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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 ..... s which are the subject matter of the present applications are drugs specified under the Drugs and Cosmetics Act, 1940 and conform to standards indicated in the Indian Pharmacopoeia. According to the learned counsel for the petitioners, since the Buprenorphine Hydrochloride injections involved in the present applications conformed to the specifications mentioned in the Indian Pharmacopoeia and were Schedule "H" Drugs under the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945, the same could not be regarded as "psychotropic substances" at all under the NDPS Act. On the other hand, learned counsel who appeared for the Respondents, urged that Buprenorphine Hydrochloride was a psychotropic substance within the meaning of the NDPS Act and that it made little difference if it also happened to be a Schedule 'H' Drug. A2. In the first instance, it is to be determined as to whether Buprenorphine Hydrochloride I.P. injections are covered under the definition of psychotropic substances under the NDPS Act. If they are not to be regarded as psychotropic substances then, clearly, no offence under the NDPS Act would be made out and the petitioners would straight away ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... layed on the left top corner of the label, and be also labelled with the following words:- "Schedule H drug G" Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only". This is so provided in Rule 97(1)(c) of the D and C Rules. I may also mention Rule 104 of the said Rules which provides that the letters "IP" and recognised abbreviations of the pharmacopoeias and official compendia of drug standards prescribed under these rules shall be entered on the label of the drug only for the purpose of indicating that the drug is in accordance with standards set out in the Indian Pharmacopoeia or in any such pharmacopoeia or official compendium of drug standards recognised under the Rules. An examination of Schedule `H' of the D and C Rules makes it clear that Buprenorphine Hydrochloride is listed therein as a `Prescription Drug.' A4. From an analysis of the above provisions, it is clear that Buprenorphine Hydrochloride, if it conforms to the standards prescribed under the Indian Pharmacopoeia, is to be known as Buprenorphine Hydrochloride I.P. It is further clear that Buprenorphine Hydrochloride is a prescription drug specified in Schedule `H& ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ed in the Schedule to the NDPS Act. The word "preparation" is defined under the NDPS Act in Section 2(ax) thereof as under:- "2(ax) "Preparation" in relation to a narcotic drug or psychotropic substance, means any one or more such drugs or substances in dosage form or any solution or mixture, in whatever physical state, containing one or more such drugs or substances: If Buprenorphine Hydrochloride were to be a preparation of Buprenorphine, in terms of the aforesaid definition, it would have to be in dosage form or any solution or mixture, in whatever physical state, containing Buprenorphine. Buprenorphine Hydrochloride, as admitted by all the counsel appearing in the matter, is neither a solution nor a mixture of Buprenorphine. In fact, it is an entirely different compound. Furthermore, it could also not be regarded as Buprenorphine is dosage form. Therefore, it is clear that Buprenorphine Hydrochloride cannot be regarded as a "preparation" of Buprenorphine. Consequently, I am left with the only alternative consideration and that is--whether Buprenorphine Hydrochloride is a "salt" of Buprenophine? If it is, then it would be a psychotropic substance within the meaning of Sectio ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... roportion) forming Buprenorphine Hydrochloride which is a compound having molecular formula C29 H41 NO4, HCl1 and not a mixture. iv) Can Buprenorphine Hydrochloride be called a solution of Buprenorphine salt? Buprenorphine Hydrochloride cannot be called a solution of Buprenorphine, it is a salt of Buprenorphine which is white or almost white crystalline powder. From the aforesaid experts' opinions, it can be safely concluded that Buprenorphine Hydrochloride is a salt of Buprenorphine. This being the case Buprenorphine Hydrochloride would be a "psychotropic substance" under the NDPS Act. A7. The learned counsel appearing for the petitioners referred to some decisions to stress the point that Buprenorphine Hydrochloride was neither a "narcotic drug" nor a "psychotropic substance". He firstly relied upon Deep Kumar v. State of Punjab (P and H): 1997 (2) Recent Criminal Reports 502 to submit that Buprenorphine Hydrochloride was not a psychotropic substance. Paragraph 13 of this decision of the Punjab and Haryana High Court reads as under:- "13. Now we are left with parcels Nos. 1 and 6 which were found to contain Binorfin and Norphen injections. On an analysis each injection ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... e allegation there was of the commission of an offence under section 21 of the NDPS Act which deals with "narcotic drugs". In the present case the petitioners have all been prosecuted for allegedly committing offences under section 22 of the NDPS Act which relates to 'psychotropic substances'. The definitions for narcotic drugs and psychotropic substances are entirely different. Therefore, the