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TMI Blog2010 (4) TMI 471X X X X Extracts X X X X X X X X Extracts X X X X ..... ort licence in Form-10A does not arise. 3. The petitioner herein is the importer and supply of drugs to the manufacturers of chemicals, drugs, pharmaceutical and food industry. The petitioner holds a licence under the Drugs and Cosmetics Act, 1940. The petitioner states that one of the substances that is regularly imported by the petitioner for supply to the dietary supplement industry is 'Benfotiamine', a synthetic nutritional dietary supplement used for manufacturing dietary supplement finished products. The said substance is supplied by the petitioner to various companies engaged in manufacturing dietary supplements. The petitioner contends that the Drugs and Cosmetics Rules, 1945 provides for exemption from taking import licence in Form-10A as regards the import of drugs specified in Schedule X. in terms of Rule 43 read with Schedule-D and Rule 123 read with Schedule - K of the Drugs and Cosmetics Rules, 1945, the petitioner states that it is entitled to have the import of 'Benfotiamine' without obtaining any licence under the Drugs and Cosmetics Rules, 1945. However, ignoring the said provision, by proceedings dated 22-2-2010, the second respondent issued a communication that ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... the contention of the petitioner has to be rejected. It is further pointed out that Rule 43 read with Schedule-D and Rule 123 read with Schedule-K of the Drugs and Cosmetics Rules, 1945, is applicable only on those products which are of non-medicinal use or is intended for purposes other than medicinal use or is of commercial quantity. Since the product imported by the petitioner does not fall under either of these clauses, the question of granting exemption on the drug formulations containing Benfotiamine does not arise. 7. Heard the learned counsel appearing for the petitioner and the learned counsel appearing for the respondents. 8. Learned counsel appearing for the petitioner laid emphasis on the provisions of the Drugs and Cosmetics Act and in particular with reference to Rule 43 and 123 of the Rules in contra distinction to Rule 23 to submit that the import of Benfotiamine was only for the purposes of supply to food manufacturing industry and not for manufacturing drugs. Consequently, the question of complying with the demand of the respondents does not arise. 9. Chapter IV of import and Registration of the Drugs and Cosmetics Rules, 1945 deals with the procedure as regar ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... pondents denied the petitioner's contention that 'Benfotiamine' imported by the petitioner is only for the purposes of use in the manufacture of food supplement. Given the fact that the subject good is imported not for the purposes of manufacture of a drug, but is to be used in the manufacture of food supplement, the question of obtaining licence, hence, has to be looked at from the point of the purpose of import and in tune with Rule 43 and 123 of the Rules and not with reference to Rule 23 of the Rule. The Act recognises import of substances as capable of multivarious use. Depending on the purpose of import and the usage for which the import is made, the Act prescribes the procedure for either getting a licence under Rule 23 or for going for an exemption under Rule 43 or 123 of the Rules, as the case may be. That being the case, when a particular drug is imported not for the purpose of use in the manufacture of a drug, but to be used in manufacture of food supplement, Rule 23 of the Act has no relevance in this case and the only other Rule which will have relevance for the purposes of considering the claim of exemption would be either Rule 43 or Rule 123 of the Act. Hence, the us ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... goods without the consent of the first respondent and that they would not import the product in future, the petitioner is bound to produce the licence in Form 10A. 16. It is hereby recorded that the petitioner has expressed its willingness to furnish end-user bond which would adequately safeguard the interest of the respondents apart from serving the purpose of the Drugs and Cosmetics Act. Considering the proceedings of the respondents dated 24th August, 2009, as disclosed in the typed set of papers filed by the third and fourth respondent, the fact that the import is not for the manufacture of the drugs but for use in the manufacture of food supplement, when the Rules themselves contemplate sufficient protection in matters of import of an item which is capable of multivarious uses, the insistence on obtaining Form 10A in terms of Rule 23 does not appear to be a correct approach and the same is contrary to the Rule and the understanding of the respondents as disclosed in the letter dated 24th August, 2009 found in the typed set of papers filed by the third and fourth respondents. Thus, going by the Rules, which provide for exemption from going for licence in Form 10A depending on ..... X X X X Extracts X X X X X X X X Extracts X X X X
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