VZCZCXRO3832
RR RUEHHM RUEHLN RUEHMA RUEHPB RUEHPOD
DE RUEHNE #0022/01 0031154
ZNR UUUUU ZZH
R 031154Z JAN 08
FM AMEMBASSY NEW DELHI
TO RUEHC/SECSTATE WASHDC 9886
RUEAUSA/DEPT OF HHS WASHDC
INFO RUEHCI/AMCONSUL KOLKATA 1490
RUEHCG/AMCONSUL CHENNAI 2176
RUEHBI/AMCONSUL MUMBAI 1285
RUEHPH/CDC ATLANTA GA
RUEHRC/DEPT OF AGRICULTURE WASHDC
RUEAIIA/CIA WASHDC
RHEFDIA/DIA WASHDC
RHEHNSC/NSC WASHDC
RHEHAAA/WHITE HOUSE WASHDC
RUEHZN/ENVIRONMENT SCIENCE AND TECHNOLOGY COLLECTIVE

UNCLAS SECTION 01 OF 16 NEW DELHI 000022 
 
SIPDIS 
 
FOR HHS SECRETARY LEAVITT FROM CDA STEVEN WHITE 
HHS PASS TO NIH 
STATE PASS TO USAID 
STATE FOR SCA; OES (STAS FEDOROFF); OES/PCI STEWART; OES/IHA SINGER 
PASS TO HHS/OGHA (STEIGER/HICKEY), CDC (BLOUNT/FARRELL), 
NIH/FIC (GLASS/MAMPILLY), FDA (LUMPKIN/WELSCH, GENEVA FOR HOFMAN) 
 
SENSITIVE 
SIPDIS 
 
E.O. 12958: N/A 
TAGS: TBIO SENV AMED KSCA IN
SUBJECT: SCENESETTER PART III: THE DEPARTMENT OF HEALTH AND HUMAN 
SERVICES (HHS) SECRETARY LEAVITT'S JANUARY 7-11, 2007 VISIT TO 
INDIA 
 
REF:     (A)  2007 New Delhi 5418 
 
         (B)  2008 New Delhi 0008 
 
NEW DELHI 00000022  001.2 OF 016 
 
 
¶1.  (SBU) Summary: This is the third scenesetter cable, which 
provides information and analysis on government authorities that 
exist and are being created for regulation of drugs, food, medical 
devices, and biotechnology.  This is a long cable and our intent is 
to provide "complete picture" for your briefing book of the 
regulatory environment for drugs and food as well as information and 
analysis of import safety. This cable also provides views of the 
private sector as far as needs for transparent regulatory 
authorities are concerned.  Finally, we provide information and 
analysis on import safety and our suggested talking points for 
meetings with the Prime Minister and other Indian Ministers you will 
be meeting during your five-day visit to India. Reftels A and B 
provided information on political, economic, life sciences, health 
sciences, and pubic health aspects of the US-India relationship. End 
Summary. 
 
¶2.  (SBU) Your visit and its focus on import safety has attracted 
attention and interest at governmental and industry levels.  Mission 
has requested meetings with the Prime Minister and Ministers of 
Health and Family Welfare, Science and Technology, Agriculture, 
Commerce, and External Affairs.  In Chennai, you will speak at an 
event hosted by the Southern Region chapter of the Confederation of 
Indian Industries (CII).  CII is inviting leaders and academics from 
southern Indian states involved in life sciences, health sciences, 
biotechnology, and health care.  In Delhi, you will speak at an 
event organized by the Federation of Indian Chambers of Commerce and 
Industries (FICCI).  FICCI is inviting leadership of pharmaceutical 
and food exporters for this event.  This will be your opportunity to 
engage with industry leaders on the topic of import safety. 
 
¶3.  (SBU) We believe that Government officials will listen and agree 
to cooperate on import safety, but the record of Indian regulatory 
authorities is not good.  The Indian officials will tell you that 
Indian products are safer as compared to China, which is more of a 
"we are better than China" sentiment than reality.  On the other 
hand, industry leaders from the drug and food sector, who are eager 
to listen to you, understand the importance of establishing standard 
operating procedures for the safety of consumer products.  There are 
sensitive and confrontational trade issues with the seafood and 
general export industries, which may come up in your meetings with 
the Agriculture and Commerce Ministers or with FICCI. 
 
¶4.  (SBU) We believe that government and industry trade organizers 
will inform you that they intend to set up in-house, 
state-of-the-art laboratories for testing products, and would 
request FDA support for setting up these laboratories.  The GOI 
would like to "test its way to food safety", if possible.  We urge 
you to emphasize that any safety testing should be backed up by a 
functional regulatory system and done by GOI accredited, independent 
laboratories that uses accepted protocols and methodologies. 
Finally, we propose you state that best available science, 
methodology, and practices should be used in testing and 
trade-related decision making.  Considering the fact that India and 
the United States are science and knowledge-based economies, our 
partnership on import safety can be a model for other bilateral and 
multilateral collaborations. 
 
PLANS TO ESTABLISH CENTRAL DRUG AUTHORITY OF INDIA (CDA) 
--------------------------------------------- ---- 
 
¶5.  (SBU) India's existing drug regulatory infrastructure does not 
adequately perform assigned functions efficiently and promptly.  The 
Drug Controller General of India (DCGI) in the Central Drugs 
Standard Control Organization (CDSCO) lacks in-house scientific and 
technical expertise required to evaluate new drugs, vaccines, 
devices, and recombinant products and is heavily dependent on 
external evaluations such as from the Indian Council of Medical 
Research (ICMR), the Department of Biotechnology (DBT) and other 
external experts.  This poses a problem as sensitive information is 
 
NEW DELHI 00000022  002.2 OF 016 
 
 
shared with external reviewers without any agreements on 
confidentiality. 
 
SIPDIS 
 
¶6.  (SBU) At present, product approvals are granted by both central 
and state-level regulatory authorities.  Disparity in 
regulatory/licensing standards among different states and their 
non-compliance with DCGI's directions throw up a variety of issues 
such as proliferation of irrational drugs, misbranding (retaining 
the brand name after change of ingredients), circumvention of 
regulatory procedures for launch of new drugs, etc.  Pharmaceutical 
companies have the freedom to approach any of the licensing 
authorities.  If the drug licensing authority of a particular state 
happens to reject an application, the company can get the same 
approved from another state and yet market the product all over the 
country (a drug manufactured in one state moves freely in 
inter-state commerce). 
 
¶7.  (SBU) With an objective to streamline the fragmented regulatory 
practices of different states and bring uniformity to the licensing 
process across India, the Government of India, in January 2007, gave 
its nod for creation of an autonomous Central Drug Authority (CDA) 
of India.  The move followed the proposals made by several expert 
bodies including the Mashelkar Committee which pitched for a 
comprehensive revamp of the drug regulatory system in the country. 
 
