DRUGS CONTROLLER GENERAL INDIA DIRECTORATE GENERAL OF HEALTH SERVICES Vs. S KESARIMAL A PARTNERSHIP FIRM REP BY ITS PARTNER K PRAKASH CHAND

JUDGEMENT

(1.) THIS writ appeal arises from the order of the learned Single Judge passed in W.P.No.4841 of 2010 filed by the first respondent in the appeal. The first respondent in the appeal who is the importer and supply of drugs to the manufacturers of chemicals; drugs, pharmaceutical and food industries, holds a licence under the Drugs and Cosmetics Act, 1940. According to him, he has been regularly importing a particular drug viz., 'Benfotiamine' which is according to the first respondent, a synthetic supplement finished product. Since as per the first respondent, the said substance is supplied by the petitioner to various companies engaged in manufacturing 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 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 itself is not sufficient and it is therefore to have a check over the attempt and in the public interest, it was felt that licence in Form 10 or Form 10A should have been obtained or in the form of no objection certificate from the authority competent, that as per the communication of the Directorate General of Health Services, Drugs Controller General (I) dated 12.12.2005, it was opined that mere exemption granted under Section 43 of the Rules, cannot be allowed to be the ruse for traders in allowing for sub-stranded and spurious drugs and therefore, inasmuch as the said communication was arrived at based on the discussion from various ministries, it is for the purpose of such check and balance, the said impugned letter was passed by the appellant department.

(3.) WE have heard the learned counsel for the appellant and respondents and we have gone through the Judgment of the learned Judge.