S. H. SHETH, S. L. TALATI, J. ( 1 ) THE petitioner is a company which is engaged in the business of manufacturing pharmaceuticals and medicinal preparations. It has been inter alia manufacturing oral drugs injections and tablets. The respondents served Upon the petitioner two notices calling upon them to pay excise duty on the manufacture of thirteen medicinal preparations. The demands were made under Rule 9 of the Medicinal and Toilet Preparations (Excise Duty) Rules 1956 13 medicinal preparations have been listed at page 3 of the petition. They are as follows:- Sr. No. Product 1 xylocaine 1 % plain vial 2 2 % plain vial 3 1 % Adrenaline vial 4 2 % Adrenaline vial 5 2 % Adrenaline cartridges 6 5 % heavy ampules 7 4 % topical vials 8 5 % ointment tubes 9 2 % jelly tubes 10 2 % Viscous vial 11 Butazolidin 3 ml. ampules 12 Irgapyrin 3 ml. ampules. 13 Irgapyrin 5 ml. ampules. items 1 to 10 are injections and items 11 to 13 are oral drugs. ( 2 ) THE petitioner challenges in this petition the validity of the impugned demands made by the Central excise authorities on more than one ground The principal contention which Mr. Nanavaty who appears on behalf of the petitioner has raised is that by virtue of a notification issued by the Central Government items 1 to 10 have been exempted from payment of excise duty under Item 14 E in the First Schedule to the Central Excises and Salt Act 1944 He has further argued that within the meaning of sec. 3 read with Item I (iii) in the Schedule to the Medicinal and Toilet Preparations (Excise Duties) Act 1955 these 13 medicinal preparations are not liable to be taxed. In support of his argument he has indeed invited our attention to Seventh Schedule to the Constitution in particular to Entry 51 in the State List and Entry 54 in the Union List. Reference to these two entries in the Seventh Schedule to the Constitution was purely elucidatory. Nothing turns upon them. Item 14 E in the First Schedule to the Central Excises and Salt Act 1944 provides as follows:-"14 E Patent or proprietary medicines not containing Alcohol Opium. Indian hemp or other Narcotic drugs or other Narcotics other than those medicines which are exclusively Ayurvedic Unani Sidha or Homoeopathic".
Nothing turns upon them. Item 14 E in the First Schedule to the Central Excises and Salt Act 1944 provides as follows:-"14 E Patent or proprietary medicines not containing Alcohol Opium. Indian hemp or other Narcotic drugs or other Narcotics other than those medicines which are exclusively Ayurvedic Unani Sidha or Homoeopathic". There are two Explanations appended to that Item. Explanation I reads as follows:- "patent or proprietary medicines means any drug or medicinal preparation in whatever form for use in the internal or external treatment of or for the prevention of ailments in human beings or animals which bears either on itself or on its container or both a name which is not specified in a monograph in a Pharmacopoeia Formularly or other publications notified in this behalf by the Central Government in the Official Gazette or which is a brand name that is a name or a registered trade mark under the Trade and Merchandise Marks Act 1958 (43 of 1958 or any other mark such as a symbol monogram label signature or invented words or any writing which is used in relation to that medicine for the purpose of indicating or so as to indicate a connection in the course of trade between the medicine and some person having the right either as proprietor or otherwise to use the name or mark with or without any indication of the indentity of that person". Explanation It brings into play the provisions of sec. 2 of the Medicinal and Toilet Preparations (Excise Duties) Act 1955 to which we have referred above. Item 14 E makes it abundantly clear that it is applicable to those patent or proprietary medicines which inter alia do not contain narcotic drugs or other narcotics so far as allopathic medicines are concerned. Rule 8 (1) of the Central Excise Rules 1944 provides as follows:- "central Government may from time to time by notification in the Official Gazette exempt subject to such conditions as may be specified in the notification any excisable goods from the whole or ally part of duty leviable on such goods.
