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Whether Buprenorphine Hydrochloride is a “psychotropic substance

 

. The common questions in these bail applications are:

1) Whether Buprenorphine Hydrochloride is a “psychotropic substance” within the meaning of the Narcotic Drugs and Psychotropic Substances Act, 1985 (hereinafter referred to as the NDPS Act) ?

2) If yes, whether Buprenorphine Hydrochloride is a “psychotropic substance” to which Chapter VII of the Narcotic Drugs and Psychotropic Substances Rules, 1985 (hereinafter referred to as the NDPS Rules) apply ? To what effect ?

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Rajinder Gupta vs The State [Along With Bail … on 22 August, 2005

Equivalent citations: 2006 CriLJ 674, 123 (2005) DLT 55, 2005 (84) DRJ 477

Author: B D Ahmed

Bench: B D Ahmed

JUDGMENT

Badar Durrez Ahmed, J.

A1. The common questions in these bail applications are:

1) Whether Buprenorphine Hydrochloride is a “psychotropic substance” within the meaning of the Narcotic Drugs and Psychotropic Substances Act, 1985 (hereinafter referred to as the NDPS Act) ?

2) If yes, whether Buprenorphine Hydrochloride is a “psychotropic substance” to which Chapter VII of the Narcotic Drugs and Psychotropic Substances Rules, 1985 (hereinafter referred to as the NDPS Rules) apply ? To what effect ?

It was contended by the petitioners that Buprenorphine Hydrochloride I.P. Injections which are the subject matter of the present applications are drugs specified under the Drugs and Cosmetics Act, 1940 and conform to standards indicated in the Indian Pharmacopoeia. According to the learned counsel for the petitioners, since the Buprenorphine Hydrochloride injections involved in the present applications conformed to the specifications mentioned in the Indian Pharmacopoeia and were Schedule “H” Drus under the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945, the same could not be regarded as “psychotropic substances” at all under the NDPS Act. On the other hand, learned counsel who appeared for the Respondents, urged that Buprenorphine Hydrochloride was a psychotropic substance within the meaning of the NDPS Act and that it made little difference if it also happened to be a Schedule ‘H’ Drug.

A2. In the first instance, it is to be determined as to whether Buprenorphine Hydrochloride I.P. injections are covered under the definition of psychotropic substances under the NDPS Act. If they are not to be regarded as psychotropic substances then, clearly, no offence under the NDPS Act would be made out and the petitioners would straight away be entitled to be enlarged on bail. On the other hand, if it were to be held that the same were psychotropic substances then Question No. 2 would require an answer. It would have to be seen as to whether merely because Buprenorphine Hydrochloride was a psychotropic substance this in itself would entail that its manufacture, sale, possession, transport, etc., would trigger the punishments under the NDPS Act, particularly the punishment under Section 22 thereof.

Re: Question No.1:

A3. Let me examine the provisions with regard to Buprenorphine Hydrochloride in the Drugs and Cosmetics Act, 1940 (hereinafter referred to as the “DandC Act”), the Drugs and Cosmetics Rules, 1945 (hereinafter referred to as the “DandC Rules”), the NDPS Act and the NDPS Rules. Rule 65 of the DandC Rules prescribes the general conditions for licenses in Forms 20, 20A, 20B, 20F, 20G, 21 and 21B. For example sub-rule (3)(1) of Rule 65 stipulates that the supply of any drug, other than those specified in Schedule X, on the prescription of a Registered Medical Practitioner shall be recorded at the time of supply in a prescription register specially maintained for the purpose and the serial number of entry in the register shall be entered on the prescription. Several particulars are required to be entered in the Register such as, serial number of the entry, the date of supply, the name and address of the prescriber etc. In the case of a drug specified in Schedule `H’, it is also necessary to record theame of the manufacturer of the drug, its batch number and the date of expiry of potency, if any.

Rule 97 of the DandC Rules contains stipulations with regard to the labelling of medicines. It specifically provides that the container of a medicine for internal use shall, if it contains a substance specified in Schedule `H’, be labeled with the symbol Rx conspicuously displayed on the top left corner of the label and shall also be labelled with the following words:-

“Schedule `H’ drug Warning: to be sold by retail on the prescription of a Registered Medical Practitioner only.”

This is so provided in Rule 97(1)(b) of the DandC Rules. However, if the substance contained in the container is one specified in Schedule `H’ and also comes within the purview of the NDPS Act, it is required to be labelled with the symbol NRx , which shall be in red and conspicuously displayed on the left top corner of the label, and be also labelled with the following words:-

“Schedule H drug G” Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only”.

This is so provided in Rule 97(1)(c) of the DandC Rules. I may also mention Rule 104 of the said Rules which provides that the letters “IP” and recognised abbreviations of the pharmacopoeias and official compendia of drug standards prescribed under these rules shall be entered on the label of the drug only for the purpose of indicating that the drug is in accordance with standards set out in the Indian Pharmacopoeia or in any such pharmacopoeia or official compendium of drug standards recognised under the Rules. An examination of Schedule `H’ of the DandC Rules makes it clear that Buprenorphine Hydrochloride is listed therein as a `Prescription Drug.’

A4. From an analysis of the above provisions, it is clear that Buprenorphine Hydrochloride, if it conforms to the standards prescribed under the Indian Pharmacopoeia, is to be known as Buprenorphine Hydrochloride I.P. It is further clear that Buprenorphine Hydrochloride is a prescription drug specified in Schedule `H’ and is to be sold by retail only on the prescription of a Registered Medical Practitioner. The stipulation with regard to the entries made in the Register as prescribed under Rule 65 have also to be complied with by the retailer making the sales. It is also to be noted that a reading of Rule 97(1)(c) clearly indicates that it is quite possible that a drug falling within the meaning of the Drugs and Cosmetics Act, 1940 and the DandC Rues and particularly one falling under Schedule `H’ can also fall within the purview of the NDPS Act. If it is so, the manufacturer is duty bound to place the symbol NRx in red on the top left corner of the label.

A5. I now come to the provisions under the NDPS Act. Section 2(ixia) defines “psychotropic substances” as under:-

“(ixia) “psychotropic substance” means any substance, natural or synthetic or any natural material or any salt or preparation of such substance or materials included in the list of psychotropic substances specified in the Schedule.”

A plain reading of the above definition makes it clear that a psychotropic substance could be any substance, natural or synthetic, or any natural material or “any salt or preparation” of such substance or materials included in the list of psychotropic substances specified in the Schedule. For this purpose, a reference to the Schedule becomes necessary. The Schedule to the NDPS Act gives a list of psychotropic substances. Entry Nos. 92 and 110 are relevant and they read as under:-

SL.No INTERNATIONAL NON-PROPRIETARY

NAMESOTHER NON-PROPRIETARY

NAMESChemical NAME

92 BUPRENORPHINE

21-cyclopropyl-7- [(S)-1 hydroxy-1,

2,2-trimethyl propyl]-6, 14-endo, ethano-6, 7, 8

14-tetrahydooripavine.

