ORDER The Drug Inspector, Giridih, when inspected a whole sale medicine shop namely, M/s Kalyan Medical Agency, Giridih, he found one drug named as A to Z Gold Soft Gelatin Capsules manufactured by petitioner no. 1 and marketed by petitioner no. 2, was being sold as dietary supplement under the license granted under the Prevention of Food Adulteration Act though the active ingredients in each of the capsules had been in the therapeutic range as prescribed under Schedule V of the Drugs and Cosmetics Rules, 1945. It was further found that on the label of the said capsules Drug Manufacturing License number had not been mentioned though the capsules were the 'Drug' and not the dietary supplement as Vitamins in particular therapeutic range is prescribed by a Doctor in particular dosage to treat vitamins deficiency and, therefore, said capsules were required to be manufactured, marketed and to be sold out under a license to be issued under the Drugs and Cosmetics Act. On the said allegation, a complaint was lodged, which was registered as Complaint Case No.185 of 2005. Upon filing of the said complaint cognizance of the offences punishable under Section 27 read with Section 18(a)(VI), 18(b) and 18(c) of the Drugs and Cosmetics Act, 1940, was taken against the petitioners and summons were issued. In response to summons, the petitioners did appear and were granted bail. Thereupon, the case was fixed for evidence before charge. When the complainant failed to produce a single witness for his examination before charge at number of occasions, the Court vide its order dated 05/04/2007, closed the case and fixed the case for 10/04/2007 for passing order. On the same day, i.e. 05/04/2007, two witnesses appeared but they were not examined as the order had already been passed fixing the date as 10/4/2007 for passing order. On 10/04/2007, an application was filed on behalf of the complainant under Section 311 Cr.P.C for recalling the order dated 05/04/2007 and to examine the witnesses. On the said application an order was passed on 30/05/2007, whereby and whereunder the order, which had been passed on 05/04/2007 was recalled and the case was ordered to be fixed for 29/06/2007 for framing charge.
On the said application an order was passed on 30/05/2007, whereby and whereunder the order, which had been passed on 05/04/2007 was recalled and the case was ordered to be fixed for 29/06/2007 for framing charge. Thereafter, an application was filed under Section 227 Cr.P.C on behalf of the petitioners stating therein that earlier the Court had called for the report but the same was not sent to the Court and, hence, nothing is there on the records to suggest that the products, which has been seized was a Drug and not a dietary supplement. That application was rejected vide order dated 04/09/2007 and the case was fixed for next dated for framing charge. Being aggrieved with that order Cr. Revision No. 929 of 207 was filed. At the same time a Cr. M.P. No. 1492 of 2007 was filed for quashing of the entire complaint case including the order dated 30/05/2007, whereby and whereunder charges were directed to be framed. 2. When the matter came up for hearing before the learned Single Judge, a plea was taken, on the basis of the order passed by Patna High Court on 04/02/2009 in C.W.J.C. No. 4065 of 2006, that A to Z Gold Soft Gelatin Capsule manufactured by the same company, which has manufactured A to Z Gold Capsule, is not a Drug, rather is a dietary supplement. On the other hand learned counsel appearing for O.P. No.2 by placing reliance on a decision reported in “AIR 202 Kerala, 357” submits that it has been held by Hon'ble Kerala High Court that vitamin capsules happen to be Drug and not a dietary supplement. 3. In the aforesaid circumstances, the learned Single Judge having found that two different High Courts have taken two different view which is diametrically opposite to each other, has been pleased to refer the matter before the Division Bench. That is how both these matters had come up before this Court. 4. Mr. P.P.N. Roy, learned senior counsel appearing for the petitioners submits that Patna High Court vide its order dated 04/02/2009, passed in CWJC No. 4065 of 206, has already decided that A to Z Vitamin capsules never happen to be a Drug, rather it is a food supplement.
4. Mr. P.P.N. Roy, learned senior counsel appearing for the petitioners submits that Patna High Court vide its order dated 04/02/2009, passed in CWJC No. 4065 of 206, has already decided that A to Z Vitamin capsules never happen to be a Drug, rather it is a food supplement. Patna High Court has been pleased to take such view on the basis of the opinion given by a committee headed by the Director General, Health Services, government of India and in such situation A to Z Gold Capsules manufactured by the same company, which manufactures A to Z Capsules can easily be held to be a food supplement and, therefore, no Drugs Manufacturing License is required either for its manufacturing, marketing or selling. In that event, entire complaint case is fit to be set aside. Further it was submitted that upon filing of the complaint, the Court took cognizance of the offences under the Drugs and Cosmetics Act. After appearance of the petitioners the case was fixed for examination of the witnesses before charge. Upon number of opportunities being given to the complainant to produce witnesses for their examination before charge but when the witnesses did not turn up, the case was closed. But the court on filing an application under Section 311 Cr.P.C reopened the case, which amounts to review/recall of its earlier order which power the criminal court does not have. In this regard it was further submitted that not only the Court vide its order dated 30/05/2007 reopened the case but passed an order for framing of charge treating the case to have arisen out of the Police report, which is quite illegal and, hence, the order dated 30/05/2007, which is under challenge in Cr. M.P. No. 1492 of 2007, is quite illegal and is fit to be set aside. 5. It was further submitted that the Court at the time of hearing of bail application had called for a report from the competent authority to find out as to whether the product, which has been seized is a Drug or a food supplement, but that report was never submitted and, therefore, an application for discharge was filed but that was rejected without assigning any cogent reason and, hence, that order dated 04/09/2007 is also fit to be set aside. 6.
6. As against this, learned counsel appearing for the State submits that the ingredients, which are there in A to Z Gold Soft Gelatin Capsules, are within the therapeutic range as prescribed under Schedule V of the Drugs and Cosmetics Rules, 1945 and as such when a Drug is being used for its use as a therapeutic range, it in terms of the provision as contained in Section 3(b)(i) of the Drugs and Cosmetics Act, happens to be a Drug and not the Food Supplement and, therefore, the petitioners were required to have had license under the Drugs and Cosmetics Act, 1940 for its manufacturing, marketing and selling, but admittedly the petitioners had no license under the Drugs and Cosmetics Act, 1940 and, thereby, the petitioners have rightly been prosecuted. Learned counsel in support of his submissions has referred to a decision rendered in a case of “Cadila Pharmaceuticals Ltd.-versus-State of Kerala [AIR 2002 Kerala 357]” and also a decision of this Court rendered in a case of “Intercorp Biotech Ltd.-versus-State of Jharkhand & Others [W.P.(Cr.) No. 126 of 2011]”, holding therein that if the component of the Drug falls within the definition of a Drug then the intention of the manufacturer of getting it use as a food supplement will hardly matter. 7. Thus, the question which is to be decided is as to whether A to Z Gold Soft Gelatin Capsules manufactured and marketed by the petitioners through medical shops falls within the definition of Drug or not? 8.
7. Thus, the question which is to be decided is as to whether A to Z Gold Soft Gelatin Capsules manufactured and marketed by the petitioners through medical shops falls within the definition of Drug or not? 8. To answer this question, one needs to take notice of the provisions as contained in Section 3(b) of the Act, which defines drugs as follows:- “Section-3 (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 prevention of any disease or disorder in human beings or animals, including preparations applied on human body for the purpose of repelling insects like mosquitoes; (ii) such substance (other than food) intended to affect the structure or 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 by notification in the Official Gazette; (iii) all substances intended for use as components of a drug including empty gelatin capsules; and (iv) such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette, after consultation with the Board”. 9. The definition of drug would go to show that it takes within its fold medicines as well as substances used for treatment, mitigation or prevention of disorders in human beings as well as in animals. Under clause (i) all medicines for internal or external use of human beings or animals and in all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals including preparation applied on human body for the purpose of repelling insects like mosquitoes are drugs. 10.
Under clause (i) all medicines for internal or external use of human beings or animals and in all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals including preparation applied on human body for the purpose of repelling insects like mosquitoes are drugs. 10. It is also relevant to note that a preparation applied on human body for the purpose of repelling insects like mosquitoes is also a drug under Clause (i), whereas under Clause-(ii) 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 by notification in the Gazette is also a 'drug'. Under Clause (iii) all substances intended for use as components of a drug including empty gelatin capsules is a 'drug' and as per Clause (iv) such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government by notification in the Gazette after consultation with the Board are also 'drug'. Thus, it is clear that the definition of drug is wide enough to include all medicines or substances for external or internal use of human beings or animals for diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or in animals except food. 11. The term 'food' has not been defined in the Act. However, we do find that substances which are used for food and drug have been kept exempted from the provision of Chapters III and IV of the Act. As per Rule 43 of the Drugs and Cosmetics Rules, drugs specified in Schedule D shall be exempted from the provisions of Chapter III of the Act and of the Rules made thereunder to the extent and subject to the conditions specified therein.
