TMI Blog2022 (9) TMI 1151X X X X Extracts X X X X X X X X Extracts X X X X ..... thin the definition of the narcotic drug under Section 2(xiv) of the NDPS Act. In other words, a preparation to be included in the NDPS Act, would at the first instance have to be declared a manufactured drug . At this stage, it is also pertinent to take note of Entry 35 in notification titled Manufactured Narcotics Drug (as contained in Government of India Notification No. S.O. 826 (E) dated 14.11.1985 and S.O. 40(E) dated 21.09.1993 and S.O. no. 1431 (E) dated 21.06.2011) issued in exercise of powers conferred by Sub Clause (b) of Clause (xi) of Section 2 of the NDPS Act which pertains to substance Methyl Morphine - as per the aforesaid notification, if any manufactured drug within the meaning of Section 2(xi)(b) of NDPS Act contains not more than 100 mg of Methyl Morphine, commonly known as Codeine, per dosage unit, and in that drug, Codeine is compounded with one or more ingredients and if in the said drug the concentration of Codeine is not more than 2.5% in undivided preparation, and the drug has been established in therapeutic practice, it will not be a preparation within the meaning of manufactured drug and, therefore it will not to be a narcotic drug . If ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ion of the learned Single Judge was drawn to a judgment of another learned Single Judge of this Court in Iqbal Singh vs. State (BAIL APPLN. 645/2020), wherein the learned Single Judge vide order dated 31.07.2020 had held that cough syrup bottle (Onerex) containing Codeine Phosphate would fall outside the scope of the definition of manufactured drug under Section 2(xi) of the NDPS Act. The aforesaid finding of the learned Single Judge was based on various provisions of the NDPS Act as well as the Drugs and Cosmetics Act, 1940. The facts of the bail application in Iqbal Singh (supra) were similar to the facts in the present bail application. 4. The learned counsel for the petitioner in the present bail application relying on the judgment of this court in Iqbal Singh (supra) had argued that in the present case too, the bottles which had been recovered were prescribed drugs which are covered under the Drugs Cosmetics Act and fall under Schedule H of The Drug and Cosmetics Rules, 1945. It was further argued that the said bottles were manufactured by a licensed manufacturer, i.e. M/s Abbot Healthcare Pvt. Ltd. 5. The learned Single Judge, while hearing the present bail applicat ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... lable in medical shops across country. The learned Single Judge further observed: 21. Be that as it may, para 8.4 and para 10(II) of the judgment of the Supreme Court in Hira Singh v. Union of India reported as (2020) SCC Online SC 382 does not make any distinction between manufactured drugs with a miniscule percentage of narcotic substance and other mixture of narcotic drugs or psychotropic substance out of a neutral substance. The judgment of Iqbal Singh (supra) is therefore contrary to a plain reading of the judgment of the Supreme Court. Since cases of this nature are common there is a strong possibility that different Single Judge Benches of this Court may take different opinions while deciding as to whether the rigour of Section 37 would be attracted or not in such cases. It would therefore be in the interest of justice that an authoritative and final pronouncement is made by a larger Bench of this Court. It is in these circumstances that the questions referred to hereinabove have been placed before us for decision. 8. Written submissions have been filed on behalf of the petitioner and as well as the respondent. 9. It is submitted on behalf of the petitio ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ircumstances of the present case as the alleged recovery in Md. Sahabuddin (supra) was extremely huge and the Codeine percentage in the cough syrup recovered therein was also 5%, which exceeded the permissible limit of 2.5%. 13. The learned counsel for the petitioner also relied upon an order dated 26.10.2005 issued by the Drug Controller General of India, inter alia, directing as under:- As you are aware there are number of Cough preparations like Corex of M/s Pfizer Ltd. Mumbai, Phensedyl of M/s. Nicholas Piramal India Limited, Mumbai, Codokuff of M/S. German Remedies, Codeine Linctus of M/s Zydus Alidac etc. moving in inter state commerce. These preparations contain among other drugs Codeine Phosphate 10 mg as one of the ingredients. By virtue of the fact that these preparations contain Codeine and it salts they do not fall under the provisions of NDPS Act and Rules of 1985 but they fall under Schedule H of the Drugs and Cosmetics Rules and are governed by the said rules. 14. The learned counsel for the petitioner had primarily relied upon judgment/order passed by learned Single Judge in Iqbal Singh (supra). Reliance was further placed on a judgment passed by learne ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... . 