SALIENT FEATURES OF CDA 
----------------------- 
 
¶8.  (SBU) The CDA will be an autonomous center located at the Food 
and Drug Bhawan, New Delhi under the Ministry of Health and Family 
Welfare (MOHFW).  The authority would be modeled on the lines of the 
United States' Food & Drug Administration (U.S.-FDA) with a 
completely centralized licensing system under the Union Government. 
It is expected that the CDA will have a three-to-five member board 
under the Chairmanship of an eminent scientist, which would handle 
policy decisions.  It will have separate divisions for oversight of 
regulatory affairs and enforcement, imports, new drugs and clinical 
trials enforcement, biologicals and biotechnology products, 
pharmacovigilance, medical devices and diagnostics, organizational 
services, training, quality control affairs and legal & consumer 
affairs. 
 
¶9.  (SBU) The executive wing of the regulator would be headed by the 
Drugs Controller, who will be a Secretary level official (Note. 
Secretary in the GOI system is highest level policy maker in the 
 
SIPDIS 
Ministry. End Note).  However, each division overseeing defined 
activities pertaining to drugs and cosmetics research and 
commercialization would be largely independent.  The authority would 
be financially self-sustaining.  It would devise a fee structure for 
its regulatory services, the proceeds from which would be utilized 
to meet its capital spending and day-to-day expenses.  The CDA would 
also get the power to prosecute clinical research organizations, 
investigators and pharmaceutical companies violating respective 
rules and regulations (including manufacture and marketing of 
spurious drug products).  CDA would closely interact with the drug 
watchdogs abroad to harness regulatory expertise.  It has been 
proposed that the centralized system of drug manufacture and 
licensing will be instituted through a phased transition over a 
period of five years. 
 
FUNCTIONS OF CDA 
---------------- 
 
¶10.  (SBU) Ministry of Health and Family Welfare has proposed the 
following functions for the Central Drug Authority; 
 
- Licensing of drug manufacturing units 
- Registration of pharmaceutical products 
- Quality control of imported drugs 
- Post marketing surveillance 
- Control on medical devices 
- Control on diagnostics 
 
NEW DELHI 00000022  003.2 OF 016 
 
 
- Control on nutraceuticals, food supplements and herbal products 
- Guidelines for promotional literature 
- Promotion of rational use of drugs 
- Guidelines for self medication 
- Monitoring of clinical trials and bio-equivalence studies 
- Monitoring of adverse drug reactions 
- Interaction with consumers and handling of complaints 
- Central nodal intelligence cum legal cell to coordinate 
inter-state activities 
- Training of regulatory and laboratory personnel 
 
¶11.  (SBU) The Health Minister has stated that the CDA will be 
modeled on the lines of the U.S. Food and Drug Administration (FDA). 
 In meetings with the Mission Health Attach, the Health Minister 
requested technical support from HHS/FDA for governance, structure 
and functioning of FDA.  Health Attache has conveyed this request to 
HHS and FDA officials.  After discussion with HHS and FDA, Health 
Attach suggested to the Minister that the Ministry submit a 
proposal with a plan of action, so that FDA staff can review it and 
respond.  The MOHFW outreach to HHS/FDA indicates its appreciation 
of the U.S. systems of review and approval that are established by 
HHS/FDA.  HHS/FDA support will ensure the development of a 
regulatory body that utilizes science-based decision making, 
transparency, and effective reporting. 
 
 
¶12.  (SBU) Since the announcement establishing the CDA by the 
Minister about a year ago, the movement on the ground for 
establishing this authority has been slow.  Ministry officials have 
informed Health Attach that the cumbersome procedures at the 
Ministry and approvals needed from other Ministries are causing 
delay in getting legislative authority for establishing this 
authority. 
 
PLANS TO ESTABLISH NATIONAL BIOTECHNOLOGY REGULATORY AUTHORITY 
(NBRA) 
--------------------------------------------- ----- 
 
¶13.  (SBU) India is emerging as a significant biotechnology hotbed 
in the Asia Pacific region.  Although relatively small in size at 
the moment, India's biotech industry is growing at a phenomenal rate 
of more than 35 percent per annum.  India's human health biotech 
firms are rapidly attaining critical mass in terms of skills and 
capabilities to produce biogeneric products and vaccines.  India is 
also becoming a hub for global outsourcing of contract research and 
contract manufacturing.  According to Department of Biotechnology 
(DBT), biotechnology as a business segment for India has the 
potential of generating revenues to the tune of USD seven billion by 
¶2010. 
 
CURRENT REGULAT0RY FRAMEWORK FOR BIOTECHNOLOGY PRODUCTS 
--------------------------------------------- ---- 
 
¶14.  (SBU) The current regulatory framework for biotechnology 
products in India is weak, complex and time-consuming.  The approval 
process involves several poorly coordinated regulatory agencies 
falling under different GOI Ministries.  In addition, there is a 
lack of expertise in dealing with biologicals on the part of these 
regulatory agencies.  The biotechnology industry perceives this as a 
major obstacle that delays product development and can potentially 
stifle the budding biotech sector in India.  At present, the 
following GOI organizations comprise the framework for evaluation, 
approval and regulation of biotechnology products in India: 
- Drug Controller General of India (DCGI) under the Ministry of 
Health and Family Welfare 
-Review Committee on Genetic Manipulation (RCGM) under Department of 
Biotechnology, Ministry of Science and Technology 
- Genetic Engineering Approval Committee (GEAC) under the Ministry 
of Environment and Forests 
 
¶15.  (SBU) Keeping in view the rapid strides being taken in the area 
of agro- and food biotechnology research and application and the 
 
NEW DELHI 00000022  004.2 OF 016 
 
 
critical need to harmonize/streamline guidelines and procedures for 
approving genetically engineered products, the GOI proposes to 
establish the National Biotechnology Regulatory Authority (NBRA). 
At present India does not permit the import or sale of genetically 
modified foods and only one biotech crop is approved for domestic 
production (cotton). 
 
SALIENT FEATURES OF NBRA 
------------------------ 
 
¶16.  (SBU) The NBRA will be an autonomous, independent, and 
professionally led single window agency for biosafety clearance of 
genetically modified products and processes in India.  The Authority 
would be headed by a scientist well known for expertise in 
biotechnology and biosafety assessment and will have representatives 
from all the relevant stakeholders.  It will be housed under the 
Department of Biotechnology of the Ministry of Science and 
Technology.  It is expected that a budget of USD 1.6 billion (INR 65 
billion) would be made available to the Department of Biotechnology 
during the Eleventh Plan for implementing the National Biotechnology 
Development Strategy (which includes the establishment of the NBRA) 
(Note: DBT's current budget is approximately USD 360 million. End 
Note). 
 