Rule 8 (1) of the Central Excise Rules 1944 provides as follows:- "central Government may from time to time by notification in the Official Gazette exempt subject to such conditions as may be specified in the notification any excisable goods from the whole or ally part of duty leviable on such goods. "the notification issued on 7th April 1962 by the Central Government under Rule 8 (1) of the said Rules provides as follows:- "in exercise of the powers conferred by Rule 8 (1) of the Central Excise Rules 1944 the Central Government hereby exempts anaesthetics from the payment of excise duty leviable thereon". The first leg of the argument raised by Mr. Nanavaty is that the Central Government itself has regarded anaesthetics as falling under Item 14e and have therefore exempted them from the payment of excise duty leviable thereon under Item 14 E in the First Schedule read with sec. 3 of the Central Excises and Salt Act 1944 The inference which Mr. Nanavaty therefore wants us to draw is that the first ten items which are anaesthetics do not contain narcotic drugs or other narcotics. According to him if they were otherwise not covered by Entry 14 E the Central Government could not have granted an exemption to them. The petitioner in its petition has stated that Items 1 to 10 which it has been manufacturing are local anaesthetics and Items 11 to 13 are broadspectrum anti inflamatory and anti rheumatic range of medicines containing a very small percentage of xylocaine as a local anaesthetic to avoid any pain arising out of administration of drug These averments made on behalf of the petitioner have not been controverted by the Central excise anthorities. It is therefore undisputed fact that whereas Items 1 to 10 are local anaesthetics Items 11 to 13 are anti inflamatory and antirheumatic range of medicines. It has further been stated by the petitioner that the medicinal preparations listed at serial Nos. 1 to 10 are used for benumbing a local area of human body on which a surgical operation is going to be performed. In view of the exemption notification to which we have referred there is no doubt about the fact that medicinal preparations at serial Nos.
1 to 10 are used for benumbing a local area of human body on which a surgical operation is going to be performed. In view of the exemption notification to which we have referred there is no doubt about the fact that medicinal preparations at serial Nos. 1 to 10 are exempt from payment of excise duty under Item 14 E of the First Schedule to the Central Excises and Salt Act 1944 ( 3 ) THE next question which arises for our consideration is whether all the 13 medicinal preparations are liable to pay excise duty under sec. 3 of the Medicinal and Toilet Preparations (Excise Duties) Act 1955 read with Item 1 in the Schedule to that Act. Sub-sec. (1) of sec. 3 of this Act provides as follows:-"there shall be levied duties of excise at the rates specified in the Schedule on all dutiable goods manufactured in India". ( 4 ) WE now turn to the Schedule. The general heading of Item I is Allopathic Medicinal Praparations. Sub-item (iii) is material for the purpose of the present case. It provides as follows:-"medicinal preparations not containing alcohol but containing narcotic drug or narcotic". We are required to find out whether 13 medicinal preparations which the petitioner has been manufacturing contain a narcotic drug or narcotic. The argument which Mr. Nanavaty has raised is that they do not contain a narcotic drug or narcotic. In support of his argument he has relied upon the exemption notification issued by the Central Government under Rule 8 (1) of the Central Excise Rules 1944 to show that within the meaning of Item 14e in the First Schedule to the Central Excises and Salt Act 1944 the Central Government itself has been regarding the first ten medicinal preparations as not containing a narcotic drug or a narcotic. According to him if they had contained a narcotic drug or a narcotic they would not have fallen within the fold of Item 14e and the question of exempting them from payment of excise duty under Item 14 E would not have arisen. The argument which Mr. Nanavaty has raised has indeed some substance.