18. Learned SPP for the customs further relies upon the judgment of the Hon ble Supreme Court in Md. Sahabuddin (supra) wherein the Hon ble Supreme Court has held that if Codeine Phosphate was being transported illegally without proper documents, it cannot be presumed that it was for therapeutic practice in spite of it being a Schedule H drug. It was further submitted that Section 80 of NDPS Act, inter alia, provides that the provisions in said Act shall be in addition to the Drugs and Cosmetics Act, 1940 and the Rules framed thereunder. It is the contention of the learned SPP that provisions of both legislations are to be read harmoniously and in the event Codeine or its preparations including salts which fall within the ambit of Schedule H is possessed, stored, transported or purchased under suspicious circumstances, the same would give rise to a reasonable suspicion that the drug is not being used for therapeutic purposes, and provisions of the NDPS Act can be invoked. 19. Reliance is also placed by learned SPP on the order/judgment dated 01.11.2017 rendered in Gavranjeet Singh @ Gavrana vs. State by the Hon ble High Court of Rajasthan in Criminal Misc. Bail No. 3790/201 ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... e the nature of the product. In terms of Entry 35 of the list of manufactured drugs (as contained in Govt. of India notifications SO 826(E) dated 14.11.1985., S.O. 40(E) dated 29.01.1993 and S.O. 1431(E) dated 21.06.2011), the product recovered from the petitioner does not fall within the ambit of a manufactured drug as the content of Codeine phosphate is less than 2.5%. 22. As far as the decision of Hon ble Supreme Court in Hira Singh (supra), is concerned, it is observed that the learned Single Judge in Iqbal Singh was of the prima facie view that the recovered substance in the said case i.e. cough syrup (having codeine as one of its ingredient) would fall outside the scope of definition of the manufactured drug under the NDPS Act and the learned Single Judge in Para 25 has held: 25. Plainly, the quantity of the mixture of a manufactured drug and a neutral substance would require to be considered for the purposes of determining whether the quantity is a commercial quantity or a small quantity for the purposes of the NDPS Act. However, a drug which is manufactured but falls outside the scope of the definition of a manufactured drug under the NDPS Act on account of th ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ivatives and poppy straw concentrate; (b) any other narcotic substance or preparation which the Central Government may, having regard to the available information as to its nature or to a decision, if any, under any International Convention, by notification in the Official Gazette, declare to be a manufactured drug; but does not include any narcotic substance or preparation which the Central Government may, having regard to the available information as to its nature or to a decision, if any, under any International Convention, by notification in the Official Gazette, declare not to be a manufactured drug; (emphasis supplied) The term opium derivative has been defined under Section 2(xvi) as: xxx (c) phenanthrene alkaloids, namely, morphine, codeine, thebaine and their salts; xxx (emphasis supplied) 27. It is an admitted position that in the present case, the seized substance i.e. 110 bottles of Phensedyl New is a preparation within the meaning of Section 2(xx) of the NDPS Act. Such preparation to be declared as manufactured drug would have to be notified by the Central Government under Section 2(xi)(b) of the NDPS Act. All m ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... rman Remedies, Codeine Linctus of M/s Zydus Alidac etc. moving in inter state commerce. These preparations contain among other drugs Codeine Phosphate 10 mg as one of the ingredients. By virtue of the fact that these preparations contain Codeine and it salts they do not fall under the provisions of NDPS Act and Rules of 1985 but they fall under Schedule H of the Drugs and Cosmetics Rules and are governed by the said rules. 31. In view of the above provisions of the NDPS Act, The Drugs and Cosmetics Act, The Drugs and Cosmetics Rules, 1945 and the aforesaid circular, the learned Single Judge in Iqbal Singh (supra) came to a prima facie conclusion that Onerex cough syrup containing 0.17% of Codeine was below the prescribed threshold and could not be construed as a manufactured drug by dissecting its ingredients and considering them in isolation. 