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UNCLAS SECTION 01 OF 07 NEW DELHI 004586 
 
SIPDIS 
 
HHS FOR OGHA STEIGER/VALDEZ/HICKEY 
CDC FOR BLOUNT/PETROSKY 
NIH FOR GLASS/MAMPILLY 
OES/PCI FOR STEWART 
OES/IHA FOR SINGER 
GENEVA FOR WHO 
FDA FOR LUMPKIN/WELCH 
 
SENSITIVE 
SIPDIS 
 
E.O. 12958: N/A 
TAGS: TBIO SENV AMED CASC KSCA IN
SUBJECT: HOUSE COMMITTEE INDIA VISIT TO ASSESS IMPROVEMENTS NEEDED 
IN THE FOREIGN DRUG INSPECTION PROGRAM 
 
REF: (A) Beijing 6252 
     (B) New Delhi 2169 
 
NEW DELHI 00004586  001.2 OF 007 
 
 
¶1.  (U) Summary: The Congressional House Committee on Energy and 
Commerce staff delegation (Staffdel) visited India September 8-15, 
¶2007.  The Staffdel accompanied a FDA team that was in India for 
inspection of a pharmaceutical company in Himachal Pradesh.  The 
purpose of their visit was to examine a variety of regulatory, 
trade, and public health issues related to the safety of 
pharmaceutical products sold to the US and consumed by the US 
citizens.  This cable outlines the key issues such as, the drug 
regulatory framework in India, the strengths and challenges 
perspective from both the Indian Government regarding drug 
inspection issues, and feasibility of the U.S. Food and Drug 
Administration (FDA) presence in India.  End Summary. 
 
Growing Presence of Indian Manufactured Drugs in the US Market - 
Calls for Tighter Quality Control Regulations 
--------------------------------------------- -------- 
 
¶2.  (U) With the increase in Indian manufactured drugs supplied to 
the U.S. there is a need for more stringent regulations to ensure 
drug quality.  India has the largest number of FDA-approved 
manufacturing facilities outside the US and is one of the leading 
suppliers of low-cost generic drugs.  Recent press reports have 
raised doubts on the quality and safety of some products and state 
that the two Asian giants, China and India, account for a 
significant amount of USD (42 billion) imports to the U.S., 
particularly of active pharmaceutical ingredients (APIs).  According 
to the Federation of Indian Chambers of Commerce and Industry 
(FICCI), a leading industry association, out of the 15,000 - 20,000 
drug manufacturers in India about 5,000 follow the Good 
Manufacturing Practices (GMP) norms laid down by the World Health 
Organization (WHO).  All Indian drug manufacturers cater to the 
domestic market, with about 150-200 of these who cater to the export 
market. 
 
¶3.  (U) According to a recent report of the Washington Post, 
presently, with India accounting for 20 percent of FDA generic drug 
approvals in 2006, it is the fourth largest producer of drugs by 
volume, currently sources 350 types of anti-depressants, antibiotics 
and cardiovascular drugs on the U.S. market, and about one in four 
applications for market authorization in the U.S. is from an Indian 
company. 
 
Low Count of FDA Inspections in India Compared to Domestic Checks 
--------------------------------------------- -------- 
 
¶4.  (U) Presently, FDA inspections of foreign facilities occur at a 
far less frequency, at once every eight years compared to the 2-year 
 
NEW DELHI 00004586  002.2 OF 007 
 
 
interval required for domestic manufacturers.  The rise of India as 
a global supplier of low-cost generics and over-the-counter (OTC) 
drugs increases doubt of the quality and safety of Indian 
pharmaceutical products.  The Washington Post has put the number of 
inspections carried out by the FDA in India in 2006 at 32, in 
comparison to 1,222 quality assurance inspections carried out in the 
U.S. in the same year. 
 
¶5.  (U) U.S. FDA's key role is to ensure the safety of drugs and 
their imports to promote public health.  FDA's strong safety record 
sets the world's gold standard for drug approval and safety.  The 
strengthening of science based tools to augment and support the drug 
safety system at all stages of the product life-cycle, from 
pre-market testing and development through post-market surveillance 
and risk management. 
 
Against this Backdrop - Staffdel Visits India 
--------------------------------------------- 
 
¶6.  (U) The House Committee on Energy and Commerce Staffdel led by 
Mr. Chris Knauer, Senior Investigator visited Chandigarh and New 
Delhi from September 8-15, 2007.  The Staffdel included Dr. Paul 
Jung, Department of Health and Human Services, Mr. Peter Spencer, 
Professional Staff Member, and Rear Admiral Ms. Brenda Holman, 
Office of Regulatory Affairs, FDA.  The Staffdel visited a 
pharmaceutical manufacturing facility in Chandigarh from September 
8-12 to follow FDA inspectors on a site visit.  In New Delhi from 
September 12-15, the delegation met with GOI officials, leadership 
of the Pharma industry, and visited two Indian and two multinational 
pharmaceutical drug and vaccine manufacturing companies. 
 
House Committee Staff On-Site with FDA Inspectors 
--------------------------------------------- ---- 
 
¶7.  (U) The Congressional Staffdel from the House Committee on 
Energy and Commerce visited one pharmaceutical plant in Himachal 
Pradesh and accompanied an FDA team that was making regular 
pre-approval inspections of the manufacturing facility that intend 
to produce and supply products to the U.S. market.  The Staffdel 
prior to their visit to India also accompanied the FDA team to 
pharmaceutical plants in China (See Reftel A.) 
 
¶8.  (U) The FDA team inspected Glenmark, a private pharmaceutical 
company in Baddi, Himachal Pradesh, which produces API's, dosage 
forms, new chemical entity research, new drug delivery system (NDDS) 
and biotech products.    The list of products from the Baddi plant 
of Glenmark for the U.S. market for which the list of Abbreviated 
New Drug Application (ANDA) is filed are Mometasone furoate cream 
USP 0.1%, Mometasone furoate ointment USP 0.1%, Betamethasone 
dipropionate augmented cream 0.05%, and Alclometasone dipropionate 
 
NEW DELHI 00004586  003.2 OF 007 
 
 
cream USP 0.05%.  The plant manufacturing capacity is 280 million 
units of tablets, 15 million units of liquid and 12 million units of 
ointment on a per shift per year basis. 
 
¶9.  (U) The Baddi plant has 214 employees, with 37 dedicated to 
quality control, 30 dedicated to quality assurance, 35 to 
production, and 72 technicians and operators. 
 
Problem of Counterfeit Drugs in India 
------------------------------------- 
 
¶10.  (U) During the meeting with the Drug Controller General of 
India (DCGI) officials, the question was raised about Indian media 
reports of spurious drugs.  The officials stated that the press was 
too critical and the situation on the ground was not that alarming. 
The DCGI plans to evaluate counterfeit in the market with a sampling 
of 50,000 products.  DCGI officials stated that "India is concerned 
about an undeserved negative image of poor quality Indian drugs in 
the international community and is working with the WHO's 
International Medical Product Anti-Counterfeiting Task Force 
(IMPACT) to study the problem of global counterfeits". 
 
¶11.  (U) Plea from Indian officials and Industry leaders is to push 
regulatory infrastructure to global standards and to ensure that 
drugs manufactured in India are of consistent quality on a 
continuous basis and to adopt a "creditable" system for quality 
drugs and introduce the "surprise element" in inspections. 
 
¶12.  (U) Indian media reports that 35 percent of drugs manufactured 
are spurious, whereas the expert committee headed by the former 
Council of Scientific and Industrial Research Director General R. A. 
Mashelkar who relied on about 40,000 samples showed that less than 
10 percent of the drugs in the market are substandard and less than 
1 percent are spurious.  (Note: The truth appears to lie somewhere 
in between.  End Note.)  According to media reports, Head of the 
Organization of Pharmaceutical Producers of India, Ranjit Shahani, 
who stated that even assuming there is only one batch of one 
counterfeit product in the market, several lives could be lost in a 
day that could add up to one jumbo jet.  Health Minister Dr. 
Anbumoni Ramadoss believes that effective management requires change 
in regulatory mechanisms, change in legal and penal mechanisms, and 
capacity building at both State and Central levels.  The GOI's bill 
to create an independent Central Drug Authority of India (CDAI) 
along the lines of the FDA is now before a standing committee that 
will make recommendations in about three months (See Reftel B). 
 
