HHS/FDA Indian offices Opened

February 4, 2009

Two new HHS/FDA food and drug safety offices in Dehli and Mumbai, India are the latest outpost of the US regulators.

This is how it is going to impact

HHS/FDA will post 10 experienced officials in India to work closely with industries that ship food and medical products to the United States, to improve safety and quality, which will facilitate the smooth flow of trade.

Along with the Office Director, HHS/FDA will have four inspectors and five senior technical experts who will cover food, medical devices and medicines.

This is what HHS/FDA personnel will provide :

These HHS/FDA personnel will provide technical advice, conduct inspections of facilities that export to the United States, and work with Indian government agencies and the private sector to develop certification programs to allow the efficient flow of safe HHS/FDA-regulated goods between the United States and India.

India is the fourth-largest exporter of drugs and biologics to the US with bilateral trade growing from $13.5bn (€10bn) in 2001 to $32bn in 2006.

Various Training based companies like ComplianceOnline conducts series of seminars regularly in India on topics like:

  • Computer System Validation and Part 11 Compliance in Practice
  • Applying Lean Principles to Controlled Documents
  • Critical Cleaning Validation for Pharmaceuticals & Biotech Industry
  • 21 CFR Part 11 Compliance in Practice and Computer System Validation
  • How To Comply With FDA Quality Systems Regulations And Pass FDA Inspections
  • Understanding US trends in Pharmaceutical and Building a Successful CMO

Click here to find more about ComplianceOnline seminars/webinars.

Source: Embassy of United States ComplianceOnline