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The International regulatory meeting held recently in Hyderabad has given the much needed impetus to build a renewed confidence among the Indian pharmaceutical exporters.
With leading food, pharma and drug regulators from United Kingdom, USA, Europe, Japan, Africa and Australia took part in the regulatory meeting; it had really helped a lot for the Indian exporters to have a firsthand understanding of the changing international regulatory landscape across the globe.
According to Uday Bhaskar, director general of Pharmexcil, the two-day international regulatory meeting has delved on various issues and challenges being faced by the exporters while exporting their products to the international markets. “Trade regulations and particularly for the pharmaceutical industry each country has its own regulatory scenario. We can say food and drug regulations vary dynamically from one country to the other. As India is also aiming to strengthen its brand India pharma image globally, it is very important for our exporters to have the knowledge of international regulations. The two-day conference was really a fruitful one as it has enabled many leading exporters and even for the new entrants into the global export market to learn many things with regard to product registrations and other international trade aspects pertaining to pharmaceuticals,” observed the Pharmexcil DG.
The Pharmexcil DG said that knowledge on regulatory and registration procedures is crucial for the exporter members, as each country has new and unique procedures. The conference has also helped the members to have a know-how on various amendments being made by the food and drug authorities across the globe with respect to the product registration requirements (DMF and ANDA filings), documentation, filings, plants audits and inspections etc.
In fact, Pharmexcil with the support of department of commerce, government of India, has initiated this programme referred to as “IKEP-International Knowledge Exchange Programme”. Its main objective is to create a platform for inviting Food & Drug Regulatory officials globally. “We have successfully organized interactive meets with some of the drug regulators including UKMHRA, NAFDAC, PMDA, DAV, ANVISA, Food & PB Kenya, EDA (Egypt), FDA Ghana etc,” informed Uday Bhaskar.
The Pharmexcil DG said that the main objective of the international regulatory meeting is to create confidence among the Indian pharma exporters by outreaching the drug regulators of various countries. It is also aimed building a Brand for the Indian pharma at an international stage and thereby instill confidence among the Indian exporters to export their products to the international markets.
Food and drug regulators from across the globe including USA, United Kingdom, South Africa, Russia, Brazil, Nigeria, Germany, Canada, Belgium, France, Australia, Kenya, United Arab Emirates, Vietnam, Philippines, Nepal, China Sri Lanka, Netherland, Myanmar, Bangladesh, Thailand, Iran, Uganda, Japan, Spain, Italy, Turkey, Tanzania, Mexico, Korea, Saudi Arabia, Argentina, Indonesia, Ghana, Ethiopia, Egypt, Mozambique, Singapore, Hungary, Congo, Zambia, Ukraine, Algeria, Iraq, Slovenia, Sudan, Afghanistan, Yemen, Israel, Malaysia, Zimbabwe, Peru, Argentina, Uzbekistan, Kazakhstan, New Zealand etc took part in the programme.
The event was also marked the presence of representatives from World Health Organisation (WHO) India and CDSCO.
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