¶13.  (U) FICCI invited fifteen industry leaders to meet with the 
Staffdel and exchange views on September 14, 2007.  Indian 
Pharmaceutical Alliance (IPA) Secretary General Mr. D.G. Shah 
informed the Staffdel that in India the IPA is running an 
 
NEW DELHI 00004586  004.2 OF 007 
 
 
anti-counterfeiting program, by which at least two raids a month are 
conducted on counterfeit drug manufacturers.  The target is 
manufacturers rather than retailers.  This, according to Shah has 
yielded results by sales of authentic drug manufacturers increasing 
by a noticeable percentage in those areas. 
 
Call by Industry for FDA to Set Base in India 
--------------------------------------------- 
 
¶14.  (U) The Staffdel heard requests/pleas from industry for 
establishing an FDA presence in India, so that Pharma companies can 
be inspected more frequently and can interact with DCGI and industry 
on a frequent basis.  Industry leaders stated that since India has 
the highest number of FDA approved plants next to the US; this will 
also ensure that the manufacturers are careful and comply with 
stipulated norms of the FDA.  The generic companies are concerned 
about their image and quality standards since the cost of failure is 
far more than the cost of compliance. 
 
¶15.  (U) Three main points that emerged from the discussion is to 
establish an FDA presence in India, enhance capacity building 
partnerships, and support India to improve the quality of its 
regulatory infrastructure as per global standards which will ensure 
consistent quality on a regular basis.  Suggestions received from 
the FICCI roundtable include: 
- FDA stations staff in India 
- FDA could assist in revamping DCGI's office 
- India sends staff to US for training and joint workshops 
- Train the trainers program; where by Indian inspectors accompany 
the USFDA inspectors during field visits in India 
- Retired staff from FDA would come to India to provide training 
- FDA shares "SOP" (Standard operating procedures) with the DCGI. 
 
¶16.  (U) The Staffdel suggested that FICCI should conceptualize a 
proposal for the possible areas of collaboration between FDA, DCGI, 
FICCI and IPA with a meeting between all parties to move forward. 
FICCI assured the Staffdel that they would work on a white paper for 
drug inspection issues. 
 
DCGI Officials Call for Harmonization with FDA 
--------------------------------------------- - 
 
¶17.  (U) DCGI officials required at least 1300 inspectors to carry 
out drug regulation inspections and presently have about 800.  One 
problem faced is that inspectors report to the State and Central 
Government on most issues other than vaccines and blood products. 
Also, licensing to factories and distribution is not Central 
government but a State government jurisdiction.  The officials were 
keen to update pharmacopeia and pharmocovigilance and were of the 
desire that the interaction presently is not enough.  DCGI is also 
 
NEW DELHI 00004586  005.2 OF 007 
 
 
keen to operate joint inspections with FDA and for greater 
harmonization with the SOP's of the FDA.  They also would like 
greater frequency of training programs, create a joint training 
environment and operate joint workshops, and travel of DCGI staff to 
FDA to train and exchange views on drug regulation.  Indian industry 
is also keen to establish and reach mutual recognition agreements 
and would like to exchange and share FDA's SOP's so as not to 
reinvent the wheel. 
 
Perspective - View from U.S. Multinationals in India 
--------------------------------------------- ------- 
 
¶18.  (U) The Staffdel visited two U.S. multinational drug companies 
who presented their view on the state of affairs of drug regulation 
in India.  The primary problem felt is that with drug regulation 
being a State issue there are some that perform and some that do 
not.  In their view, the State drug regulatory authorities at Mumbai 
and Hyderabad are OK but lacunae exists in other States where the 
local drug administration officials are not trained and there is a 
lot to be accomplished in the area of adverse drug reaction and 
vaccine regulation.  Some industries do take on training programs 
through workshops and industry believes that joint training programs 
with industry for drug officials could be beneficial, however 
require pooled resources. 
 