110 Salts and Preparations of above

Entry No. 110 was originally entry No 77. It was re-numbered as Entry No. 106 in 1992 and as Entry No. 110 with effect from 11th June, 2003. From a conjoint reading of Section 2(ixia) and the aforesaid Entry Nose 92 and 110 of the Schedule to the NDPS Act, it becomes clear that Buprenorphine Hydrochloride is not mentioned by name in the schedule and that it is only Buprenorphine which has been listed as a psychotropic substance. The next question to be answered is whether Buprenorphine Hydrochlorides a “salt or preparation” of Buprenorphine which is a psychotropic substance specified in the Schedule to the NDPS Act. The word “preparation” is defined under the NDPS Act in Section 2(ax) thereof as under:-

“2(ax) “Preparation” in relation to a narcotic drug or psychotropic substance, means any one or more such drugs or substances in dosage form or any solution or mixture, in whatever physical state, containing one or more such drugs or substances:

If Buprenorphine Hydrochloride were to be a preparation of Buprenorphine, in terms of the aforesaid definition, it would have to be in dosage form or any solution or mixture, in whatever physical state, containing Buprenorphine. Buprenorphine Hydrochloride, as admitted by all the counsel appearing in the matter, is neither a solution nor a mixture of Buprenorphine. In fact, it is an entirely different compound. Furthermore, it could also not be regarded as Buprenorphine is dosage form. Therefore, it is clear that Buprenorphine Hydrochloride cannot be regarded as a “preparation” of Buprenorphine. Consequently, I am left with the only alternative consideration and that is–whether Buprenorphine Hydrochloride is a “salt” of Buprenophine? If it is, then it would be a psychotropic substance within the meaning of Section 2(xxiii) as well as Entry 110 read with Entry 92 of the Schedule to the NDPS Act. For this purpose I had, during the course of hearing, sought clarifications from the Chemical Examiner with regard to the nature of Buprenorphine Hydrochloride. The letter dated 8th January, 2005 written by the Chemical Examiner Grade-II, Customs Laboratories, Customs House, Kandla, addressed to Mr Satish Aggarwal, Senior Special Pblic Prosecutor was placed before me. In that letter, it has been stated that Buprenorphine Hydrochloride is a salt of Buprenorphine. It was further indicated that Buprenorphine and its salts including Buprenorphine Hydrochloride give a positive test for Buprenorphine on testing. A similar letter by the same Chemical Examiner was written on 3rd of February, 2005 where he has again indicated as under:-

“In my opinion Buprenorphine Hydrochloride may be said to be a salt of Buprenorphine”.

A6. Thereafter, the Joint Director (Dr. Y.K.S. Rathore), Central Revenue Control Laboratory, Hill Side Road, Pusa, New Delhi by his letter dated 4th February, 2005 also confirmed that Buprenorphine Hydrochloride is a salt of Buprenorphine. Furthermore, four specific queries were raised by me during the course of arguments and they were as under:-

“1. Why is Buprenorphine dissolved in Hydrochloric Acid?

2. Why does Buprenorphine dissolve in Hydrochloric Acid and why not in water?

3. Whether the combination of Buprenorphine and Hydrochloric acid is a compound or a mixture? And

4. Can Buprenorphine hydrochloride be called a solution of Buprenorpohine salt?

In response to this, a letter dated 22nd February, 2005 by the Chemical Examiner, Central Revenue Control Laboratory, was placed before me. The answers were as under:-

“The point wise reply to above referred letter is as under:-

i) Why Buprenorphine is dissolved in Hydrochloride acid? (ii) Why Buprenorphine dissolves in Hydrochloride acid and why not in water?

Buprenorphine is nitrogen containing organic compound which is basic in nature. It dissolves in Hydrochloric acid being basic in nature and forms a salt with it. Usually organic basic compounds are insoluble in water or very slightly soluble in water.

iii) Whether the combination of Buprenorphine and Hydrochloric acid is a compound or a mixture.

The combination of Buprenorphine and Hydrochloric acid is a Chemical reaction (in animalcular proportion) forming Buprenorphine Hydrochloride which is a compound having molecular formula C29 H41 NO4, HCl1 and not a mixture.

iv) Can Buprenorphine Hydrochloride be called a solution of Buprenorphine salt?

Buprenorphine Hydrochloride cannot be called a solution of Buprenorphine, it is a salt of Buprenorphine which is white or almost white crystalline powder. From the aforesaid experts’ opinions, it can be safely concluded that Buprenorphine Hydrochloride is a salt of Buprenorphine. This being the case Buprenorphine Hydrochloride would be a “psychotropic substance” under the NDPS Act.

A7. The learned counsel appearing for the petitioners referred to some decisions to stress the point that Buprenorphine Hydrochloride was neither a “narcotic drug” nor a “psychotropic substance”. He firstly relied upon Deep Kumar v. State of Punjab (PandH): 1997 (2) Recent Criminal Reports 502 to submit that Buprenorphine Hydrochloride was not a psychotropic substance. Paragraph 13 of this decision of the Punjab and Haryana High Court reads as under:-

“13. Now we are left with parcels Nos. 1 and 6 which were found to contain Binorfin and Norphen injections. On an analysis each injection in parcel No.1 was found to contain 0.32 mg of Buprenorphine. The contents of parcel No.6, on analysis were found to contain 0.3 mg of Buprenorphine. This psychotropic substance does not fall within the ambit of Schedule I annexed to the Narcotic Drugs and Psychotropic Substances Rules, 1985, but is found to contain in Schedule III thereof. This substance, be ingot covered by Schedule I of the Rules, shall be governed by the Drugs Act and Rules framed hereunder. The quantity of Buprenorphine has been found within the permissible limit and the petitioners were possessed with a valid Drug License to keep and dispense such injections. Therefore, it cannot be said that the possession of Binorfin and Norphen injections was in contravention of section 22 of the Narcotic Act.”

This decision itself proceeds on the basis that it is a psychotropic substance. It is a different matter that, as no reference to buprenorphine was found in Schedule I to the NDPS Rules, the court held that it would be governed by the D and C Act and Rules. That is an aspect which I shall discuss in answer to question No.2. For the present, this much is clear that Buprenorphine Hydrochloride is a psychotropic substance within the meaning of the NDPS Act.

A8. The next case referred to by the counsel for the petitioners was the decision of a learned single judge of the Madras High Court in K.R. Nagappan v. State: 1996 (1) Crimes 502. In that case there was a recovery of 55 ampoules of 2 ml Tidigesic injections. Each ml whereof contained 0.3 mg Buprenorphine Hydrochloride. The appellant therein had been convicted for the offence under Section 8 read with section 21 of the NDPS Act. After examining the definitions of “opium” and “opium derivatie” in section 2 and section 2(xvi) of the NDPS Act as well as the Explanation appended to section 2 pertaining to the above definitions, the court held:-“A casual reading of the definitions given above in Section 2 of the NDPS Act, clinches the fact that such of the opium and opium derivatives containing not more than 0.2 per cent of morphine have been excluded from the narcotic and psychotropic substances. 0.2 per cent of morphine cannot be equated with the 0.3 mg of Buprenorphine found in each of the 55 ampoules which is conspicuously and manifestly far lesser than 0.2 per cent of morphine.” This decision also would be of no help to the petitioners. The allegation there was of the commission of an offence under section 21 of the NDPS Act which deals with “narcotic drugs”. In the present case the petitioners have all been prosecuted for allegedly committing offences under section 22 of the NDPS Act which relates to ‘psychotropic substances’. The definitions for narcotic drugs and psychotropic substances are entirely different. Therefore, the decision in K. R. Nagappan (supra) also cannot be pressed in aid of the petitioners’ submissions.

