Focus on India

For India-based manufacturers of APIs and finished products, the ability to understand, assess, and mitigate U.S. compliance and enforcement risks is critical to market success—and depends in large part on the strategic guidance these companies get from their attorneys. With our extensive industry and agency experience, we provide comprehensive support at all stages in the process.

Whether they are looking to market and sell pharmaceuticals, medical devices, biologics, dietary supplements, or food ingredients in the United States, Indian firms, like companies from any country, are subject to the regulatory scrutiny and compliance risks posed by the U.S. Food & Drug Administration (FDA). Many of our attorneys have worked in industry and regulatory bodies and have a long history of taking clients, both domestic and international, through the FDA’s paces. We have helped our large, multinational, India-based clients identify and address risks that might occur at any point in the product life cycle, design compliance programs, and understand the complex statutory and regulatory issues they are bound to face.

Alston & Bird has worked with our India-based clients to prepare their executives for regulatory meetings, to provide evidence to help lift import alerts, and to address FDA warning letters, as well as respond to untitled letters—much of this work on-site at multiple locations in India.

In addition, we have provided our Indian clients with litigation support on FDA issues, assisted on pre-approval matters, advised on relevant pending legislation, dealt with inspection delays and refusals, and provided counseling on questions related to drug product packaging and labeling. We have also conducted surveys across all 50 U.S. states to better advise our clients on issues related to interstate shipments.

Our experience and knowledge have and will continue to serve our Indian clients well as they embark on clinical trials, promote products, enter new markets, and deal with both current good manufacturing practice (CGMP) and quality system regulation (QSR) requirements. Our creative and business-minded, evidence-based solutions help clients anticipate compliance and enforcement risks, whether they are dealing with highly visible litigation or discreet resolution of charges.

In short, marketing and selling pharmaceuticals, medical devices, and food products in the United States can be challenging, regardless of where the company is based. What makes the difference in risk mitigation, however, is the experience and the action your law firm is able to take, from inspection to courtroom, throughout the product life cycle, and as new regulations and legislation continue to develop and unfold.

Alston & Bird, through our deep bench of attorneys with industry and FDA experience, as well as our tradition of seamless multidisciplinary approaches to legal problem-solving, offers Indian companies not only a unique lens to view U.S. regulatory regimes and legislative initiatives but also a comprehensive approach to mitigating risk in the process.

Experience Overview

We have provided strategic advice and counseling to several large India-based multinational manufacturers of active pharmaceutical ingredients (APIs) and finished products on FDA compliance and enforcement issues. This work has included:

  • Preparing executive management for regulatory meetings.
  • Assisting in providing evidence that ultimately resulted in the FDA lifting import alerts.
  • Strategic advice and counsel on large-scale remediation efforts designed to address FDA warning letters.
  • Assisting in developing warning letter and Form FDA 483 responses that have ultimately resulted in voluntary action indicated (VAI) inspection classifications. This work has included on-site support at multiple locations in India.
  • Assisting in responding to untitled letters.

In addition to providing inspection-related support, our team has:

  • Provided litigation support on FDA issues in third-party litigation.
  • Assisted on pre-approval issues.
  • Provided advice and counsel on product exclusivities.
  • Provided counseling on drug product packaging and labeling issues.
  • Conducted 50-state surveys on interstate shipment of products.

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