1. This is an appeal against order No. C-642/BII-144/83 dated 21st March, 1983 passed by the Collector of Central Excise (Appeals), Bombay which arose from order No. V(14E)4-6/ 1980/4609 dated 31-12-1981 of the Assistant Collector of Central Excise, Bombay. The dispute is with respect to a medical preparation of M/s. Mac Laboratories Pvt. Ltd. which the appellants call Kemicetine Vaginal Suppositories (KVS) which contain the antibiotic chloramphenicol (CAF). The preparation is manufactured in two different strengths, namely, 0.25 gms and 0.50 gms chloramphenicol content. The KVS preparations arc classified as patent and proprietary medicines and are assessed under item 14E of the Central Excise Tariff. The dispute arose when the central excise issued five demand notices listed below :---------------------------------------------------------------S. No. Period of demand Total amount of Date of duty involved demand-------------------------------------------------------------- Rs.5.
1-1-1981 to 30-4-1981 25,548.41 8-5-1981 2,40,403.70 2. Under Notification No. 116/69-C.E., dated 3-5-1969 exemption was given under Rule 8, Sub-rule (1) of the Central Excise Rules, 1944 of duty in excess of 2 1/2% ad valorem to patent and proprietary medicines falling under item 14E containing 'chloramphenicol and its esters for oral and parenteral use'. This notification was amended by Notification No. 106/80-C.E., dated 19-6-1980 by which the exemption became total.
The manufacturers claim that their preparation KVS was entitled to this exemption. It appears that the assessment was being made under this notification till the demands we have mentioned above were issued by the central excise because they thought that the preparation was not entitled to the exemption and that the medicine should pay duty @ 12.5% ad valorem (+5% special excise duty from 1-3-1978) for the period from January, 1978 to April, 1981.
3. This disagreement revolves around the meaning of the word parenteral. The central excise say that KVS are not patenteral in their application, while M/s. Mac Laboratories maintain that they are nothing but parenteral. Each side has quoted several authorities in support of its point of view.
4. The word parenteral has been understood to refer to medication applied in such a manner that it bypasses the alimentary canal, which has its opening point in the mouth and ends in the anus. Thus if a medication is applied by injecting the medicine directly into the blood stream with a needle and a syringe, it is a parenteral administration.
Similarly, if a medicine is applied by injecting it into the muscles, it is also a parenteral administration. The two sides agree on this, but they do not agree about certain other applications like a suppository inserted into the body. The vaginal suppositories are called by the appellants parenteral and by the centtal excise nonparenteral. But there is no disagreement that the administration of medicines parenterally and non-parenterally will depend on the systemic' absorption of the drug or medicine. In other words, M/s. Mac Laboratories maintain that their suppositories have systemic effect, and therefore, qualify to be classed as parenteral. Central excise dispute it. The learned counsel for the department said the suppositories were not parenteral but have only local/topical use because, to be parenteral, the medication must be administered as an injection. At the time of the argument, the learned counsel for the appellants objected to the department's contention at this late stage that the suppositories have only local/topical administration. He objected to this as being a new point which had never been taken before, and therefore, should not be taken into account.
5. Much arguments were given and affidavits filed by the two sides. On behalf of the appellants, affidavits were sworn by Mr. A.D. Bharwada, Mr. Dalip Zaveri and Dr. D.K, Tank. The affidavits given by Mr. Zaveri in February, 1984 and second one in June, 1984 are in fact no more than exposition of the appellants' case and are really arguments that were advanced before us at the hearing of the appeal. The affidavit by Mr.
Bharwada, similarly states the history of the case leading to the demand and this appeal which we are hearing now. Both these persons are employees of M/s. Mac Laboratories, Mr. Bharwada as Accountant and Mr.
Zaveri working in the Research and Development Department of the Laboratory. The affidavit by Dr. Tank also expounds the meaning of the word parenteral and it also expresses his opinion in the shape of answers to questions to explain different methods of administration, effects, routes and the research and development that have gone into alternative routes of administration of drugs, the effect on metabolism and the efficacy of new route administration of drugs already in use.
Similarly, the affidavit given by Mr. C.Y. Dewasthali, Superintendent of Central Excise is really an exposition of his opinion and contains the opinion of technical authorities of the Food and Drug administration, the Dy. Chief Chemist of the Department. It cites a number of books that deal with drug administration, and their routes.
It is in this affidavit that the department said for the first time that the drug had only a topical local use, producing the objection from the appellants that we have already referred to above. It is in the second affidavit of Mr. Zaveri dated 5-6-1984 that a detailed presentation of the appellants claim is put forward. He filed the second affidavit to reply to Mr. Devasthali's affidavit. It even goes much further and sets up the case of the appellants in detail, with extensive reference to authorities and publications to establish that KVS is a parenteral medicine and will, therefore, qualify for the exemption which is disputed by the central excise.
6. He began by saying that the definition given to the word parenteral in DORLAND'S POCKET MEDICAL DICTIONARY, 21st edition was changed by the 22nd edition of the same book to give the word a mere restricted meaning. The 21st edition defined the word parenteral as "otherwise than through the alimentary canal". The 22nd edition, however, limits the definition of the word parenteral only to administration by injections, thus : "not through the alimentary canal, but rather by injection through some other route, as subcutaneous, intramuscular etc.". He says that pharmaceutical science is a developing science and its principles, concepts and terminology often change. The publication was not made by a pharmaceutical society or official agency, and therefore, the book only reflect the author's own perception of the subject and should not be taken as an authority and that it would not be possible, from the 22nd edition of Dorland's Dictionary, to conclude that parenteral means only injection administration. He said that he had already shown from Dorland's Illustrated Medical Dictionary 25th edition, that the word injection is used and understood in a very wide sense and is not restricted to preparations administered by hypodermic syringes only. In his earlier affidavit he said that injections could be classified into solutions, suspensions, powders etc. and that there were several routes such as intravenous, intradermal, intravascular, by which injections can be administered. The administration is followed by prolonged action, slow and controlled release of parenteral products such as pellets, crystal, etc. which are implanted into the body at proper sites by special hypodermic syringes or by surgical methods.
