2000 (11) TMI 497 - AT - Customs

Agglutinating Sera in freeze dried form eligible to concession under Notification No. 13/95-Cus

Summary

Issues:
- Denial of exemption from duty for "Agglutinating Sera" due to form difference.
- Interpretation of "Agglutinating Sera" and eligibility for duty exemption.
- Freeze-dried form eligibility for duty exemption.
- Definition of serum, antibodies, and antigen in the context of sera production.
- Process of producing monoclonal antibodies and freeze-drying.
- Validity of freeze-dried form as "Agglutinating Sera" for diagnostic purposes.
- Clarification from Drug Controller of India and Lady Hardinge Medical College.
- Application of earlier order's ratio for duty exemption eligibility.

1. Denial of Exemption from Duty:
The authorities denied duty exemption for "Agglutinating Sera" due to the goods being in freeze-dried form, unlike the traditional fluid fraction separated from blood after clotting. The Bill of Entry classified the goods under Customs Tariff Heading 3002.10. However, the Tribunal previously accepted that agglutinating sera can be in liquid or freeze-dried form. The freeze-dried form was deemed eligible for duty exemption under Notification No. 208/81. The Tribunal's earlier order clarified the acceptable forms of agglutinating sera, supporting the current appeal's contention for duty exemption.

2. Interpretation of "Agglutinating Sera":
The judgment delved into the definition of serum, antibodies, and antigens to clarify the concept of "agglutinating sera." Serum is defined as the fluid fraction separated from blood after clotting, containing antibodies produced in response to antigens. Antiserum, derived from immunized animals, contains antibodies specific to injected antigens. The production of monoclonal antibodies involves fusing spleen cells with myeloma cells to create specific antibodies. Monoclonal antibodies, crucial for diagnostic purposes, are often freeze-dried for extended shelf life and easy storage, a process known as lyophilization.

3. Validity of Freeze-Dried Form for Duty Exemption:
The appellants argued that freeze-drying is necessary for diagnostic antiserum to enhance shelf life and facilitate transport and storage. This argument was supported by documentation showing that agglutinating sera, including freeze-dried forms, were certified for import by medical authorities. The Drug Controller of India and Lady Hardinge Medical College confirmed the liquid or freeze-dried nature of agglutinating sera, emphasizing the necessity of freeze-drying for diagnostic purposes. The Tribunal found the reasons for denying the imported product as not valid, leading to the allowance of the appeal based on the earlier order's precedent.

In conclusion, the judgment clarified the eligibility of freeze-dried "Agglutinating Sera" for duty exemption, based on the interpretation of serum components, the process of producing monoclonal antibodies, and the necessity of freeze-drying for diagnostic purposes. The detailed analysis of serum definitions, antibody production, and lyophilization process supported the decision to grant duty exemption, aligning with previous rulings and expert clarifications from medical authorities.