TABLE CONFERANCE OF INDIAN EXPORTERS WITH US FDA

Mohammad Shahbaz Alam, New Delhi

April 15, 2016

A high-level Indian delegation, led by Sudhanshu Pandey, joint secretary in the Union
ministry of commerce and industry, recently visited US FDA under Brand India Campaign to
discuss several issues being faced by the Indian exporters and to find an amicable solution to
these issues.
Drug Controller General of India (DCGI) Dr. G N Singh and director general of Pharmexcil
Dr. P V Appaji were the other members of the 3-member delegation which took up several
issues being faced by the Indian pharma exporters to US including quality of Indian generic
drugs with top US FDA officials. Dr Appaji says, This is first time we visited US to
understand the issues and problem faced by the exporters. We had a discussion related to
several issues and Indian regulatory system. The commerce ministry also had a follow up
meeting with the DCGI and DCGI is already taking action on several matters.
Most importantly we met minister of health services, commissioner of US FDA and senior
official from US Indian Business Chamber in a programme organised by Pillsbury.
Representatives from several companies and government of US have appreciated our
initiative of strengthening the pharma trade between two countries and this initiative has
given clarity to both the sides on several issues. The meeting was positive and they have also
understood the Indian drug regulatory system.
He further informed that US is an important market to us as 33 per cent of our exports are to
US market. The visit was an attempt to have a clarity on issues related to US FDA, supply
chain management and Indian regulatory system from both the sides.
Issues related to quality, US FDA and supply chain management was discussed in broad. In
an exhibition the delegates met several representatives from different pharma companies like
Teva, Actavis, Almirall, Dr Reddy, Sandoz and Sumitomo Dainippon. They also made an
attempt to have a discussion with the associations in US like Association of Physicians of
Indian Origin and American Generic Pharmaceutical Association and met senior officers of
US
Pharmacopoeia.
The Brand India Campaign is to project the attractiveness of India as an emerging destination
for business. The campaign uses both India as huge market for products and services as well
as a lucrative destination for investment. Amongst the leading organisations working on
building Brand India is India Brand Equity Foundation (IBEF), a public-private partnership
between the ministry of commerce and industry, government of India, and the Confederation
of Indian Industry. It aims to effectively present the India business perspective and leverage
business partnerships in a globalising market-place.

This is really a good team work among pharma stake holders to resolve global issue.Do we
can join hands together to resolve fixed dose combination issue as a team?
Email:medicarechief@gmail.com