Page 783 of Dorland's Illustrated Medical Dictionary, 25th edition describes injection and the different types of this administration such as anatomical injection, epifascial injection, intracutaneous injection, jet injection, and many others. A paper written by Dr. Mario Ferruzzi on the use of chloramphenicol by vaginal route in the treatment of annexitis were annexed to the affidavit and contained very interesting reports of experiment and research conducted in the administration of the antibiotic and narrated six cases of acute, sub-acute, inflammatory forms of the female genital apparatus treated with CAF (chloramphenicol) ovular suppositories. The paper also reports a case of typhoid fever in a 30 year old woman who, after treatment with CAF by the oral route without any response, was subsequently treated with CAF ovular suppositories by the vaginal route after suitable douching with sterile water. The paper reported an improvement in the clinical symptomatology and abatement in temperature. Continuing the treatment, the patient was considered cured. The other five cases reported in the paper all deal with inflammations and laceration of the genitals or a case of abortion in the third month which resulted in profuse leucorrhea, corpusuteri slightly increased in size. Another was a case of profuse leucorrhea and also gonococci in the vaginal smear.
Another case was a patient who had appendectomy and had also suffered from bilateral annexitis and severe cystitis. There was one case of a patient suffering from dysmenorrhea and severe leucorrhea. All these cases showed that the vagina was an effective route for administration.
7. Mr. Zaveri suggests that the word parenteral is used in Remington's Pharmaceutical Sciences in a very wide sense and that it would not be correct to understand the word as referring only to preparations introduced into the body by hypodermic syringes. This book contains an article Parenteral Products. The parenteral administration of drug has been divided into three headings-(i) drug pellet absorption; (ii) solution absorption and (iii) parenteral dispersion absorption. The book shows a few advantages that parenteral administration has over oral administration, because certain medications like hormones are inactivated in the digestive tract. Implantation is another method of parenteral administration and compressed pellets of hormones are placed in the subcutaneous tissues to be absorbed into the body fluid over a period of time. The medicines themselves are in various form. Some are in aqueous solution, others in oil, though the use of oil is said to be not ideal and may not be free from allergens. The publication deals in some detail with injection administration, and even illustrates the needle points and discusses the types of syringes, nasal douches, rectal syringes, vaginal syringes and enema syringes.
8. The affidavit refers to the book Principles of Drug Action : The Basis of Pharmacology, Second edition, by Avram Goldstein, Lewis Aronow and Summer M. Kalman. This book discusses drug absorption and routes of administration thus "The possible routes of drug entry into the body may be divided into two classes-enteral and parenteral. In enteral administration the drug is placed directly in the gastrointestinal tract by placing it under the tongue (sublingual), by swallowing it (oral. p.o., per os), or by rectal administration. In parenteral administration the gastrointestinal tract is bypassed. There are many parenteral routes. The commonest are subcutaneous (s.c), intramuscular (i.m), and intravascular: but drugs may also be applied to the skin or injected intradermally, for local effect or to be absorbed percutaneously: they may be inhaled for direct action on the bronchial tree or to be absorbed into blood at the alveoli: they may be injected into or near the spinal canal : they may be introduced intravaginally." 9. The Pharmaceutical Handbook edited by Ainley Wade (The Pharmaceutical Society of Great Britain) defines parenteral as "not by way of the alimentary tract; administered by a route other than that of the alimentary tract". The next one quoted is the Faber Medical Dictionary edited by Sir Cecil Wakeley which defines parenteral "(1) Outside the intestinal tract; (2) Relating to administration of a substance by a way other than that of the alimentary tract e.g. by subcutaneous, intramuscular or intraveous injection." The same article defines parenteral diarrhoea as diarrhoea in infants when caused by a disease outside the alimentary tract e.g. by a respiratory infection.
Black's Medical Dictionary edited by William A.R. Thomson defines parenteral as the word applied to the administration of drugs by any route other than by the mouth or by the bowel. A book called Churchill Livingstone Pocket Medical Dictionary, Nacy Roper, defines parenteral as not via the alimentary tract.
10. Lewis's Pharmacology, James Crossland, Fifth Edition, contains articles about administration of drugs such as by way of intraarterial, intrathecal and intraventricular injeetions, defining that these, strictly speaking are forms of local application but since they involve introduction of the drug directly into the body fluids they are more conveniently classified with the other forms of parenteral administration. A rarely used route viz. intraperitoneal injection is briefly discussed in this book which points out that it is very rarely employed in human beings because of risk to the organ-filled and infection-prone abdominal cavity.
11. In an annexure to the affidavit dated 5th June, 1984, Mr. Zaveri explains that the word parenteral has been used in a narrow sense in the Drugs and Cosmetics Rules to facilitate prescribing the standards and requirements of the factory premises, special equipments and testing to be performed for certain drugs. He explains that Schedule 'C and 'C-1' consists of biological and special products for the convenience of licencing provisions and reference to the relevant portions of Schedule 'M' and 'U'. He explains that the word parenteral as used in the Drug Rules has to be understood with reference to Section B to Schedule 'U' (Parts I, II and III), and Section 'K' of Schedule 'M'. Schedule 'M' and Schedule 'U' are meant for manufacturers only and all the words and expressions used in it do not necessarily reflect the normal or trade usages of such words. The annexure ends by stating that the Drug's Act and Drug's Rules are frequently amended and that as recently defined, drugs would include even packaging materials, soaps, mosquito repellants.
12. An affidavit has been filed by a Dr. D.K. Tank, who practices as a consulting Gynecologist and obstretician. He has given opinion in the form of answers to questions put to him. He defines the word parenteral as referring to the route of administration of drugs. He considers that the dictionary meaning of the word is wide enough to cover administration of drugs otherwise than through the alimentary canal where the drug is desired to have systemic effect. In support, he cites the Chamber's 20th Century Dictionary, which defines the word parenteral as "not intestinal; not by way of alimentary tract".
Dorland's Pocket Medical Dictionary defines parenteral as "otherwise than through the alimentary canal." in Butterworth's Medical Dictionary the word means "Introduced subcutaneously, intravenously or by any route other than by way of digestive tract". The Complete Medical Guide -Benjamin F. Miller at P. 576 describes parenteral as "Not in the intestine - designates substances introduced through the mucous membrances, skin, blood, or other means than the intestine." 13. He describes how vaginal suppositories are applied. The suppositories are semi-solid and are introduced into the vagina by hand. They are made of wax-like material which melts at the temperature of the vagina. The medicine may then get absorbed into the systems by or through the epithelium or mucous membrane lining the vagina, and also act locally. He describes how work on this subject of vaginal administration of drugs had encouraging results. A book Drug Delivery Systems published by Oxford University Press in 1980, the chapter contributed by Chien on "Controlled Drug Release from Polymeric Systems" reviews the progress made on 'Intravaginal drug delivery systems'. Some passages are quoted from the book to show that this route can be employed for administration of drugs, especially drugs which present problems if administered by the oral route. One quotation is as follows - It has been known for several decades that some systematically active drugs, such as steroid hormones, may be effectively absorbed through the vaginal mucos a (Rock et al 1947). The effectiveness of vaginal absorption was illustrated more than 20 years ago by the intravaginal administration of progesterone via a drug-impregnated suppository formulation (Mishell et al 1972); the orally inactive progesterone became active when administered intravaginally.
