Letter from the Indian Network for People Living with HIV/AIDS to Prime Minister Manmohan Singh on Protection of Pharmaceutical Test Data

June 28, 2006

Dr. Manmohan Singh
Hon'ble Prime Minister of India

The Prime Minister's Office
South Block, Raisina Hill,
New Delhi,
India-110 011.
Telephone: 91-11-23012312
Fax: 91-11-23019545 / 91-11-23016857
New Delhi

Dear Prime Minister,

I write to you on behalf of the Indian Network for People Living with HIV/AIDS (INP+). INP+ is a national network for, by and of people living with HIV/AIDS (PLHA) in India. We started in 1997 as a support group, and have now grown into a national movement of 22 affiliated State Level Networks, 106 District Level Networks and more than 32,000 members across the country.

In the past few years' availability of affordable generic medicines manufactured in India has changed the nature of HIV/AIDS in India and around the world - from a life threatening disease to a manageable chronic disease. However whether we have a life threatening disease or a chronic one is dependent on one major factor - the continued availability of affordable generic antiretroviral medicines.

For a combination of three essential antiretroviral drugs from $ 10,439 per patient per year, prices have fallen to $ 150 per patient per year in a matter of four years (2001 - 2005) because of generic production and competition from India. The impact of price reduction on the availability of essential AIDS medicines is evident - the government of India is currently treating 20, 000 PLHAs and hopes to upscale to 100, 000 PLHAs in the coming year.

With the 2005 Patents (amendment) Act, which provides for granting patents on pharmaceuticals INP+ is being forced to take up prolonged and complicated legal battles to prevent the patenting of antiretrovirals used in the treatment of AIDS. Many of these applications are related to claims that are not related to 'new chemical entities' but are derivatives (salts, polymorphs) of older (pre-1995) drugs.

We have now come to know through media reports that the government is considering an amendment to the Drugs and Cosmetic Act. This move is apparently related to the Government of India's commitments under the TRIPS agreement; specifically Article 39.3 of TRIPS. The clinical trial data that originator companies submit to Regulatory Authorities (anywhere in the world) are at the centre of the debate on Article 39.3.

Based on the briefing note published by the World Health Organisation, there are two legal options before the government of India:

  1. Data protection i.e. i.e. non - disclosure of clinical trial data to third parties. This according to WHO will be TRIPS compliant and at the same time will not interfere with the work of a government body (the drug regulator) if he/she relies on clinical trial data to approve of affordable generic essential drugs.

  2. Data Exclusivity i.e. a certain length of time during which the Regulatory Authority is prohibited from relying on the available clinical trial data in order to register a generic version of the same product.

However data exclusivity could prevent the registration of generic versions of medicines even when there is no patent on a medicine, for example when a pharmaceutical does not meet the standards for patentability (e.g. because it is not new).

A delay in registration i.e. marketing approval can seriously impact the lives of people living with HIV/AIDS who face the threat of drug resistance every four years and are therefore dependent on generic manufacture in India to access newer drugs and treatment at affordable prices. We also remain highly susceptible to other infections; for instance as you may be aware HIV and TB co-infection is of increasing concern for persons living with HIV/AIDS. Access to affordable essential drugs for opportunistic infections is also critical in ensuring long, healthy and productive lives for persons living with HIV/AIDS.

The UPA in its Common Minimum Programme, had assured us that the government will "take all steps to ensure availability of life saving drugs at affordable prices". More recently we have been heartened by the Government of India's commitment to ensuring access to healthcare for all as evidenced by its role at the UNGASS review meeting in May 2006. The Indian delegation in the face of stiff resistance succeeded in getting global political commitment reaffirming that TRIPS "can and should be interpreted and implemented in a manner supportive of the right to protect public health and, in particular, to promote access to medicines for all including production of generic antiretroviral drugs and other essential drugs for AIDS- related infections."

An inter-ministerial task force will meet on July 12, 06 to decide on the two options - data protection or data exclusivity. We therefore strongly urge you to take into consideration public health needs of patients in India and other developing countries when implementing Article 39.3 of the TRIPS Agreement. We request you to ensure that generic competition remains viable and possible in India. So many of us are depending on it for access to affordable medicines worldwide. For us it is a matter of life and death.


K.K. Abraham
Indian Network for People Living with HIV/AIDS
Tel: 09840066386
Flat No: 6, Kash Towers,
#93, South West Boag Road,
T. Nagar, Chennai -17


Sri Ramvilas Paswan, Hon'ble Minister of Chemicals and Fertilizers; Shastri Bhawan, Dr. Rajendra Prasad Road, New Delhi 110 001, Tel: 23386519, Fax: 23384020; Dr Anbumani Ramadoss, Hon'ble Minster of Health and Family Welfare; Nirman Bhavan, Maulana Azad RoadNew Delhi 110011, Tel: 23061751, Fax: 23062358; Sri Kamal Nath, Hon'ble Minster of Commerce & Industry, Room No. 45, Udyog Bhavan, New Delhi, Tel: 23061008, Fax: 23012947; Mrs. Sonia GandhiPresident, Indian National Congress Party & Member of Parliament, 10, Janpath New Delhi 110 001 Tel: 23014161, 23012656

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