¶17.  (SBU) NBRA will have separate divisions for biopharmaceutical 
products, agriculture/transgenic crops, industrial products, 
transgenic food/feed and transgenic animal/aqua culture.  It will 
also be responsible for setting up policy guidelines and ensuring 
need based periodical evaluation of the regulatory mechanism.  It 
will update all existing guidelines and put in place guidelines for 
transgenic research and product/process development in animal, aqua 
culture, food, phyto-pharma and environmental applications.  NBRA 
will have a Standing Advisory Committee consisting of nominees of 
State Governments, so as to maintain close liaison with State 
Governments in matters relating to the release and monitoring of 
genetically modified strains of crops, farm animals and fish.  An 
advanced school of learning will be a part of the NBRA in order to 
ensure adequate in-service training and updating for regulatory 
personnel engaged in this fast evolving field. 
 
CURRENT STATUS 
-------------- 
 
¶18.  (SBU) Following several weeks of discussion and negotiations 
with the Ministry of Health and Family Welfare, consensus has 
emerged that NBRA should be housed under the Department of 
Biotechnology (DBT) of the Ministry of Science and Technology. 
Secretary DBT has informed Health Attach that the decision for DBT 
 
SIPDIS 
to house the NBRA was made at the Prime Minister's office level. 
DBT has initiated the preparation for setting up this Authority by 
inviting expression of interest from external agencies/consultants. 
Secretary DBT has informed Health Attach that the Government of 
 
SIPDIS 
India would like to work closely with U.S. regulatory bodies such as 
the Food and Drug Administration (FDA), U.S. Environmental 
Protection Agency (EPA) and U.S. Department of Agriculture (USDA). 
 
¶19.  (SBU) The NBRA Bill is expected to be introduced in the 2008 
budget session of the Parliament after getting Cabinet approval. 
According to Dr MK Bhan, Secretary DBT, NBRA is expected to be fully 
functional in about two years.  Secretary Bhan is known to be a 
data-driven professional who keeps (and forces staff) to keep to 
timelines.  Therefore, it is likely that this authority may be 
established within the proposed timeline.  However, the competing 
interests and "ownership" issues from other Ministries (Ministry of 
Agriculture and Ministry of Environment) may derail this DBT 
initiative. 
 
PLANS TO ESTABLISH MEDICAL DEVICE REGULATORY AUTHORITY (MDRA) 
--------------------------------------------- ---- 
 
¶20.  (SBU) Several biomedical devices and critical care equipment 
are being used in India for diagnostic and therapeutic purposes.  In 
 
NEW DELHI 00000022  005.2 OF 016 
 
 
addition, a number of research organizations and private 
entrepreneurs are showing active interest in the development and 
manufacture of medical devices in India. Unfortunately, the Indian 
market for medical devices is poorly regulated.  The country lacks a 
comprehensive regulatory framework for certification, quality 
assurance, safety evaluation and post-market surveillance of medical 
devices. 
 
¶21.  (SBU) With an objective to ensure that at least certain devices 
meet accepted quality norms, the Ministry of Health and Family 
Welfare, has from March, 2006, included select medical devices (10 
sterile devices including cardiac and drug eluting stents) under the 
definition of medical drugs, thus putting them under the purview of 
the Drug and Cosmetic Act.  This notification entrusted the Central 
Drugs Standard Control Organization (CDSCO) under the Drug 
Controller General of India (DCGI) with the responsibility of 
regulating these devices in India (this is an additional 
responsibility for CDSCO over and above its primary function of 
laying down regulations and standards for import, manufacture and 
sale of drugs, blood products, intravenous fluids, vaccines, 
diagnostics and cosmetics).  The CDSCO now has guidelines that 
stipulate that all importers of select medical devices need to apply 
for import licenses and file product registrations with the DCGI. 
These applications must include such documentation as the master 
file, detailed product information, post-marketing surveillance 
procedures, and safety and quality system standards for the device. 
 
 
¶22.  (SBU) However, several medical devices continue to remain 
unregulated.  While imported devices have come under the purview of 
the Drug and Cosmetic Act, locally manufactured and non-sterile 
devices continue to be sold freely in the market.  Some 
low-technology devices like thermometers and weighing machines seek 
certification from the Bureau of Indian Standards (BIS) and that too 
is optional. 
 
EVENTS PERTAINING TO REGULATION OF MEDICAL DEVICES 
--------------------------------------------- ---- 
 
¶23.  (SBU) The creation of the Indian Medical Devices Regulatory 
Authority (IMDRA - as the apex body for the implementation of the 
country's regulatory system for biomedical devices) was proposed by 
the Indian Council of Medical Research (ICMR) and the Society for 
Biomedical Technology (SBMT - an inter-ministerial organization set 
up under the Defense Research and Development Establishment with the 
objective to utilize defense research spin offs for healthcare) 
several years ago.  SBMT sponsored a review of the existing 
certification procedures and regulatory mechanisms in other 
countries and on the basis of the information compiled by the 
review, it conceptualized a framework for regulation of medical 
devices in India. 
 
¶24.  (SBU) In 2004, the Mashelkar Committee called for the creation 
of a specific medical devices division within the Central Drugs 
Standard Control Organization (CDSCO) to address the management, 
approval, certification and quality assurance of all medical devices 
in India. 
 
¶25.  (SBU) In October, 2005, the Ministry of Health and Family 
Welfare declared that select medical devices (cardiac stents, drug 
eluting stents, catheters, intra-ocular lenses, intravenous 
cannulae, bone cements, heart valves, scalp vein sets, orthopedic 
implants, and internal prosthetic replacements) be considered as 
medical drugs under the Drug and Cosmetic Act.  It was also notified 
that control over import and manufacture of these devices would be 
exercised by the Drug Controller General of India (DCGI). 
 
¶26.  (SBU) The U.S.-India Business Council (USIBC - comprised of 
more than 300 U.S. companies with investment interests in India and 
about 25 global Indian companies) hosted a U.S.-India High 
Technology Cooperation Group (HTCG) meeting in February 2007.  At 
this meeting, attended by both U.S. and Indian government 
 
NEW DELHI 00000022  006.2 OF 016 
 
 
representatives, discussions on medical devices were included for 
the first time and it was decided to spearhead a joint 
private-sector working group dedicated to issues facing the medical 
device industry in India, foremost the development of a regulatory 
regime for medical devices. 
 
¶27.  (SBU) In early 2007, the Ministry of Health and Family Welfare 
proposed to create a new national drug authority called Central Drug 
Authority (India).  It was communicated that this new authority will 
have a dedicated division for medical devices. 
 
¶28.  (SBU) In September, 2007, the Department of Science & 
Technology, within the Ministry of Science and Technology, proposed 
to bring in new legislation to enforce uniform and effective 
standards of medical devices throughout the country.  The objective 
of this initiative is to ensure that substandard devices are not 
exported, especially to developing countries, which do not have 
medical device regulation in place.  The government also proposed to 
create a regulatory authority that will seek to establish and 
maintain a national system of certification relating to quality, 
safety, efficacy and availability of medical devices. 
 