Using the vagina as the route of administration for contraceptive drugs has several advantages. Among these, the most practical one is that a drug-releasing vaginal device, such as a medicated, resilient vaginal ring could permit self-insertion and removal and provide continuous administration of an effective does level, thus ensuring better patient compliance. Additionally, this continuous "infusion" of drug through the vaginal epithelium can prevent the possibility of systemic toxicity or inefficient biological activity resulting from the surging and ebbing plasma drug levels which occur with the intermittent use of oral contraceptive pills (Flynn et al 1976).
Moreover, hepatic "first-pass effects" and gastrointestinal incompatibility can be bypassed when drugs are administered intravaginally. The perineum venous plexus, which drains the vaginal tissue and rectum, flows into the pudentum vein and ultimately into the vena cava, thus by passing, initially, the portal circulation.
This is in marked contrast to gastrointestinal blood, which drains into the portal vein and passes directly through the liver before reaching the general circulation and the target tissue(s). Thus, the vaginal route may be of great value with drugs like progesterone and estradiol, which have poor bioavailability when taken orally because they are extensively inactivated by hepatic metabolism (Flynn et al, 1976). In addition, the intravaginal route of administration can also be beneficial for drugs such as the prostaglandins. which cause adverse gastrointestinal irritation (Lauersen and Wilson, 1976a, 1976b; Nuwayser and Williams, 1974). On the other hand, the vaginal tissues may have a metabolism which is different from that of liver and intestine.
14. Dr. Tank quotes from the Annual Reports in Medical Chemistry Vol.
18, sponsored by the Division of Medicinal Chemistry of the American Chemical Society and published in 1982, mentioning Chapter 28 at p.
275, contributed by Norman Henderson, which relates that drugs which are inactivated in or poorly absorbed by the gastrointestinal tract and which are subject to extensive first pass metabolism are usually administered parenterally. Various body orifices and organs are explored as alternative routes of administration of certain drugs. From p. 282 these words are reproduced- Uterine/vaginal intrauterine and intravaginal devices have been in use since the early 1970's to deliver contraceptive steroids to the target organ. The book by Chien contains individual chapters on intrauterine devices, intravaginal devices and devices for esterus control in animals. A recent report by Morimoto and co-workers on the vaginal absorption of insulin from polyacrylic acid gels indicates that this route also has potential for the systemic administration of drugs.
15. The learned counsel for M/s. Mac Laboratories, Mr. Narasimhan reiterated the views expressed by various affidavits. He maintained that the classification having been repeatedly approved over a period of years, it cannot be suddenly changed. The burden is on the central excise authorities to prove their case and they have not done so. They have not been able to dispute or effectively answer the technical authorities cited by the appellants. The technical authorities have been set out very clearly in the affidavits submitted by the appellants. The central excise, having accepted the declaration in the classification lists filed under Rule 173B from 1969, should have specified clearly the basis on which such exemptions were given and the new facts that required the reopening and revision of the earlier decisions. The Appellate Collector makes a reference to the price lists for concluding that the appellants them-selves did not describe KVS preparations as parenteral and that only injections have been described as parenteral. The learned counsel answered this by saying that the price lists were available to the officers in all the earlier years when they sought approval of the classification. Labels of the drugs were also seen before the classification lists were approved. All the relevant facts were known to central excise. It was urged by the learned counsel where two views are possible, the classification should go in favour of the assessee. In all the cases, the RT-12 have been finalised long before the adjudication order was passed by the Assistant Collector and there was no case for demand. He cited the Central Board of Excise & Customs decision in Fertilizer Corporation (1982 E.L.T. 818 Dec. issue).
16. The learned counsel said that Rule 10 was repealed on 17-11-1980, and therefore, no notice could be issued thereunder after this date.
(AIR 1970 S.C. 494) and Anr. case of the Allahabad High Court (1982 E.L.T. 201). Even if the above submissions of Rule 10 are not accepted, since there was no allegation of suppression, fraud, colusion, etc. the 5 year period in Rule 10 or Section 11A of Central Excises and Salt Act, 1944 is not applicable. Therefore, all demands for periods of more than six months were time-barred. He quoted in support 1983 E.L.T. 1994 (CEGAT) : 1983 E.L.T. 2037 (CEGAT) and Government circular letter at page T3 of January, 1984 E.L.T.17. The learned counsel told the Tribunal that it is not correct nor does it establish anything conclusively to rely on the words "other than parenteral" in Schedule 'C-1' of the Drug Rules, 1945, because classification was for the purpose of control on import, manufacture, distribution and sale of drugs. The classification under the Drug Rules was done more than 10 years before the concessional rate of duty was notified. Schedule 'C-1' involves less stringent Regulations and hence the appellants did not contest this classification. In any case, classification of a patent medicine for the purpose of drugs control is not relevant or binding in central excise. He cited the following in support : - (4) The discussion at page 299 to page 301 of Taraporewala's Law of Central Excise Second edition.
18. The learned counsel's last submission was that an estoppel operates against the central excise authorities. According to the Drugs (Price) Control Order, only the excise duty that will be charged in the ultimate price to the consumer can be added as excise duty. This is the duty approved by the central excise in the classification lists under Rule 173B(2) over the years. The central excise, therefore, are estopped from demanding and recovering duty for the past periods retrospectively revising the classification, when the appellant has no power to recover the duty now demanded from him and which is more than what he recovered from his customers. He quotes the following cases in support - (iii) Ravindra Hindustan Platinum (P) Ltd, v. U.O.I. 1981 E.L.T. 871 (Bom.).
19. The following cases were cited by the learned counsel for M/s. Mac Laboratories in support of his arguments :- (6) Order No. 118/84-C Ballarpur Industries v. C.C.E.- 1984 (17) E.L.T. 378.
(18) Bansal Exports (P) Ltd. v. U.O.I. Full Bench Delhi High Court-AIR 1983 Delhi 445.
(19) Ravindra Hindustan Platinum (P) Ltd. v. U.O.I.-198I E.L.T. 871 (Bom.).
