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IDMA condemns USTR Report for making false allegation that 55% of global seizures of counterfeit drugs originated in India
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Shardul Nautiyal, Mumbai
June 15 , 2019
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The Indian Drug Manufacturers’ Association (IDMA) has condemned the
United States Trade Representative (USTR) 2019 Report for making false
allegations that 55 per cent of global seizures of counterfeit drugs
originated in India.
In a letter to the Union Commerce Ministry,
IDMA national president Deepnath Roy Chowdhury has said that USTR 2019
report, clearly reproduced from unsubstantiated 2017 report of the
Organization for Economic Co-operation and Development (OECD), merits
condemnation and deploration.
The letter further states that USTR
has been putting India in “Priority Watch List” for few years now.
Indian Pharmaceutical Alliance (IPA) had responded to the 2018 report of
the USTR in February, 2019. The 2019 report released in April is
substantially similar to the 2018 report, except for few points of
appreciation and one very false allegation that “55 per cent of global
seizures of counterfeit pharmaceuticals by total value, originated in
India, shipped around the globe with special focus on Africa, Europe and
USA.”
Irresponsible and unsubstantiated statements like this
reproduced verbatim from elsewhere tends to destroy the credibility of
the USTR Report.
The 2019 USTR Report had to accept and
acknowledge substantial improvements and exemplary performance by the
office of the controller general of patents in India. Major reforms such
as reduction of timelines in patent and trade mark (TM) grants by
amendment of patent rules and recruitment of examiners, acceding to
World Intellectual Property Organisation (WIPO) Internet Treaty and Nice
Agreement, Revision of Manual of Patent Examination, Cell for IPR
Promotion and Management (CIPAM) based training programs, extensive
digitalization process, crime enforcement initiative etc have been
clearly acknowledged.
“It is unfortunate and unfair that the USTR
continues to pursue the Trade Facilitation and Trade Enforcement Act of
2015 to identify those foreign countries that deny (as viewed by USA
and USTR) adequate and effective protection of intellectual property
(IP) rights or deny fair and equitable market access to United States
persons that rely upon IP Protection”, IDMA in its letter stated.
Ironically,
the preamble to this Act of USA, refers to the Uruguay round of 1994,
which is a multilateral treaty globally adopted unanimously by all
including USA. To enforce additionally self-proclaimed unilaterally
prescribed conditions on member firms (like India) who are already
following Trade-Related Aspects of Intellectual Property Rights (TRIPS)
and World Trade Organisation (WTO) regimes, is truly unfair and
unfortunate, to say the least.
The Agreement on TRIPS is an international legal agreement between all the member nations of the World Trade Organization (WTO).
Today
Indian pharmaceutical industry exports generic medicines worth approx.
US$ 19billion dollars to more than 200 countries across the world
including those with Stringent Regulatory Authorities (SRA) such as US
FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical
Devices Agency of Japan (PDMA), Therapeutic Goods Administration (TGA)
of Australia, South African Health Products Regulatory Authority
(SAHPRA) and others. Also World Health Organisation (WHO) has approved
more than 2000 units complying with WHO GMP for supplies. Almost 70 per
cent of the WHO vaccine requirements are met by India.
Around 90
percent of the prescriptions in the US are for generic drugs. Forty
percent of the generic drugs consumed in the US are supplied by the
Indian pharmaceutical manufacturers implying that a large section of US
population is being treated by Indian Generics. These generic drugs are
not only helping in saving healthcare costs but also saving lives of
millions.
USTR must realise that it is time to take note of the
ground realities and discontinue listing India in Priority Watch List.
Complaining over Compulsory License (CL) in India when India has granted
just one CL in 2012 (while USA grants innumerable CLs in form of
third-party use (through 28 USC 1498) clearly indicates that USTR needs
to change its stance. India expects USTR to review its stand with
respect to India. It is time to revisit the Super 301 Report and the
watch list itself and review its relevance under the WTO Regime.
In
the meantime, a book written by an investigative journalist, Katherine
Eban, titled “Bottle of Lies” has attempted to come up with more
derogatory statements and highly distorted and exaggerated stories
bordering on fiction filled with personal bias about the Indian
pharmaceutical (generic) industry and the Indian regulatory
establishment.
The Indian pharma regulator Central Drugs
Standard Control Organisation (CDSCO), headed by the Drugs Controller
General India (DCGI), has been doing a commendable job, comparable to
even developed countries. By attempting to make derogatory allegations,
the lack of credibility of the author and her contributors stand.
Indian
Pharmaceutical Industry which is widely known and acknowledged as the
“Pharmacy of the World”, will continue to grow and excel both in quality
and in providing affordable access to millions of patients all over the
world, the letter concluded.
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