During the two-day State Visit of His Excellency Shri Narendra Modi, Hon’ble Prime Minister of the Republic of India to Bhutan from 22 to 23 March 2024, the following Agreement and Memorandum of Understanding (MoU) concerning BFDA and the relevant competent authorities in India were signed. The Agreement/MoU were signed between the Dasho Pemba Wangchuk, Secretary, Ministry of Health and Shri Sudhakar Dalela, Ambassador of India to the Kingdom of Bhutan and it was exchanged in the presence of the two Prime Ministers, Shri Narendra Modi and Lyonchen Dasho Tshering Tobgay. 

1. Agreement for recognition of official control exercised by Bhutan Food And Drug Authority (BFDA) by Food Safety and Standards Authority Of India (FSSAI)

The Agreement was signed between the Bhutan Food and Drug Authority (BFDA), Ministry of Health, Royal Government of Bhutan and the Food Safety and Standards Authority of India (FSSAI), Ministry of Health and Family Welfare, Government of India and this marks a significant step in strengthening bilateral ties between Bhutan and India in food and agricultural products trade.

The Agreement is aimed at ensuring that food and agricultural products exported from Bhutan to India are safe and wholesome. The signing of the Agreement would mean that the national food control system will have to be continually strengthened at par with international standards, in order to meet the importing country requirements and consequently, facilitate trade. As per the Agreement, the export inspection certificate issued by BFDA in accordance with the prescribed import requirements will be accepted by the FSSAI at the Indian border points.  

For the food businesses in Bhutan, the implementation of this Agreement will promote the ease of doing business between the two countries and reduce compliance cost. It would mean that, once their products are inspected, tested and certified by BFDA as per the requirements defined by FSSAI, including any other applicable regulatory requirements, there is no need for double inspection, testing and certification on the other side. This arrangement will not only save costs incurred on the Bhutanese food businesses but also facilitate cross-border trade. 

Through this partnership, BFDA’s objective is to establish an effective national food control system that not only protects the health of consumers through production and trade of safe foods, but also enhances the competitiveness of our local food industry in the international market. Further, BFDA looks forward to establishing similar technical collaborations with other food safety competent authorities in the region, to ensure protection of public health through safe food trade. 

2. MoU on cooperation concerning sharing reference standard, pharmacopoeia, vigilance and testing of medicinal products

The MoU signed between the Bhutan Food and Drug Authority (BFDA) and the Indian Pharmacopoeia Commission (IPC) aims to promote safety and quality of medical products in the region through enhancing cooperation between the parties in sharing pharmacopeia, reference standards, vigilance, and testing of medical products, in accordance with the respective laws and regulations. The MoU will allow for acceptance of Indian Pharmacopoeia by Bhutan as a book of standards for medicines and supply of generic medicines at affordable price.