According to him if they had contained a narcotic drug or a narcotic they would not have fallen within the fold of Item 14e and the question of exempting them from payment of excise duty under Item 14 E would not have arisen. The argument which Mr. Nanavaty has raised has indeed some substance. But what the Central Government thought of medicinal preparations 1 to 10 in the context of Item 14e in the First Schedule to the Central Excises and Salt Act 1944 cannot finally conclude the question of applicability or otherwise of Item 1 (iii) in the Schedule to the Medicinal and Toilet Preparations (Excise Duties) Act 1955 Even then the argument raised by Mr. Nanavaty cannot be said to be irrelevant. While construing Item 1 (iii) in the Schedule to the Medicinal and Toilet Preparations (Excise Duties) Act 1955 we have got to bear in mind the behaviour of the Central Government in granting exemption to first ten medicinal preparations for payment of excise duty under Item 14 E of the Central Excises and Salt Act 1944 ( 5 ) WE now turn to Item 1 (iii) itself. It renders liable to payment of excise duty the medicinal preparations which contain narcotic drug or narcotic but do not contain alcohol. It is nobodys case that any of these 13 preparations contain alcohol. Therefore it is not necessary for us to dwell on that aspect at all. ( 6 ) NARCOTIC drug or narcotic has been defined by the Act. At the relevant time in respect of which impugned demands have been made narcotic drug or narcotic was defined as follows by sec. 2 (h):-"narcotic drug or narcotic means a substance (other than alcohol) which when swallowed or inhaled by or injected into a human being induces drowsiness sleep stupefaction or insensibility in the human being (and includes all alkeloids of opium)". It is in light of this definition that we have to examine whether each one of these 13 medicinal preparations fall within the fold of Item 1 (iii ). A close look at the definition shows the effect of a narcotic drug in four stages. The first effect which it produces when it is swallowed or inhaled by or injected into a human body is drowsiness. Drowsiness matures into sleep which with the passage of time results into stupefaction and finally culminates into insensibility.
A close look at the definition shows the effect of a narcotic drug in four stages. The first effect which it produces when it is swallowed or inhaled by or injected into a human body is drowsiness. Drowsiness matures into sleep which with the passage of time results into stupefaction and finally culminates into insensibility. Indeed or has been used in the definition while chronicalling these four stages. But it does not suggest four alternatives. The four stages are stages of progression which follow one after another. In that sense or means and. Now there is no doubt and there cannot be any doubt about the fact that all these four stages affect the central nervous system. The final and culminating effect is that an individual who has swallowed or inhaled a narcotic drug or narcotic or into whose body it has been injected loses his senses and become unaware of what is happening to and around him. In other words the administration of a narcotic drug or a narcotic produces celebral sensorium of central nervous system. It is common knowledge that unless the central nervous system is effected in one way or the other drowsiness then sleep then stupefaction and lastly insensibility are unlikely to follow. When a general anaesthetic is administered to a person it produces one after another all these symptoms because it effects the central nervous system. ( 7 ) WE have already stated that indisputably Items 1 to 10 which the petitioner has been manufacturing are local anaesthetics. The remaining three are anti inflamatory and anti rheumatic medicines. What is the difference between a local anaesthetic and a general anaesthetic ? Encyclopaedia Britannica Vol. 1 1972 Edition at page 919 deals with anaesthetics. This is what has been stated in that behalf:- General anaesthesia involves loss of consciousness usually for the purpose of relieving the pain of surgical operation. Local anaesthesia involves lose of sensation in the area of the body by block of conduction in nerves. . . General Anaesthesia is manifested superficially by loss of consciousness but consists of depression of various central nervous system centres sub-serving sensation muscle activity respiration circulation other autonomic and viseral functions and mental activity. At page 920a this is what has been stated:- A local anaesthesia or conduction block has enjoyed a substained popularity for relief of surgical pain of minor operations. . . .