A9. Lastly, the learned counsel for the petitioners referred to the decision of a learned single judge of the Punjab and Haryana High Court in the case of Amtrak Singh v. The State of Punjab: 1996 (2) All India Criminal Law Reporter 714. This was a case where the petitioner having been found to be in possession of 35 bottles of PHENSEDYL (a cough medicine) of 125 ml each was being prosecuted for an offence under section 21 of the NDPS Act. The samples taken disclosed that every 5 ml of the medicine containe 9.5 mg of Codeine Phosphate. In this context the Court observed:-

“9. The learned State Counsel has argued that the preparation in question is being widely used for intoxicating purposes by students, teenagers and other addicts; that the petitioner was indulging in the sale of such drugs without prescription of the doctor to the addicts and he could not produce the purchase bill/cash memo and the license required for the sale of such item, and as such the petitioner is liable under section 21 of the Act.

10. The aforesaid argument of the learned State Counsel is misconceived. If the petitioner sells any drug to a person in contravention of license granted to him or that he fails to produce the bill/cash memo or the license for the sale of such item, he can be proceeded against under the provisions of the Drugs and Cosmetics Act, 1940 by the Drug Inspector in accordance with the provisions of the said Act. Section 21 of the Act in hand is not attracted for such violation or contravention.”

This case is clearly distinguishable on facts. In any event, like the decision in K. R. Nagappan (supra) this case also related to section 21 of the NDPS Act.

While on the subject of precedents, it must be noted that Buprenorphine Tidigesic injections have been held to be psychotropic substances by the Supreme Court in Hussein v. State of Kerala: 2000 (4) Crimes 144 (SC) [at 146].

Re: Question No.2:

A10. So, it is clear that buprenorphine hydrochloride is a psychotropic substance within the meaning of the NDPS Act. But, would that in itself make the possession, sale or tranportation of buprenorphine hydrochloride injections an offence under the NDPS Act, punishable under section 22 thereof? The answer is in the negative. In the context of section 21 of the NDPS Act which is an analogous provision in respect of “narcotic drugs”, the Supreme Court, in the case of Sajan Abraham v. State of Keral: . It is thus apparent that what is made punishable under Section 21 is possession, sale, purchase, etc. of the drugs and preparations mentioned therein in contravention of any provision of the Act or any rule or order made or condition of license grated there under. Obviously, therefore, if any rule permits a person to possess any psychotropic substance within the limits specified under the rule and subject to such conditions as the rule may prescribe, such a person cannot be held guilty of the offence under Section 21 of the Act if it is shown that his possession is not in contravention of such rule.”

This would apply equally to the offence punishable under section 22 of the NDPS Act in relation to psychotropic substances. This is clear as, in the case of Ouseph v. State of Kerala: , the

Supreme Court had observed that [at page 447]:-

“If it is a psychotropic substance, possession of it would become an offence only if it was in contravention of the Rules prescribed.” And, in Hussain v. State of Kerala: , the Supreme Court had already held that:-“If it was “psychotropic substance” possession of the same would amount to an offence only if it was in contravention of Section 8 of the Act. That section shows that no person shall possess any psychotropic substance except for medical or scientific purposes and in the manner and to the extent provided by the provisions of this Act or the Rules or orders made there under.”

Therefore, an examination of section 8 of the NDPS Act and the provisions of Chapter VII of the NDPS Rules is called for. Firstly, Section 8 of the NDPS Act reads as under:-

“8. Prohibition of certain operations.– No person shall–

(a) cultivate any coca plant or gather any portion of coca plant; or

(b) cultivate the opium poppy or any cannabis plant; or

(c) produce, manufacture, possess, sell, purchase, transport, warehouse, use, consume, import Interstate, export Interstate, import into India, export from India or transship any narcotic drug or psychotropic substance,

except for medical or scientific purposes and in the manner and to the extent provided by the provisions of this Act or the rules or orders made there under and in a case where any such provision, imposes any requirement by way of license, permit or authoisation also in accordance with the terms and conditions of such license, permit or authorisation:

Provided that, and subject to the other provisions of this Act and the rules made there under, the prohibition against the cultivation of the cannabis plant for the production of ganja or the production, possession, use, consumption, purchase, sale, transport, warehousing, import Interstate and export Interstate of ganja for any purpose other than medicinal and scientific purpose shall take effect only from the date which the Central Government may, by notification in the Official Gazette, specified in this behalf.

Provided further that nothing in this section shall apply to the export of poppy straw for decorative purposes”

Section 8, which is relevant for our purpose as it deals with psychotropic substances, prohibits the manufacture, possession, sale, use etc., of any psychotropic substance “except for medical or scientific purposes and in the manner and to the extent” provided by the provisions of the NDPS Act or NDPS Rules or orders made there under. This means that while there is a general prohibition against the manufacture, possession, sale, use etc., of a psychotropic substance, if the same is a medicine and is to be used for a medical purpose then the manner and extent of its manufacture, possession, sale, use shall be as provided in the NDPS Act or NDPS Rules or orders made there under. We must remember that buprenorphine hydrochloride I.P. is a Schedule Drug within the meaning of the D and C Act and Rules. Its manufacture, sale etc., is regulated by the DandC Act and DandC Rules. Coming back to the NDPS Act, I find that in the case of a medication, which also happens to be a psychotropic substance within threading of the NDPS Act, its “extent and manner” of use etc., would be governed by the other provisions of the NDPS Act or NDPS Rules.

A11. Section 9 of the NDPS Act empowers the Central Government to permit, control and regulate, inter alia, the manufacture, possession, sale, transportation of psychotropic substances. The NDPS Rules have been formulated by the Central Government in exercise of that power. Chapter VII of the NDPS Rules deals with “Psychotropic Substances”. Rules 64 to 67 fall under this Chapter VII. Rule 64 prescribes the general prohibition. It provides that —

