9911796707
TMI Blog1994 (9) TMI 160X X X X Extracts X X X X X X X X Extracts X X X X ..... . 31/88. 3. The main question involved in this case is as to whether they had rightly availed the benefit of this notification and whether in this connection they were required to produce End-use Certificate. 4. The proceedings against the appellants have been initiated in view of the Circular No. 8/90-CX-III dated 6-3-1990 issued by CBEC which prescribed at that End-use Certificate was required for the purpose of availing the benefit of this notification. 5. However, CBEC itself has in a recent circular No. 26/94-CX VI dated 30-3-1994 reported in 1994 (70) E.L.T. T-28 to T-30 has referred to the above circular and clarified that the End-use Certificate may be insisted upon only in respect of other bulk drugs mentioned in the list a ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ctually used in the formulation is unwarranted and not contemplated in the notification. 12. In fact this notification does not stipulate production of End-use Certificate in order to earn the concession. It is a settled legal position that a condition which is not mentioned in the Notification cannot be imported in it to deny the benefit. It was also his submission that the scope of notification could not be enlarged or abridged by a trade notice. 13.In any eventuality the appellants have actually produced the End-Use Certificate for each of the bulk drug in question. These were examined and accepted by the A.C. 14. The Ld. Counsel also stated that they had cleared these drugs on the basis of final approved classification list ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ief Chemist was obtained which shows that these could be considered as bulk drugs subject to their being of pharmacopoeial standard (IP, BP or USP) as per the letter of the Dy. Chief Chemist dated 1st Jan. 1993. 19. It was also his submission that the Board has of course issued the circular dated 6-3-1989 modifying its earlier circular and confining the requirement of End-Use Certificate to other bulk drugs but it was upto the Tribunal to take its own view in the matter. 20. The Ld. Collector (Appeals) is right in stating that the Drug Control Authority can only certify that the bulk drugs can be used for formulation purposes but whether they have been actually was utilised can only be verified on the basis of End-Use Certificates is ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... or had obviously erred in dealing with this notification without indicating the basis of his satisfaction that they were drugs of pharmacopoeial standard. Neither inclusion in the Merk Index nor the certificate of the Drug Controller could help the cause unless this essential requirement was first satisfied. The Collector (Appeals) has also not noticed this aspect; And both the lower authorities have proceeded on the assumption that the items in question were bulk drugs. 26. The appellants have also filed before the Tribunal some `End Use Certificates' issued by the customers but those which were not produced before the Collector (Appeals) (who specifically refers to non-production of such certificates) were in the nature of the new e ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... d. 30. That apart, in the Drug Controller's permission produced by the appellants the pharmacopoeial standard has been prescribed for only some of the items (such as Ampicillin) whereas for others the `in-house specifications' have been allowed. This is significant in as much as it would go to show that they were free to manufacture such drugs according to their own specifications. 31. Therefore, the benefit of the exemption notification would be admissible only in respect of these drugs subject to their being shown in the Merk Index with no alternative use and also subject to their `In-house specifications' being the same as the pharmacopoeial standard. 32.With these observations, the appeal is allowed as already announced in ..... X X X X Extracts X X X X X X X X Extracts X X X X
|
