Amendment status not verified — confirm the current text below against the official source.
Name of the raw material (new bulk drug substance): (1) .................................................................. (2) ................................................................ (3) …............................................................... Dated .............. Signature .......................... Name and designation of Licensing Authority. Conditions for Grant of Permission /Approval (1) The raw material (new bulk drug substance) shall conform to the specifications approved by the Licensing Authority. (2) The raw material (new bulk drug substance) can be sold to only those manufacturers who have permission, in writing, from Licensing Authority, either to use the drug for development purpose/clinical trial-bio-equivalence study or to manufacture the formulation. (3) For manufacture of the formulation in the country, separate approval under rule 122B shall be obtained from the Licensing Authority.]