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TMI Blog2005 (8) TMI 677X X X X Extracts X X X X X X X X Extracts X X X X ..... ule would have no applicability in respect of those psychotropic substances which are not to be found in Schedule I to the NDPS Rule. Clearly, then, inasmuch as Buprenorphine Hydrochloride is not included in Schedule I to the NDPS Rules, its manufacture, possession, sale, transport would neither be prohibited nor regulated by the NDPS Rules and consequently by the NDPS Act. It being Schedule H drug would fall within the rigours of the D and C Act and Rules. Finally, it must be noted that Buprenorphine Hydrochloride I.P. is also a medication and is used as a pain reliever. Recently it is also being used to treat opiate addiction (such as addiction to heroin). It has legitimate uses as an analgesic and for de-addiction. However, it is also capable of misuse being a psychotropic substance. Perhaps because of this reason, it was left out of Schedule I to the NDPS Act but is very much regulated under the D and C Act and Rules. Application for grant of bail - The petitioner is aged about 70 years and is said to be suffering from heart problems. It is further contended that he was taking treatment in Iran and is undergoing such treatment now in Tihar Jail. Only 1091 ampoules of Buprenorph ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ll observations made in this order, whether common to all the applications or specific to each of the applicants, are only prima facie in nature. They are only for the purposes of consideration of the aforementioned bail applications and are not to be regarded at the time of trial of the respective cases. All the applications stand disposed of. - HON'BLE BADAR DURREZ AHMED, J. For the Appellant : K.K. Sud and K.T.S. Tulsi, Sr. Advs., Jayant K. Sud, Neeraj Jain, Sanjiv Gupta and Rahul Mehra, Vikas Pahwa, R.D. Mehra, V.K. Singh, Vinod Kumar, K.K. Manan, R.S. Malik, Mahipal Malik, Sanjay Suri, Ajay Bansal, R.K. Jha and Mukesh Kalia, Advs For the Respondent : Satish Aggarwal, Ashish Aggarwal, Mala Sharma, V.S. Mishra, Inder Kaul, Pawan Sharma, V.K. Malik and M.N. Dudeja, Advs. JUDGMENT Badar Durrez Ahmed, J. A1. The common questions in these bail applications are: 1) Whether Buprenorphine Hydrochloride is a psychotropic substance within the meaning of the Narcotic Drugs and Psychotropic Substances Act, 1985 (hereinafter referred to as the NDPS Act) ? 2) If yes, whether Buprenorphine Hydrochloride is a psychotropic substance to which Chapter VII of the Narcotic Drugs and Psychotro ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... a Registered Medical Practitioner shall be recorded at the time of supply in a prescription register specially maintained for the purpose and the serial number of entry in the register shall be entered on the prescription. Several particulars are required to be entered in the Register such as, serial number of the entry, the date of supply, the name and address of the prescriber etc. In the case of a drug specified in Schedule `H', it is also necessary to record the name of the manufacturer of the drug, its batch number and the date of expiry of potency, if any. Rule 97 of the D and C Rules contains stipulations with regard to the labelling of medicines. It specifically provides that the container of a medicine for internal use shall, if it contains a substance specified in Schedule `H', be labeled with the symbol Rx conspicuously displayed on the top left corner of the label and shall also be labelled with the following words:- Schedule `H' drug Warning: to be sold by retail on the prescription of a Registered Medical Practitioner only. This is so provided in Rule 97(1)(b) of the D and C Rules. However, if the substance contained in the container is one specified in S ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... es it clear that a psychotropic substance could be any substance, natural or synthetic, or any natural material or any salt or preparation of such substance or materials included in the list of psychotropic substances specified in the Schedule. For this purpose, a reference to the Schedule becomes necessary. The Schedule to the NDPS Act gives a list of psychotropic substances. Entry Nos. 92 and 110 are relevant and they read as under:- SL. No NAMESOTHER NON-PROPRIETARY INTERNATIONAL NON-PROPRIETARY Chemical NAME 92 BUPRENORPHINE 21-cyclopropyl-7- [(S)-1 hydroxy-1, 2,2-trimethyl propyl]-6, 14-endo, ethano-6, 7, 8 14-tetrahydooripavine. 