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Pharmexcil meets US FDA officials, discusses export related issues faced by industry

Suja Nair Shirodkar
Wednesday, March 25, 2015, 08:00 Hrs  [IST]

In a bid to boost exports to the US, the Pharmaceuticals Export Promotion Council of India (Pharmexcil) recently submitted a well documented representation to the visiting members of the US FDA on the Indian perspective and ongoing issues faced by the Indian pharma cos. The Council is believed to have had a very fruitful dialogue with the US FDA on establishing a trust worthy, problem free trade relation with the other for a mutually beneficial business relation.

To clarify and clear any ambiguity on the Indian drug regulatory system and quality of pharma products, the council had for the very first time organized an interactive meeting with not only the top regulatory officials and CEOs of the pharma companies but also major national associations from across the healthcare spectrum as well. Dr Appaji director general of Pharmexcil informed that the main aim behind this move was to impress upon the US regulatory officials, that Pharmexcil as the government body is actively connected and involved with all the stakeholders on all the export related issues.

While he also added that this meeting was also targeted to involve other stake-holders which includes members from the ASU, medical device, biotechnology sector as well to be part of such important process. Interestingly, Council had invited not only the top national industry associations like IDMA, Indian Pharmaceuticals Alliance (IPA), Bulk Drug Manufacturers Association (BDMA), Association of Biotechnology Led Entrepreneurs (ABLE), Ayurvedic Drug Manufacturers Association (ADMA), but also by other professional bodies like International Society for Pharmaceutical Engineering (ISPE) , Federation Of Pharma Entrepreneurs (FOPE), Parenteral Drug Association (PDA), Indian Pharmaceutical Congress (IPC) and United States Pharmacopeia (USP).

Not only were the top exporters to US were asked to be part of this interactive meeting, even those having non substantial exports to US like the biotech and ASU sector was also invited. All India Drugs Control Officers' Confederation (AIDCOC), which plays a very important part as a association representing the regulators of the country was also a very active part of the meeting.

This was strategic decision aimed at sensitizing all the stakeholders about the huge potential of US market, while also showing them that, they too play a major role in boosting the exports from the country. We got a tremendous response from all the stakeholders and even the FDA officials were really impressed by our show of strength. We wanted the US counterparts to know that Pharmexcil represents the whole of the healthcare sector in the country and thus should be used as point of reference for all the export related issues, which had been impressively done, Dr Appaji pointed out.

He further added that to boost the confidence on the Indian drug regulatory system and squash any doubts over the competency, top government and drug regulatory officials like Sudhanshu Pandey, joint secretary, department of commerce; DCGI, Dr G N Singh; Dr Somani, joint drug controller; Dr Eswara Reddy, and Dr Chandrashekar, deputy drug controllers was also privy to the meeting.

The Council also organized first of its kind tele-conference between the FDA officials and top regulatory chiefs of the Indian companies like Lupin, Dr Reddys, Aurbindo Pharma, Cipla, Emcure, J B Chemicals, MSN Labs, Force India, Sun Pharma. S M Mudda, executive director of Micro Labs made a detailed presentation to the FDA officials on the Indian pharma industry and the issues relating to the US that Indian exporters are facing.


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