32. In Mohd. Sahabuddin (supra), the Hon ble Supreme Court was dealing with the case of seizure of 347 cartons with each carton containing 100 bottles of 100 ml of Phensedyl cough syrup and 102 cartons of 100 bottles of 100 ml bottles of Recodex cough syrup which were found concealed, along with other household articles, in a ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... d by it, we do not find any scope to interfere with the same. 33. Recently, the Hon ble Supreme Court in State of Punjab vs. Rakesh Kumar (2019) 2 SCC 466, reversed a decision of the Hon ble High Court of Punjab and Haryana, granting suspension of sentence to the convicts under Section 389 Cr.P.C and held as under: 10. In the present case, the respondent-accused were found in bulk possession of manufactured drugs without any valid authorisation. The counsel on behalf of the appellant State has extensively stressed that the actions of the respondent-accused amounts to clear violation of Section 8 of the NDPS Act as it clearly prohibits possession of narcotic substances except for medicinal or scientific purposes. In furtherance of the same, the counsel on behalf of the appellant State has put emphasis on the judgment rendered by this Court in Union of India v. Sanjeev V. Deshpande , wherein it was held that : (SCC pp. 12-13, paras 25-26) 25. In other words, DEALING IN narcotic drugs and psychotropic substances is permissible only when such DEALING is for medical purposes or scientific purposes. Further, the mere fact that the DEALING IN narcotic drugs and psychotropi ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ed as Vibhor Rana vs. Union of India, 2021 SCC Online All 908, after analyzing the provisions of the NDPS Act, The Drugs and Cosmetics Act, and the Drugs and Cosmetics Rules, observed as under: 24. The prohibition contained in Section 8 of the Act is applicable to Narcotic Drugs and since Phensedyl New Cough Linctus contains Codeine compounded with one other ingredient, namely Chlorpheniramine Maleate and since Phensedyl New Cough Linctus contains merely 10 milligrams per dosage unit of 5 ml, which is not more than 100 milligrams of the drug per dosage unit in undivided preparations and the concentration of Codeine in Phensedyl New Cough Linctus is merely 0.2%, which obviously is not more than 2.5% and which has been established in Therapeutic practice, it is not a Manufactured Drug and, therefore, it is not a Narcotic Drug , the prohibition contained in Section 8 of the Act does not apply to it. 25. Phensedyl New Cough Linctus contains Codeine which is mentioned at Serial Number 20 in Schedule H1 appended to the Drugs Rules, 1945 and a note appended to Schedule H1 provides that Preparations containing the above drug substances and their sales excluding those inten ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... tter vide our letter number X-11029/27/05-D dated 26/10/2005 to all State Drugs Controllers with a copy to various associations and a copy Narcotic Control Bureau New Delhi (copy enclosed). The above circular inter alia stated that these preparations (Cough Linctus containing Codeine Phosphate) contains among other drugs Codeine Phosphate 10 mg as one of the ingredients. By virtue of the fact that these preparations contain Codeine and its salts they do not fall under the provisions of NDPS Act and the Rules of 1985 but they fall under Schedule H of the Drugs and Cosmetic Rules and are governed by the said rules. Though stocking and sale of these drugs do not attract the provisions of NDPS Act and Rules 1985, however these formulations are prescriptions drugs and are to be dispensed on the prescriptions of a registered Medical Practioner only. Further you may be aware that under notification number S.O.826(E) dated 14th November, 1985 under the Narcotic Drugs and Psychotropic Substances Act and Rules 1985 certain preparations are exempted as manufactured drugs provided the preparations contain the Narcotic drug to the extent permitted. In respect of Codeine under entry no. 35 it is ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... w Cough Linctus falls within the exception mentioned in entry 35 of the Notification dated 14-11-1985 or not and consequently, whether the provisions of the NDPS Act would apply to it or not. Therefore, both the aforesaid judgments are not relevant for deciding the question involved in the present Writ Petition. 37. It may be noted that in the judgment of Hon ble Supreme Court in Md. Sahabuddin (supra) it had been observed that the twin conditions in Entry 35, as aforesaid mentioned, would be fulfilled only if the recovered substance was being used for therapeutic practice and further observed in Para 11 of the said judgment; 11 Therapeutic practice as per dictionary meaning means contributing to cure of disease . In other words, the assessment of codeine content on dosage basis can only be made only when the cough syrup is definitely kept or transported which is exclusively meant for its usage for curing a disease and as an action of remedial agent. The Division Bench in Vibhor Rana (supra) had an occasion to deal with the expression used in the aforesaid Entry 35 viz. established in Therapeutic Practice and held as under: 41. The expression established ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... der Sections 8, 21 (c), 22, 25, 29 and 60 (3) of the NDPS Act in the Court of Special Judge, NDPS Act at Jaunpur. 