110 Salts and Preparations of above Entry No. 110 was originally entry No 77. It was re-numbered as Entry No. 106 in 1992 and as Entry No. 110 with effect from 11th June, 2003. From a conjoint reading of Section 2(ixia) and the aforesaid Entry Nose 92 and 110 of the Schedule to the NDPS Act, it becomes clear that Buprenorphine Hydrochloride is not mentioned by name in the schedule and that it is only Buprenorphine which has been listed as a psychotropic substance. The next question to be answered is whether Buprenorphine Hydrochlorides a salt or prepa ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... Furthermore, four specific queries were raised by me during the course of arguments and they were as under:- 1. Why is Buprenorphine dissolved in Hydrochloric Acid? 2. Why does Buprenorphine dissolve in Hydrochloric Acid and why not in water? 3. Whether the combination of Buprenorphine and Hydrochloric acid is a compound or a mixture? And 4. Can Buprenorphine hydrochloride be called a solution of Buprenorpohine salt? In response to this, a letter dated 22nd February, 2005 by the Chemical Examiner, Central Revenue Control Laboratory, was placed before me. The answers were as under:- The point wise reply to above referred letter is as under:- i) Why Buprenorphine is dissolved in Hydrochloride acid? (ii) Why Buprenorphine dissolves in Hydrochloride acid and why not in water? Buprenorphine is nitrogen containing organic compound which is basic in nature. It dissolves in Hydrochloric acid being basic in nature and forms a salt with it. Usually organic basic compounds are insoluble in water or very slightly soluble in water. iii) Whether the combination of Buprenorphine and Hydrochloric acid is a compound or a mixture. The combination of Buprenorphine and Hydrochloric acid is a Chemical ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... hotropic substance within the meaning of the NDPS Act. A8. The next case referred to by the counsel for the petitioners was the decision of a learned single judge of the Madras High Court in K.R. Nagappan v. State: 1996 (1) Crimes 502. In that case there was a recovery of 55 ampoules of 2 ml Tidigesic injections. Each ml whereof contained 0.3 mg Buprenorphine Hydrochloride. The appellant therein had been convicted for the offence under Section 8 read with section 21 of the NDPS Act. After examining the definitions of opium and opium derivate in section 2 and section 2(xvi) of the NDPS Act as well as the Explanation appended to section 2 pertaining to the above definitions, the court held:- A casual reading of the definitions given above in Section 2 of the NDPS Act, clinches the fact that such of the opium and opium derivatives containing not more than 0.2 per cent of morphine have been excluded from the narcotic and psychotropic substances. 0.2 per cent of morphine cannot be equated with the 0.3 mg of Buprenorphine found in each of the 55 ampoules which is conspicuously and manifestly far lesser than 0.2 per cent of morphine. This decision also would be of no help to the petitione ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ) [at 146]. Re: Question No.2: A10. So, it is clear that buprenorphine hydrochloride is a psychotropic substance within the meaning of the NDPS Act. But, would that in itself make the possession, sale or transportation of buprenorphine hydrochloride injections an offence under the NDPS Act, punishable under section 22 thereof? The answer is in the negative. In the context of section 21 of the NDPS Act which is an analogous provision in respect of narcotic drugs , the Supreme Court, in the case of Sajan Abraham v. State of Keral: . It is thus apparent that what is made punishable under Section 21 is possession, sale, purchase, etc. of the drugs and preparations mentioned therein in contravention of any provision of the Act or any rule or order made or condition of license grated there under. Obviously, therefore, if any rule permits a person to possess any psychotropic substance within the limits specified under the rule and subject to such conditions as the rule may prescribe, such a person cannot be held guilty of the offence under Section 21 of the Act if it is shown that his possession is not in contravention of such rule. This would apply equally to the offence punishable under ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... pic substances, prohibits the manufacture, possession, sale, use etc., of any psychotropic substance except for medical or scientific purposes and in the manner and to the extent provided by the provisions of the NDPS Act or NDPS Rules or orders made there under. This means that while there is a general prohibition against the manufacture, possession, sale, use etc., of a psychotropic substance, if the same is a medicine and is to be used for a medical purpose then the manner and extent of its manufacture, possession, sale, use shall be as provided in the NDPS Act or NDPS Rules or orders made there under. We must remember that buprenorphine hydrochloride I.P. is a Schedule Drug within the meaning of the D and C Act and Rules. Its manufacture, sale etc., is regulated by the D and C Act and D and C Rules. Coming back to the NDPS Act, I find that in the case of a medication, which also happens to be a psychotropic substance within threading of the NDPS Act, its extent and manner of use etc., would be governed by the other provisions of the NDPS Act or NDPS Rules. A11. Section 9 of the NDPS Act empowers the Central Government to permit, control and regulate, inter alia, the manufacture ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ted psychotropic substances in Schedule I to the NDPS Rules. It may be mentioned here that the Supreme Court, in the afore-mentioned decisions16, was not called upon to examine this aspect of the matter, namely, whether Rule 66 of the NPS Rules applied to all psychotropic substances or only those specified in Schedule I to the NDPS Rules. It is, therefore, open to this Court to consider and decide this aspect of the matter. Rule 65(1), inter alia, provides that the manufacture of any psychotropic substance other than those specified in Schedule I shall be in accordance with the conditions of license granted under the D and C Rules and D and C Act. In other words, insofar as the psychotropic substances not mentioned in Schedule I to the NDPS Rules but mentioned in the Schedule to the NDPS Act are concerned, their manufacture shall be governed by the D and C Act and Rules and not by the NDPS Act or NDPS Rules. Rule 66 relates to possession etc., of psychotropic substances. Sub-Rule (1) thereof provides that no person shall possess any psychotropic substance for any of the purposes covered by the D and C Rules, unless he is lawfully authorised to possess such substance for any of the ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... e appended to the said Notification, at Entry No. 169, Buprenorphine has been specified and the small quantity has been mentioned as 1 gram whereas the commercial quantity has been specified as 20 grams. However, there is no specific mention of Buprenorphine Hydrochloride. The said Entryo.169 and Entry 239, which, apparently, is a residual entry, read as:- Sl. No Name of Narcotic Drug and Psychotropic Substance [International Commercial Quantity(In gm./kg.) non-proprietary name (INN)]Other non- proprietary name Chemical Name Small quantity(in gm.) 1 169 21-cyclopropyl-7- alpha-[(S)-1 hydroxy-1,2 Buprenorphine 2 trimethyl propyl]-6, 14-endo, ethano-6, 7,8,14-tetrahydooripavine 20 gm Any mixture or preparation that of with or without a neutral material, of any of the above drugs. Lesser of the small quantity between the quantities given against the respective narcotic drugs or psychotropic substances mentioned above forming part of the mixture. Lesser of the commercial quantity between the quantities given against the respective narcotic drugs or psychotropic substances mentioned above forming part of the mixture. Note 1 to the said table reads as under:- Note.-(1)The small quantity ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... lso contends that the said ampoules were labeled in accordance with Rule 97 of the Drugs and Cosmetics Rules, 1945 and bore the symbol Rx 17 on the top left corner of the label. They also contained the usual Schedule 'H' drug warning as under:- Schedule H drug Warning: To be sold by retail on the prescription on a Registered Medical Practitioner only. B2. The petitioner further submitted that all purchase and supplies have been made through proper documents, as required in the normal course of business. It is further contended that the petitioner has a drug license under the Drugs and Cosmetics Act and Rules. The license bears No. DL-2(2380) 20B and 21B. The license in Form 20B is issued under Rule 61(1) of the Drugs and Cosmetics Rules, 1945 whereas the license in Form 21B is issued under Rule 61(2) of the Drugs and Cosmetics Rules, 1945. Copies these licenses have been filed at pages 17 and 18 of the paper book and they clearly indicate that the Firm ADS Associates is licensed to sell, stock or exhibit or offer sale or distribute by wholesale the drugs specified therein. Schedule H Drugs have not been excluded and, therefore, according to the petitioner the said Firm had ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... orphine Hydrochloride IP injections and that from the premises of Raj Kumar Arora, 40,001 Buprenorphine Hydrochloride injections were recovered. No recovery was affected from the petitioner of any kind. The recovered drug, according the petitioner, is covered by the Indian Pharmacopoeia and is a Schedule-H Drug under