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RR RUEHAST RUEHHM RUEHLN RUEHMA RUEHPB RUEHPOD RUEHTM
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FM AMEMBASSY NEW DELHI
TO RUEHC/SECSTATE WASHDC 2945
RUEHCI/AMCONSUL KOLKATA 2569
RUEHCG/AMCONSUL CHENNAI 3311
RUEHBI/AMCONSUL MUMBAI 2387
RHEBAAA/DEPT OF ENERGY WASHDC
RUCPDC/NOAA NMFS WASHINGTON DC
RUEAUSA/DEPT OF HHS WASHDC
RUEHRC/DEPT OF AGRICULTURE WASHDC
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RUCPDOC/DEPT OF COMMERCE WASHDC
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RUEHZN/ENVIRONMENT SCIENCE AND TECHNOLOGY COLLECTIVE

UNCLAS SECTION 01 OF 06 NEW DELHI 002166 
 
STATE FOR OES/PCI, OES/STC, OES/SAT, OES/EGC, AND SCA/INS 
STATE FOR STAS 
STATE PASS TO NSF FOR INTERNATIONAL PROGRAMS 
HHS PASS TO NIH 
STATE PASS TO USAID 
STATE FOR SCA, OES (STAS FEDOROFF), OES/PCI STEWART; OES/IHB MURPHY 
PASS TO HHS/OGHA (STEIGER/ABDOO/VALDEZ), CDC (BLOUNT/FARRELL), 
NIH/FIC (GLASS/MAMPILLY/HANDLEY), FDA (LUMPKIN/WELSCH, GENEVA FOR 
HOFMAN) 
PASS TO MAS/DAS/JESTRADA 
PASS TO MAC/DAS/HVINEYARD 
 
SENSITIVE 
SIPDIS 
 
E.O. 12958: N/A 
TAGS: TBIO SENV AMED CASC KSCA ECON ETRD BEXP EINV PGOV
SUBJECT: NEW DELHI BI-WEEKLY ESTH REPORT 
 
REF: NEW DELHI 1086 
 
NEW DELHI 00002166  001.2 OF 006 
 
 
¶1.  (U) SUMMARY:  This edition of the New Delhi ESTH biweekly 
includes an S&T section update on the new Indian Institutes of 
Technology and a new Indian public-private partnership to assist 
small and medium scale entrepreneurs and the postponement of the 
launch of the Indian lunar mission "Chandrayan-I".  The environment 
section reports on the need to design and market better cooking 
stoves due to the environmental risks of respiratory diseases.  The 
health section includes information about the upcoming FDA Good 
Clinical Practices (GCP) workshop, an update on the meeting with the 
Drug Controller General of India on policy and regulatory affairs, 
the status of the creation of the Central Drug Authority, and HHS 
India Health Office support to visiting Medical Device and 
Pharmaceutical Policy Mission of the U.S. - India High-Technology 
Cooperation Group and upcoming health related workshops.  The health 
report also includes a HHS/CDC Lab Assessment of National Reference 
Laboratories and a media report of suspected Hantavirus in India, in 
addition to an Avian Influenza and Polio Update and news on the Food 
Safety and Standards Authority new CEO appointment.  END SUMMARY. 
 
New Indian Institute of Technologies start functioning 
--------------------------------------------- - 
 
¶2.  (U) The Ministry of Human Resource Development (MHRD) announced 
the opening of eight new Indian Institutes of Technologies (IITs) 
this year in the States of Bihar, Andhra Pradesh, Himachal Pradesh, 
Gujarat, Madhya Pradesh, Orissa, Punjab, and Rajasthan, with an 
allocation of USD 25 million each for their establishment.  The 
older IITs are expected to mentor the new IITs to help them 
establish themselves.  All of them except the one at Madhya Pradesh 
are expected to start functioning from temporary campuses by the end 
of this month.  Minister of State for Higher Education Ms 
Purandeswari inaugurated the first of the new IITs, IIT Rajasthan on 
August 2, 2008, which started functioning from its mentor 
institute's campus at IIT Kanpur.  MHRD Minister Arjun Singh will 
inaugurate IIT Bihar on August 7, 2008.  It will start functioning 
from a temporary campus in Patna.  All the IITs are expected to have 
their own permanent campus in 2 years time.  The biggest challenge 
for these IITs will be finding capable faculty.  Due to capacity 
addition on account of the MHRD's new reservation policy, they are 
cumulatively expected to need about 3000 faculty in the next couple 
of years.  To at least temporarily overcome this problem, the MHRD 
and the IITs together seem to be planning to develop a special 
package to rehire IIT faculty who retire at the age of 65 and also 
scientists who retire at age of 60 from Council for Scientific and 
Industrial Research (CSIR) labs (a cluster of 39 national 
laboratories).  Finding the remaining faculty will be a very 
daunting task. 
 