“No person shall manufacture, possess, transport, import inter-state, export inter-state, sell, purchase, consume or use any of the psychotropic substances specified in Schedule I.” It is to be noted that this “Schedule I” is different to the Schedule to the NDPS Act. This Schedule I is appended to the NDPS Rules and is in two parts – (I) Narcotic Drugs and (II) Psychotropic Substances. We are concerned with psychotropic substances. There is a list of 33 specific psychotropic substances with entry no. 34 being “Salts and preparations of above”. It is significant to note that neither buprenorphine hydrochloride nor buprenorphine find mention in this list. This clearly means that Buprenorphine Hydrochloride is not included in Schedule I to the NDPS Rules and therefore the general prohibition contained in Rule 64 of the NDPS Rules does not apply to it2. Consequently, rules 65 to 67, which also have reference to psychotropic substances specified in the said Schedule I, would also not be applicable in respect of Buprenorphine Hydrochoride3. In this connection, it is pertinent to point out that there are several psychotropic substances which find place both in the schedule to the NDPS Act and in Schedule I to the NDPS Rules. For example: Methaqualone4, Delorazepam5, Ketazolam6, Loprzolam7, Pipradrol8, Tetrazepam9. At the same time, there are others like Buprenorphine10, Amphetamine11, Bromazepam12, Lorazepam13, Phenobarbital14 and Pemoline15 which, though specified in the Schedule to the NDPS Act, do not find mention in Schedule to the NDPS Rules. Clearly, by conscious design, all psychotropic substances mentioned in the schedule to the NDPS Act have not been listed in Schedule I to the Rules. The prohibition contained in Rule 64 of the NDPS Rules applies only to those psychotropic substances which are specified in Schedule I to the NDPS Rules. In other words, the prohibition of Rule 64 of the NDPS Rules is not applicable to those psychotropic substances, which, although they are listed in the Schedule to the NDPS Act, are not part of the listed psychotropic substances in Schedule I to the NDPS Rules. It may be mentioned here that the Supreme Court, in the afore-mentioned decisions16, was not called upon to examine this aspect of the matter, namely, whether Rule 66 of the NPS Rules applied to all psychotropic substances or only those specified in Schedule I to the NDPS Rules. It is, therefore, open to this Court to consider and decide this aspect of the matter.

Rule 65(1), inter alia, provides that the manufacture of any psychotropic substance other than those specified in Schedule I shall be in accordance with the conditions of license granted under the DandC Rules and DandC Act. In other words, insofar as the psychotropic substances not mentioned in Schedule I to the NDPS Rules but mentioned in the Schedule to the NDPS Act are concerned, their manufacture shall be governed by the DandC Act and Rules and not by the NDPS Act or NDPS Rules. Rule 66 relates to possession etc., of psychotropic substances. Sub-Rule (1) thereof provides that no person shall possess “any psychotropic substance” for any of the purposes covered by the DandC Rules, unless he is lawfully authorised to possess such substance for any of the said purposes under the NDPS Rules. The expression “any psychotropic substance” obviously has reference to those listed in Schedule I to the NDPS Rules. Rule 64 is the governing rule in Chapter VII of the NDPS Rules. When a psychotropic substance des not find mention in Schedule I to the NDPS Rules, the prohibition qua possession contained in Rule 64 does not apply. That being the case, in respect of such a psychotropic substance, Rule 66 would also not apply as it has reference to only those psychotropic substances which are included in Schedule I to the NDPS Rules. Rule 67 of the NDPS Rules relates to transport of psychotropic substances. It is expressly subject to the provisions of Rule 64 and clearly has reference to the transport, import inter-state or export inter-state of those psychotropic substances which are included in Schedule I to the NDPS Rules. The rule would have no applicability in respect of those psychotropic substances which are not to be found in Schedule I to the NDPS Rule. Clearly, then, inasmuch as Buprenorphine Hydrochloride is not included in Schedule I to the NDPS Rules, its manufacture, possession, sale, transport would neither be prohibited nor regulated by the NDPS Rules and consequently by the NDPS Act. It being Schedule H drug would fall within the rigours of the DandC Act and Rules.

Re: “Small quantity”, “Commercial quantity”

A12. For the sake of completeness, another aspect of the matter which, although academic in the context of the answer to question 2 above, requires some clarification (before I discuss the individual merits of each of the applicants) is with regard to the status of “small quantity” and “commercial quantity”. These expressions are defined under Sections 2 and 2(vii-a) of the NDPS Act, which read as under:-(xxiii-a) “small quantity”, in relation to narcotic drugs and psychotropic substances, means any quantity lesser than the quantity specified by the Central Government by notification in the Official Gazette.”

(vii-a) “commercial quantity” in relation to narcotic drugs and psychotropic substances, means any quantity greater than the quantity specified by the Central Government by notification in the Official Gazette.”

By a Notification dated 19th October, 2001 the Central Government specified the “small quantity” and “commercial quantity” of each of the Narcotics Drugs/Psychotropic substances listed therein. In the table appended to the said Notification, at Entry No. 169, Buprenorphine has been specified and the small quantity has been mentioned as 1 gram whereas the commercial quantity has been specified as 20 grams. However, there is no specific mention of Buprenorphine Hydrochloride. The said Entryo.169 and Entry 239, which, apparently, is a residual entry, read as:-

Sl.No Name of Narcotic Drug and Psychotropic Substance [International

non-proprietary name (INN)]Other non-

proprietary name Chemical Name Small

quantity(in gm.)

Commercial Quantity(In gm./kg.)

1 169 Buprenorphine

21-cyclopropyl-7- alpha-[(S)-1 hydroxy-1,2

2-trimethyl”propyl]-6, 14-endo, ethano-6, 7,

8,14-tetrahydooripavine

3. 20gm

Any mixture or preparation that of with or without a neutral material, of any of the above drugs.

Lesser of the small quantity between the quantities given against the respective narcotic drugs or psychotropic substances mentioned above forming part of the mixture.

Lesser of the commercial quantity between the quantities given against the respective narcotic drugs or psychotropic substances mentioned above forming part of the mixture.”Note 1 to the said table reads as under:-“Note.-(1)The small quantity and the commercial quantity given against the respective drugs listed above apply to isomers, within specific Chemical designation, the esters, ethers and salts of these drugs, including salts of esters, ethers and isomers, whenever existence of such substance is possible.” Upon a collective reading of the said Note 1, entry 239 and entry 169 of the said table it becomes clear that the small quantity for Buprenorphine Hydrochloride is also 1 gram and the commercial quantity is 20 grams as in the case of Buprenorphine, of which it is a salt.

A13. Finally, it must be noted that Buprenorphine Hydrochloride I.P. is also a medication and is used as a pain reliever. Recently it is also being used to treat opiate addiction (such as addiction to heroin). It has legitimate uses as an analgesic and for de-addiction. However, it is also capable of misuse being a psychotropic substance. Perhaps because of this reason, it was left out of Schedule I to the NDPS Act but is very much regulated under the DandC Act and Rules.

This concludes the discussion on the common issues. I shall now take up each application for grant of bail.

Bail Application No. 73/2005Rajinder Gupta (Petitioner)

B1. The petitioner is a partner in the firm known as M/s. A.D.S. Associates. The allegation against the petitioner is that he, as a partner of the said firm sold 2,61,000 ampoules of Buprenorphine Hydrochloride Injections under the brand name Bunogesic which he had allegedly received from M/s Pharma Deal Agencies, 487/35, National Market, New Delhi. It is further alleged that the petitioner had not maintained any record by way of consignment Form-6, as required under Rules 66 and 67 of the NDPS Rulesn respect of sales of the aforesaid quantity of ampoules of injections. Accordingly, it is alleged that the petitioner has contravened the provisions of Section 8(c) of the NDPS Act which is an offence punishable under Section 22(c) of the NDPS Act. Te petitioner was arrested on 13.10.2004 and is in judicial custody since then. No recovery of the said Buprenorphine Hydrochloride Injections was, however, made from the petitioner. According to the petitioner these injections are covered under Schedul “H” of the Drugs and Cosmetics Rules, 1945. The petitioner also contends that these Buprenorphine Hydrochloride Injections conform to the standard laid down by the Indian Pharmacopoeia. The petitioner also contends that the said ampoules were labeled in accordance with Rule 97 of the Drugs and Cosmetics Rules, 1945 and bore the symbol “Rx”17 on the top left corner of the label. They also contained the usual Schedule ‘H’ drug warning as under:-

“Schedule H drug” Warning: To be sold by retail on the prescription on a Registered Medical Practitioner only.”