At page 920a this is what has been stated:- A local anaesthesia or conduction block has enjoyed a substained popularity for relief of surgical pain of minor operations. . . . The local anaestheties produce anaesthesia by preventing the depolariazation of the nerve fibre membrane thus hindering the conduction of nerve impulses. Infiltration of an area of the body with a local anaesthetic prevents perception of sensory stimuli by nerve endings in the area and blocks conduction of impulses over nerve fibres passing through the area. This distinction between a general anaesthetic and a local anaesthetic makes it clear that the latter does not affect the central nervous system. It only benumbs a local area. In order to be a narcotic drug or a narcotic it is necessary that it must effect the central nervous system and produce drowsiness sleep stupefaction and insensibility. ( 8 ) IN Steadmans Medical Dictionary 1968 Reprint Anaesthesia has been defined as loss of sensation in a part or in the body generally induced by the administration of a drug. The pharmacological Basis of Therapeutics by Goodman and Gilman Third Edition 1975 (Section III) states that a local anaesthetic is suitable for injection to produce nerve block. These reference leave no doubt in our minds that 13 medicinal preparations which the petitioner has been manufacturing do not contain a narcotic drug or narcotic because they are incapable as the evidence goes of producing raising stages drowsiness sleepiness stupefaction or insensibility. General anaesthetics which affect the central nervous system and produce these symptoms can be more appropriately be said to contain a narcotic drug or narcotic within the meaning of the definitions of those expresion given in sec. 2 (h) at the relevant time of the Medicinal and Toilet Preparations (Excise Duties) Act 1955 ( 9 ) IT has been argued by Mr. Patel on behalf of the respondent that the first ten medicinal preparations manufactured by the petitioners are xylocaine in different forms. According to him xylocaine is a narcotic drug. He has in that behalf invited our attention to the same book the Pharmacological Basis of Therapeutics by Goodman and Gilman Fifth Edition 1975 It has been stated that Lidocaine which is also called xylocaine produces sleepiness as the unique after effect.
According to him xylocaine is a narcotic drug. He has in that behalf invited our attention to the same book the Pharmacological Basis of Therapeutics by Goodman and Gilman Fifth Edition 1975 It has been stated that Lidocaine which is also called xylocaine produces sleepiness as the unique after effect. According to him therefore one of the requirements laid down by the definition of the expression narcotic drug or narcotic is satisfied and that therefore it contains a narcotic drug. The argument advanced by Mr. Patel suffers from certain fallacies also cannot be accepted. The first fallacy in our opinion arises from the misconception of the definition of narcotic drug or narcotic given in sec. 2 (h) of the Medicinal and Toilet Preparations (Excise Duties) Act 1955 Merely because while describing the four stages of the effects the expression Or has been used it does not mean that if a drug produces one of the four effects it answers the description of a narcotic drug or a narcotic given in the definition. In our opinion a narcotic drug or a narcotic should produce all the four effects one after another with the passage of time. The second fallacy is sleepiness is not the direct effect of xylocaine. It is an after effect. A unique aftereffect in our opinion is one which characterizes a particular drug by producing that effect after all has been said and done. An after effect is not a direct proximate ordinary or a normal effect. An after effect in this context is in our opinion a side effect which is produced after the utillity of the drug for the purpose for which it has been administered is exhausted. Therefore it is difficult to say that the first ten medicinal preparations which are known by the name of xylocaine (indeed in different forms) contain a narcotic drug or narcotic:- ( 10 ) MR. Patel has then invited our attention to Pharmacology and Pharmacotherapeutics by Satoskar and Bhandarkar Third Revised Edition 1975 in which reference has been made to Lignocaine which is also another name for xylocaine. It has been stated in that context that it is recommended inter alia for nerve blocks and may cause drowsiness but produces no action on the blood vessels. According to Mr.