20. The learned counsel for the department opposed the appeal saying that whatever may have been done or said by the appellants or by the department the fact remains that the suppositories have only local or topical applications There is no way of getting round the accepted meaning of the word parenteral that will support the contention of the appellants that kemicetine suppositories are parenteral. Applications of medicines and drugs can be by two ways One, by the alimentary canal or passage, the other, through the skin bypassing the alimentary canal.
The most common form of this second mode of application is an injection. Injections can be given directly into the blood vessels or into the muscles or given subcutaneously. The two methods have their own separate uses : the same drug can be applied either way depending on the disease to be treated and the best method that has been devised for combating the disease. A drug that may be administered by the mouth can also be administered as an injection directly into the body. A third mode of application-local or topical, is also employed when the ailment affects only a localized spot on the surface of the body. He pointed out to definitions in Remington's Pharmaceutical Sciences which have described rarenteral administration of drug as an injection given through layers of the skin or mucous membrane. He also referred to the various technical authorities cited by the appellants themselves to argue that a parenteral administration cannot be given but by an injection. He read various dictionaries and books of reference to illustrate that parenteral administration is always understood to be by routes such as intravenous, intradermal, intravascular, subcutaneous etc etc The references to treatment of diseases like typhoid fever by the vaginal route was only an experiment reported by a research worker and does not establish a general system of therapy, which can be said to have modified the accepted meaning in the definition of the word parenteral.
21. He dwelt at length on the fact that the price lists published by M/s. Mac Laboratories show kemicetine under Schedule 'C-1' of the Drug Rules. Schedule 'C-1' covers drugs and medicines other than parenteral.
The learned counsel emphasised that this classification had been made by M/s. Mac Laboratories for a long time but when they came to the central excise for the purposes of exemption, they classified kemicetine suppositories as entitled to concession under Notification No. 116/69-C.E. This clearly proves that the factory know before it took the concession that its drug was not a parenteral drug. The factory is now claiming it to be a parenteral drug simply because they want the exemption, and they succeeded for a long time. They suppressed the fact that while, on the one hand, they classified their KVS to the drugs control authorities as a non-parenteral drug, they claimed the exemption from central excise duty by falsely claiming that the medication was a parenteral preparation. There can be no clearer case of fraudulent declaration and misstatement of fact than this. They clearly stood to gain by presenting their KVS to the central excise as preparations for parenteral administration. He referred to the opinion given by the Food and Drug Administration which said that kemicetine vaginal suppositories fell under Schedule 'C-1' of the Drugs and Cosmetic Rules, 1945. Another certificate given by Dr. (Mrs.) S.G.Ghorpode opines clearly that kemicetine vaginal suppositories manufactured by M/s. Mac Laboratories were non-parenteral drugs and that it was not a life saving drug, but a drug only for topical/local use. He said that the Assistant Collector and the Appellate Collector have given the right order and in view of the clear suppression and falsification, the action to demand duty under the extended period was quite correct.
22. The counsel for M/s. Mac Laboratories said in reply that the reference by the department now to local and topical use is a new argument and should not be accepted at this late stage. The assessee never had a chance to deal with or refute this contention, and it cannot be allowed to be raised now by the counsel for the department.
He further said that it would be wrong to see in their declaration of kemicetine suppositories under Schedule 'C-1' as meaning that they had been classifying their product under this Schedule. In all likelihood, this had been made by the drug control authorities but they had nothing on record to prove this, as this is a very old practice, the origin of which is no longer known to them. It makes no difference to their manufacture since they had given the full details to the drug control authorities and if they choose to put their preparations under Schedule 'C-1', it made no adverse effect on the manufacture and so nothing was done about it. But when an exemption was given to a medicine which, in their view, was a parenteral administered preparation, they saw no reason why they could not claim the exemption when they are entitled to it. The central excise are required to verify and satisfy themselves before they approve the classification list. If they did not, it was not the factory's fault. The manufacturers cannot be accused of suppression or falsification when it was open to the central excise to enquire, investigate and satisfy itself that the claimant was entitled to the exemption. It was for the central excise to reject the claim; but it did not do so. The manufacturers are not aware what enquiries were made by the central excise, but they must be assumed to have made them because the law requires them to do so when the assessee filed his classification list and claimed the exemption. He said that some of the claims were time-barred and that the five-year time-limit cannot apply since there was no misdeclaration or falsification of anything in any manner.
23. He argued also that it is not permissible to retrospectively require duty to be paid in the manner proposed to be done by the central excise because all the assessments were made with the knowledge and after full approval of the concerned authorities. In answer to a question from the Bench, he reiterated that although provisions for making demands are present in the law, it would not be permissible to issue demands for past periods in a case like this in which the assessee acted in accordance with the law and after placing all the facts and obtaining approval of the assessment and exemption from the central excise. He repeated emphatically that there is no case of revising the classification even prospectively because the kemicetine suppositories are parenteral administration drugs and are therefore fully entitled to the concessional duty.
24. To properly understand this problem, we need to understand the manner of administration of drugs for the treatment of diseases, ailments and other afflictions of the body. The most and oldest method of administering drugs and medications is the introduction of the therapeutic agent into the mouth. The introduction of the drug into the mouth and the swallowing that follows it, brings the drug into contact with the stomach and the intestines. It is here that the drug is absorbed into the system and, in course of time, reaches the target area or the affected spot in the body in order to act upon it to combat and remove the cause of the disorder. This mode of administration had certain disadvantages such as patient rejection. For instance, after swallowing, the patient may involuntarily regurgitate the medicine, especially if a medicine is one that causes nausea or one that agitates the stomach, causing the patient to void it. In small children, a bitter tasting medicine will be spat out. In this case, the rejection is in the very primary stage of administration. Another disadvantage is that the patient may not co-operate. This can happen when the physician is not present to administer the medicine but leaves it to the patient to administer it to himself. If the patient, for whatever reason, dislikes the medicine, either because of its taste or its affects, he may not administer the medicine. Another disadvantage of oral administration is that its affects are usually not felt until the lapse of, in some cases, a considerable time. Administration of medicine through the other end of the alimentary canal-the anus-has only limited application because the drugs administered by this route sometimes will not reach into the higher intestines. Frequently, the medicines are inactivated by the body fluids, the enzymes and other digestive secretions. At other times, the drug has deleterious effects on intestinal walls, flora and fauna.