MEDICAL DEVICES REGULATION BILL 
------------------------------- 
 
¶29.  (SBU) The objectives of the bill are to consolidate laws 
related to medical devices in India and to establish the Medical 
Device Regulatory Authority of India (MDRA) for establishing and 
maintaining a national system of controls relating to quality, 
safety, efficacy, and availability of medical devices used in India 
(whether produced in India or elsewhere) and exported from India. 
The primary function of MDRA would be to regulate and monitor the 
design, testing and evaluation, manufacture, packaging, labeling, 
import, sale, usage and disposal of medical devices, to ensure 
availability of safe medical devices for human use in the country. 
 
¶30.  (SBU) MDRA shall specify standards that will form the basis for 
the conformity assessment of the medical devices.  It shall be 
binding on manufacturers of medical devices to conform to the 
essential principles of safety and performance and to demonstrate 
conformity before placing the medical devices on the market or 
export from India.  Manufacturers shall be liable to allow the MDRA 
to carry out necessary inspections and also to supply it with all 
relevant documentation. 
 
STATUS OF MEDICAL DEVICES REGULATION BILL 
----------------------------------------- 
 
¶31.  (SBU) The Department of Science and Technology has published 
the draft version of the Medical Devices Regulation Bill on its 
website (http://www.dst.gov.in/whats_new/main-new.htm ).  The medical 
device industry has been requested to provide comments and 
suggestions for its improvement as well as both positive and 
negative impact of the same on the industry. At present, Biomedical 
Technology Wing, Sree Chitra Tirunal Institute for Medical Sciences 
and Technology is coordinating and compiling the feedback being 
received from the Industry.  Following, this Bill is expected to be 
tabled in the parliament. 
 
PLANS TO ESTABLISH FOOD SAFETY AUTHORITY 
---------------------------------------- 
 
¶32.  (SBU) The Government of India has announced plans to establish 
a single food safety agency in 2008 under the Ministry of Health and 
Family Welfare.  Currently, India has multiple, overlapping laws and 
entities that regulate food safety.  There are more than 20 laws 
relating to food safety and roughly 14 implementing agencies.  Many 
of the sanitary laws were drafted soon after Independence under 
conditions very different from today; when trade was small and 
adulteration was the primary concern. 
 
¶33.  (SBU) With a highly fragmented national structure -- spread 
 
NEW DELHI 00000022  007.2 OF 016 
 
 
across a minimum of three central government ministries -- food 
import and export safety controls are handled via different systems 
and by separate Ministries.  Many food safety rules are "on the 
books" but not observed in practice.  Multiple laboratories are 
jockeying for the position of being "the" export certification or 
pre-clearance laboratory.  The issuing of inspection certificates 
(including self-certification or producer group certification) is a 
frequent, but unregulated practice.  This overlapping, bureaucratic 
and fragmented system allows for officials to avoid responsibility 
and significant trade takes place in the unorganized sector. 
 
¶34.  (SBU) The Ministry of Health and Family Welfare was of the view 
that the Food Safety Authority will be established in 2007. 
However, Ministry of Health has had to deal with several 
controversial issues in 2007, which has led to delay in setting up 
this new authority.  The Secretary of Health and Family Welfare, 
Naresh Dayal, has stated that "setting up this authority is a top 
priority".  He has also requested technical support from FDA and 
USDA for this initiative. At present, the new food safety authority 
is in limbo, and there is no single counterpart agency equivalent to 
FDA. 
 
PRIMER ON FOOD SAFETY? 
---------------------- 
 
¶35.  (SBU) Import safety - including food and agricultural products 
- has been discussed at both the technical and political level in 
the U.S.-Indo Trade Policy Forum (TPF).  The TPF is a Presidential 
initiative, chaired by the U.S. Trade Representative and the Indian 
Ministry of Commerce.  With a generally defensive posture, the GOI's 
actions on import safety and trade are highly political and 
generally "top-down."  In recent negotiations on import safety, the 
Indian side took their "case to the media" and leaked inaccurate and 
denigrating information on U.S. imports to the local press in 
advance of bilateral talks. 
 
¶36.  (SBU) India's food and marine products industries have evolved 
considerably since the 1950s and exporters today - especially of 
spices, cashews and shrimp-are politically well organized and highly 
sensitive to perceptions of negative quality or safety issues. 
Suggestions of retaliation are frequent knee-jerk reactions to 
"foreign" claims of poor food safety and quality in India.  Public 
charges of lax food safety provoke very strong, defensive political 
reactions from the Indian government and related industries.  India 
is currently struggling with European Union (EU) concerns about 
dioxin, pesticide residues and other import safety issues - with 
Indian industry groups claiming the EU's requirements are market 
access barriers put up by developed countries seeking to 
discriminate against emerging economies like India.  Requests for 
data are rejected as "excessive" and the GOI has claimed in official 
forums, such as CODEX committees, that they should not be held to 
the same standards as the U.S. and EU. 
 
¶37.  (SBU) Old and outdated pesticides and veterinary drugs are 
still used in India because companies are reluctant to register new 
products due to lax data protection.  The GOI defends domestic use 
of "old" farm chemicals and inability to meet international 
standards as a condition of their developing country status and 
frequently points to their "livelihood" issue (needing to protect 
its small/marginal farmers and companies).  The over-use of banned 
antibiotics by aquaculture farmers threatens the reputation of 
seafood exporters and the central government has little ability to 
enforce standards or inspections. 
 
¶38.  (SBU) The government of India's use of modern food safety 
practices is limited.  India's domestic food producers and 
processors are subject to more relaxed regulations.  Imports of 
foreign food products to India are highly regulated and taxed. The 
U.S. maintains a 4:1 trade imbalance in food and agriculture, with 
India shipping USD 1.4 billion to the U.S. (mainly shrimp, cashews, 
spices and tea) while the U.S. exported only USD 370 million in 
food/agriculture products to India in 2006.  The U.S. recently 
 
NEW DELHI 00000022  008.2 OF 016 
 
 
granted market access to Indian mangoes after much work on various 
protocols and safety issues.  However, India refuses to allow in 
U.S. wheat and dairy products, for example claiming that our 
products are not safe or clean enough. 
 
¶39.  (SBU) The Ministries of Commerce, Health and Agriculture 
-together with domestic industry associations-have a role in 
regulating export food safety.  However, the government of India, 
mainly through the Ministry of Commerce, depends heavily on the 
Export Inspection Council (EIC) to administer pre-shipment 
inspections.  The EIC in turn works with semi-public industry bodies 
to administer both export promotion and ad hoc safety programs.  The 
EIC is not directly linked to either the laws or systems 
administered by the Ministries of Agriculture and Health. 
 
