India plays an important role in the global pharmaceuticals and vaccine industry. It is the largest provider of generic medicines globally. The country has a share of 20% in the global supply volume and contributes to around 60% of the global vaccines. India ranks third in the world in terms of volume and is the fourteenth largest in terms of value. Key segments of the Indian pharmaceutical industry are OTC medicines, Generics, APIs, Vaccines, Biosimilars, and Custom Research Manufacturing (CRM).
Pharmexcil is a promotion body set up by the Government of India to promote the Indian pharmaceutical industry. The roles of the council are to advise the government, organize seminars and meetings on export-related issues, organize business meetings in India and abroad and also organize trade delegations. The council also assists its members in getting Market Access Incentive (MAI) claims from the Government of India.
Expertise in Pharmexcil License
The EP(Pharma) Division deals with export promotion of Pharmaceutical products and the administrative matters pertaining to the Export Promotion Council for Pharma viz. Pharmaceutical Export Promotion Council of India (Pharmexcil).
India exports pharmaceutical products to North America, Africa, the EU, ASEAN, Latin America & Caribbean (LAC), Middle East, Asia, CIS and other European regions. Nearly two-thirds of India’s exports goes to NAFTA, Europe, and Africa. The top five export destinations for Indian Pharma Industry in 2021-22 were USA, the UK, South Africa, Russia, and Nigeria
USA, the UK and Russia are among the largest importers from India at a share of 29%, 3% and 2.4%, respectively during 2021-22. India’s exports of pharma products to these countries in FY21-22 were: USA with US$ 7,101.6 million, the UK with US$ 704.5 million, South Africa with US$ 612.3 million, Russia with US$ 597.8 million, and Nigeria with US$ 588.6 million. India’s pharma exports to USA in value grew at a CAGR of 6.9% over last three years. Additionally, for UK and Russia, it grew at a CAGR of 3.8%, and 7.2%, respectively over the same period.
As of August 2021, the number of USFDA approved facilities stood at 741. Additionally, the number of ANDAs won by the Indian firms till December 2020 stood at 4,346. USFDA inspections were not conducted during the last couple of years due to the Covid pandemic, however, the inspections have started happening now and are expected to further increase Indian exports to USA.
The following documents are required for shipping pharmaceuticals from India:
