9911796707
TMI Blog2010 (4) TMI 471X X X X Extracts X X X X X X X X Extracts X X X X ..... onal and ultra vires the provisions of the Drugs and Cosmetics Act, 1940 and the rules framed thereunder and to consequently direct the respondents to permit import of Benfotiamine dietary supplement by the petitioner meant for non-medical use without insisting upon import licence in Form-10A in view of the exemption from import licence as provided under Rule 43 read with Schedule-D and Rule 123 read with Schedule-K of the Drugs and Cosmetics Rules, 1945. 2. The petitioner contends that in view of Rule 43 read with Schedule-D and Rule 123 read with Schedule-K of the Drugs and Cosmetics Rules, 1945, the question of the petitioner obtaining import 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 ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... used in the treatment of patients with nerve damage and nerve pain and also shown to be effective in diabetic retinopathy, nephropathy and neuropathy, since some of the drug formulations contain Benfotiamine, the import of the same that it is for manufacture of food supplement, cannot be accepted, it is further stated that the consignments of the petitioner were earlier released on the letter of guarantee executed by the petitioner, wherein the petitioner had clearly given an undertaking that they would not dispose of the goods without the consent of the first respondent. In the light of the Letter of Guarantee dated 25-9-2008 and the undertaking, 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 ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... nal use. Where the imported substance is of commercial quality, the importer need not obtain licence in the Form 10A. 12. Schedule K to Rule 123 of the Rule specifies numerous conditions on exemption for the drugs, it is not denied by the petitioner that the imported goods concerned can be used for more than one stated purpose and depending on the use, the licence for exemption is to be obtained. As in this case, if the use of the imported substance is for manufacturing a drug, the import requires a licence and does not qualify for exemption as provided for under the above said Rule. 13. A reading of the counter affidavit shows that nowhere the respondents 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 s ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... the Drug Controller General (India), (Import Registration Division) shows that the third respondent had no objection for importing Benfotiamine to be used as an key ingredient for captive use in the manufacturing of GMAB plus, without attracting the provisions of GSR 604(E) dated 24-8-2001. in the said letter, it is further stated that all the containers of the subject material should be labelled as "not to be used in drugs" before releasing the consignment by the concerned Port Officers. The respondents, however, insist that having regard to the earlier consignment released on a Letter of Guarantee and an undertaking that they would not dispose of the 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 ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... notice. However, having regard to the plain meaning of Rule 43 and 123 of the Rules and the practice of the respondents as indicated in the letter dated 24th August, 2009 that Benfotiamine was allowed to be cleared with a stamping in every consignment that the import is not to be used in drugs, I have no hesitation in rejecting the objection of the respondents in granting the relief to the petitioner. The petitioner has also expressed its willingness to furnish end-user bond which would be in consonance with Rule 43 of the Rules. 20. Having regard to Schedule D read with Rule 43 of the Rules, I have no hesitation in accepting the plea of the petitioner that the consignments shall carry the stamping that the import is not for the purpose of use in the manufacture of drugs. 21. In the light of the above circumstances, I reject the plea of the respondents on the availability of alternative remedy as well as on the merits of the detention. Having regard to the view that I have taken and in the light of the willingness expressed to furnish end-user bond by the petitioner that the import is for the purpose of use in the manufacture of food supplement and hence, governed by Rule 43 re ..... X X X X Extracts X X X X X X X X Extracts X X X X
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