It has been stated in that context that it is recommended inter alia for nerve blocks and may cause drowsiness but produces no action on the blood vessels. According to Mr. Patel since xylocaine produces drowsiness it answers the description of a narcotic drug or a narcotic as given in the definition of that expression in the said Act. It is necessary to read closely what the authors have said in that behalf. They do not say that it causes drowsiness. They say it may cause drowsiness. therefore depending upon the biochemical reaction which a particular human body produces to the administration of xylocaine it may or may not produce drowsiness. It is necessary to remember that nerve blocks do not make a man insensible because they do not effect the central nervous system. For this reason and also in light of the definition of the expression narcotic drug narcotic which we have interpreted we are unable to uphold the argument raised by Mr. Patel that merely because the first ten medicinal preparations manufactured by the petitioners are likely to produce drowsiness or sleepiness as a unique after effect they contain a narcotic drug or narcotic within the meaning of that expression given in the definition. We are not concerned in this case with the scientific character of a narcotic drug or narcotic because the Act was its own dictionary. We are therefore required to find out whether these medicinal preparations contain a narcotic drug or narcotic within the meaning of that definition and not on consideration of any scientific data material or information. ( 11 ) IT has next been argued by Mr. Patel that within the meaning of Item 1 (iii) in the Schedule to the said Act if there is a medicinal preparation which contains a narcotic drug of a narcotic it is enough to subject such a preparation to the payment of excise duty irrespective of whether the combination of that narcotic drug or narcotic with other ingredients in a particular medicinal preparation produces drowsiness sleepiness stupefaction or insensibility. According to him the very presence of a narcotic drug or a narcotic in a medicinal preparation attracts the applicability of Item 1 (iii) in the Schedule to the said Act.
According to him the very presence of a narcotic drug or a narcotic in a medicinal preparation attracts the applicability of Item 1 (iii) in the Schedule to the said Act. In that context he has further argued that a narcotic drug or a narcotic which is a component part of a medicinal preparation when administered singly should be capable of producing drowsiness sleepiness stupefaction and insensibility. However according to him it does not mean that it need necessarily produce those effect when it forms a component along with others of a medicinal preparation. The distinction which Mr. Patel has tried to draw is indeed very ingenious It is quite probable that a narcotic drug or a narcotic may produce when administered singly drowsiness sleepiness stupefaction and insensibility. It may not produce such symptoms when it acts on human body as a component of a particular medicinal preparation which has been manufactured out of several other things. ( 12 ) IF we were required to examine the concept of a narcotic drug or narcotic in light of scientific data available in that behalf we would have indeed given greater weight to the argument which Mr. Patel has advanced. In the instant case we are not required to do so because we are required to examine the characteristics of a narcotic drug or a narcotic as specified in sec. 2 (h) of the said Act at the relevant time. It is wrong to say therefore that though a narcotic drug or a narcotic is one which should produce drowsiness sleepiness stupefaction or insensibility it need not necessarily produce such symptoms when it forms a component part of medicinal preparation which is made up of several other things. When a narcotic drug or a narcotic which is a component part of a medicinal preparation ceases to produce the symptoms laid down in the definition of that expression given in sec. 2 (h) of the Act it ceases to be a narcotic drug or narcotic. What other characteristics are retained we are not concerned with. ( 13 ) WHETHER the medicinal preparations which the petitioner has been manufacturing contain a narcotic drug or narcotic (as under stood and argued by Mr. Patel) was a question which we put to him. We do not have on record the scientific analysis of the components which enter into the manufacture of 13 medicinal preparations in question.