B2. The petitioner further submitted that all purchase and supplies have been made through proper documents, as required in the normal course of business. It is further contended that the petitioner has a drug license under the Drugs and Cosmetics Act and Rules. The license bears No. DL-2(2380) 20B and 21B. The license in Form 20B is issued under Rule 61(1) of the Drugs and Cosmetics Rules, 1945 whereas the license in Form 21B is issued under Rule 61(2) of the Drugs and Cosmetics Rules, 1945. Copies these licenses have been filed at pages 17 and 18 of the paper book and they clearly indicate that the Firm ADS Associates is licensed to sell, stock or exhibit or offer sale or distribute by wholesale the drugs specified therein. Schedule “H” drus have not been excluded and, therefore, according to the petitioner the said Firm had a license to deal in and sell the said Buprenorphine Hydrochloride Injections. The said injections bearing the branded name “Bunogesic” were of 2 ml each. And, ech ml thereof contained Buprenorphine Hydrochloride IP equivalent to Buprenorphine Hydrochloride 0.3 mg and water for injection. These injections were manufactured by Rusan Health Care Private Limited which is a licensed manufacturer. It is further dated that the said Rusan Health Care Private Limited had informed the petitioner firm on 21.10.2004 that they had deleted their product under the name “Bunogesic” and requested the petitioner firm to return the unsold stock lying with them. It is sated that the petitioner thereafter never dealt with the said product of the said manufacturer. It is further stated that the petitioner is a bona fide licensed trader and has an absolutely clean and un-blemished record. He is authorised to sell and dal in Schedule “H” medicines which includes Buprenorphine Hydrochloride IP injections.

B3. The allegation against the petitioner is that he contravened Rules 66 and 67 of the NDPS Rules and thereby contravened section 8(c) of the NDPS Act and, as a result thereof, became liable for punishment under section 22(c) of the NDPS Act. As indicated above, Buprenorphine Hydrochloride is a Schedule H drug under the DandC Act and Rules and, though it is a psychotropic substance under the NDPS Act, it is not included in Schedule I to the NDPS Rules. That being the case, its manufacture, possession osale is not prohibited. As such, there is no contravention of the provisions of the NDPS Rules. Consequently, the offence under section 8 of the NDPS Act is not made out. Obviously, punishment under section 22 of the NDPS Act is also not attracted.

B4. Clearly, in these circumstances as no offence under the NDPS Act is made out, the petitioner would be entitled to bail. Accordingly, he is directed to be released on bail on furnishing a personal bond in the sum of Rs. 25,000/- with one surety of thelike amount to the satisfaction of the concerned trial court.

Bail Application 53/2005 Mohd. Shehber Khan (petitioner)

C1.In this case the petitioner is in custody since 13.10.2003 in respect of having allegedly committed offences punishable under section 22 and 29 of the NDPS Act. The allegations against him are that he was in conspiracy with one Raj Kumar Arora in the sale of Buprenorphine Hydrochloride IP injections and that from the premises of Raj Kumar Arora, 40,001 Buprenorphine Hydrochloride injections were recovered. No recovery was affected from the petitioner of any kind. The recovered drug, according the petitioner, is covered by the Indian Pharmacopoeia and is a Schedule-H Drug under the Drugs and Cosmetics Rules, 1945. It is stated by the petitioner that the co-accused Devang Bipin Parikh has already been granted bail by an order dated 11.1.2005.

In the complaint, it is stated that the premises of one Raj Kumar, proprietor of Kanishka Cargo Service was searched and a recovery of 25 corrugated card board cartons was made there from. These cartons were said to contain glass ampoules containing transparent water coloured liquid. Apart from the above, it is alleged that the officers also recovered a single ampoule apparently of the same size and shape as the unlabelled ampoules recovered from 25 cartons and also having similar single red coloured rang marking round the neck of the ampoule containing apparently similar transparent water coloured liquid and having a label with the following description:-Rx 2 ml.

BUPRENORPHINE HYDROCHLORIDE INJECTION I.P.

BUPRIGESICNEON LABORAtorIES LIMITED Mfg. Lic No. 752B. No. 19559

995 printed paper sheets were also found lying on the side of the table and each sheet contained the following description:-Rx 2 ml.

BUPRENORPHINE HYDROCHLORIDE INJECTION IPBUPRIGESICNEON LABORAtorIES LIMITED Mfg. Lic. No. 752B.No.

It is alleged that the said Raj Kumar Arora could not produce any authorisation for possession of the unlabelled glass ampoules.

C2. Nothing was recovered from the petitioner. Furthermore, the entire allegation is with regard to the alleged recovery of Buprenorphine Hydrochloride made from one Raj Kumar Arora. It has already been indicated above that Buprenorphine Hydrochloride is a Schedule H drug under the DandC Act and Rules and, though a psychotropic substance under the NDPS Act, it is not included in Schedule I to the NDPS Rules. That being the case, its manufacture, possession or sale is not prohibited. As such, there is contravention of the provisions of the NDPS Rules. Consequently, the offence under section 8 of the NDPS Act is not made out. Obviously, punishments under sections 22 or 29 of the NDPS Act are also not attracted.

C3. In these circumstances, as no offence under the NDPS Act is made out, the petitioner would be entitled to bail. Accordingly, he is directed to be released on bail on furnishing a personal bond in the sum of Rs. 25,000/- with one surety of the like amount to the satisfaction of the concerned trial court.

Bail Application 64/2005 Vijay Kumar Mittal (Petitioner)

FIR No. 79/2004 dated 13/10/2004under sections 22, 29 NDPS Act, 1985P.S. Narcotics Branch

D1. The case for the prosecution is that a secret information was received in which it was alleged that one Mahesh and one Surinder were going to purchase a huge quantity of Buprenorphine from the petitioner without bill and were further going to sell the same to the retailers and small chemists etc. A raid was allegedly conducted and 2325 ampoules of Buprenorphine Hydrochloride “Bunogesic” and 3950 ampoules of Buprenorphine Hydrochloride were allegedly recovered from Mahesh and Surinder respectively. It is alleged that 3950 ampoules which were recovered were purchased from the petitioner and each of these ampoules contained 2 ml. of psychotropic substance. The other 2325 ampoules were alleged to have been purchased from one Mr Jain. On the bass of the disclosure statements of Mahesh and Surinder, the present petitioner (Vijay Kumar Mittal) was arrested on 14.10.2004 for allegedly selling the injections without bill to these two persons. It is stated that the petitioner is an income tax payer and carries on business of sale and purchase of medicines under the trade name of “Mittal Medical Agency”. The petitioner holds a valid license No. 26 (1102) 20B and 21B which was issued on 29.12.1999 and the said license has been renewed up to 31.12.2007. The said firm is authorised under the license to sell, stock or exhibit or offer for sale or distribute by wholesale Buprenorphine Hydrochloride Drug in addition to other drugs permitted there from. It is stated that the charge-sheet has been field in this case and the petitioner has been arrested solely on the basis of disclosure statements made by Mahesh and Surinder. It is the petitioner’s contention that no drug of any kind has been sold by the petitioner to the said Mahesh or Surinder and the case is entirely false and fabricated. It is further contended that 3950 ampules are alleged to be related to the petitioner. Each ampoule contains 2 ml. And, therefore, the total quantity comes to 7900 ml. The Buprenorphine Hydrochloride contained in each ml. is 0.3 mg (or 0.0003 gm). Therefore, the total content in respect of these 3950 ampules would come to 7900 x 0.0003 = 2.37 gms which is far below the commercial quantity of 20 gms.

