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Shardul Nautiyal, Mumbai June 15 , 2019
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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