25. An injection, on the other hand, overcomes many of the disadvantages of administration by or into the alimentary canal. It is quick in its effect ; it is not subject to patient rejection and does not depend too much on gatient co-operation. But it too has certain disadvantages-it is irreversible. In some cases, injections cause considerable amounts of pain to the subject. But it has gained great popularity because of its other advantages over oral administration and in many cases, where chemotherapy is indicated, it has to a very large extent, supplanted oral administration when rapid effect is needed. We have seen from the authorities quoted that there are several methods of administering injections. The last mode of administration is application of a drug or a medicine to a localized part on the surface of the body which is affected. For example, a burnt hand or a spot of the face that is afflicted with rash or a skin disease, will have a drug in the form of an ointment applied to that part until the affliction is removed. There can be localized/topical application of a medicine even in areas not exposed on the surface, such as the ear or the nose or even the mouth when the infection is a local one and needs to be treated as a local disease.
26. What distinguishes the first two modes of administration from the third one is that they both act systematically-that is to say, the medicine, in order to act, penetrates and enters the body, affecting the circulatory system, the tissues, the bones, nerves and muscles and generally the body as a whole, the entry being through the alimentary canal or through the blood vessels or muscles, or through the skin.
There is always systemic absorption of the therapeutic chemical or drug or agent. There seems to be general agreement that systemic absorption is superior when the administration is through the parenteral route because the gastrointestinal or alimentary tract can and does have many impediments and interfering factors such as food, the gastric juices and enzymes and the natural acids secreted by the body which may interfere or even neutralise the drugs. The body organ such as the liver, the pancreas, secrete substances which in varying degrees may act upon the drug. Many of the actions of the body fluids are not completely understood as yet by science. However, when drugs are introduced directly into the system through the skin or the muscles, into the blood vessels or veins, they bypass many of the harmful interfering secretions and other foreign matters normally present in the enteral tract. In all the authorities cited by M/s. Mac Laboratories, and the dictionaries quoted by them, the word parenteral has been defined variously as the method of administration of drug when the drug is introduced intravenously, subcutaneously or by any route other than by way of the digestive tract, or introduced not into the intestines but introduced through the mucous membranes, skin, blood even by injection of a fluid into the spinal fluids. Various definitions and explanations in the authorities also speak of implantation of pellets under the skin to be absorbed during periods that may range upto a few months. They are not even reports of injections to the heart muscles in an extreme case. All the dictionaries agree that parenteral refers to introduction of a medicine by a route other than the alimentary tract.
27. The appellants have taken these definitions to mean that the word parenteral, therefore, refers to any mode of administration which is not by way of the gastrointestinal or alimentary tract. They understand the word to refer to administration whether it is injection or application by any other method or to any other area or spot on the body except by the mouth and the anus.
28. There is considerable doubt about this as will be shown below :- Principles of Drug Action : The possible routes of drug entry into the body may be divided into two classes-enteral and parenteral, in enteral administration the drug is placed directly in the gastrointestinal tract by placing it under the tongue (sublingual) by swallowing it (oral, p.o., per os), or by rectal administration. In parenteral administration the gastrointestinal tract is bypassed. There are many parenteral routes. The commonest are subcutaneous (s.c), intramuscular (i.m.), and intravascular : but drugs may also be applied to the skin or injected intradermally, for local effect or to be absorbed percutaneously : they may be inhaled for direct action on the bronchial tree or to be absorbed into blood at the alveoli; they may be injected into or near the spinal canal : they may be introduced intravaginally.
29. At first sight it would appear that this paragraph supports the appellant's contentions because it speaks of drugs being also applied to the skin or injected intradermally, for local effect or to be absorbed percutaneously. The heading of the article is Drug Absorption : Routes of Administration : it is the absorption of a drug administered parenterally or enterally that is the subject of discussion; the absorption into the body system and involves penetration into the tissues and body fluids.
30. The article carries a paragraph on Sustained Release from Parenteral Depots which are said to serve two purposes : (a) a long-sustained nearly zero-order absorption into the circulation, simulating a slow constant intravenous infusion and (b) a prolonged local release for drug action on tissues in the immediate vicinity, avoiding significant systemic effects as the drug is diluted in the general circulation. This is an illustration of an administration that appears local but which in fact is meant to have systemic effect.
31. Lewis's Pharmacology, James Crossland, (fifth edition), Churchill Livingstone, carries a chapter on routes of administration under the heading, The Administration of Drugs (page 33) under the subject article; the chapter gives an article on Parenteral Administration.
This is how the book describes the methods - The term parenteral administration (par-beyond, enteral-intestinal) implies that the drug is given by a route which takes it directly into the body fluids, bypassing the preliminary process of transport through the intestinal wall or pulmonary alveoli which is necessary when drugs are ingested, inhaled or placed in the rectum. With all forms of parenteral administration, sterile precautions are necessary.
Some of the parenteral administrations discussed are subcutaneous administration, intramuscular injection, intraperitoneal injection. In a sub-article Microinjection and Microiontophoretic administration, the book relates that these are the most refined forms of local administration yet devised for use in the laboratory. They permit the application of minute quantities of drugs directly to individual neurones in the central nervous system; however they have no clinical application being of value largely to the laboratory worker. There is also a paragraph on Vaginal Administration reproduced here- The drug is presented in the form of a pessary or tablet or it may be used to impregnate a vaginal tampon. Although the method can be used for drugs which are absorbed through the vaginal mucous membrane into the circulation it is usually restricted to cases requiring the local treatment of vaginal conditions.
Drugs can also be applied locally to the eye. Rarely they are administered, by urethral bougies, directly to the urethra. In emergencies, adrenaline may be directly injected into the wall of the heart, providing a rather extreme example of the local application of a therapeutic agent.
32. We can see from this that when this authority discusses parenteral administration, it refers to a method that involves absorption into the body fluids and system of the drug or the active therapeutic agent.
Lewis's Pharmacology places vaginal administration outside parenteral administration, although it acknowledges that the method can be used for drugs which are absorbed through the vaginal membrane into the circulation but takes care to mention that it is usually restricted to local treatment of vaginal conditions.
33. A book Drug Delivery Systems : Characteristics and Biomedical Applications edited by R.L. Juliano, Oxford University Press, carries the following interesting paragraphs on Intravaginal Drug Delivery Systems : It has been known for several decades that some systematically active drugs, such as steroid hormones, may be effectively absorbed through the vaginal mucosa (Rock et al., 1947). The effectiveness of vaginal absorption was illustrated more than 20 years ago by the intravaginal administration of progesterone via a drug-impregnated suppository formulation (Mishell et al., 1972); the orally inactive progesterone became active when administered intravaginally.
