The FDCs falling under the purview of the definition of the term New Drug under Rule 122E of Drugs and Cosmetics Rules, 1945 are only considered as New drugs. The requirements for the approval of FDCs are prescribed under Appendix VI of Schedule Y of Drugs and Cosmetics Rules 1945, according to which every FDC is not required to undergo all phases of clinical trials. The available records in the office of the Drugs Controller General (India) [DCG(I)] reveal that the concerned manufacturing firm was asked vide letter dated 20.6.1997 to conduct clinical trial before grant of the permission.
As per the available information, the FDC of Flupenthixol with Melitracen was already approved in other countries viz Austria, Italy, China, Luxembourg, Switzerland, Singapore, Jordan etc. at the time of approval. As per the letter of Dr. Udayan Kasthigar, the then Psychiatrist, Lady Hardinge Medical College, Delhi, a report was submitted on the open study of safety and efficacy of FDC of Flupenthixol 0.5mg with Melitracen 10mg in major depressive disorders on 10.08.1998 to the then DCG(I). Dr. Kasthigar mentioned that FDC of Flupenthixol 0.5mg with Melitracen 10mg in an initial loading dose of 2 tablets daily for one week followed by a maintenance dose of 1 tablet daily for three weeks was quite effective in mild to moderate depressed patients. The approval for FDC of Flupenthixol with Melitracen (Deanexit) was granted on 28.10.1998.
There is no provision in Indian laws, prohibiting the sale of a drug in the country on the basis of prohibition of sale in the country of origin.
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