the Drugs and Cosmetics Rules, 1945. It is stated by the petitioner that the co-accused Devang Bipin Parikh has already been granted bail by an order dated 11.1.2005. In the complaint, it is stated that the premises of one Raj Kumar, proprietor of Kanishka Cargo Service was searched and a recovery of 25 corrugated card board cartons was made there from. These cartons were said to contain glass ampoules containing transparent water coloured liquid. Apart from the above, it is alleged that the officers also recovered a single ampoule apparently of the same size and shape as the unlabelled ampoules recovered from 25 cartons and also having similar single red coloured rang marking round the neck of the ampoule containing apparently similar transparent water coloured liquid and having a label with the following description:-Rx 2 ml. BUPRENORPHINE HYDROCHLORIDE INJECTION I.P ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... esh and Surinder, the present petitioner (Vijay Kumar Mittal) was arrested on 14.10.2004 for allegedly selling the injections without bill to these two persons. It is stated that the petitioner is an income tax payer and carries on business of sale and purchase of medicines under the trade name of Mittal Medical Agency . The petitioner holds a valid license No. 26 (1102) 20B and 21B which was issued on 29.12.1999 and the said license has been renewed up to 31.12.2007. The said firm is authorised under the license to sell, stock or exhibit or offer for sale or distribute by wholesale Buprenorphine Hydrochloride Drug in addition to other drugs permitted there from. It is stated that the charge-sheet has been field in this case and the petitioner has been arrested solely on the basis of disclosure statements made by Mahesh and Surinder. It is the petitioner's contention that no drug of any kind has been sold by the petitioner to the said Mahesh or Surinder and the case is entirely false and fabricated. It is further contended that 3950 ampules are alleged to be related to the petitioner. Each ampoule contains 2 ml. And, therefore, the total quantity comes to 7900 ml. The Buprenorp ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... recovered from the petitioner. Therefore, taking the content of each 2ml ampoule (as per the complaint itself) to be 0.6 mg of Buprenorphine Hydrochloride, the recovery from the petitioner is only of 1091 x 0.6 = 658.2 mg or 0.6.82 gm of Buprenorphine Hydrochloride which amount is even smaller than the specified small quantity of 1 gm. Moreover, even if all the ampoules are taken to be recovery from the petitioner they would total to 7235 ampoules of 2 ml. each. That would translate to a content of only 4.341 gms of Buprenorphine Hydrochloride and not 14.5 kg as erroneously calculated by the learned Additional Sessions Judge in his order dated 7.8.2004 whereby the petitioner's bail application was rejected. Even this quantity is far below the commercial quantity of 20 gm. E3. I have already held that Buprenorphine Hydrochloride is beyond the pale of Chapter VII of the NDPS Rules and therefore, it being a Schedule H drug under the D and C Act and Rules, the offence under section 8 is not made out. Consequently, punishments under section 22, 23, 28 or 29 of the NDPS Act would not be attracted. Furthermore, assuming that an offence under the NDPS Act was, prima facie, made out, t ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ve already held that Buprenorphine Hydrochloride is beyond the pale of Chapter VII of the NDPS Rules and therefore, it being a Schedule H drug under the D and C Act and Rules, the offence under section 8 is not made out. Consequently, punishments under section 22 or 29 of the NDPS Act would not be attracted. Nothing was recovered from the petitioner. And, the petitioner is being roped in only on the basis of an alleged disclosure statement of the said Pravin Kumar alias Sonu proprietor of Surya Phamaceuticals. As indicated in Manoj Kumar Gupta v. State N.C.T. Of Delhi: 2003 [1] JCC 205, the disclosure statement of a co-accused is not substantive evidence. F3. In view of all these circumstances the petitioner would be entitled to bail. Accordingly, he is directed to be released on bail on furnishing a personal bond in the sum of ₹ 25,000/- with one surety of the like amount to the satisfaction of the concerned trial court. Bail Application 205/2005 Raj Kumar Arora (petitioner) G1. The petitioner is alleged to have contravened Rule 66 of the NDPS Rules and thereby committed offences punishable under sections 22 and 29 of the NDPS Act. The petitioner states that he is a licensed ..... X X X X Extracts X X X X X X X X Extracts X X X X
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