decision in K. R. Nagappan (supra) also cannot be pressed in aid of the petitioners' submissions. A9. Lastly, the learned counsel for the petitioners referred to the decision of a learned single judge of the Punjab and Haryana High Court in the case of Amtrak Singh v. The State of Punjab: 1996 (2) All India Criminal Law Reporter 714. This was a case where the petitioner having been found to be in possession of 35 bottles of PHENSEDYL (a cough medicine) of 125 ml each was being prosecuted for an offence under section 21 of the NDPS Act. The samples taken disclosed that every 5 ml of the medicine container 9.5 mg of Codeine Phosphate. In this context the Court observed:- "9. The learned State Counsel has argued that the preparation in question is being widely used for intoxicatin ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ble under section 22 of the NDPS Act in relation to psychotropic substances. This is clear as, in the case of Ouseph v. State of Kerala: the Supreme Court had observed that [at page 447]:- "If it is a psychotropic substance, possession of it would become an offence only if it was in contravention of the Rules prescribed." And, in Hussain v. State of Kerala: , the Supreme Court had already held that:-"If it was "psychotropic substance" possession of the same would amount to an offence only if it was in contravention of Section 8 of the Act. That section shows that no person shall possess any psychotropic substance except for medical or scientific purposes and in the manner and to the extent provided by the provisions of this Act or the Rules or orders made there under." Therefore, an examination of section 8 of the NDPS Act and the provisions of Chapter VII of the NDPS Rules is called for. Firstly, Section 8 of the NDPS Act reads as under:- "8. Prohibition of certain operations.-- No person shall-- (a) cultivate any coca plant or gather any portion of coca plant; or (b) cultivate the opium poppy or any cannabis plant; or (c) produce, manufacture, possess, sell, purchase, ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... regulate, inter alia, the manufacture, possession, sale, transportation of psychotropic substances. The NDPS Rules have been formulated by the Central Government in exercise of that power. Chapter VII of the NDPS Rules deals with "Psychotropic Substances". Rules 64 to 67 fall under this Chapter VII. Rule 64 prescribes the general prohibition. It provides that-- "No person shall manufacture, possess, transport, import inter-state, export inter-state, sell, purchase, consume or use any of the psychotropic substances specified in Schedule I." It is to be noted that this "Schedule I" is different to the Schedule to the NDPS Act. This Schedule I is appended to the NDPS Rules and is in two parts - (I) Narcotic Drugs and (II) Psychotropic Substances. We are concerned with psychotropic substances. There is a list of 33 specific psychotropic substances with entry no. 34 being "Salts and preparations of above". It is significant to note that neither buprenorphine hydrochloride nor buprenorphine find mention in this list. This clearly means that Buprenorphine Hydrochloride is not included in Schedule I to the NDPS Rules and therefore the general prohibition contained in Rule 64 of the NDPS ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... thorised to possess such substance for any of the said purposes under the NDPS Rules. The expression "any psychotropic substance" obviously has reference to those listed in Schedule I to the NDPS Rules. Rule 64 is the governing rule in Chapter VII of the NDPS Rules. When a psychotropic substance des not find mention in Schedule I to the NDPS Rules, the prohibition qua possession contained in Rule 64 does not apply. That being the case, in respect of such a psychotropic substance, Rule 66 would also not apply as it has reference to only those psychotropic substances which are included in Schedule I to the NDPS Rules. Rule 67 of the NDPS Rules relates to transport of psychotropic substances. It is expressly subject to the provisions of Rule 64 and clearly has reference to the transport, import inter-state or export inter-state of those psychotropic substances which are included in Schedule I to the NDPS Rules. The rule 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, ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ces mentioned above forming part of the mixture." Note 1 to the said table reads as under:-"Note.-(1)The small quantity and the commercial quantity given against the respective drugs listed above apply to isomers, within specific Chemical designation, the esters, ethers and salts of these drugs, including salts of esters, ethers and isomers, whenever existence of such substance is possible." Upon a collective reading of the said Note 1, entry 239 and entry 169 of the said table it becomes clear that the small quantity for Buprenorphine Hydrochloride is also 1 gram and the commercial quantity is 20 grams as in the case of Buprenorphine, of which it is a salt. A13. 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. This concludes the discussion on the common issues. ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... le the drugs specified therein. Schedule "H" Drugs have not been excluded and, therefore, according to the petitioner the said Firm had a license to deal in and sell the said Buprenorphine Hydrochloride Injections. The said injections bearing the branded name "Bunogesic" were of 2 ml each. And, each ml thereof contained Buprenorphine Hydrochloride IP equivalent to Buprenorphine Hydrochloride 0.3 mg and water for injection. These injections were manufactured by Rusan Health Care Private Limited which is a licensed manufacturer. It is further dated that the said Rusan Health Care Private Limited had informed the petitioner firm on 21.10.2004 that they had deleted their product under the name "Bunogesic" and requested the petitioner firm to return the unsold stock lying with them. It is sated that the petitioner thereafter never dealt with the said product of the said manufacturer. It is further stated that the petitioner is a bona fide licensed trader and has an absolutely clean and un-blemished record. He is authorised to sell and dal in Schedule "H" medicines which includes Buprenorphine Hydrochloride IP injections. B3. The allegation against the petitioner is that he contravened ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... similar transparent water coloured liquid and having a label with the following description:-Rx 2 ml. BUPRENORPHINE HYDROCHLORIDE INJECTION I.P. BUPRIGESICNEON LABORATORIES LIMITED Mfg. Lic No. 752B. No. 19559 995 printed paper sheets were also found lying on the side of the table and each sheet contained the following description:-Rx 2 ml. BUPRENORPHINE HYDROCHLORIDE INJECTION IPBUPRIGESICNEON LABORATORIES LIMITED Mfg. Lic. No. 752B.No. It is alleged that the said Raj Kumar Arora could not produce any authorisation for possession of the unlabelled glass ampoules. C2. Nothing was recovered from the petitioner. Furthermore, the entire allegation is with regard to the alleged recovery of Buprenorphine Hydrochloride made from one Raj Kumar Arora. It has already been indicated above that Buprenorphine Hydrochloride is a Schedule H drug under the D and C Act and Rules and, though a psychotropic substance under the NDPS Act, it is not included in Schedule I to the NDPS Rules. That being the case, its manufacture, possession or sale is not prohibited. As such, there is contravention of the provisions of the NDPS Rules. Consequently, the offence under section 8 of the NDPS Act is ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... hat 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 Buprenorphine Hydrochloride contained in each ml. is 0.3 mg (or 0.0003 gm). Therefore, the total content in respect of these 3950 ampules would come to 7900 x 0.0003 = 2.37 gms which is far below the commercial quantity of 20 gms. D2. 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 or 29 of the NDPS Act would not be attracted. Additionally, the petitioner is being roped in only on the basis of disclosure statements of the said Mahesh and Surinder. As indicated in Manoj Kumar Gupta v. State N.C.T. Of Delhi: 2003 [1] JC 205, the disclosure statement of a co-accused is not substantive evidence. Furthermore, assuming that an offence under the NDPS Act was, prima facie, made out, the quantity linked to the present petitioner is only 2.37 gm, much lower than the commercial quantity of 20 gm. Accordingly, even in this assumed s ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... 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, the quantity linked to the present petitioner is only 4.341 gm, much lower than the commercial quantity of 20 gm. Accordingly, even in this assumed scenario, the rigours of section 37 of the NDPS Act would not apply. E4. 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 Rs. 25,000/- with one surety of the like amount to the satisfaction of the concerned trial court. Bail Application 115/2005 Amit Dawar (Petitioner) FIR No. 86/2003 dated 3/10/2003under sections 22, 29 NDPS Act P.S. Narcotics Bureau F1. The case of the prosecution is that on 21.7.2003 the premises of M/s Gill Sandhu, Haryana Transport Com. At 3902 Mori Gate, Delhi was searched and 40 Cartons of "Norphin" (Buprenorphine Hydrochloride) injections purported to have been manufactured by M/s Unichem Laboratories Ltd. are said to have been recovered. It is alleged that the Manager of the said Transport Company informed the Drug Inspector that the ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... 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 Customs Clearing House Agent and is a proprietor of M/s Kanishka Cargo Services having its office at 198, Office Complex, Jhandewalan Cycle Market, New Delhi. The case of the prosecution is that a raid was conducted on the office premises of the petitioner on 27/28.9.2003 and alleged recovery of 40,001glass ampoules containing water coloured liquid preparation suspected to be injectable preparation of Buprenorphine Hydrochloride is said to have been recovered. The petitioner was arrested on 27/28.9.2003 and has been in judicial custody since then. The petitioner states that he is not a beneficiary, manufacturer or seller of the medicinal drugs and is only a licensed Customs House Agent. The petitioner was handling consignments of its clients including M/s Sarvodaya Enterprises which is owned by c-accused Devang Bipin Parikh who has been granted bail by this Court on 11.1.2005. Various medical consignments have been cleared from Customs by the petitioner on behalf of the said client for export as well as import. G2. As ..... X X X X Extracts X X X X X X X X Extracts X X X X
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