Industrial body and Government come together to help Micro, Small, 
and Medium Entrepreneurs (MSME) innovate 
--------------------------------------------- -- 
 
¶3.  (U) The Confederation of Indian Industries (CII), an industry 
led and managed NGO, and the Indian Department of Scientific and 
Industrial Research (DSIR), which manages 39 national laboratories, 
have joined hands to help Indian MSMEs.  The public-private 
partnership is called the Technology Export Development Organization 
(TEDO) and it hopes to enhance the technological competitiveness of 
MSMEs.  This year TEDO has selected 150 companies spanning 6 
different sectors to help to innovate and add value to their 
products and then export the same through participation in 
international exhibitions in the target country.  The sectors are 
automobile components, agro food processing, dies and molding, 
 
NEW DELHI 00002166  002.2 OF 006 
 
 
casting and forging, process plant and machinery, and Information 
Technology enabled Engineering Services.  They have involved about 
33 consultants with diverse domain expertise to help these MSMEs. 
As reported earlier the GOI has also set up provision for free 
patent filing by MSMEs (Reftel). 
 
Indian Moon Mission "Chandrayan-I" Postponed 
-------------------------------------------- 
 
¶4.  (SBU) Indian's unmanned moon mission "Chandrayan-I" which was 
planned for launch by mid September has been postponed.  According 
to press reports, Indian Space Research Organization (ISRO) Chairman 
G Madhavan Nair has said that the new date would probably be around 
15 October 2008.  Dr. Madhavan Nair has further said that the 
satellite integration was almost complete and ISRO would be starting 
the Thermovac test in about a week's time.  As this test would take 
about 45-50 days, ISRO would announce the new launch date after 
that.  After September the next launch window available based on 
appropriate alignment between planets is expected to be in October. 
When SciFSN spoke to ISRO personnel, they confirmed the same and 
further added that for some reason if the tests are not completed, 
the launch may be further shifted to 15 November 2008. 
 
Need to Design and Market Better Cooking Stoves 
------------------------------------------- 
 
¶5.  (U) In anticipation of an upcoming HHS/CDC Joint Indo-U.S. 
Workshop on Indoor Air Pollution next month in Chandigarh, SciOff 
met with staff from two local NGOs to discuss their efforts to 
reduce people's exposure to smoke from household heating and 
cooking.  The NGO Development Alternatives said it feels more R&D is 
needed because only a "quantum leap" in stove technology will 
attract people to a cleaner-burning product.  Winrock International 
India said that GOI has shied away from improved cookstove 
distribution programs because they are an "administrative nightmare" 
with no government champion.  Both organizations agreed that future 
programs must use more social marketing to help people understand 
the negative health effects of indoor air pollution.  Details from 
the meetings will inform a pending cable on indoor air pollution in 
India. 
 
USFDA Collaborations with India on Growth Curve 
------------------------------------------- 
 
¶6.  (U) The first of the series of collaborations between HHS/FDA 
and the Ministry of Health (MOH)/Drug Controller General of India 
(DCGI) is due to kick start during the first week of September in 
New Delhi.  HHS/FDA in collaboration with the MOH/DCGI will hold the 
first of a three-part series of 'train-the-trainer' workshops to 
develop knowledge and skills in inspecting clinical trial sites, 
implementing a Good Clinical Practices (GCP) inspection program, and 
training future GCP inspectors.  HHS/FDA subject experts will 
provide the training to GOI officials including DCGI officials and 
State Drug Controllers.  The workshop will include a visit to an 
industry-run clinical research site. 
 
¶7.  (SBU) The DCGI suggested that he will invite the Health Minister 
to formally inaugurate the FDA Bhavan (Building) one-day prior to 
the GCP September workshop.  SciOff feels this will be a good 
photo-op and media blitz for the USFDA to kick-start its 
collaborations on regulatory affairs with India and will seek to 
make this a joint Mission PA event with DCGI's office with 
high-level Mission participation. 
 
¶8.  (SBU) India presently is dragging its feet on making a policy 
 
NEW DELHI 00002166  003.2 OF 006 
 
 
decision and the approval is pending with the Ministry of Health as 
to who the partner countries will be for collaborations in the area 
of regulation of drugs and pharmaceuticals, medical devices, 
clinical trials, biologics.  To ascertain the status of this 
decision, Mission Health Attach and FSN met with the DCGI Dr. 
Surinder Singh.  The DCGI upfront spoke of the pending policy 
decision on India regulatory collaborations with Health Secretary 
Naresh Dayal.  Singh requested the assistance of Health Attach, 
with his ability and rapport with the Health Minister, to direct the 
policy decision in favor of the USFDA, and not towards Health 
Canada.  DCGI stated that Health Canada was not of the same caliber 
as the USFDA.  Health Attach has met Minister's Personal Secretary 
and found out that Minister is aware of Secretary Dayal's views and 
that the Minister also wants close interactions with FDA.  [Comment: 
It seems that collaborations on regulations of biologics will be to 
Health Canada and the other areas such as regulation of medical 
devices, drugs and pharmaceuticals, clinical trials with the USFDA. 
According to the DCGI, Secretary Dayal in spite of his personal 
opinions on who to collaborate with in the various aspects of 
regulatory affairs will in all likelihood give in to the wishes of 
his Minister.  End Comment.] 
 
¶9.  (SBU) The DCGI also expressed his Office's inability to properly 
function due to a shortage of technically-qualified inspectors. 
There are just 12 inspectors with a mandate to increase to 50 for 
engaging with a potential USD 1 billion drug industry and a USD 2 
billion medical devices market. 
 
¶10.  (SBU) In the same meeting, the DCGI provided an update of the 
status of the pending legislation on the Central Drug Authority or 
CDA.  The DCGI said that a new technicality has arisen in the 
bureaucracy of the CDA, originally spoken of in the media and other 
circles as the Central Drug Authority.  A re-look at the Mashelkar 
Committee Report observed that it recommended the creation of a 
'Central Drug Administration' and not a 'Central Drug Authority' as 
widely believed.  The DCGI is in fact relieved it will be an 
'Administration' and not an 'Authority' for multiple reasons.  The 
first is that an 'Administration' will function as a Department 
under the MOH and the DCGI will report directly to the Health 
Secretary.  Secondly, this Department will have a separate budget 
allocation.  Thirdly, the likelihood of a Board constituting 5 
'retirees' to whom the DCGI will have to function in consensus with 
will not be required.  In the 'Authority' model, this would have in 
the DCGI's opinion retarded fast-track growth of his organization 
with 'retirees' putting into force their own personal agendas with 
industry.  The DCGI is looking forward to directly reporting to the 
Secretary Health in the new proposed system instead of the present 
reporting to the Directorate General of Health Services. 
 
HHS Office supports Mission for DAS Vineyard's India Visit 
--------------------------------------------- ----- 
 
¶11.  (SBU) HHS India Office supports Mission for the upcoming visit 
of Ms. Holly Vineyard, the Deputy Assistant Secretary (DAS) for 
Africa, the Middle East, and South Asia at the U.S. Department of 
Commerce International Trade Administration.  She will be visiting 
New Delhi from August 25-28, 2008 as the chief interlocutor of the 
U.S. - India High Technology Cooperation Group (HTCG).  Ms. Vineyard 
is leading a delegation of U.S. regulatory officials and 
representatives from the private sector including senior officials 
from pharmaceutical companies. 
 
HHS India Office Support to Other Upcoming Events 
--------------------------------------------- 
 
 
NEW DELHI 00002166  004.2 OF 006 
 
 
¶12.  (U) The HHS/NIH/National Institute of Allergy and Infectious 
Diseases (NIAID) CTU site visit was held at B.J. Medical College in 
Pune on August 6, 2008.  Acting Director General of the Indian 
Council of Medical Research Dr. S.K. Bhattacharya and Health Attach 
attended the site visit. 
 
¶13.  (U) HHS/NIH/NIAID and India's Ministry of Defense are 
co-hosting the Medical Countermeasures for Radiation Injury workshop 
from August 17-20 in New Delhi to explore mutual research interests 
related to the detection and treatment of injuries associated with 
intentional or accidental radiation exposure.  Approximately 100 
participants are expected including Indian Defense Ministry 
leadership, senior officials from the National Disaster Management 
Authority and the Defense Research and Development Organization. 
The U.S. delegation will include NIAID and DoD scientists, 
Biomedical Advanced Research and Development Authority (BARDA), 
leadership and researchers from U.S. academic institutions. 
 
HHS/CDC Lab Quality Assessment of National Reference Laboratories 
--------------------------------------------- --- 
 
¶14.  (SBU) At the request of India's National AIDS Control 
Organization (NACO), HHS/CDC in collaboration with the World Health 
Organization (WHO) and other partners, led an independent assessment 
of the 13 National Reference Laboratories (NRLs) across India to 
provide an unbiased view of the current quality of HIV testing and 
to provide recommendations linked to observed deficits for further 
strengthening these laboratories.  The assessment report has been 
submitted to the GOI who has initiated implementation of several of 
the report recommendations.  The assessment focused on 8 quality 
systems elements across all HIV testing.  Gaps were found in: 1) 
documentation and record; 2) organization and personnel; 3) 
equipment; 4) procurement and inventory; 5) information and 
management; 6) process control, external and internal quality 
assurance and customer service; 7) occurrence and incidence 
management process; and 8) facility and safety.  HHS/CDC Team has 
made recommendations on each of the above areas and NACO has started 
implementing recommendations.  Over the next year most of these NRLs 
will be strengthened, re-assessed and then go through an NABL 
accreditation (international standards are followed for this level 
of accreditation).  NACO has agreed to provide funds to each lab for 
NABL accreditation.  For further information on this please contact 
New Delhi CDC Country Representative Dr. Rubina Imtiaz (email 
Imtiazr@in.cdc.gov). 
 