¶40.  (SBU) For example, the Ministry of Commerce's Agriculture and 
Processed Food Products Export Development Authority (APEDA) is 
responsible for promotion and development of India's food and 
agriculture export industries.  APEDA registers exporters; 
establishes export standards, specifications; certifications and 
quality parameters.  Shrimp and seafood exports are administered and 
promoted by the Marine Products Export Development Authority.  The 
Ministry of Commerce also promotes and regulates exports of tea, 
spices, coffee, rubber and tobacco through statutory industry 
boards.  Similarly, the spices export is promoted and regulated by 
the Spices Board of the Ministry of Commerce, which is based in 
Cochin. 
 
ISSUES RELATED TO EXPORT OF SHRIMP TO THE U.S. 
--------------------------------------------- - 
 
¶41.  (SBU) On December 31, 2003, the Southern Shrimp Alliance 
(composed of shrimp industry groups from Alabama, Florida, Georgia, 
Louisiana, Mississippi, North Carolina, Texas, and South Carolina) 
filed antidumping petitions with the Commerce and the International 
Trade Commission (ITC) against imports of frozen and canned 
warm-water shrimp from Brazil, China, Ecuador, India, Thailand, and 
Vietnam.  As a result of U.S. Department of Commerce (Commerce) and 
ITC actions, imports of frozen warm-water shrimp from India, as well 
as China, Brazil, Ecuador, Thailand and Vietnam, are subject to 
antidumping duties with margins ranging from four to 24 percent for 
participating companies. 
 
¶42.  (SBU) In July 2004, Customs and Border Protection (CBP) 
authorized ports to impose increased bond requirements in connection 
with antidumping (AD) and countervailing (CV) duties on agriculture 
and aquaculture goods.  CBP has for a number of years required 
importers to post bonds as security for compliance with customs and 
other regulations.  The bond requirement applies in addition to 
existing bonds and cash deposits.  Following the final affirmative 
antidumping determination by Commerce in February 1, 2005, CBP 
imposed a substantially higher bond requirement on importers of 
shrimp from the above mentioned countries. 
 
¶43.  (SBU) The Indian Government is concerned that the continuous 
bonding requirement imposed by U.S. CBP is an excessive financial 
burden on importers of Indian shrimp.  CBP imposed the continuous 
bonding requirement in response to concern from Congress and others 
that importers were avoiding payment of antidumping and 
countervailing duties.  The Indian Government requested the 
establishment of a WTO panel to review the consistency of the 
continuous bonding requirement with our WTO obligations.  On April 
24, 2006, Thailand requested consultations with the United States, 
followed by India on June 6, 2006.  Consultations were held on July 
31 and August 1, 2006, with additional discussions thereafter. 
While India's complaint is limited to the bonding issue, Thailand 
additionally challenged Commerce's use of so-called "zeroing" to 
calculate weighted average dumping margins in the shrimp case. 
 
¶44.  (SBU) Thailand and India principally alleged that the 
imposition of the continuous bond requirement on importers of shrimp 
constitutes "specific action against dumping" not in accordance with 
 
NEW DELHI 00000022  009.2 OF 016 
 
 
the WTOAD Agreement.  (Note: They also argued that the bond 
requirement breaches various other provisions of the AD Agreement. 
End Note.)  The panels found that the additional bond requirement, 
as applied to importers of shrimp from India and Thailand, was 
"specific action against dumping" not in accordance with Articles of 
the Antidumping Agreement.  As part of their analysis of this claim, 
the panels concluded that the requirement did not constitute 
"reasonable" security permitted by the AD. 
 
¶45.  (SBU) The panel addressing India's claim also found that: I) 
the United States had acted inconsistently with Article 7.2 of the 
AD Agreement (which limits security prior to imposition of an order 
to the dumping margin established in the preliminary determination) 
insofar as it applied the directive to a small number of importers 
of shrimp from India prior to imposition of the order; and  II) the 
United States had acted inconsistently with Article 18.5 of the AD 
Agreement and 32.6 of the SCM Agreement because it had failed to 
notify the directive to the AD and SCM Committees. 
 
¶46.  (SBU) Under WTO rules, such interim reports are confidential, 
and are not final.  Parties have the opportunity to file comments 
and there is the option for either party to appeal.  It is 
unfortunate that someone has chosen to breach the WTO rules and 
publicly comment on the confidential interim report.  The panel in 
its interim report did not agree with the United States that the 
bond requirement as applied to Indian and Thai shrimp was not 
inconsistent with the AD Agreement and constituted reasonable 
security.  The panel report is not yet final, and the U.S. side will 
be submitting comments on the interim report to the panel.  The 
disputing parties (the United States, India, and Thailand) have an 
opportunity to submit comments on the interim report.  The panel was 
scheduled to issue its final, public report sometime in December. 
After that, either party would be entitled to appeal the report to 
the WTO Appellate Body. 
 
¶47.  (SBU) U.S. imports of shrimp from India totaled about USD 253 
million in 2006, down from USD 314 million in 2005.  Imports in 2007 
are running approximately 25 percent below the pace of imports in 
¶2006.  India supplies roughly 10 percent of U.S. shrimp imports. 
 
 
EXPORT OF SPICES TO THE U.S. 
---------------------------- 
 
¶48. (SBU) The export of spices to the U.S. is in the form of spice 
powder and extract and is not as controversial as the export of 
shrimp.  While products from some spice exporters have been found to 
be contaminated with artificial color and infectious organisms, the 
reputed companies have enjoyed an increase in exports to the U.S. 
You will visit two spice exporters in the city of Cochin, AVT 
McCormick and Synthite Chemical Industries.  AVT McCormick is a 
joint venture with Baltimore-based McCormick Spices.  Synthite 
Chemicals exports extracts of spices to several U.S. food processing 
companies.  In addition to visiting the facilities of these 
companies, you will meet with spice exporters and visit the Port 
facility in Cochin. 
 
¶49.  (SBU) Unlike the trade-related issues with the shrimp industry, 
spice exporters are welcoming safety guidelines that would govern 
the export of spices to the U.S.  Some spice exporters are not happy 
with the Spices Board conducting laboratory analysis of their 
products.  AVT McCormick and Synthite Chemicals state that their 
in-house laboratories are better equipped and staffed as compared to 
the laboratories of the Spices Board.(Note. The Ministry of Health 
and Family Welfare has no direct oversight on Indian spices exports, 
nor does the Ministry of Agriculture have direct oversight of 
pesticides use of post harvest practices, per se. 
 
¶50.  (SBU) According to the Spices Board, Ministry of Commerce, the 
total export figures for spices from India was USD 125 million in 
2005,  USD 145.6 million in 2006, and USD 164 million (provisional) 
in 2007 (exchange of Rupees 40 = 1USD).  The total quantum of spice 
 
NEW DELHI 00000022  010.2 OF 016 
 
 
exports in the corresponding years is 42,402 tons in 2005; 43,243 
tons in 2006; and 46,935 tons in 2007.  The total export for spices 
to the U.S. market is estimated to rise to 79,580 tons with a value 
of USD 437 million in 2008. 
 
