TMI Blog2013 (1) TMI 119X X X X Extracts X X X X X X X X Extracts X X X X ..... away and supersede the statutory provisions contained in Rule 43 of Rules as extracted above. As correctly found by the learned Judge, the department is not left in lurch, in the event of any of the unscrupulous importer attempted to use or sell the above said drugs for medicinal purpose. A joint reading of the above said provision categorically shows that the exemption granted to the importer from the applicability of Chapter III is available, only when the conditions contemplated under Rule 43 read with schedule D of the Rules is fulfilled scrupulously. If only the department comes to a conclusion on evidence and proof that there is breach of such condition of Rule 43 of Schedule D, the moment it is proved, the importer loses his right of exemption under Chapter III of the Act. Certainly, the authority in such circumstances would have a right to interfere for insisting necessary licence or make necessary search and enforce the provision under Section 13 of the Act for any violation. When such powers are available to the authorities, it is not known as to how the appellant is repeatedly referring to the word 'public interest'. Simply because the authorities who are expected to ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... Act. The said contention found favoured with the learned Single Judge, and, in the impugned judgment has allowed the writ petition and held that by virtue of Rule 43 read with Rule 123 of Schedule D of Drugs and Cosmetics Rules, 1945, the question of obtaining licence either in Form 10 or Form 10-A does not arise. The learned Judge has also held that if the first respondent in the guise of getting exemption under Rule 43 of the Rules, but attempted to use the imported drugs for medicinal use, it is always open to the authorities to take appropriate action under the Act, it was with that observation, the writ petition came to be allowed and the impugned letter of the drugs authorities came to be set aside. It is as against the said order of the learned Judge, the appellant department has filed the present appeal. 2. The main ground on which the appeal has been filed is that by allowing the importer to use the provision of Rule 43 of the Rules, there is a possibility of spurious drugs being circulated to the human use which will be neither allowable nor permissible , that mere fact that the consignment label carries stamping given by the importer, it is not for medicinal use itsel ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... nment under Rule 123 of the Act, the statutory rule always prevail and it cannot be sought to be explained by executive instruction as relied on by the learned counsel for the first respondent. 5. We have heard the learned counsel for the appellant and respondents and we have gone through the Judgment of the learned Judge. 6. On the face of it, it is no body's case that that the said 'Benfotiamine'is not a drug, the question is as to whether the drug is to be used for medicinal use or not. In this regard, it is relevant to refer to the word 'drug' which is defined as follows: 2(b) "drug" includes- (i) all medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or preventive of any disease or disorder in human beings or animals, including preparations applied on human body for the purpose of repelling insects like mosquitos." The definition makes it clear that the term 'drug' included drug usable not only for human beings, but also to animals. Chapter III of the Drugs and Cosmetics Act deals with the import of drugs and cosmetics. In effect that this Chapter which stipulates the ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... intended for medical use" under the caption "Class of drugs"'. The said schedule D also contains the conditions based on which exemption is granted. The conditions are extracted below: "All provisions of Chapter III of the Act and rules thereunder subject to the condition that if the substance is imported in bulk, the importer shall certify that the substance is imported for non-medical uses, and if imported otherwise than in bulk, each container shall bear a label indicating that the substance is not intended for medicinal use or is intended for some purposes other than medicinal use or is of commercial quality" 9. Therefore the condition in respect of drugs which are not intended for medical use is that if the substance is imported in bulk and it should be certified that it is imported for non-medical use and each of the container shall bear a label indicating that the substance is not intended for medicinal use and therefore if the said conditions are complied with, Chapter III of the Act does not apply. Consequently, the question of obtaining Form 10 or Form 10A in the form of licence in respect of those drugs, does not arise. 10. It is not in dispute that in respect o ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ed by importers for medicinal use. However, the containers of such substances should carry the label "Not for Medicinal Use." Sd/- Drugs Controller General(I) 11. A reference to the said circular shows that the department has taken a view that giving blanket exemption from the applicability of Chapter III of the Drugs and Cosmetics Act, would cause harm to the public interest and therefore to have a supervision over the use of the said drugs, the importer must be directed to obtain licence in Form 10. The said circular even though is stated to have been issued by taking note of the public interest, after consulting the various Ministries, in our considered view, cannot attempt to take away and supersede the statutory provisions contained in Rule 43 of Rules as extracted above. As correctly found by the learned Judge, the department is not left in lurch, in the event of any of the unscrupulous importer attempted to use or sell the above said drugs for medicinal purpose. A joint reading of the above said provision extracted would categorically show that the exemption granted to the importer from the applicability of Chapter III is available, only when the conditions con ..... X X X X Extracts X X X X X X X X Extracts X X X X
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