TaxTMI 
TaxTMI 
2013 (1) TMI 119
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....ng dietary supplements and not for manufacturing medicine, as per Rule 43 of the Drugs and Cosmetics Rules, 1945, the exemption granted in respect of the implementation of Chapter III of the Drugs and Cosmetics Act, enables him to continue to import without getting approval in Form 10 or Form 10A. However, the appellant in the impugned communication dated 22.02.2010, has informed the first respondent that since the Assistant Drug Controller, Custom House has opined that the subject consignment 'Benfotiamine' cannot be released without importer's licence in Form- 10, a direction was issued to the first respondent to produce the licence in Form 10 for the purpose of clearance of the consignment. It was against the said communication of the Assistant Drugs Controller, the first respondent has filed the above said W.P.No.4841 of 2010 on the ground that inasmuch as the consignment sought to be released by way of import was not intended to use for medicinal use, there is no question of obtaining any licence, since as per Rule 43 of the Drugs and Cosmetics Rules, the first respondent is exempted from being an importer from the provisions of Chapter III of the Drugs and Cosmetics Act. The ....
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....orities have lost their right of control in respect of distribution of spurious drugs. 4. On the other hand, Mr.Satish Parasaran, learned counsel for the first respondent/original writ petitioner has submitted that inasmuch as by virtue of Rule 43 of the Rules, the application of Chapter III itself has been exempted, there is no question of issuance of licence either in Form 10 or Form 10A of the Act. It is his submission that when once the importer follows the condition contemplated under Rule 43 of Schedule D of the Act, necessarily he has got a statutory right of exemption of application of Chapter III. According to him, it is not as if the department is left in lurch. In the event of failure in person acting as per Rule 43 read with Schedule D, of the Act, certainly he loses his right of exemption from the provisions of Chapter III, it is always open to the authority to take appropriate action for any violation and simply because, the department is unable to take action in respect of the unscrupulous traders, which does not mean that the rule has to be given a go bye. It is his submission that inasmuch the said rule is a statutory rule by virtue of the power of the Govern....
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....es the authority, apart from taking criminal action to confiscate the goods. Therefore, the said Chapter, which speaks about the maintenance of quality of drugs, gives ample power upon the authorities not only to supervise that the drugs are properly distributed for the specific purpose, but also enables the authority to take appropriate action in the public interest. It is by virtue of the powers conferred under Section 12 of the Act, the Central Government has framed the Drugs and Cosmetic Rules 1945, as enabled by the Government under Section 12(2)(o) of the Act, extracted above. In the said Drugs and Cosmetics Rules, 1945, the Central Government has granted exemption in respect of some of the drugs under Rule 43 of the Rules which is as follows: "Rule 43 The drugs specified in Schedule D shall be exempt from the provisions of Chapter III of the Act and of the rules made thereunder to the extent, and subject to the conditions specified in that Schedule." 8. As per the said rule, the drugs which are substances under schedule D are exempted from the provisions of Chapter III of the Act. A reference to schedule D shows that the product in issue comes under Item No.1 "s....
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....urposes other than medicinal use. Representations have also been received from various actual users of such bulk drugs that are used as an intermediate for the manufacture of other drugs. These issues were examined in consultation with the Ministry of Health & Family Welfare and DGFT, Ministry of Commerce and Industry. A view has been taken that a blanket exemption from registration and from provisions contained in Chapter III of the Drugs & Cosmetics Act as given in Schedule D to the Drugs & Cosmetics Rules, cannot be given for import of such categories of drugs, which are not intended for medicinal use or drugs which may themselves be used as drugs but are used for manufacture of other drugs. To waive registration and import licence in Form 10 for import of drugs not intended for medicinal purpose, the importer will have to make an application to CDSCO, HQ where case to case examination will be done and after due scrutiny, permission to import dual purpose drugs, for non-medicinal use, without registration and import licence maybe granted. The Zonal/Sub Zonal Officers of CDSCO with the help of State Drug Control will ensure random post import checks ....