USFDA inspection: Key Agendas and Expectations

With India being a key player in the global pharmaceutical market, the expeditious approval of USFDA inspection is imperative

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USFDA Inspection audit
USFDA Inspection

Last Updated on January 24, 2024 by The Health Master

USFDA inspection

USFDA inspection: As the 14th Trade Policy Forum (TPF) meet kicks off in New Delhi, all eyes are on the crucial talks between India and the United States.

The three-day summit, co-chaired by US Trade Representative Katherine Tai and India’s Commerce and Industry Minister Piyush Goyal, promises discussions on a multitude of issues.

Let’s delve into the key agendas and expectations shaping this significant bilateral dialogue.

Agenda Highlights

1. A Game-Changer for Indian Professionals

The much-anticipated Social Security Pact, also known as a totalisation agreement, takes center stage.

If ratified, this agreement will provide social security to Indian professionals employed in the US.

Notably, the pact aims to eliminate dual social security deductions, benefiting a vast number of Indian expatriates, especially those in the tech sector.

2. USFDA Inspection: Streamlining Processes

On the negotiation table is a proposal to expedite the US Food and Drug Administration (USFDA) inspection of Indian pharmaceutical companies.

With the US being India’s largest pharma export market, the swift approval of inspections is crucial.

The backlog caused by COVID disruptions has significantly impacted the pharmaceutical sector, affecting approvals and renewals.

3. Visa Delays and Export Priorities

India seeks to address issues such as delays in visa processing and the expansion of exports, focusing on table grapes, pharmaceutical goods, and marine products like wild-caught fish and shrimp.

Additionally, the reinstatement of the Generalized System of Preferences (GSP) status for India is a key concern.

4. Export Control Regulations

The discussions will also touch upon export control regulations for high-tech products and technologies.

Furthermore, there is an emphasis on securing more access for Indian mangoes in the American market, reflecting the broader spectrum of trade-related concerns.

Social Security Pact

The Social Security Pact, often referred to as a totalisation agreement, holds immense significance for Indian professionals in the US.

The agreement, once implemented, will exempt expatriates from contributing to the social security schemes of both their home country and the host nation.

This will notably benefit Indian tech professionals who, despite contributing to the US social security, currently do not reap its benefits.

India has already furnished comprehensive information, including data from various social security schemes such as the Employees’ Provident Fund (EPF), New Pension Scheme (NPS), and Employees’ State Insurance Corporation.

The proposed pact aims to streamline the process, ensuring equitable treatment for Indian professionals abroad.

A Crucial Facet of Pharma Exports

With India being a key player in the global pharmaceutical market, the expeditious approval of USFDA inspection is imperative.

The COVID-induced disruptions have led to a substantial backlog in inspections, adversely affecting the approval and renewal processes for medicines and manufacturing facilities.

India’s pharma exports to the US, standing at $6.79 billion (as of April-February 2023), highlight the significance of resolving these inspection challenges.

The proposal to fast-track inspections through digital or physical means underscores the urgency to return to pre-COVID inspection levels.

Trade Policy Forum

The Trade Policy Forum serves as the primary platform for India and the US to collaboratively address trade and investment challenges.

With focus groups dedicated to agriculture, investment, innovation, services, and tariff and non-tariff barriers, the TPF plays a pivotal role in sustaining the robust India-US economic relationship.

As of 2022-23, the total bilateral trade between the two nations reached $129.4 billion, a testament to the strategic economic partnership.

The TPF discussions aim to further enhance this collaboration, fostering growth in various sectors.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.


FAQs

  1. Q: What is the Social Security Pact, and how does it benefit Indian professionals in the US? A: The Social Security Pact, or totalisation agreement, exempts Indian expatriates in the US from contributing to both their home country and host nation’s social security schemes, providing them with equitable treatment.
  2. Q: Why are USFDA inspections crucial for Indian pharmaceutical companies? A: USFDA inspections are vital for the approval and renewal of medicines and manufacturing facilities. The backlog caused by COVID disruptions has impacted India’s pharma exports to the US.
  3. Q: What are the key export priorities for India in the TPF discussions? A: India aims to address visa delays, expand exports of table grapes, pharmaceutical goods, and marine products, reinstate the GSP status, and secure more access for Indian mangoes in the American market.
  4. Q: How has COVID affected the TPF discussions and bilateral trade? A: COVID disruptions have led to challenges in USFDA inspections and impacted the approval and renewal processes for medicines and manufacturing facilities, affecting bilateral trade dynamics.
  5. Q: What is the total size of India-US bilateral trade as of 2022-23? A: The total bilateral trade between India and the US reached $129.4 billion as of 2022-23, reflecting the strong economic partnership between the two nations.

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