Using the vagina as the route of administration for contraceptive drugs has several advantages. Among these, the most practical one is that a drug-releasing vaginal device, such as a medicated, resilient vaginal ring, could permit self-insertion and removal and provide continuous administration of an effective dose level, thus insuring better patient compliance. Additionally, this continuous "infusion" of drug through the vaginal epithelium can prevent the possibility of systemic toxicity or inefficient biological activity resulting from the surging and ebbing plasma drug levels which occur with the intermittent use of oral contraceptive pills. (Flynn et al., 1978).
34. There can be no doubt whatever from these paragraphs which have been relied upon by the appellants that when they speak of vaginal drug delivery by which the drug is absorbed, the drug spoken of is a systematically active steroid hormone, and is said to be effectively absorbed through the vaginal mucosa. The drug being a hormone, its effects will depend on its systemic absorption, although the administration of the progesterone was by means of a suppository. This route appears to have been explored because progesterone was found to be orally inactive. Even for the contraceptive, the article describes the advantage of the continuous infusion when the vaginal route is used, as it can prevent the possibility of systemic toxicity that can result from the surging and ebbing plasma drug levels. The systemic absorption and action of the drug is beyond doubt. In other words, the paragraph describes a systemic drug administration through the route of the vagina.
Thus, the vaginal route may be of great value with drugs like progesterone and estradiol, which have poor bioavailability when taken orally because they are extensively inactivated by hepatic metabolism (Flynn et al., 1976). In addition, the intravaginal route of administration can also be beneficial for drugs such as the prostaglandins, which cause adverse gastrointestinal irritation (Lauersen and Wilson, 1976a, 1976b; Nuwayser and Williams, 1974). On the other hand, the vaginal tissues may have a metabolism which is different from that of liver and intestine.
We have not yet heard of administration of prostaglandins except when it is required for systemic operation. Prostaglandins are known to occur naturally in human biological fluids and are known to have significant effect on certain metabolical processes and are also thought to effect the nervous system. For the drug to have fully effect, it must be systematically absorbed. The vaginal route has been preferred because as reported in the book prostaglandins irritate the intestinal tract. In the article appearing at page 36 of the same book, Drug Delivery Systems in describing a vaginal control drug administration, the author describes that the steps for the drug-dispersing vaginal ring, "consist of the dissolution of the finely ground, well-dispersed drug particles into the surrounding polymer structure, diffusion through the polymer matrix to the device surface, partition into and then deffusion across the vaginal fluid (which is sandwiched between the vaginal ring and vaginal walls), uptake by and then penetration through the vaginal wall, and, transport and distribution of the drug molecules by circulating blood and/or lymph to a target tissue".
36. The book Annual Reports in Medicinal Chemistry, Volume 18, editor-in-chief, Hans-Jurgen Hess Academic Press, has a paragraph Uterine/Vaginal under the heading Routes of Administration, speaks of a recent report of Morimoto and co-workers on the vaginal absorption of insulin from polyacrylic acid gets indicates that this route also has potential for the systematic administration of drugs.
37. None of the authorities who have been presented before us speak of the intravaginal route of administration as parenteral except when the administration is meant to be a systemic administration, the drug or medicine being systematically absorbed, and penetrates into the body lymph, blood or tissues in a more or less complete manner. Whatever the area of application, the aim is the same - to cause the drug to penetrate into the body system, thereto act and to be physiologically taken up and become integral with the system in such a manner that after a lapse of a period, depending upon the speed and degree of penetration/absorption, rejection whether voluntarily or involuntarily becomes impossible. The appellants are mistaken when they speak of their kemicetine vaginal suppositories as being parenterally administered. It was argued by the learned counsel that the term parenteral diarrhoea has been used for a diarrhoea caused by agents outside the intestinal tract: but this is to misunderstand the implication of the description. Diarrhoea is always associated with the entric system, beginning and ending in the alimentary tracts, being caused by organisms taken into the alimentary tract by the subject.
When the diarrhoea is caused by reasons outside the alimentary tract, it could be described as a parenteral diarrhoea, but that is all for the purpose of differentiating it from the diarrhoea normally encountered in clinical observations. For reasons that are obvious, the symptoms are enteral in their manifestations even when the implicated agents are lodged outside the alimentary system, because diarrhoea must be a disturbance of the gastrointestinal passage, and of nothing else.
The case does not, in any way, reinforce the appellant's case.
38. Strong reliance was placed by M/s. Mac Laboratories on the research reports of Dr. Mario Ferruzzi reporting on the use of chloramphenicol by the vaginal route in the treatment of typhoid fever. The paper reports a case in which the research worker had under treatment a case of typhoid fever in a 30 year old woman verified both clinically and scrologically. The treatment was began by CAF by the oral route but the patient complained of incoercible vomitting and violent headache after the second administration. The worker consequently was compelled to suspend oral route, and began treatment with 3 g Caf ovular suppositories per day (supplied by Carlo Erba, the collaborators with Mac Laboratories), by vaginal route, previously giving a vaginal douche with sterile water. An improvement was noted in the clinical symptomatology by the second day, together with abatement in temperature and slight improvement in the general condition. Treatment was continued until 10 g were reached, after which the patient could be considered cured and in convalescence. (The other cases reported in the same paper deal with inflammation of the female genitals and treatment with CAF ovular suppositories). Unfortunately, the typhoid treatment does not seem to be anything but a stray case. It is not corroborated by sustained application as to be a clinically accepted method. It is known that research cases are not always fully developed as to bacome a general practice of medicine. The successful steatment of one case of typhoid fever with chloramphenicol vaginal supposu lies cannot establish a medically acknowledged system of typhoid therapy. Nor can it prove KVS to be parenteral medicines.
39. The appellants suggest that this report proves that the KVS arc parenteral medicine and deserves to be classified as such. The kemicetine suppositories have been advertised by Mac Laboratories as "an effective and convenient dosage form for treating several common infections of the female genital tract. Absorption of the antibiotic from this dosage form is so good that it is found in internal genitals and eradicates trichomoniasis not only from the superficial mucosa but also from extra vaginal lacunae thereby preventing relapses." The first page of the paper announces that the suppositories are "for treatment of infectious vaginitis" and its indications are infectious, acute and chronic vulvovaginitis, cervicitis, cervical erosion". In an inner page of the paper is reported a case of treatment with KVS in a research project. It reports "The local treatment was given by pessary of 0.25 G Chloramphenicol which has a PH of 5.7, and the base is used as a mixture of polyethylene glycols. Unlike Tetracyclines, Chloramphenicol pessary had no direct effect on the vaginal epithelium in the form of massive desquamation. In our study, the treated group had clearer smears, providing better hormonal interpretation than the untreated group." (This is an abstract from : Acta Cytological, Vol. 19, No. 4, 1975 of the International Academy of Cytology). The epithelium is a non-vascluar tissue forming the outer layer of the mucous membranes in animals. It should be noted that the report speaks of the treatment with the pessary as a local treatment.