SAFETY OF PHRAMACEUTICALS 
------------------------- 
 
¶51.  (SBU) The Indian pharmaceutical industry has a mixed record of 
performance on safety.  While name brand finished product 
pharmaceutical companies have a good safety record and follow 
international norms, many pharmaceutical companies that cater to 
domestic and unregulated international markets do not follow 
rigorous safety protocols.  Counterfeit and spurious drugs produced 
by small time manufacturers, mostly in the northern states of Uttar 
Pradesh, Bihar, and Punjab, has been recognized as a problem by the 
Ministry of Health and Family Welfare.  Lack of jurisdiction by 
central drug authorities over state regulatory systems has allowed 
growth of this industry in India. Brand name companies and 
pharmaceutical trade associations have in-house systems to counter 
counterfeit and spurious drug production, which includes 
coordinating with police in conducting raids on shops and small size 
companies. 
 
¶52.  (SBU) In Nov. 2007, generic major manufacturer Ranbaxy, India's 
largest pharmaceutical company, announced a voluntary recall of 73 
million tablets of its 600 milligram and 800 milligram dosages of 
Gabapentin from the U.S. retail market after discovering impurities 
outside the approved specification limit.  This is not the first of 
Ranbaxy's FDA problems.  In June 2006, FDA raised questions on its 
Paonta Sahib plant.  In Feb. 2007, FDA shut down Ranbaxy's US 
headquarters, located in New Jersey. 
 
¶53.  (SBU) India has the largest number of Active Pharmaceutical 
Ingredient (API) producing companies in the world, with many of them 
producing APIs for U.S. pharmaceutical companies.  The bulk APIs for 
HIV/AIDS drugs are made in India for Indian generic manufacturers 
use and for the use of generic and brand name manufacturers in the 
United States. 
 
INDIAN RESPONSE TO IMPORT SAFETY 
-------------------------------- 
 
¶54.  (SBU) We believe that in your meetings with Ministers and other 
government officials, you will be hear the steps India is taking to 
ensure the safety of drugs and food produced in India for domestic 
and international markets.  You will also be told that products from 
Indian companies are safer and better as compared to consumer 
products from China.  Despite this public posturing, they will be 
eager to hear your views and entertain the proposal to establish a 
bilateral agreement on import safety.  They would also be eager to 
talk to you about the new authorities GOI is establishing for drugs, 
food, devices, and biotechnology.  They will also seek technical 
assistance from FDA, and likely urge FDA to pre-clear food exports 
to the U.S. and/or accept industry testing or self inspection. 
 
¶55.  (SBU) The export of agricultural products and pharmaceuticals 
is governed and regulated by several Ministries.  While the industry 
has to follow technical norms developed by Ministry of Health and 
Family Welfare (for finished drugs), Ministry of Chemicals and 
Fertilizers (for bulk drugs), Ministry of Environment (for 
recombinant products), Ministry of Science and Technology (for 
biotechnology products), the Ministry of Commerce is the key 
Ministry as far as export of products are concerned.  The Ministry 
of Commerce provides incentives, support, and regulation through 
independent boards.  This complicated system of inter-ministerial 
decision making makes it difficult for Indian policy makers to 
achieve consensus in a timely manner. 
 
¶56.  (SBU) Compared to the governmental view and response, industry 
leaders of the food and pharmaceutical sectors are eager to develop 
standard operating procedures that would satisfy regulators in the 
 
NEW DELHI 00000022  011.2 OF 016 
 
 
United States for import.  Some industry leaders, especially from 
the shrimp and horticulture industry, have publicly stated that the 
U.S. is placing "excessive" safety requirements on them, but 
privately admit the need to institute safety procedures. 
 
¶57.  (SBU) According to Mr. Vijay Topa of the Federation of Indian 
Chambers of Commerce and Industries (FICCI), many industry leaders 
view following best practices in their interest not only for 
expanding their export to the United States, but also to other 
countries and the domestic market.  One industry leader told Mission 
Health Attach that there is domestic and international "market 
value" for stating "safety norms followed as per FDA regulations". 
However, FICCI, like the GOI, would like to emphasize testing rather 
than a systemic approach to import safety by its own laboratory 
 
YOUR MEETINGS WITH INDIAN LEADERS 
--------------------------------- 
 
¶58.  (SBU) We suggest that in your meetings with different Ministers 
and the Prime Minister, you convey the following messages: 1) we 
value the existing productive and vibrant partnership on health 
sciences and public health; 2) we seek to increase technical 
collaboration and capacity building through HHS, USAID, and USDA; 3) 
there is value and a need for science and data-based prompt and 
transparent decision making; 4) the safety of consumer products, 
such as drugs and food, is a public health issue in the interest of 
India and the United States; and 5) India and the United States, two 
knowledge-based economies, can set examples for other countries to 
follow regarding the safety of consumer products. 
 
MEETING WITH THE PRIME MINISTER 
------------------------------- 
 
¶59.  (SBU) We suggest you: 
 
¶1.  Congratulate and thank the Prime Minister for his "Concept of 
One Health Based on Integrated Approach for Animal and Human 
Health", which he stated at the New Delhi Ministerial Meeting on 
Avian and Pandemic Influenza.  You can inform the Prime Minister 
that your department has posted 10 scientists and public health 
experts to work with the Indian Ministry of Health and Science and 
Technology, including two on avian and seasonal influenza. 
 
¶2.  Thank the Prime Minister for his personal involvement in 
eradication of polio from the affected regions of Uttar Pradesh and 
Bihar.  You should reiterate USG support for India's polio 
eradication through your department and USAID.  We suggest you 
propose that his government appoint a senior administrative 
official, who will exclusively focus on the administrative, 
management, logistic, and funding aspects of polio eradication. 
 
¶3.  Inform him that you met Health Minister Dr. Ramadoss in Chennai, 
where you and the Minister visited an HIV/AIDS hospital and a youth 
group that promotes education and awareness for HIV/AIDS in college 
students.  You should tell him that you offered to the Minister 
technical support in conducting scientific workshops on Disease 
Burden Estimation, Control, and Prevention, with focus on 
cardiovascular disease, diabetes, mental health, malaria, and 
measles.  You believe that we have the tools and technologies to 
fight, even eliminate, diseases like malaria and measles.  We also 
need to get a better handle on chronic disease, such as heart 
disease, diabetes, and mental health, so that we can develop better 
control and prevention strategies.  We have national and 
international experience in all these areas, and will be pleased to 
work with your Ministry of Health and Family Welfare. 
 
¶4.  Inform that American citizens, like Indian citizens, are 
cautious about safety of food, drugs, and other consumer products. 
They are expecting and demanding actions from political, policy, and 
technical leaders.  The issue is pertinent to products made in the 
United States as well as products imported into the United States. 
 
