Just a moment...

Top
Help
AI Drafter

Generate professional replies to Show Cause Notices, assessment orders, audit objections, and other legal communications using TaxTMI's AI Drafter.

Step 1 – Issue Identification & Review

The AI analyses your query, notice, order, or uploaded documents and identifies the key issues involved.

• Review the issues identified by the AI
• Add, edit, remove, or refine issues as required


Step 2 – Draft Generation

Once you approve the issues, the AI performs issue-wise legal research and prepares a structured draft response.

• Relevant statutory provisions
• Judicial precedents and Supreme Court, High Court and other citations
• Issue-wise legal analysis
• Practical arguments and supporting content
• Professionally structured draft ready for further review.

Try Now
×

By creating an account you can:

Logo TaxTMI
>
Call Us / Help / Feedback

Contact Us At :

E-mail: [email protected]

Call / WhatsApp at: +91 99117 96707

For more information, Check Contact Us

FAQs :

To know Frequently Asked Questions, Check FAQs

Most Asked Video Tutorials :

For more tutorials, Check Video Tutorials

Submit Feedback/Suggestion :

Email :
Please provide your email address so we can follow up on your feedback.
Category :
Description :
Min 15 characters0/2000
TMI Blog
Home / RSS

1993 (7) TMI 194

X X   X X   Extracts   X X   X X

Full Text of the Document

X X   X X   Extracts   X X   X X

....d in the manufacture of Medicinal Products, namely, DAKTARIN GEL and GYNODAKTARIN GEL. They are prepared by using Miconazole Nitrate as an active ingredient which is the salt of the base chemical miconazole. They claimed exemption in respect of the above products in terms of exemption Notification No. 122/86 dated 1-3-1986. While claiming the exemption it was submitted on behalf of the appellants relying upon various affidavits and extracts from relevant Pharmacopoeias that whenever any medicine is prepared with Miconazole as one of the active ingredient which is usually used in its salt form miconazole nitrate. Miconazole nitrate is the only form in which miconazole can be administered to cure mycotic/fungal vulvo-vaginal infections. The e....

X X   X X   Extracts   X X   X X

Full Text of the Document

X X   X X   Extracts   X X   X X

.... British Pharmacopoeia 1980 Vol. 1, 28th Edition which referred to miconazole injection, which was not relied upon either in the Show Cause Notice or in the order passed by the Assistant Collector or in any evidence produced by the appellants. Since the Collector (Appeals) did not disclose this evidence to the appellants during the course of proceedings, they had no occasion to rebut it. Hence, they are filing the miscellaneous application for taking an affidavit of Dr. A.V. Dangi on record as an additional evidence to rebut new evidence. In the affidavit of A.V. Dangi it was stated that bulk drug miconazole is invariably used in the salt form miconazole nitrate in India. No manufacturer of pharmaceutical products in India ever manufactures....

X X   X X   Extracts   X X   X X

Full Text of the Document

X X   X X   Extracts   X X   X X

....he word `Miconazole' be amended as miconazole nitrate but shall be substituted. This amended notification is clarificatory in nature as the same was clarified in the classification issued by the Ministry as per copy of the Ministry's letter dated 25-11-1986 addressed to all Collectors, Central Excise. The clarification was issued not only on the representation and references have been received from the Industry but also from the Central Excise Collectorates since they felt the exemption notification as it then stood would not serve the purpose for which exemption was granted. Further it was stated that all provisional assessments may be finalised as per the guidelines specified in Notification No. 455/86. Shri Dada argued that there would b....

X X   X X   Extracts   X X   X X

Full Text of the Document

X X   X X   Extracts   X X   X X

....onsequently amodiaquine hydrochloride is entitled to exemption under Notification No. 116/69." Further it was held in the case of Super Cassettes Industries Ltd. v. Collector of Customs, reported in 1992 (58) E.L.T. 105 that what was implicit in the original notification has been made explicit by the amending notification and, accordingly, amendment is only clarificatory in nature. 5. Shri Sharad Bansali, learned SDR for the Revenue submitted that miconazole nitrate is different and distinct from miconazole. They are neither synonymous nor interchangeable. Whether miconazole was used or not by the party in the preparation is not the criteria to avail exemption as the very item could be used in the medicine as can be seen in the lite....

X X   X X   Extracts   X X   X X

Full Text of the Document

X X   X X   Extracts   X X   X X

....as appeared in Paras 3 & 6 of the judgment are as follows :- ***** In the instant case sufficient evidence was brought on record by the appellants to show that miconazole in the base form as such was not used in the preparation by the manufacturers in India and this fact was not rebutted by the Department. This gets substantiated also from the fact that the Government of India itself amended the said notification later to read as "miconazole nitrate." Though an exemption notification is to be strictly construed yet if so construed, the said Notification No. 122/86 would be of no benefit to any one as miconazole as such was not used in the medicinal preparation by any manufacturer in India. The exemption to miconazole is exemption to m....

X X   X X   Extracts   X X   X X

Full Text of the Document

X X   X X   Extracts   X X   X X

...., the benefits of Notification No. 122/86-C.E. may be extended to P or P formulations containing the specified ingredients referred to in Sl. Nos. mentioned above even if such formulations contain ingredients in their salt forms as specified in Notification No. 455/86-C.E., dated 21-11-1986 and all provisional assessments may be finalised as per the above guidelines. The field formations and the industry may be suitably advised. Kindly aknowledge receipt of this letter." In the amended notification since the expression used was `miconazole nitrate' shall be substituted and in the subsequent clarification issued by the Government of India that provisional assessment may be finalised as per the guidelines of Notification No. 455/86, we ....