manufacturer, of any ARV, that wished to submit its files the opportunity to have them classified as true generics. Since most were from Indian manufacturers, the FDA had to offer the patent holders the right to lodge a legal challenge. None did so.
As of December 2007, only 2 ARVs on WHO's Prequalification Programme had been certified as true generics by the FDA out of the 162 different products listed. Another 19 had been granted "tentative approval by the FDA".
As of October 2009, the FDA announced that 100 ARVs or OIs had been granted status as true generics.
The remaining ARVs or OIs on WHO's Prequalification Programme that are not offered directly by patent holders are copy drugs. By definition of stringent regulatory authorities, these are substandard drugs.
Lastly, there is no Indian manufacturer that has produced an innovative or patentable ARV or OI. While India may dominate the ARV market, it does so with the intellectual property of others.
As one of the co-authors, UNITAID might well have stated that while it procures ARVs and OIs that have only been approved by WHO, it then remits to WHO a commission for each drug purchased. Further, while these drugs are approved by WHO, its sole metric is GMP--a certificate which it issues. This is a manufacturing standard rather than a product standard.
These facts would have mitigated the statement that "the analyses quantify and confirm the exceptional role that India has played in providing quality ARVs to people with HIV/AIDS". When the ARVs or OIs have not been approved by a regulatory authority, they violate the UN Universal Declaration on Human Rights and its provision for informed consent with patients.
Sincerely,
Jeremiah Norris
Director
Center for Science in Public Policy
Hudson Institute
Washington, DC
Competing interests
None declared
Response to comment posted by Jeremiah Norris
28 October 2010
We are sorry to see yet another muddled and misinformed statement by the Hudson Institute. We wonder how a Center for Science in Public Policy can ignore the most basic requirement for science: to verify the facts. For example, generic medicines legally registered and produced in India according to Indian patent law and regulations, are not copy drugs but legal products in their own right. The statement that they would become 'true generics' by FDA approval is misformed.
While UNITAID has contracted WHO to assist in its quality assurance programme for all medicines procured with UNITAID funds, there is no volume-related commission which would create a conflict of interest. Jeremiah Norris should check his facts before making such unfounded accusations against WHO or its public interest partners.
Dr Hans V. Hogerzeil
Director
Essential Medicines and Pharmaceutical Policies
World Health Organization
Competing interests
None declared