 
NEW DELHI 00000022  012.2 OF 016 
 
 
 
¶5.  Inform you were in China last month and signed bilateral 
agreements that would allow agencies of our two governments to 
cooperate on safety of consumer products that are exported from 
China into the United States. 
 
¶6.  Inform that you have talked to Minister Ramadoss about the 
safety of drugs and food in Chennai and plan to meet other Ministers 
to discuss this issue.  You can tell him you are meeting with the 
Ministers of Health, Agriculture, Commerce, Science and Technology, 
and External Affairs to initiate discussion on establishing 
bilateral agreements on Import Safety. 
 
MEETING WITH THE MINISTER OF HEALTH AND FAMILY WELFARE 
--------------------------------------------- ---- 
 
¶60.  (SBU) This is your third meeting with the Minister of Health 
and Family Welfare Dr. Anbumani Ramadoss.  The previous two meetings 
were in your office, when you signed bilateral agreements on 
HIV/AIDS and STD, Emerging and Reemerging Infectious Diseases, and 
Environment and Occupational Health.  He will accompany you to the 
visit to the HIV/AIDS hospital and the Red Ribbon Club meeting at a 
local college.  You will have a formal meeting with him at your 
hotel. 
 
¶61.  (SBU) Based on information available to us, Minister Ramadoss 
is likely to seek technical assistance in a few areas.  These areas 
and your suggested response is below: 
 
¶1. Technical support from CDC for setting up a tobacco laboratory. 
 
Suggested response: CDC is collaborating with the ICMR's National 
Institute of Occupational Health in Ahmedabad.  We sent a technical 
team early this year and they visited a few institutions and 
submitted a report to ICMR.  I understand there have been some 
delays in getting some projects started, which may be due to a 
change in leadership of the institute.  We are eager to collaborate 
on this activity with you and provide technical assistance. 
 
¶2. Technical support from CDC for Integrated Disease Surveillance 
Program 
 
Suggested response:  This topic is important to me.  Dr. Julie 
Gerberding reported to me your meeting with her and the commitment 
she made to send a technical team to review your disease 
surveillance project.  As you know the team spent 2 weeks in India 
and a report was submitted to you.  We remain your committed 
partners in the fight against emerging and remerging disease as well 
as chronic diseases.  I believe MOH, World Bank, and CDC should 
partner together to develop the best disease surveillance program 
possible.  I understand that a team from your National Institute of 
Communicable Diseases has been invited to visit CDC.  This is a good 
collaboration and having your technical staff meet with our staff is 
the best way to share experiences. 
 
¶3. Technical help from FDA for setting up the Central Drug Authority 
and the Food Safety and Standards Authority 
 
Suggested response:  I would have the Commissioner of FDA respond. 
FDA Commissioner's response: Mr. Minister, I am aware of your 
meetings with my predecessors on this topic.  I am pleased to note 
the progress of your Ministry in establishing the authority on food 
and drugs.  I would like to suggest you have someone, preferably a 
technical leader, communicate with Dr. Lumpkin on specific needs. 
This will allow us to find someone at the FDA or recommend someone 
from FDA alumni who could provide help to your officials.  Please 
note that we are eager to find more information and are ready to 
assist. 
 
¶4. Technical cooperation from NIH in establishing a program on low 
cost health care devices 
 
 
NEW DELHI 00000022  013.2 OF 016 
 
 
Suggested Response: NIH has recently signed a bilateral agreement 
with the Ministry of Science and Technology on Low Cost Health 
Technologies.  I think partnering with the Ministry of Health and 
Family Welfare is a natural extension of this new collaboration.  I 
will convey this message to Dr. Zerhouni. 
 
¶5. Continued support from CDC for polio. 
 
Suggested response: I am aware of the challenge you face, both at 
the national and international level.  I would like to thank you for 
your leadership and courage to keep the focus on your program.  I 
commit to continued support from the United States government. 
There is commitment to stay with you till you eliminate polio from 
India.  You have some of my finest polio experts from CDC working 
through WHO on the polio elimination program.  Sometimes I think of 
what I would do if this was a problem in the United States.  There 
are no easy solutions, buy we know that vaccination has worked in 
India and other countries where polio was endemic.  So lowering the 
guard is not an option.  As a strategy, I would propose you appoint 
a senior official in your Ministry responsible for all management, 
logistic, and funding aspects of the polio elimination program. 
This person should only work on polio, so she/he could give 100 
percent of his/her time to the project.  Such a position, dedicated 
solely to polio eradication, may increase the effectiveness of your 
program. 
 
ADDITIONAL SUGGESTIONS 
---------------------- 
 
¶62.  (SBU) I would like to congratulate you on hosting a successful 
New Delhi Ministerial Meeting on Avian and Pandemic Influenza last 
month.  Because of last minute administrative reasons I could not 
attend the meeting, but Ambassador John Lange reported on the 
meeting.  From all accounts I heard, it was a successful meeting. 
Also, congratulate him for a successful CODEX meeting on Food 
Hygiene jointly chaired with the U.S. 
 
¶63.  (SBU) I would like to talk to you about the safety of drugs and 
food that are exported to the United States.  As you know, we had 
import safety problems with some consumer products from China. 
There have been similar incidences of product safety in the case of 
shrimp, spices, and more recently with generic drugs from Ranbaxy. 
One of my purposes in visiting India is to meet with government 
leaders and industry leaders, so that I can talk about import 
safety.  I was in China last month and signed agreements that would 
allow agencies of our two governments to work towards the safety of 
consumer products.  I would like to initiate a discussion with you 
and your counterparts in other Ministries on establishing agreements 
on import safety. 
 
¶64.  (SBU) I am pleased that your Ministry is establishing 
independent authorities on drugs and food.  There is a need for such 
authorities and it would be appropriate for our two regulatory 
agencies to cooperate to ensure the safety of products.  I recognize 
there is involvement of multiple Ministries in the case of food 
exports, and I am hoping to talk to your Ministers of Agriculture 
and Commerce, so that I can get their views as well. 
 
¶65.  (SBU) Mr. Minister, drug and food safety is a human health 
issue. You know this better than many people engaged in 
administering health programs.  American citizens, like Indian 
citizens, demand safe drugs, vaccines, medical devices, food, and 
other consumer products.  It is their right to demand products that 
would not harm them, and it is our responsibility to provide safe 
drugs, vaccines, devices, and food to them.  For us it is a domestic 
and international issue.  It is an international issue, because we 
import a large quantity of drugs from China and India.  Therefore, 
there is a need to work together to make sure that the products we 
import and/or export are safe as determined by the best available 
science and methodology. 
 
MEETING WITH THE MINISTER OF SCIENCE AND TECHNOLOGY 
 
NEW DELHI 00000022  014.2 OF 016 
 
 
--------------------------------------------- ---- 
 
¶66.  (SBU) Your meeting with Mr. Kapil Sibal, Minister of Science 
and Technology has not been confirmed.  He will be out of Delhi, but 
we can schedule meeting with Secretary of Biotechnology.  Our 
suggestions for this meeting are: 
 
¶1.  I am pleased that your Ministry and the agency of my Department 
are engaged in some excellent life sciences and health sciences 
projects.  We should take pride in our partnership and congratulate 
our scientists. 
 
