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2005 Supreme(Del) 830

High Court Of Delhi
RAJINDER GUPTA - Appellant
Versus
STATE - Respondent
BAIL APPLICATION : 73 of 2005
Decided On : 08/22/2005

Advocates Appeared:
AJAY BANSAL, ASHISH AGARWAL, INDER KAUL, JAYANT SUD, K.K.MANAN, K.K.SUD, K.T.S.TULSI, M.N.DUDEJA, MAHIPAL MALIK, MALA SHARMA, MOHD.SHEHBER KHAN, MUKESH KALIA, NEERAJ JAIN, PAVAN SHARMA, R.D.MEHRA, R.K.Jha, R.S.MALIK, RAHUL MEHRA, RAJKUMAR ARORASAVINDER SINGH KOHLI, Sanjay Suri, SANJIV GUPTA, SATISH AGRAWAL, V.K.Malik, V.K.SINGH, V.S.MISHRA, VIJAY MITTAL, VIKAS PAHVA, VINOD KUMAR

Headnote:Narcotic Drugs and Psychotropic Substances Act, 1985 - Section 2(xx), 2 (xxiii), 8, 9, 21, 22, Entry 110 read with Entry 92 of Schedule read with Drugs and Cosmetics Act, 1940 & Rules 64 to 67 & 97 of Drugs and Cosmetics Rules, 1945 — Buprenophine Hydrochloride — Psychotropic substance — Buprenorphine Hydrochloride is psychotropic substance with the meaning of NDPS Act — Not included in Schedule 1 of NDPS Rules — Prohibition not regulated by NDPS Act and Rules because it is also medication and used as pain reliever and has analgesic use — Regulated under Drugs and Cosmetics Act and Rules — No contravention of provisions NDPS Act and Rules — Bail granted on furnishing personal bond of Rs. 25,000/-

BADAR DURREZ AHMED, J.

( 1 ) 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 Psychotropic Substances Rules, 1985 (hereinafter referred to as the NDPS Rules) apply ? To what effect ?

3) was contended by the petitioners that buprenorphine Hydrochloride I. P. Injections 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 substancesat 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.

( 2 ) 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 be entitled to be enlarged on bail. On the other hand, if it were to be held that the same were psychotropic substances then question No. 2 would require an answer. It would have to be seen as to whether merely because Buprenorphine hydrochloride was a psychotropic substance this in itself would entail that its manufacture, sale, possession, transport, etc. , would trigger the punishments under the ndps Act, particularly the punishment under Section 22 thereof.

( 3 ) LET me examine the provisions with regard to buprenorphine Hydrochloride in the Drugs and Cosmetics act, 1940 (hereinafter referred to as the Dandc Act), the Drugs and Cosmetics Rules, 1945 (hereinafter referred to as the Dandc Rules), the NDPS Act and the NDPS rules. Rule 65 of the Dandc Rules prescribes the general conditions for licences in Forms 20, 20a, 20b, 20f, 20g, 21 and 21b. For example sub-rule (3) (1) of Rule 65 stipulates that the supply of any drug, other than those specified in Schedule X, on the prescription of 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 Dandc 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 Dandc rules. However, if the substance contained in the container is one specified in Schedule `h and also comes within the p














































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