D2. I have already held that Buprenorphine Hydrochloride is beyond the pale of Chapter VII of the NDPS Rules and therefore, it being a Schedule H drug under the DandC Act and Rules, the offence under section 8 is not made out. Consequently, punishments under section 22 or 29 of the NDPS Act would not be attracted. Additionally, the petitioner is being roped in only on the basis of disclosure statements of the said Mahesh and Surinder. As indicated in Manoj Kumar Gupta v. State N.C.T. Of Delhi: 2003 [1] JC 205, the disclosure statement of a co-accused is not substantive evidence. Furthermore, assuming that an offence under the NDPS Act was, prima facie, made out, the quantity linked to the present petitioner is only 2.37 gm, much lower than the commercil quantity of 20 gm. Accordingly, even in this assumed scenario, the rigours of section 37 of the NDPS Act would not apply.

D3. In view of all these circumstances the petitioner would be entitled to bail. Accordingly, he is directed to be released on bail on furnishing a personal bond in the sum of Rs. 25,000/- with one surety of the like amount to the satisfaction of the concerned trial court.

Bail Application 2062/2005 Sawinder Singh Kohli (Petitioner)

E1.The petitioner is alleged to have committed offences punishable under sections 22, 23, 28 and 29 of the NDPS Act. It is alleged that on 9.5.2004, the petitioner was going to Tehran via Dubai on Flight No. EK-513. It is further alleged that he was stopped at the departure hall of IGI Airport, New Delhi and 1091 ampoules of 2 ml. each of Buprenorphine Hydrochloride Injection IP under the printed name of Buprenorphine Hydrochloride are alleged to have been recovered from him. It is further alleged that the customs officer recovered a further 6144 ampoules of Buprigesic from flat No. WP-207A Pitampura, Delhi, which belongs to the brother-in-law of the petitioner.

E2. The petitioner is aged about 70 years and is said to be suffering from heart problems. It is further contended that he was taking treatment in Iran and is undergoing such treatment now in Tihar Jail. Only 1091 ampoules of Buprenorphine Hydrochlorideare alleged to have been recovered from the petitioner. Therefore, taking the content of each 2ml ampoule (as per the complaint itself) to be 0.6 mg of Buprenorphine Hydrochloride, the recovery from the petitioner is only of 1091 x 0.6 = 658.2 mg or 0.6.82 gm of Buprenorphine Hydrochloride which amount is even smaller than the specified small quantity of 1 gm. Moreover, even if all the ampoules are taken to be recovery from the petitioner they would total to 7235 ampoules of 2 ml. each. That would tranlate to a content of only 4.341 gms of Buprenorphine Hydrochloride and not 14.5 kg as erroneously calculated by the learned Additional Sessions Judge in his order dated 7.8.2004 whereby the petitioner’s bail application was rejected. Even this quantity is far below the commercial quantity of 20 gm.

E3. I have already held that Buprenorphine Hydrochloride is beyond the pale of Chapter VII of the NDPS Rules and therefore, it being a Schedule H drug under the DandC Act and Rules, the offence under section 8 is not made out. Consequently, punishments under section 22, 23, 28 or 29 of the NDPS Act would not be attracted. Furthermore, assuming that an offence under the NDPS Act was, prima facie, made out, the quantity linked to the present petitioner is only 4.341 gm, much lower than the commercial quantity of 20 gm. Accordingly, even in this assumed scenario, the rigours of section 37 of the NDPS Act would not apply.

E4. In view of all these circumstances the petitioner would be entitled to bail. Accordingly, he is directed to be released on bail on furnishing a personal bond in the sum of Rs. 25,000/- with one surety of the like amount to the satisfaction of the concerned trial court.

Bail Application 115/2005 Amit Dawar (Petitioner)FIR No. 86/2003 dated 3/10/2003under sections 22, 29 NDPS Act P.S. Narcotics Bureau

F1. The case of the prosecution is that on 21.7.2003 the premises of M/s Gill Sandhu, Haryana Transport Com. At 3902 Mori Gate, Delhi was searched and 40 Cartons of “Norphin” (Buprenorphine Hydrochloride) injections purported to have been manufactured by M/s Unichem Laboratories Ltd. are said to have been recovered. It is alleged that the Manager of the said Transport Company informed the Drug Inspector that the said “Norphin” injections were booked for Delhi in their Chandigarh Branch and no caimant came forward to receive the consignment of the above said injections. Samples of the said “Norphin” injections were sent by the Drug Inspector to the manufacturer Co. i.e. Unichem Laboratories Ltd. which confirmed that it was their product was of standard quality. On 1.8.2003, it is alleged, the proprietor of Surya Pharmaceutical, Jalandhar claimed the consignment of the said “Norphin” injections and submitted the purchase bill issued from M/s Laxmi Medical Hall, Chandigarh. On 1.10.2003 one Pravin Kumar alias Sonu proprietor of Surya Pharmaceuticals was arrested and he allegedly made a disclosure statement alleging therein that the present petitioner (Amit Dawar) was the financer of the said consignment of Buprenorphine Hydrohloride injections. On the basis of this disclosure statement, the petitioner was arrested on 12.10.2003. No recovery was made from the present petitioner Amit Dawar and it is the petitioner’s case that at the maximum even if the entire prosecution caswere to be believed, only the commission of an offence punishable under Section 27 of the Drug and Cosmetics Act, 1940 is made out and that the maximum imprisonment therefore is three years imprisonment and the same is friable by the Court of the Metroplitan Magistrate.

F2. I have already held that Buprenorphine Hydrochloride is beyond the pale of Chapter VII of the NDPS Rules and therefore, it being a Schedule H drug under the DandC Act and Rules, the offence under section 8 is not made out. Consequently, punishments under section 22 or 29 of the NDPS Act would not be attracted. Nothing was recovered from the petitioner. And, the petitioner is being roped in only on the basis of an alleged disclosure statement of the said Pravin Kumar alias Sonu proprietor of Surya Phamaceuticals. As indicated in Manoj Kumar Gupta v. State N.C.T. Of Delhi: 2003 [1] JCC 205, the disclosure statement of a co-accused is not substantive evidence.

F3. In view of all these circumstances the petitioner would be entitled to bail. Accordingly, he is directed to be released on bail on furnishing a personal bond in the sum of Rs. 25,000/- with one surety of the like amount to the satisfaction of the concerned trial court.

