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High level Indian delegation visits US FDA to resolve issues faced by pharma exporters
Swati Rana, Mumbai | Thursday, April 14, 2016, 08:00 Hrs  [IST]

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.

Comments

Saloni Apr 14, 2016 11:25 PM
It would have been nice to have some details around their discussions. Also, Indian manufactured medicines (generics) were banned as the quality of these products did not meet the US FDA compliance standards. Stating that "they have understood the Indian drug regulatory system" is not going to resolve any of the lingering quality concerns of the FDA. Indian companies need to change/modify some of their ways of manufacturing medicines and meet the cGMP compliance standards per the US regulations to avoid such incidents in the future. That may possibly be the only way to avoid such incidents and save the country's reputation of being the 'generics capital of the world.'

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