(1) If anyone wants to conduct a clinical trial of a new drug or vaccine, he shall obtain a permit as prescribed by the department for such work. Explanation: For the purposes of this section, "clinical trial" means "clinical trial" for the purpose of ascertaining whether a new drug or vaccine is suitable for use or not. As specified in the permit, it is the act of administering medicine or vaccination to a patient or other person in a hospital or similar hospital according to their will.
(2) Notwithstanding anything written in sub-section (1), the Government of Nepal may grant permission to an institution or company developing a vaccine under clinical trial in accordance with the permission of a foreign country's government or related regulatory body if it wishes to conduct a clinical trial of such a vaccine in Nepal.
(3) According to sub-section (2), other procedures related to granting permission and conducting clinical trials shall be as determined by the Government of Nepal.