2016 (3) TMI 565 - AT - Central Excise

Classification - products manufactured namely Oxy-Tetracycline Hydrochloride Skin Ointment 5G/15G, Oxy-Tetracycline Hydrochloride AF Tabs and Oxy-Tetracycline 500mg Capsule - classifiable under 3003.20 as medicaments other than Patent or Proprietary medicaments or under 3003.10 as Patent or Proprietary medicaments - Held that - Definition of Patent or Proprietary Medicaments it can be seen that if the name of the medicament is appearing in any of the above pharmacopoeia, it shall not be classifiable as Patent or Proprietary Medicaments therefore it is not medicament as such but only name is significant. In the present case the Oxy tetracycline IP and oxy tetracycline Hydrochloride IP is admittedly appearing in the Indian pharmacopoeia. It is also observed that Oxytetracycline capsule is specifically appearing in the Indian pharmacopoeia. The product name Oxytetracycline Hydrochloride skin ointment and Oxytetracycline Hydrochloride (AF) tablet though not verbatim appearing in the pharmacopoeia, medicaments are generic medicament and the name of the drug and medicament is appearing in the Indian Pharmacopoeia, therefore in our view the medicament produced by the respondent have names appearing in the Indian pharmacopoeia and therefore the same are not Patent or Proprietary Medicaments . Our this view is supported by the judgment of Endolabs Ltd ( 2004 (3) TMI 456 - CESTAT, NEW DELHI ) wherein division bench of this Tribunal held that name Norfloxacin Piroxicam capsule specified in Indian Pharmacopoeia whereas assessee was manufacturing Norfloxacin 100 DT and Piroxicam Gel despite this itself Tribunal as held that the products manufactured by the assessee are not Patent or Proprietary Medicaments classifiable under sub heading 3003.20. In the case of Hindustan Biologicals Vs Commissioner of Central Excise, Mumbai 2004 (6) TMI 341 - CESTAT, MUMBAI the fact was that drugs name Domperidone Paediatric suspension is specified in Indian Pharmacopoeia and the label of the medicament bearing the name of Albenzole Suspension , the Tribunal held that since the drug name is appearing in the Indian Pharmacopoeia, the product of the assessee could not be treated to fall under the heading 3003.10 as Patent or Proprietary Medicaments . In view of the above discussion and the case laws, we are of the considered view that the Ld. Commissioner has rightly classified the products in question under Chapter 3003.20. - Decided against revenue

Summary

Issues Involved:
Classification of medicaments under CH 3003.10 as Patent or Proprietary medicaments or under CH 3003.20 as other medicaments.

Detailed Analysis:

1. Issue of Classification:
The appeal by the revenue challenges the Order-in-Original dropping proceedings against the respondent for manufacturing Oxy-Tetracycline products. The main issue is whether these products fall under CH 3003.10 as Patent or Proprietary medicaments or under CH 3003.20 as other medicaments. The revenue argues that since the product names do not appear in the pharmacopoeia, they should be classified as Patent or Proprietary medicaments. However, the respondent claims that the products are covered under the names Oxy-Tetracycline Hydrochloride IP and Oxy-Tetracycline Capsule, which are listed in the Indian Pharmacopoeia, thus not qualifying as Patent or Proprietary medicaments.

2. Contentions of the Parties:
The revenue contends that any medicament not listed in a pharmacopoeia should be considered as Patent or Proprietary medicaments. On the other hand, the respondent argues that as long as the medicament name appears in any pharmacopoeia, it should not be classified as Patent or Proprietary. Reference is made to the judgment of Commr. of Customs & Central Excise, Indore Vs. Endolabs Ltd supporting this argument.

3. Legal Interpretation:
To determine the classification, the Tribunal examines the definition of 'Patent or Proprietary Medicaments' which specifies that if a medicament's name appears in any pharmacopoeia, it should not be considered as Patent or Proprietary. In this case, Oxy-Tetracycline products are found to have names appearing in the Indian Pharmacopoeia, thus not meeting the criteria for Patent or Proprietary classification. Citing precedents like Endolabs Ltd and Hindustan Biologicals, the Tribunal upholds the Ld. Commissioner's classification under Chapter 3003.20, dismissing the revenue's appeal.

4. Judgment and Conclusion:
The Tribunal concludes that the products in question, despite not verbatim matching the pharmacopoeia names, are generic medicaments with names present in the Indian Pharmacopoeia. Drawing on previous rulings, the Tribunal affirms that the products do not qualify as Patent or Proprietary medicaments under CH 3003.10 but fall under CH 3003.20. Therefore, the impugned order is upheld, and the revenue's appeal is dismissed.

In summary, the judgment clarifies the classification of medicaments based on their names appearing in pharmacopoeias, emphasizing the distinction between Patent or Proprietary and other medicaments under relevant chapters. The decision is supported by legal interpretations and precedents, ensuring consistency in classification practices.