40. The infections treated with kemicetine vaginal suppositories are all local infections and inflammations of the female genital tract. The absorption aimed at is clearly a local absorption of the drug for the purpose of combating and eradicating trichomoniasis not only in the mucosa but also in the extra vaginal lacunae to eradicate inflammation and infection; and it needs to be understood that there is no need, for the drug to operate effectively, to penetrate and be absorbed systematically, because, as we have seen, the infections are all local in the vulva, vagina and cervix region. The paper indeed does not suggest anywhere that for the treatment of these maladies, there is any need for systemic absorption of the drug. The reason for this is obvious. The target areas are all superficial- that is -not inside the system but outside the internal body system, although in a protected/covered cavity or orifice. M/s. Mac Laboratories have not shown any evidence to satisfy us and to convince us that their kemicetine vaginal suppositories are parenteral in their operation and effect. They are not required to be parenteral as their activity is to combat infecting organism which lie on the surface of the body system rather than within the body system itself. The surface may be unexposed as in this case, but we should understand this in contrast to the internal body system. The vagina is a sheath with walls that form it.
The word is from the Latin vagina meaning, a sheath or scabbard.
41. We have no doubt, therefore, in our mind that M/s. Mac Laboratories' kemicetine vaginal suppositories are not parenteral in their operation and are, therefore, not entitled to the exemption under Notification No. 116/69-C.E., dated 3-5-1969. The authorities, dictionaries and books of reference quoted by them do not support their contention that the suppositories are parenteral preparations. The demands issued by the Assistant Collector are, therefore, correct.
42. A good deal of arguments were made back and forth at the hearing on whether the time-bar operated in respect of these demand notices. The department said that there had been false declaration and misstatement by the assessee and that it id obtain undue benefit under the notification. The learned counsel for the department argued that they had been declaring the goods to drugs control authorities as non-parenteral while to the department they said it was a parenterally administered drug. This would justify a demand for five years. It is true that the manufacturers had been dealing with the drug control office as if their KVS were non-parenteral, but the counsel for M/s.
Mac Laboratories said that this was a very old practice for which they no longer had any record and they are unable to ascertain its origin.
In all likelihood this had been done on the initiative of the drugs control authorities but he was not able to vouch for this. The counsel for the department said that the manufacturers were experts in the field and they would have known the difference in the declaration to the drugs control authorities and to the central excise, and that their declaration to central excise would make all the difference between assessment to full duty and assessment to reduced duty or nil duty.
There has been fraudulence in their dealing with the central excise, and there fore, the demands were all in order.
43. If there was fraudulence in M/s. Mac Laboratories' dealings with central excise, we cannot see it in the orders and proceedings before the central excise authorities. None of the show cause notices charged M/s. Mac Laboratories with fraudulence or suppression; they merely say that the party had been clearing the material at concessional rate of duty under notification No. 116/69-C.E., dated 4-5-1969. As the medicine kemicetine vaginal suppositories were neither oral nor parenteral, application of the Notification was incorrect, and therefore, the medicines were liable to duty at 12 1/2% basic and 5% special duty. There is not so much as a sentence charging M/s. Mac Laboratories with suppression or misstatement. The notices do not even say that the five year limit for demand was to be invoked. They say that the amount was recoverable under Rule 10 of Central Excise Rules, 1944.
44. The order of the Assistant Collector dated 31-12-1981, however, rejects the assessee's contention on time-bar on the ground that the short levy resulted "due to wilful misstatement, suppression of facts at the time of filing the classification lists in respect of the said product with the intent to evade payment of duty". But the Assistant Collector throws no light at all on what the wilful misstatement or suppression of fact was. If there were wilful misstatement and suppression of fact, we expect the adjudicator to spell them out in detail, because a wrong payment of duty at a lower rate is not always from wilfulness or fraudulent intentions. If the authorities thought there was wilful misstatement and suppression of facts, they must put down in writing in the records so that all who read them can see from the proceedings, without going into the past histories and bygone operations of the main actors, what was done and by whom, and how it constituted a wilful misstatement or suppression of fact and how it infracted the law? Here in this case the show cause notices do not so much as even hint that there had been wilful misstatement or suppression of fact. The Assistant Collector declares that there had been wilful misstatement and suppression of facts but without supporting his words without concrete instances and examples of how he based such a declaration. There may, indeed, have been misstatement and suppression of facts, but it is not enough to say so. The department must provide foundation and reveal the basis and evidence on which it says so. It is not that what one thinks is always the right thing. The adjudicator may be mistaken; he may have misunderstood a fact or the law. If he is to carry conviction, he must lay bare and expound fully his case for saying that a fraud had been committed or that facts had been suppressed etc. etc. We can see none of this in these proceedings.
In fact, we would even say that the Assistant Collector exceeded his powers by saying that there had been wilful misstatement and suppression of facts when the notices of demand did not charge the assessee with such malfeasance. It is also a matter of great significance that the proceedings do not invoke the penal provisions of the central excise laws, nor did the Assistant Collector impose a penalty, which we think should be done if an assessee has defrauded the revenue. Non imposition of a penalty is an indication, generally speaking, of the absence of any criminal wrong doing. We are not satisfied by the proceedings that the Central Excise have succeeded in bringing home a charge of suppression or misstatement. They made no attempt to establish such a charge. They merely profess they have discovered one. Unless a charge of this kind is explicitly proved, we will not be able to accept it.
45. An objection was raised by the learned counsel for M/s. Mac Laboratories that the argument of the department that the suppositories were topical or local in their application was a new argument and should not be permitted. The objection misses the point. The department had begun by saying that the medicine was not a parenterally administered drug. It is accepted by Mac Laboratories that it is not an oral drug. The application of the drug can only be local or topical, that is to say, the application is confined to treatment of local condition in contrast to an application that has systemic and body penetration. We are unable to accept the learned counsel's objection that this sets up a new argument. It is an argument that naturally flows from all that had gone before it. The appellants' own affidavits discuss local/topical application of drugs. It does not depart from the direction of the arguments. As we have demonstrated, KVS are not parenteral, and therefore, they must be local or topical in action. It needs to be recorded here that local or topical application can lead to a certain amount of systemic absorption, especially if the area is a tender area covered only by a mucous membrane or when the surface is inflammed. But the systemic absorption encountered in such instances is largely incidental and not meant to be part of the treatment method.
