C.S.P.SINGH,J. - (1.) THE petitioner is a pharmaceutical concern and inter alia carries on the manufacture of drugs and rectified spirit. It appears that the petitioner had a licence for the manufac­ture of a number of drugs including 'Weak Tincture Ginger'. This licence according to the averments made by the petitioner was valid till December 31, 1978. However, as the petitioner wanted to shift his place of manufacture to new premises, he made an application for permission to manufacture drugs in the newly constructed pre­mises. It transpires that the Director of Medical and Family Plan­ning U.P. by letter dated May 31, 1977 granted a new manufactur­ing licence for the newly constructed premises, valid upto Decem­ber 31, 1978. The licene was granted in Form No. 25. But the new licence did not permit the petitioner to manufacture Weak Tincture of Ginger as earlier. Subsequently, the petitioner submitted tenders to the State Corporation of Sri Lanka, for supply of Weak Tincture of Ginger, and this was accepted by the Corporation (vide their letter dated October 14, 1977). After having secured this order, thei peti­tioner approached the Drug Controller U.P. by letter dated October 19, 1977 for being granted approval for manufacturing Weak Tinc­ture of Ginger., This was followed by another letter application, dated October 19, 1977 making the same request. The Director of Medical Health Services, however, by the order dated November 2, 1977 refused the permission sought for. The petitioner then made a representation to the State Government, but this was rejected by order dated December 13, 1977. The order dated May 31, 1977 of the Director Medical and Family Planning deleting item of Weak Tinc­ture of Ginger, as also the order dated November 3, 1977 passed by the same authority, and the order of the State Government dated December 13, 1977 are impugned in this petition. A prayer has also been made for issue of a mandamus commanding the respondents not to interfere with the petitioner's right to manufacture Weak Tincture of Ginger.
(2.) SO far as challenge to the order dated May 31, 1977 is concern­ed, that appears to be belated, as the petition was filed on Novem­ber 19, 1977, and no reason has been given for the delay in challeng­ing this order. It is apparent that the petitioner at the time when the impugned order was passed, was not interested in challenging the order as he had no firm orders for supply of Weak Tincture Gin­ger, and it is only after October 1977 when his tenders were accept­ed by the Pharmaceutical Corporation of Sri Lanka that the peti­tioner felt the necessity for being granted permission to manufac­ture this drug. Now, as to the two orders passed by the Director and the State Government, no reasons appear in the order refusing the licence. In the counter-affidavit filed, it has been averred that the licence was refused on the ground that Weak Tincture Ginger was not a drug in the Indian Pharmacopoei. During the hearing of the petition, the Standing Counsel, however, urged that this was not the sole con­sideration on which the application of the petitioner was rejected. In view of the course that we are inclined to adopt in the present case, it is not necessary to consider whether the other reasons which weighed with the Government for refusing the licence were rele­vant for the decision, as we propose to remand the case to the State Government for a fresh consideration. We will, therefore, confine our attention to the grounds disclosed in the counter-affidavit in refusing the licence.
(3.) SECTION 3 (b) of the Drugs and Cosmetics Act, 1940 defines the words 'drug' as under: - "3(b) 'drug' includes- (i) all medicines for internal or external use of human being or animals and all substances intended to be used for or in the diagnosis, treatment mitigation or prevention of disease in hu­man being or animals; (ii) such substances (other than food) intended to affect the structure of any function of the human body or intended to be used for the destruction of vermin or insects which cause dise­ase in human beings or animals, as may be specified from time to time by the Central Government bv notification in the Official Gazette;" 4. It is not denied that Weak Tincture Ginger is a drug. Section 16 of the Act sets out the quality of Drugs which have to be maintain­ed by manufacturers, while manufacturing a particular drug. The second schedule to the Act mentions the specific standards to be complied with by imported drugs and by drug manufacturers for sale etc. in the country. The relevant item of this Schedule with which we are concerned is item No. 5. This item relates to drugs not already enumerated in items Nos. 1 to 4-A. Item No. 5 runs: - Class of drug. with. 5. Other drugs; Standard of identity, purity (a) Drugs included in the Indian Pharma­copeia Standard to be complied and strength specified in the Indian Pharmacopoeia. edition of the for the time being and such other standards as may be prescribed. (b) Drugs not included in the Indian Pharmacopoeia but which are included in any Pharmacopoeia of any other country. Standard of identity, purity and strength specified for the drugs in the edition of such Pharmacopoeia for the time being and sdch other standards as may be prescribed. ;