( 13 ) WHETHER the medicinal preparations which the petitioner has been manufacturing contain a narcotic drug or narcotic (as under stood and argued by Mr. Patel) was a question which we put to him. We do not have on record the scientific analysis of the components which enter into the manufacture of 13 medicinal preparations in question. Mr. Patel fell back upon the text books to which we have made reference and which say that xylocaine may produce drowsiness and has a unique after effect of producing drowsiness. Therefore Mr. Patel started his argument from the wrong end and said that since they produce this symptom they contain a narcotic drug or a narcotic. This argument raised by Mr. Patel suffers from a serious fallacy. We cannot start from a wrong end and determine the character of a medicinal preparation only from its effects in a human organism. Suffice it to say that a heavy meal produces drowsiness and some times sleepiness. It cannot therefore be said to contain a narcotic or a narcotic drug. We are therefore unable to accede to the argument which Mr. Patel has raised before us in that behalf. We are of the opinion that within the meaning of sec. 3 read with Item I (iii) and sec. 2 (h) as it was at the relevant time 13 medicinal preparations which the petitioner has been manufacturing are not liable to pay excise duty under the Medicinal and Toilet Preparations (Excise Duties) Act 1955 because they do not contain a narcotic drug or narcotic. The first contention raised by Mr. Nanavaty is therefore upheld. ( 14 ) THE next contention which Mr. Nanavaty has raised turns upon Art. 14 of the Constitution. The facts which he has stated in that behalf are as follows. The Medicinal and Toilet Preparations (Excise Duties) Act 1955 is a Central Act which is applicable to the whole of India In States other than Gujarat. excise duties are not levied on local anaesthetics and such other medicinal preparations. Only in the State of Gujarat they are levied. The averments made to that effect in the petition have not been controverted by the respondents. According to Mr. Nanavaty therefore to collect from one excise duty on a particular medicinal preparation and not to collect it from another introduces undue discrimination between the two. The argument raised by Mr.
Only in the State of Gujarat they are levied. The averments made to that effect in the petition have not been controverted by the respondents. According to Mr. Nanavaty therefore to collect from one excise duty on a particular medicinal preparation and not to collect it from another introduces undue discrimination between the two. The argument raised by Mr. Nanavaty is well founded and must be upheld. It is not open to the central excise authorities to levy throughout the country on a particular medicinal preparation excise duty under the said Act and to collect it from some of its manufacturers and not to collect it from others. ( 15 ) IN reply Mr. Patel who appears on behalf of the State of Gujarat has argued that since the proceeds of the excise duties collected under the said Act go to the State Exchequer a comparison between what is done in two States cannot be made. The argument raised by Mr. Patel is misconceived. It is immaterial to which Exchequer the proceeds of the tax goes. The fact remains that the said Act imposes an all India levy which must be uniformly collected from all the concerned manufacturers in the country. Therefore the action of the central excise authorities in levying and collecting the excise duty on 13 medicinal preparations which the petitioner has been manufacturing is hit by Art. 14 of the Constitution. ( 16 ) THE next argument which has been raised by Mr. Nanavaty turns upon the promissory estoppel. The facts which he has stated in order to attract the applicability of the doctrine is that by issuing the notification under sub-rule (1) of rule 8 of the Central Excise Rules 1944 under which the Central Government has exempted from the payment of excise duty local anaesthetics otherwise dutiable under Item 14 E in the First Schedule to the Central Excises and Salt Act 1944 the Central Government has assured the petitioner and all other persons in similar situations that local anaesthetics do not contain a narcotic drug or a narcotic. According to Mr. Nanavaty it is upon that assurance that the petitioner acted and did not charge his consumers the excise duty on the first 10 medicinal preparations which it has been manufacturing.
According to Mr. Nanavaty it is upon that assurance that the petitioner acted and did not charge his consumers the excise duty on the first 10 medicinal preparations which it has been manufacturing. Now if the Central Government turns round and says that the first 10 medicinal preparations which have been manufactured by the petitioner contain a narcotic drug or a narcotic the Central Government will be going back upon the assurance which it gave by issuing the said notification. We are not impressed by this argument at all. What the Central Government did in relation to Item 14 E in the First Schedule to the Central Excises and Salt Act 1944 cannot amount to a promise in respect of dutiability or otherwise of an article under Item 1 (iii) in the Schedule to the Medicinal and Toilet Preparations (Excise Duties) Act 1955 Secondly the promise upon which Mr. Nanavaty relies was not a promise made to the petitioner. In our opinion therefore the doctrine of promissory estoppel does not come into play in the present case. The argument raised in that behalf is therefore rejected. The rest of the judgment is not material for the reports. Petition allowed. .