Industry Perspective - Other Views 
---------------------------------- 
 
¶19.  (U) Staffdel and Mission staff visited Sanofi-Pasteur, a 
leading global vaccine manufacturer, and an Indian vaccine 
manufacturer, Panacea.  These bio-pharmaceutical companies stated 
that there is greater professionalism in the DCGI's office with 
shorter timelines for approval.  That said, the company officials 
cited that the biggest hurdle faced is regulation on biologicals and 
vaccines with the biotechnology sector on the upswing in India. 
(Comment:  The shorter timelines for approvals from the DCGI's 
office could imply that there is no one to evaluate vaccine filings 
with the experts on pharmaceuticals also doubling up as experts on 
vaccine/biologicals filings.  End Comment.) 
 
¶20.  (SBU) The senior officials of Ranbaxy, a leading Indian drug 
manufacturer stated that the DCGI is a weak agency and there is need 
for training and capacity building of DCGI officials, and the need 
for an FDA presence in India. 
 
FDA Presence in India - Way Forward 
----------------------------------- 
 
¶21.  (SBU) Health Attache proposed to the Staffdel that having FSN 
Scientific Advisor dedicated to FDA work in the Health Attach's 
 
NEW DELHI 00004586  006.2 OF 007 
 
 
office could be an option.  The Staffdel appreciated the proposal. 
This FSN Advisor would be FDA's "eyes and ears" on ground and could 
travel with the inspectors on inspections of FDA's choice.  The FSN 
Advisor could also visit plants and do any pre-inspection work for 
FDA inspectors.  The FSN Advisor could also gather information on 
"companies of interest" for FDA in drug, food, devise and other 
areas.  The FSN Advisor could also organize workshops for DCGI-FDA 
interests. 
 
¶22.  (SBU) In response to a question about funding options and 
mechanisms available, Health Attache indicated that the HHS and HHS 
agencies do not have legislative authority, like USAID's Limited 
Scope Grant Agreement (LSGA), for funding Indian agencies/entities. 
The Staffdel took note of the need for HHS to have the authority to 
use LSGA for international work.  The Staffdel mentioned that HHS 
needs this authority to fight diseases such as AI and engage with 
Indian government agencies and institutions for U.S.-India 
collaborations. 
 
FDA Office in India - Better Regulate Emerging Pharma Market - Key 
Benefits to U.S. and India 
--------------------------------------------- -------- 
 
¶23.  (U) The Staffdel felt that "FDA presence in India" as desired 
by the Indian officials and Indian drug industry representatives 
would help assist FDA better regulate the emerging pharmaceutical 
market with key benefits to both countries. 
 
Further Updates 
--------------- 
 
¶24.  (SBU) The FICCI interaction of September 14 had mooted the idea 
of creating a consultative group with the Health Ministry.  FICCI 
has informally cleared this with Ministry of Health (MOH) Secretary 
Naresh Dayal, who has responded to this request positively.  FICCI 
Adviser V.K. Topa has requested Health Attach's assistance in 
developing the working group and has also requested suggestions from 
the U.S. FDA.  Health Attach will discuss this with the Department 
of Health and Human Services (DHHS) and FDA staff during his 
forthcoming visit to the U.S. 
 
¶25.  (SBU) Health Attach, about eight months ago, suggested to 
Health Minister Ramadoss that he appoint a technical expert to guide 
the CDAI, such as the Indian Council of Medical Research (ICMR) 
Director General Dr. N.K. Ganguly.  The Health Minister has 
confirmed that the Secretary of the newly created Department of 
Health Research (DHR) and Director General of ICMR, Dr. N.K. Ganguly 
has been named as a co-chair of a committee to guide the 
establishment of the CDAI.  This gives clear indication that Mission 
suggestions are being listened to and implemented.  A formal 
 
NEW DELHI 00004586  007.2 OF 007 
 
 
announcement of this appointment will be made in 2-3 weeks by the 
Ministry of Health and Family Welfare. 
 
¶26.  (U) This cable was cleared by Chris Knauer and Paul Jung. 
 
MULFORD