39. The aforesaid judgments, however, have not considered the scope of Section 9(1)(a)(va) of the NDPS Act which provides as under: 9. Power of Central Government to permit, control and regulate.- (1) Subject to the provisions of Section 8, the Central Government may, by rules- (a) permit and regulate- xxx (va) the manufacture, possession, transport, import inter-State, export inter-State, sale, purchase, consumption and use of essential narcotic drugs: Provided that where, in respect of an essential narcotic drug, the State Government has granted licence or permit under the provisions of Section 10 prior to the commencement of the Narcotic Drugs and Psychotropic Substances (Amendment) Act, 2014, such licence or permit shall continue to be valid till the date of its expiry or for a period of twelve months from such commencement, whichever is earlier. xxx 40. The aforesaid sub-clause (va) was introduced by the Narcotic Drugs and Psychotropic Substances (Amendment) Act, 2014 (No. 16 2014), which came into effect on 01.05.2014 ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... odan, Scophedal, Tebodol and the like), its esters and the salts of its ester and preparation, admixture, extracts or other substances containing any of these drugs 250 Milligrammes 4. Dihydrocodeinone (commonly known as Hydrocodone), its salts (such as Dicodide, Codinovo, Diconone, Hycodan, Multacodin, Nyodide, Ydroced and the like) and its esters and salts of its ester, and preparation, admixture, extracts or other substances containing any of these drugs 320 Milligrammes 5. 1-phenethyl-4-N-propionylanilino-piperidine (the international non-proprietary name of which is Fentanyl) and its salts and preparations, admixture, extracts or other substances containing any of these drugs Two transdermal patches one each of 12.5 microgram per hour and 25 microgram per hour: Provided that the Controller of Drugs or any other officer authorised in this behalf by him may by special order authorise, in Form 3-B, any such practitioner to possess the aforesaid drugs in quantity larger than as specified in the above Table: Provided fur ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... by a Registered Medical Practitioner. (3) The research institution, hospital and dispensary referred to in sub-rule (2) shall maintain proper accounts and records in relation to the purchase and consumption of the psychotropic substance in their possession. A bare perusal of the aforesaid rule clearly shows that the reliance placed on the same by learned counsel appearing on behalf of the petitioner is misplaced. The aforesaid Rule 66 relates to psychotropic substances and therefore, is not applicable to codeine which is admittedly a narcotic drug under the NDPS Act. 42. As mentioned earlier, the term essential narcotic drugs has not been defined under the NDPS Act but the table in Rule 52A, Sub-Rule (3), at serial no. 2, under the title Name of essential narcotic drug gives a description of Methyl Morphine (commonly known as Codeine ), which is an exact verbatim copy of Entry no. 35 in notification titled Manufactured Narcotics Drug (as contained in Government of India Notification No. S.O. 826 (E) dated 14.11.1985 and S.O. 40(E) dated 21.09.1993 and S.O. no. 1431 (E) dated 21.06.2011). A combined reading of Rule 52A of The NDPS Rules and Entry no. 35, in th ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... and regulating any activity of DEALING IN narcotic drugs or psychotropic substances. (emphasis supplied) 45. The aforesaid amended provisions of the NDPS Act and the Rules made thereunder were not brought to the notice of the learned Single Judge of this court in Iqbal Singh s case (supra) as well as to the notice of the division bench of the Hon ble Allahabad High Court in Vibhor Rana s case (supra). 46. In view of the foregoing analysis of various provision of the NDPS Act, NDPS Rules, The Drugs and Cosmetics Act and the Drugs and Cosmetics Rules and the judgments referred to, we answer the reference in the following terms: Question - (c) whether Note 4 of the S.O. 1055 (E) dated 19th October, 2001 published in the Gazette of India,. Extra., Pt.II, Sec3 (ii) dated 19th October 2001, as amended on 18.11.2009, should be made applicable to cough syrups containing miniscule percentage of Codeine since it has medicinal value and is also easily available? Ans: If the contraband recovered in a particular case is covered by Rule 52A of the NDPS Rules made under Section 9(1)(a)(va) of the NDPS Act, then violation of the said Rules would be punishable under the NDPS ..... X X X X Extracts X X X X X X X X Extracts X X X X
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