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TMI Blog2016 (1) TMI 2X X X X Extracts X X X X X X X X Extracts X X X X ..... there is no bar to keep the medicines. As per allegations in the FIR, the petitioner was apprehended while driving his vehicle and from the search of his vehicle, various medicines including Buprenorphine were recovered. An application was also moved by the petitioner before the Judicial Magistrate Ist Class, Rajpura for getting his statement recorded under Section 164 of the Cr.P.C but the same was dismissed by passing cryptic mechanical order on the same date i.e 04.08.2015. Learned counsel further submits that as per Rule 64, 65-A and 66 of the NDPS Rules, 1985 (here-in-after referred to as 'the Rules'), there was no bar in keeping medicines being a doctor. Learned counsel also submits that a registered Medical Practitioner is exempted from all provisions of Chapter IV of the Drugs and Cosmetics Act, 1940 and Rules thereunder, except the requirement of purchasing the drug from a licensed dealer or manufacturer. The petitioner has been complying with the conditions as mentioned under the Rules. Learned counsel also submits that there is no provision of law that Buprenorphine therapy can be given only to indoor patients and not on OPD basis and the petitioner's claim of b ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ner was dismissed on the ground that the petitioner, being a doctor, he can only prescribe medicines but cannot stock such huge quantity of the medicines. It is to be decided as to whether Buprenorphine Hydrochloride I.P. injections are covered under the definition of psychotropic substance under the NDPS Act. If they are not to be regarded as psychotropic substances then no offence under the NDPS Act would be made out. In such a situation, the petitioner becomes entitled to be enlarged on bail. In case, it is held that being a doctor, he cannot keep said medicine, the provisions of NDPS Act would be attracted or not. The question is also for consideration as to whether merely by keeping the possession of Buprenorphine Hydrochloride would attract the punishment under NDPS Act. The provisions with regard to Buprenorphine Hydrochloride in Drugs and Cosmetics Act, 1940 (hereinafter called as the "D and C Act"), the Drugs and Cosmetics Rules, 1945 (hereinafter called as the "D and C Rules"), the Narcotic Drugs and Psychotropic Substances Act and the NDPS Rules. Rule 65 of the D and C Rules prescribes the general conditions for licences in Forms 20, 20A, 20B, 20F, 20G, 21 and 21B. Sub-r ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... cription 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' and is to be sold by retail only on the prescription of a Registered Medical Practitioner. The stipulation with regard to the entries made in the Register as prescribed under Rule 65 have also to be complied with by the retailer making the sales. It is also to be noted that a reading of Rule 97(1)(c) clearly indicates that it is quite possible that a drug falling within the meaning of the Drugs and Cosmetics Act, 1940 and the D and C Rules and particularly one falling under Schedule 'H' can also fall within the purview of the Narcotic Drugs and Psychotropic Substances Act. If it is so, the manufacturer is duty bound to place the symbol NRx in red on the top left corner of the label. Section 2(xxiii) defines "Psychotropic substances" as under :- "(xxiii) "psychotropic substance" means any substance, natural or synthetic or any natura ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... n 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 Section 2(xxiii) as well as Entry 110 read with Entry 92 of the Schedule to the NDPS Act. For this purpose I had, during the course of hearing, sought clarifications from the Chemical Examiner with regard to the nature of Buprenorphine Hydrochloride. The letter dated 8th January, 2005 written by the Chemical Examiner Grade-II, Customs Laboratories, Customs House, Kandla, addressed to Mr Satish Aggarwal, Senior Special Public Prosecutor was placed before me. In that letter, it has been stated that Buprenorphine Hydrochloride is a salt of Buprenorphine. It was further indicated that Buprenorphine and its salts including Buprenorphine Hydrochloride give a positive test for Buprenorphine on testing. A similar letter by the same Chemical Examiner was written ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... (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, transport, warehouse, use, consume, import Interstate, export Interstate, import into India, export from India or transship any narcotic drug or 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 and in a case where any such provision, imposes any requirement by way of license, permit or authorisation also in accordance with the terms and conditions of such license, permit or authorisation: Provided that, and subject to the other provisions of this Act and the rules made there under, the prohibition against the cultivation of the cannabis plant for the production of ganja or the production, possession, use, consumption, purchase, sale, transport, warehousing, import Interstate and export Interstate of ganja for any purpose other than medicinal and scientific purpose shall take effect only from the date which the Central Government may, by notification in the Official Gazette, ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... 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 Rules does not apply to it . Consequently, rules 65 to 67, which also have reference to psychotropic substances specified in the said Schedule I, would also not be applicable in respect of Buprenorphine Hydrochoride 3. In this connection, it is pertinent to point out that there are several psychotropic substances which find place both in the Schedule to the NDPS Act and in Schedule I to the NDPS Rules. For example: Methaqualone 4, Delorazepam 5, Ketazolam 6, Loprzolam 7, Pipradrol 8, Tetrazepam 9. At the same time, there are others like Buprenorphine 10, Amphetamine 11, Bromazepam 12, Lorazepam 13, Phenobarbital 14 and Pemoline 15 which, though specified in the Schedule to the NDPS Act, do not find mention in Schedule to the NDPS Rules. Clearly, by conscious design, all psychotropic substances mentioned in the Schedule to the NDPS Act have not been listed in Schedule I to the Rules. The prohibition contained in Rule 64 of the NDPS Rules applies only to those psychotropic substances whic ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ces 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. 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 misuser being a psychotropic substance. Perhaps because of this reason, it was left out of Schedule I to the Narcotic Drugs And Psychotropic Substances Act but is very much regulated under the D and C Act and Rules. As indicated above, Buprenorphine Hydrochloride is a Schedule H drug under the D and C Act and Rules and, though it is a psychotropic substance under the Narcotic Drugs And Psychotropic Substances Act, it is not included in Schedule I to the NDPS Rules. That being the case, its manufacture, possession of sale is not prohibi ..... X X X X Extracts X X X X X X X X Extracts X X X X
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