Section 150H in The Drugs and Cosmetics Rules, 1945
150H. Procedure of approving authority.
(1)If the approving authority after such further enquiry, if any, as he may consider necessary, is satisfied that the requirements of the rules made under the Act have been complied with and that the conditions of the approval and the rules made under the Act will be observed, he shall grant an approval in Form 37.(2)If the approving authority is not so satisfied, he shall reject the application and shall inform the applicant of the reasons for such rejection and of the conditions which must be satisfied before an approval could be granted.