Bail Application 205/2005 Raj Kumar Arora (petitioner)

G1. The petitioner is alleged to have contravened Rule 66 of the NDPS Rules and thereby committed offences punishable under sections 22 and 29 of the NDPS Act. The petitioner states that he is a licensed Customs Clearing House Agent and is a proprietor of M/s Kanishka Cargo Services having its office at 198, Office Complex, Jhandewalan Cycle Market, New Delhi. The case of the prosecution is that a raid was conducted on the office premises of the petitioner on 27/28.9.2003 and alleged recovery of 40,001glass ampoules containing water coloured liquid preparation suspected to be injectable preparation of Buprenorphine Hydrochloride is said to have been recovered. The petitioner was arrested on 27/28.9.2003 and has been in judicial custody since then. The petitioner states that he is not a beneficiary, manufacturer or seller of the medicinal drugs and is only a licensed Customs House Agent. The petitioner was handling consignments of its clients including M/s Sarvodaya Enterprises which is owned by c-accused Devang Bipin Parikh who has been granted bail by this Court on 11.1.2005. Various medical consignments have been cleared from Customs by the petitioner on behalf of the said client for export as well as import.

G2. As indicated above, Buprenorphine Hydrochloride is beyond the pale of Chapter VII of the NDPS Rules and therefore, it being a Schedule H drug under the DandC Act and Rules, the offence under section 8 is not made out. Consequently, punishments under section 22 or 29 of the NDPS Act would not be attracted. Moreover, the petitioner was only a Customs House Agent who cleared medical consignments on behalf of his clients.

G3. In view of all these circumstances the petitioner would be entitled to bail. Accordingly, he is directed to be released on bail on furnishing a personal bond in the sum of Rs. 25,000/- with one surety of the like amount to the satisfaction of the concerned trial court.

H1. It is made clear that all observations made in this order, whether common to all the applications or specific to each of the applicants, are only prima facie in nature. They are only for the purposes of consideration of the aforementioned bail applications and are not to be regarded at the time of trial of the respective cases.

All the applications stand disposed of.

 

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Life Saving Drugs in India

 

(1) Where a cosmetic or a drug other than life saving drug, as the case may be, contains ingredients of non- vegetarian origin, the package shall carry label bearing the following symbol in red colour on the principal display panel just close a proximity to name or brand name of the drug or cosmetic:-

(2) Where a cosmetic or a drug other than life saving drug, as the case may be, contains ingredients wholly of vegetarian origin, the package shall bear the following symbol in green colour on the principal display panel just close in proximity to name or brand name of the drug or cosmetic:-

(3) Where a cosmetic or a drug other than life saving drug has ingredients of vegetarian of non- vegetarian origin, a declaration shall be made in writing on the package indicating the nature of the origin of the product.

(4) The Director General of Health Services/Drugs Controller General, Government of India, shall issue a list of Life Saving Drugs within a period of two months.”

 

 

 

 

 

IN THE SUPREME COURT OF INDIA

CIVIL APPELLATE JURISDICTION

CIVIL APPEAL NO. 5644 OF 2003

INDIAN SOAPS & TOILETRIES MAKERS

ASSOCIATION …. APPELLANT

Versus

OZAIR HUSAIN AND OTHERS .… RESPONDENTS

WITH

CIVIL APPEAL NO. 5645 OF 2003

UNION OF INDIA AND ANOTHER …. APPELLANTS

Versus

OZAIR HUSAIN .… RESPONDENT

J U D G M E N T

SUDHANSU JYOTI MUKHOPADHAYA, J.

These appeals have been preferred by the appellants against the judgment dated 13th November, 2002 passed by the Division Bench of the Delhi High Court in a Public Interest Litigation (Civil Writ Petition No.837 of 2001) whereby the High Court held that the consumer has the fundamental right to know whether the food products, cosmetics and drugs available for human consumption are of non-vegetarian or vegetarian origin and ordered as follows:

"In so far as cosmetics are concerned, the same must be treated at par with articles/packages of food for the purpose of disclosure of their ingredients.

Till such time the requisite amendments are carried out, we direct as under:-

(1) Where a cosmetic or a drug other than life saving drug, as the case may be, contains ingredients of non- vegetarian origin, the package shall carry label bearing the following symbol in red colour on the principal display panel just close a proximity to name or brand name of the drug or cosmetic:-

(2) Where a cosmetic or a drug other than life saving drug, as the case may be, contains ingredients wholly of vegetarian origin, the package shall bear the following symbol in green colour on the principal display panel just close in proximity to name or brand name of the drug or cosmetic:-

(3) Where a cosmetic or a drug other than life saving drug has ingredients of vegetarian of non- vegetarian origin, a declaration shall be made in writing on the package indicating the nature of the origin of the product.

(4) The Director General of Health Services/Drugs Controller General, Government of India, shall issue a list of Life Saving Drugs within a period of two months.”

2. The Public Interest Litigation was filed by the respondent claiming the right of a consumer of cosmetics, drugs and articles of food to the full disclosure of ingredients of such product whereby a clear indication as to its origin (vegetarian/non-vegetarian) is made. The High Court referring to the constitutional rights guaranteed under Articles 19(1)(a), Articles 21 and 25 of the Constitution of India held:

“…………..It seems to us that to enable a person to practise the beliefs and opinions which he holds, in a meaningful manner, it is essential for him to receive the relevant information, otherwise he maybe prevented from acting in consonance with his beliefs and opinions. In case a vegetarian consumer does not know the ingredients of cosmetics, drugs or food products which he/she wishes to buy, it will be difficult for him or her to practise vegetarianism. In the aforesaid context, freedom of expression enshrined in Article 19(1)(a) can serve two broad purposes – (1) it can help the consumer to discover the truth about the composition of the products, whether made of animals including birds and fresh water or marine animals or eggs, and (2) it can held him to fulfil his belief or opinion in vegetarianism.”

“…..In this view of the matter, we have no hesitation in holding that Article 21 grants freedom to an individual to follow and to stick to his opinions, and for pursuing such a course he had right to receive information and also a right to know the ingredients or the constituents of cosmetics, drugs and food products.”

“……In view of the aforesaid discussion, we are of the view that it is the fundamental right of the consumers to know whether the food products, cosmetics and drugs are of non- vegetarian or vegetarian origin, as otherwise it will violate their fundamental rights under Articles 19(1)(a), 21 and 25 of the Constitution. Accordingly, we answer the main question in the affirmative. Since there is a constitutionally guaranteed right of the consumers to the full disclosure of the ingredients of cosmetics, drugs and articles of food, answers to remaining questions (ii) and (iii) necessarily are required to be answered in the affirmative. We, accordingly, answer the questions (ii) and (iii) also in the affirmative……”

“……In so far as food products are concerned, adequate provisions have been made for informing the consumers as to whether or not the article of food is vegetarian or non- vegetarian. As regards drugs and cosmetics, necessary amendments have not been made in the relevant statutes. In so far as life saving drug is concerned, there is a view point that the information: whether or not it is derived or manufactured, wholly or partly, from an animal, should not be disclosed since it is meant to fight disease and save life. In other words, a patient, who is suffering from serious ailment, which can be fatal if a life saving drug is not administered to him, need not be informed in his own interest as to whether or not the drug contains part of any animal as it is conductive to preservation of life and, therefore, in tune with Article 21 of the Constitution, this also means that he should not have a choice in the matter of administering life saving drug to him. In many cases patients are unconscious and they have to be put on life saving drugs. In any event they cannot exercise an informed choice in the matter of selection of drugs. In the circumstances, therefore, the aforesaid view must prevail in case of life saving drugs. This limited exception will apply only to life saving drugs. It needs to be clarified that all drugs do not qualify for being treated as life saving drugs. Drugs which are not life saving drugs must stand at part with the food products and must disclose whether or not they are made of animal, whether in whole or in part.

