IGMPI India

US Food and Drug Administration have announced the initiation of Secure Supply Chain Pilot Program to increase the security of imported drugs. The goal of the program is to enable the FDA to evaluate resource savings that will allow the agency to focus imports surveillance resources on preventing the importation of adulterated, misbranded, high-risk drugs, or unapproved drugs that are the most likely to compromise the quality and safety of the U.S. drug supply.

The notice was published in August, 2013 in the Federal register (78 FR 51192) to solicit companies to voluntarily submit applications for participation in this two-year program. The FDA will evaluate the effectiveness of the program in increasing imported drug compliance with FDA regulations, during these two years. If the FDA found the program to be effective, a more permanent program may be established and possibly extended to additional participating companies.

Till now, thirteen prequalified companies have been designated to take part and will receive expedited entry for the import of not more than 5 selected drug products into United States. The participating companies met multiple participation conditions, e.g, having a validated secure supply chain protocol or having effective recall and corrective action plans in place. Additionally, the companies have to maintain control over their drugs from the time of manufacture abroad through the entry into the United States. The prequalified companies accepted into the program are:

•  AbbVie Inc.
•  Allergan, Inc.
•  Astellas U.S. Technologies, Inc.
•  Bristol-Myers Squibb Company
•  Celgene Corporation
•  GE Healthcare Inc.
•  GlaxoSmithKline LLC
•  Merck Sharp & Dohme Corporation
•  Mylan Pharmaceuticals Inc.
•  Novartis Pharmaceuticals Corporation
•  Pfizer, Inc.
•  Teva Pharmaceuticals USA, Inc.
•  Watson Laboratories, Inc.