As per Rule 43 of the Drugs and Cosmetics Rules, drugs specified in Schedule D shall be exempted from the provisions of Chapter III of the Act and of the Rules made thereunder to the extent and subject to the conditions specified therein. One item, which is exempted under Schedule D is item 5, which reads as follows:- “The following substances which are used both as articles of food as well as drugs: (1) all condensed milk or powered milk whether under pure skimmed or malted fortified with vitamins and minerals, (2) Farex, Oats, Lactose and all other similar preparations whether fortified with vitamins or otherwise excepting those that are parenteral use.” 12. Similarly, Rule 123 provides that the drugs specified in Schedule K shall be exempted from the provisions of Chapter IV of the Act and the Rules made thereunder to the extent and subject to the conditions specified in that Schedule. Item 10 of Schedule K deals with condensed or powdered milk, farex, oats and other similar cereal preparations whether fortified with Vitamins or otherwise excepting those for parenteral use. It be further stated that Rule 123, which speaks about the drugs specified in Schedule K shall be exempted from the provision of Chapter IV of the Act and the Rules made thereunder to the extent and subject to the conditions specified in that schedule. Item no. 1 of said Schedule relating to the class of drugs and also extent and conditions of exemption be referred too, which reads as follows:- Class of Drugs Extent and Conditions of Exemptions 1. Drugs falling under clause (b)(i) of section 3 of the Drugs and Cosmetics Act, not intended for medicinal use. All the provisions of Chapter IV of the Act and the rules thereunder, subject to the conditions that the drug is not sold for medicinal use or for use in the manufacture of medicines and that each container is labeled conspicuously with the words ?NOT FOR MEDICINAL USE?. 13. All these things clearly indicate that but for the exemption those items would have been subjected to the licensing and other procedures under Chapters III and IV of the Act and the Rules.
13. All these things clearly indicate that but for the exemption those items would have been subjected to the licensing and other procedures under Chapters III and IV of the Act and the Rules. But the drugs in question cannot be taken to be a food supplement by virtue of the definition of the drug in the Act as a substance which is taken for mitigation or prevention of disease in human beings or in animals is a medicine and a drug. It is well known that Vitamin deficiencies in human beings may result in certain diseases. In such cases, Doctors prescribe these vitamin capsules in a particular dose which is for mitigation or for prevention of such diseases. Not only that the standard of the Vitamins for prophylactic use and also for therapeutic use is to be maintained/followed in terms of the provision as is there under Rule 124(B) of the Drugs and Cosmetics Rules as prescribed in Schedule-V. Schedule-V does lay down the standard of the unit of vitamins for prophylactic use as well as therapeutic use. It was pointed out by the learned counsel appearing for the State that the unit (IU) which has been used for some of the vitamins is that much, which is required to be put in for therapeutic use. If that is so, then certainly A to Z Gold Soft Gelatin Capsules happen to be the drug in terms of the provision as is there under Section 3(b)(i) of the Act. 14. In fairness to the stand taken by the petitioners, we may refer to a decision of the Patna High Court, wherein A to Z Capsule has been found to be a food supplement. His Lordship has arrived at to such a finding on the basis of the report submitted to the Court by the Director General, Health Services, Government of India opining therein that A to Z Capsule is a food supplement. 15. However, on consideration of the several provisions as discussed above, if the product in question falls drug within the definition of the drug as given under Section 3(b)(i) of the Act, opinion of anybody would be not very material. 16. Thus, we do not have any hesitation in holding that A to Z Gold Soft Gelatin Capsule is drug. Thus, the question posed is answered in positive. 17.
16. Thus, we do not have any hesitation in holding that A to Z Gold Soft Gelatin Capsule is drug. Thus, the question posed is answered in positive. 17. Going further in the matter, it be stated that the case has arisen out of the complaint and not on a police report and, therefore the procedure which is to be followed is to be followed as has been given under the Code of Criminal Procedure in category B of Chapter XIX dealing with the matter relating to cases instituted otherwise than on police report. But the Court by passing the order dated 30/05/2007, has wrongly held that the case be taken to have arisen out of a police report and, thereby, the Court wrongly fixed the case for framing charge without examination of the witnesses before charge. 18. Accordingly, that order dated 30/05/2007, is hereby quashed. The Court would proceed taking the case to have arisen otherwise than a police report and, therefore, the procedure laid down under Sections 244 to 250 of the Code of Criminal Procedure, needs to be followed. 19. Thus, both these applications stand disposed of.