With the listing of Manufacture of Pharmaceuticals under the priority List of activities in the Foreign Direct Investment (FDI) Policy 2010, DRA is in receipt of applications from potential manufactures andas per the instruction from the 17th Bhutan Medicines Board meeting, DRA is to propose clear policies to prioritize the type of pharma and medical products industries.Therefore, this document is developed with the aim to guide the potential applicants in fulfilling the technical and regulatory requirements for manufacture of medicinal products in accordance to the Medicines regulation and also for promoting uniformity and transparency in making the regulatory decisions. In this context, we would like to request interested individuals/firms to provide comments on the prescribed format attached along with this draft document latest by 30 December 2018 to dra@dra.gov.bt