¶2.  The example of rota virus vaccine development is a good example 
of our collaboration.  If this vaccine, which is being developed by 
an Indian company with technical support from CDC and NIH, works we 
will be able to prevent hundreds of thousands of children in India 
and around the world from dying. 
 
¶3.  I understand that your Ministry has plans to establish centers 
for Translational Research.  I am aware of the discussions your 
scientists have had with scientists of NIH on this topic and there 
is an interest in establishing a bilateral agreement.  This 
collaboration should include training and collaborative 
opportunities in laboratories in both countries.  I would like to 
see your scientists working in our laboratories and our scientists 
working in your laboratories.  I think answers to some of most 
complex questions will come from international collaborations, so I 
support this new initiative. 
 
¶4.  I would like to talk to you about the safety of drugs and food 
that are exported to the United States.  I visited Dr. Reddy's 
pharmaceutical company and Bharat Biotech International Limited in 
Hyderabad on Tuesday, where I had an opportunity to talk about 
import safety.  As you know, we had import safety problems with some 
consumer products from China.  One of my purposes of visiting India 
is to meet with government and industry leaders so that I can talk 
about import safety.  I was in China last month and signed 
agreements that would allow agencies of our two governments to work 
towards the safety of consumer products.  I would like to initiate a 
discussion with you and your counterparts in other Ministries on 
establishing agreements on import safety. 
 
¶5.  I am pleased that your Ministry is establishing independent 
authorities on medical devices and biotechnology.  There is a need 
for such authorities and it would be appropriate for our two 
regulatory agencies to cooperate to ensure the safety of products. 
I recognize there is involvement from multiple Ministries in the 
case of drugs and food exports, and I am hoping to talk to your 
Ministers of Agriculture and Commerce so that I can get their views 
as well. 
 
¶6.  Mr. Minister, the safety of medical devices, drugs, and food is 
a human health issue.  American citizens, like Indian citizens, 
demand safe drugs, vaccines, devices, food, and other consumer 
products.  It is their right to demand products that would not harm 
them, and it is our responsibility to provide safe drugs, vaccines, 
devices, and food to them.  For us it is a domestic and 
international issue.  It is an international issue, because we 
import a large quantity of drugs from China and India.  Therefore, 
there is a need to work together to make sure that the products we 
import and/or export are safe as determined by the best available 
science and methodology. 
 
MEETING WITH MINISTER OF COMMERCE 
--------------------------------- 
 
¶67.  (SBU) Your meeting with Minister Kamal Nath has been confirmed. 
This is a critical Ministry for export of food to the United States. 
 This Ministry does not have technical expertise, but they are 
involved in regulating and promoting export of food through 
independent entities that are headed by Ministry of Commerce 
officials.  We suggest you share information on the existing and 
 
NEW DELHI 00000022  015.2 OF 016 
 
 
growing U.S.-India collaboration on health sciences and then talk 
about import safety.  This Minister would not be adequately briefed 
on the large portfolio of U.S.-India health activities, so sharing 
what we do with India on health will be of strategic value for this 
meeting.  We believe Minister Nath will welcome developing norms 
that ensure safety of food, but he may state that they have safety 
regulations in place.  You should mention to him that you visited 
two spice exporters in Cochin and met with leaders of the food and 
drug industry at FICCI earlier today. 
 
¶68.  (SBU) He would know that you have signed bilateral agreements 
with China on import safety, so you should state that one of your 
purposes of visiting India is to meet with government and industry 
leaders for discussions on import safety.  We believe that this 
Ministry may be our initial counterpart Ministry for establishing a 
bilateral agreement on food safety, so continuation of discussion 
with this Minister and his ministry officials will be important over 
the next few months.  Import safety -including food and agricultural 
products-has been discussed at both the technical and political 
level in the U.S.-Indo Trade Policy Forum (TPF).  The TPF is a 
Presidential initiative, chaired by the U.S. Trade Representative 
and the Indian Ministry of Commerce.  However, real import safety 
will be achieved only if/when the Ministry of Commerce cooperates 
with the line Ministries and provides enforcement rather than more 
tests as a way to ensure import safety. 
 
¶69.  (SBU) We suggest you discuss the import safety of food in the 
context of a human health issue, where food safe from diseases and 
harmful chemicals have to me assured to consumers.  You should state 
that American citizens, like Indian citizens, demand safe drugs, 
vaccines, medical devices, food, and other consumer products.  It is 
their right to demand products that would not harm them, and it is 
our responsibility to provide safe food to them.  For us it is a 
domestic and international issue.  It is an international issue, 
because we import a large quantity of drugs from China and India. 
Therefore, there is a need to work together to make sure that the 
products we import and/or export are safe as determined by the best 
available science and methodology. 
 
MEETING WITH MINISTER OF AGRICULTURE 
------------------------------------ 
 
¶70.  (SBU) Your meeting with Minister of Agriculture Mr. Sharad 
Pawar is not confirmed yet, but we expect it be confirmed.  Mr. 
Pawar is a senior politician, whose party is a coalition member of 
the Congress Party-led UPA government.  He is generally not well 
informed on technical issues, but is known to protect the interests 
of farmers irrespective of the issue or the facts.  We also suggest 
a strategy similar to one we have proposed for your meeting with the 
Minister of Commerce, where you first talk about the rich history of 
collaboration followed by a discussion on import safety. 
 
¶71.  (SBU) As far as collaboration with this Ministry is concerned; 
you should highlight the importance of the U.S.-India Agriculture 
Knowledge Initiative between USDA/USAID and the Indian Ministry of 
Agriculture. 
 
¶72.  (SBU) You should congratulate him for a successful New Delhi 
Ministerial Conference on Avian and Pandemic Influenza, which he 
co-chaired with Minister Ramadoss. 
 
¶73.  (SBU) We suggest you discuss the import safety of food in the 
context of a human health issue, where food safe from diseases and 
harmful chemicals have to me assured to consumers.  You should state 
that American citizens, like Indian citizens, demand safe drugs, 
vaccines, medical devices, food, and other consumer products.  It is 
their right to demand products that would not harm them, and it is 
our responsibility to provide safe food to them.  For us it is a 
domestic and international issue.  It is an international issue, 
because we import a large quantity of drugs from China and India. 
Therefore, there is a need to work together to make sure that the 
products we import and/or export are safe as determined by the best 
 
NEW DELHI 00000022  016.2 OF 016 
 
 
available science and methodology. 
 
¶74.  (SBU) We look forward to your productive visit and stand ready 
to support you and your delegation in Chennai, Hyderabad, Cochin and 
Delhi. 
 
WHITE