But then even the outer tougher skin can absorb a good bit of medicine, as when a rash is treated and the medicine that is applied to it can and does penetrate the outer skin sufficiently to soften it and get at the root of the infection. Even ordinary water can penetrate and soften the skin. We are unable to accept the learned counsel's objection as it is completely beside the point.
46. Schedule'C and Schedule 'C-1' of the Drugs and Cosmetics Rules, 1945 were subjects of spirited debate between the two sides. Schedule 'C has a heading Biological and Special Products. Schedule 'C-1' has a heading Other Special Products. Chlorarnphenicol is listed under Item 11 of Schedule 'C which is for drugs and preparations thereof in a form to he administered parenterally. It is clear from this that the form will determine whether the preparation is to be administered parenterally, and not the drug itself. The difficulty arises in respect of those arguments is that M/s. Mac Laboratories claimed the drugs as parenteral. It is a different matter that the department does not accept it. What matters, however, is that the assessee did place the drugs before the central excise for classification claiming at the same time exemption under notification. This classification claimed by the assessee was accepted by the central excise which approved them until it changed its mind to say that the preparations were not parenterally administered. There is much to be said for the assessee's argument that the department had the duty to satisfy itself and make enquiries before approving the classification lists. If it did approve them, it cannot blame the assessee later on for misstatement. The learned counsel for the department countered this argument by saying that the officers of central excise were not experts and cannot always determine the nature of the products. In our opinion, this is a weak argument and will not stand scrutiny. The short answer is that, since the assessment depended on the nature of the product, the central excise officers must know what they are about, unless of course, they maintain that they can approve anything without verification. The very fact that they did discover and change their mind about the nature of the drug proves that the officers can do it and we know for a fact that they have done it in countless instances in the past by issuing demands after approving a classification in one manner, only to discover that the product was different from what they thought it was.
47. The learned counsel for M/s. Mac Laboratories argued that they cannot be made to pay duty for the past as it amounts to the Assistant Collector revising his own decisions and this is not permissible. He cited many decisions in this respect.
48 The learned counsel quoted a case of J. K. Synthetics v. Union of India-1981 E.L.T. 328 (Del.). The Court ruled that the department should be restrained from capriciously changing its stand and inflicting unnecessary proceedings and hardship upon assessees. It also ruled that "for no reasons at all there should be no departure from the view taken in an earlier year". It held, however, that "an authority can depart from a finding arrived at in an earlier year only for cogent reasons. There should be either fresh facts or a change of law or at least a suggestion that while arriving at the conclusion of the earlier year, certain material facts or provisions had not been considered and that if they had been considered a different view might have been taken". The last quotation answers the counsel's objection fully. There has been a discovery of certain material facts which were not known to central excise before they started these proceedings. The circumstances in which those facts did not come to the knowledge of central excise, is not a point here.
49. The learned counsel then quoted the decision of the Bombay High Court in Mis. Deepak and Company v. Collector of Central Excise, Bombay. He relied on the words ''merely because the Superintendent of Central Excise thinks that the earlier decision of the Assistant Collector was erroneous, he cannot hold the assessee liable to duty.
Mere change of an opinion without any basis is not sufficient to conclude that the earlier orders were incorrect." We are not quite clear what support this passage lends to the counsel's case. It is not a case of the Superintendent's thinking that the earlier decision of the Assistant Collector was erroneous. Regular proceedings were started and the Assistant Collector himself demanded and ordered the recovery of duty that he held to be short levied in the past on account of erroneous assessment, which he said was brought about by the wrong declaration of the assessee. In the same order, the Court held also "it must be remembered that the mere change of the opinion without any basis, is not sufficient to conclude that the earlier orders were incorrect". It is not so here. There was strong basis for central excise demanding duty and for saying that the previous assessment was erroneous. The Court's decision quoted here does not debar the action taken by central excise in respect of M/s. Mac Laboratories 50. The next case quoted by the learned counsel for Mac Laboratories, is Bhor Industries v. Union of India- 1980 E.L.T. 752. The Assistant Collector had classified certain goods in a certain manner and this was challenged in appeal. At this stage, the Collector sitting in appeal set aside the order of the Assistant Collector and ruled in favour of the manufacturer. The central excise, however, reopened the proceedings by issuing a fresh show cause notice. The fresh notice to show cause used languages found in proceedings of the conference of the Collectors of Central Excise. The Court criticized the reliance by central excise adjudicating authority, on decisions taken in the Collectors' conference. The Court, of course, went into the merits of the assessment of the goods and came to its own conclusion; but it also gave the authorities liberty to hold fresh enquiry after the issue of fresh show cause notice to the party if assessment is preferred under a different heading. This decision does not, in any way, support the case of the appellants, 51. The decision of this Tribunal in TISCO v. Collector of Customs, Calcutta - 1983 E.L.T. 1113 says that "abrupt changes in classification without assigning any reasons are unjustified in law". We totally agree with these sentiments but we can find nothing here that will help the appellants.
52. In view of the above, it is not necessary for us to discuss other decisions quoted by the counsel for the appellants. These decisions are Nevchem Plastics v. Collector of Central Excise, Delhi-1983 E.C.R., 1888 D and Ballarpur Industries Limited v. Collector of Central Excise, Delhi-Order No.53. But there is no decision that says that an Assistant Collector cannot issue a demand in accordance with law. As long as the demand is issued in accordance with law, we cannot pronounce it to be illegal. It has to be borne in mind that all demands are reviews or modifications of a previous assessment made by somebody. The law does not state the decision making authority in respect of whose decision a notice of demand can be issued. All that is necessary for the power to be brought into play is for a short levy to be discovered. What gave rise to the short levy is not at all an issue. We, therefore, reject this argument of the learned counsel. We also reject this appeal.
54. The counsel for the appellants has listed a very large number of Court decisions ; but our decision in respect of the assessment of kemicetine vaginal suppositories are based only on the nature of the product. None of the decisions quoted by the appellants relate to assessment of chloramphenicol vaginal suppositories or to whether or not they are parenterally administered medicines. The decisions, therefore, are not relevant to the case before us. Nor has there been any decision in the cases quoted before us what should constitute parenteral or oral, or local/topical administration.
55. We direct that duty be paid by M/s. Mac Laboratories as demanded; but such recovery shall be restricted to a period of six months before the date of the notices.