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Pharmaceuticals Export Promotion Council of

(Setup by Ministry of Commerce & Industry, Govt. of India)

27th October 2016, Hyderabad:

Ref: Drug resistance Revealed: How dirty production of NHS drugs helps create
superbugs dated October 18, 2016 by Andrew Wasley and Madlen Davies.
The Pharmaceuticals Export Council of India (Pharmexcil) is set up by Ministry of
Commerce and Industry, Government of India under foreign trade policy with an objective to
promote the Pharmaceutical exports.

About Indian Pharmaceutical Industry:

India in the field of pharmaceuticals has made its presence globally and has been
recognized as pharmacy of the developing world. Indian pharma industry is present in all
therapeutic segments with almost all types of dosage forms and also a rich source of most
of the APIs (Active Pharmaceutical Ingredients). India's noble act of delivering ARVs (Anti

Retro Viral) cost effectively compared to the innovator's ruling prices has alleviated the
misery of millions of people across the globe, especially in Africa and some parts of LAC.
Indian pharmaceutical exports globally in 2015-16 has been to a tune of $16.89 Billion.

Global Presence of Indian companies in Generics:

Eight Indian companies are among the top 20 global Generic manufacturers .The
companies like Sun Pharma, Lupin, Dr Reddys, Aurobindo, Glenmark, Zydus Cadila,
Torrent and Hetero are among the top 20 companies. Several other overseas generic
players are also utilizing Indian facilities and also sourcing APIs from India due to expertise
and cost effectiveness.

As per its given mandate, Pharmexcil with the active support of Government of India, has
been taking several initiatives successfully, for the growth of Indian Pharmaceutical Industry
in overseas markets.

Almost all (about 3000) pharmaceutical exporter companies,

including Large Pharma companies are also members of the Pharmexcil.

In the given background Pharmexcil is noticing a disturbing trend. In the recent past much
of adverse propaganda is taking place against the Indian companies with an intention to
malign the image of Indian pharma and ultimately depriving the developing world to have an
access to the quality drugs manufactured by Indian companies at affordable cost. The
following news item published in Times of India, Hyderabad dated Aug 30, 2015 clearly
indicates the capabilities of Indian pharmaceutical Industry in producing and selling cost
effective drugs.

"Greg Jefferys, a 61 years old historian and author from Australia, hit international
headlines when he flew to Chennai to use generic SOFOSVUBIR to successfully cure
himself of hepatitis C. He spent 1/100th just about $1000, the amount it would have cost
him if he were to use the patented version. Jefferys has since helped hundreds of patients
access the medicines cheaply from here."

One latest news item that has come to council's notice is a story published by ' the bureau
of investigative journalism ' on 18 th Oct 2016, captioned " Revealed : How dirty production
of NHS drugs helps create superbugs" authored by Andrew Wasley and Madlen Davies. In
substance, the story alleges that ' Indian Pharmaceutical companies adopt dirty production
methods and there are no checks and regulations in place. The growth of superbugs
(antibiotic resistant bacteria) is a big threat to human safety and that polluting drug
companies are contributing to this. In this regard the reporting agency has stated that some
soil/water samples collected at different places in India (including nearby places of some
major Indian Pharmaceutical companies) have shown significant presence of antibiotic
resistant bacteria and also made several allegations.

Pharmexcil agrees with the fact that there is a serious threat to public health from the
emerging ' antibiotic resistance bacteria (superbugs) which is due to various reasons
including environmental control. The Govt of India has recently expressed its serious
concern and the Indian drug regulator has recently announced some measures to curb
excessive / irrational use of antibiotics by medical profession and consumption by patient

community. We are also aware of the impact of antibacterial resistance on India and
committed to the cause.

Based on this serious allegation and its likely adverse impact on Indian
Pharmaceutical industry in overseas markets, Pharmexcil has carried out a
preliminary assessment of the report and contacted our member companies. The
following observations were made,

The manufacturing facilities of Companies registered in strongly regulated markets

like USA and EU are facing very regular audits from respective FDAs and are
complying with all requirements. It is a fact that as on Feb2016, 631 sites complies
with EU GMP, approximately 1400,WHO GMP certified plants and 605 sites are
registered with USFDA ( as on April 2015) . It clearly demonstrates the strength and
capabilities of Indian pharmaceutical industry.

Indian Pharmaceutical industry is controlled by a strong regulatory mechanism for

GMP and environmental controls. This is being enforced by regular Audits so as to
ensure the adherence to the regulatory compliance.

Several international customers are also regularly auditing Environment, Health, and
Safety (EHS) systems of manufacturing units of our member companies for

compliance with their requirements. Several units also hold ISO 14000 EMS

It looks that the report has selectively targeted only one country namely India and
named some select major exporters inclusive of Aurobindo.

The authors did not access the national regulatory agencies to validate their
observations before reporting.

It is not clear whether the objective of the study is with a concern for human safety or
any other motive against Indian pharma industry.

Statements like "70% of E-Coli bacteria present in water originating from the
perimeter of Indian company are resistant to fluoroquinolones" is not supported by
any facts or reference. Unit 7 of M/s. Aurobindo do not manufacture Ciprofloxacin

The above observations makes us believe that the report is not based on verified facts and
is baseless and concocted

to cause confusion in the minds of general public and

international drug procurement agencies and in turn disturb the Indian Pharma Industry

To quote an example on the allegation against one of our member Company

Highest level of antibacterial resistance observed in test samples collected
near Unit VII, which produces penicillins, cephalosporin, carbapenem, and
To our surprise Unit VII is a non-beta-lactam, non-cephalosporin,
Non-carbapenem facility. Fluoroquinolones are manufactured at Unit VII
(dedicated exclusively for finished dosage forms) but even they
constitute only 2% of the total production at the site.

Certain reports mentions wastewater flowing from Unit XI in Pydibhimavaram

Village instead of being sent to the sea.
There is no wastewater discharge from Aurobindos Unit XI in to any of
the adjoining surface water bodies. The wastewater, after treatment and
conforming to norms, is discharged to marine outfall through closed
pipeline approved by regulatory agencies concerned, under the
supervision of regulators.

Similar to the above mentioned examples there are several inaccurate reporting
which leads us to suspect the objective of the reporting itself.

The motive behind publication of such report is perhaps due to the role of some vested
interests against Indian companies in general and Aurobindo in particular, who are

contributing significantly to the global health care. Pharmexcil will also seek the guidance
and intervention from various agencies of the Government of India to avoid such
occurrences in the future.
For any media queries please contact:
Hari Prasad /9618883774
Ravi Uday Bhaskar
M-7331136965/ 040-23735456