HIV/AIDS Related News 
--------------------- 
 
¶15.  (U) A study conducted by the WHO for NACO estimates that nearly 
10,000 HIV infected people are being treated by private physicians 
in India.  These physicians are following irrational drug 
combinations and faulty regimens making the patients resistant to 
the first line antiretroviral (ART) drugs faster than usual.  Around 
17 percent of the drugs being recommended by private practitioners 
are single ingredient drugs while the standard international 
protocol to treat HIV/AIDS is with a triple drug combination 
therapy.  The study, presented at the 17th International AIDS 
Conference in Mexico City also observed that some Indian pharma 
companies are delivering the highly toxic ART drugs directly to 
overcome patient's reluctance to visit pharmacies, in fear of stigma 
and discrimination. 
 
¶16.  (U) India's greatest challenge is in its fight against AIDS are 
gay men.  An alarming increase in the number of gay men with NACO 
estimates of 2.5 million gays of which 100,000 are at a high risk of 
 
NEW DELHI 00002166  005.2 OF 006 
 
 
contracting HIV due to multi-partner and commercial sexual 
practices.  According to NACO, gays are a very high risk community 
in India.  At present, India has 800 targeted interventions of which 
200 are for gays.  India believes that 5% of all sexually active 
males in India have sex with other men, with Tamil Nadu, Andhra 
Pradesh and Orissa reporting the highest number of cases. 
 
¶17.  (U) Swiss drug maker F Hoffmann-La Roche Ltd may move the 
Madras High Court against patent infringement of its anti-infection 
drug Valcyte by Cipla Ltd., intensifying an ongoing legal battle 
between the two companies over patented drugs and their copycat 
versions.  Cipla had launched a cheap generic version of 
valganciclovir (the active ingredient of Valcyte) in India under the 
brand name Valcept.  Valcyte is widely prescribed for infections 
related to HIV/AIDS.  If it is filed, the suit will be Roche's 
second in India related to patent infringement.  In the first case, 
pending with the Delhi High Court, the company had sought an 
injunction on its cancer drug Tarceva, also by Cipla. 
 
New FSSA CEO to take Charge 
--------------------------- 
 
¶18.  (U) India's Ministry of Health and Family Welfare (MOH) Food 
Safety and Standards Authority (FSSA) CEO Mr. G. Balachandran has 
taken a new position as Additional Secretary in the MOH.  Mr 
Jatinder Pal Singh I.A.S.of the 1977 cadre is slated to take charge 
as FSSA CEO.  Mr. Singh prior appointment was as Chief Secretary of 
Goa State. 
 
West Bengal AI Update 
--------------------- 
 
¶19.  (U) As of August 4, 2008, the Public Health Branch of the 
Directorate of Health Services, Government of West Bengal, has 
notified that there is no avian influenza (AI) reported in poultry 
from the Animal Resources Department.  There is also no human case 
reported for AI.  The Government of India also reports no cases of 
poultry of human Avian Influenza in the rest of India. 
 
India Polio Update 
------------------ 
 
¶20.  (U) According to the World Health Organization (WHO), as of 
August 4, 2008, 15 new polio cases (P1=2 and P3=13) were reported 
for 2008.  The total number of polio cases in 2008 stands at 346 
(P1=10 and P3=336). 
 
Suspected Hantavirus in India 
----------------------------- 
 
¶21.  (U) According to India press reports (Hindustan Times, August 
5, 2008), one girl died and another was hospitalized with suspected 
Hantavirus pulmonary syndrome (HPS)caused by Hantavirus in India's 
State of Uttarakhand from Dehradun and Tehri areas.  The State 
administration has sent blood samples from the hospitalized patient 
to the National Institute of Virology (NIV) in Pune and the National 
Institute of Communicable Diseases (NICD) in New Delhi for testing. 
All India Institute of Medical Sciences Professor of Medicine Dr. 
Randeep Guleria stated "This disease is very rare in India."  Though 
reports are claiming the presence of the virus in India this needs 
to be confirmed by the NIV Pune.  [Comment:  If confirmed India's 
public health authorities will be concerned.  However, Hantaviruses 
that cause HPS in the U.S. are only known to be transmitted by 
certain species of rodents.  End Comment.] 
 
 
NEW DELHI 00002166  006.2 OF 006 
 
 
 
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