Section 21(d) in The Drugs and Cosmetics Rules, 1945
(d)[ "manufacturer", includes a manufacturer of drugs, who may be a Company or a unit or a body corporate or any other establishment in a country other than India, having its drugs manufacturing facilities duly approved by the National Regulatory Authority of that country, and who also has a free sale approval of the drugs approved by the said authority in the concerned country, and/or in other major countries. [Inserted by G.S.R. 604(E), dated 24.8.2001 (w.e.f. 1.1.2003).]
