First, one has to get a license to manufacture the drug. However, I believe the problem is to get contracts from other countries. One may get a license and go through the whole process but what is more important than anything else is to get a contract from another country.
Does the legislation help you to obtain contracts from other countries? Whether you have a license or not, if you cannot qualify, that is a major obstacle. How can you sell it if you don't have a contract? Is it difficult for you to qualify and to get contracts?