"In so far as cosmetics are concerned, the same must be treated at par with articles/packages of food for the purpose of disclosure of their ingredients.”

3. The appellant Union of India is afraid of serious paradox in so far as drugs are concerned. According to the learned senior counsel, it is not possible to distinguish as to which drug is a ‘Life Saving Drug’ or otherwise; under a given circumstance and condition of patient, a drug which ordinarily may not be treated as a ‘Life Saving Drug’, can be used as a Life Saving Drug. In some other case it may be general. Thus, it is not possible to demarcate the drugs as life saving or otherwise. Therefore, the direction issued by the High Court to the extent it requires Union of India to prepare a list of Life Saving Drugs would neither be appropriate nor proper, particularly when there is no definition of ‘Life Saving Drug’ in pharmacology of the modern system of medicines.

4. It was further contended that every drug is considered to be useful in either saving or prolong the life by curing, mitigating or preventing diseases. Given that every disease has the eventuality of taking life if not properly treated in time, the identification of ‘Life Saving Drug’ will depend upon identification of different situations when they are required.

5. Further, according to the learned counsel for the Union of India, the direction of the High Court for affixing Red Label which is symbolic of danger on drugs and cosmetics is inappropriate particularly when a Cosmetics Sectional Committee had recommended the use of ‘Brown’ colour for labelling certain cosmetic products. He also placed reliance on the report submitted by the ‘Drug Technical Advisory Committee’ constituted under Section 5 of the Drugs and Cosmetics Act wherein the reason was shown for not providing any identification as to ‘ingredient of non-vegetarian origin’.

6. Learned counsel appearing on behalf of the appellant-Indian Soaps & Toiletries Makers Association (hereinafter referred to as the ‘Association’) submitted that it is neither practicable nor desirable to give any identification as to ingredients of ‘vegetarian’ or ‘non- vegetarian’ origin. It has no relevancy as the use of cosmetics has nothing to do with the vegetarian or non- vegetarian origin ingredients; they are not ‘food products’ and are not meant for ingestion. It was submitted that it is difficult to identify the origin of non-vegetarian ingredients, as it is very difficult to know the basic source from which such ingredient is derived.

7. The following arguments were also advanced on behalf of the Association:

(a)Unlike food items, generally cosmetic items are not ingestible. Every single dictionary definition of words “vegetarian” “non- vegetarian” relate to food or the act of eating. Therefore, the sentimental feeling that is brought upon by the consumers for any edible items are not applicable to cosmetic items. The rationale, i.e. emotional, religious, cultural, sentimental, health values which necessitate different treatment in terms of vegetarian and non-vegetarian for food items coming from animal and non-animal sources respectively does not hold good for cosmetic items (i) on account of its external application and (ii) on account of long held and general awareness amongst consumers about cosmetic composition.

b) Unlike the food industry where the processing of food takes place near to the primary produce or a step away from the primary produce center and not many intermediary stages are involved before the final food item is packed for consumption, cosmetic industry is far removed from the stage of raw material sources. Cosmetics are manufactured from a significantly large number of raw materials which in turn contain composite ingredients while food items are manufactured generally from 4 to 5 basic raw materials.

c) Unlike food items where the analysis mechanism is reasonably established through PFA Act ad Rules, the analysis of cosmetic products by its sheer complexity is difficult, which difficulty gets compounded on account of non-availability of technology, large number of ingredients coming in from different sources. In the absence of such technology being available the requirement of indicating symbols on labels would be impractical and would lead to chaos and confusion in as much as cosmetics with animal origin ingredients would carry vegetarian symbol or vice versa, and thus it will defeat the very purpose for which such requirement is intended.

d) Unlike food products which are normally manufactured and consumed in India, barring a few exceptions, the cosmetic industry competes with international products both in terms of import as well as exports and consequently, requiring the industry to put such a label without any technology being available for making such distinction would not only add enormous cost on the industry but also place the Petitioners members at disadvantage in competing with international cosmetic products. Such labelling without any technology for analysis is also likely to be challenged against the Petitioner’s members who instead of promoting and encouraging exports from India would be left with fighting legal battles at enormous cost and at the cost of foreign exchange.

8. According to the appellant-Association, the High Court failed to appreciate that cosmetic formulation is complex in nature as compared to drugs or the food products. The appellant-Association relied on following facts to justify their finding:

(1) There are as many as 66 dosage forms in cosmetic formulations as listed in one of the standard reference books- The Chemistry & Manufacture of Cosmetics by Maison deNavaree, Allured Publishing.

2) Schedule S of Drugs & Cosmetics Act recognizes 29 of such types of cosmetics.

3) Each type of formulation has wide choice of 12,000 ingredients approved by CTFA or INCI directory of ingredients and are safe for use in cosmetic products. Ref.: CTFA on-line web site.

4) In fact, some of the INCI ingredients are mixture of ingredients in various proportions of similar compounds. For example, commonly used CARBOMER is a homopolymer of acrylic acid cross linked with allyl ether of pentaerythritol, allyl ether of sucrose or allyl ether of propylene. It has 7 different technical names based on different grades, 32 trade names and 7 trade name mixtures.

5) Mostly a perfume is component of cosmetic preparation. The perfumes are proprietary formula by itself and are mixture of several ingredients. Each ingredient of perfume could be synthetic, natural or animal in origin. Example – Musk perfume is trade secret composition. It may contain any number of ingredients coming from any source as synthetic, natural or animal origin. Generally perfume contains 10-100 different ingredients.

6) All of these ingredients are purified several times to reach the acceptable form as required by INCI requirements. At this stage it is at least 4th or 10th step of purification, wherein original starting material can not be traced back to even ppb level. Example – Fatty acid based surfactants from plant origin or purely synthetic or animal origin.

7) In case of food and drug related formulae, there is list of limited excipients or additives. In case of drug formulae, mostly the excipients are only a few and are published monographs in official pharmacopoeia. In case of food, the formulae are simple and contain very few ingredients being declared on the pack. So the origin is very easy to verify.

8) Cosmetic formulae are far more complex to drug formulae. The source of thousands of ingredients being used in multiples of combination in the cosmetic formulae, make the task extremely difficult to check and certify the origin of ingredients used.

9. It was also contended that the power of determination of labelling requirements including their contents is vested with the Union of India’s authorities such as the Drug Technical Advisory Board. In such case the High court ought not to have given a finding to provide certain mark on the labelling of the drugs and cosmetics based on vegetarian or non-vegetarian origin.

10. Learned counsel appearing on behalf of the respondent submitted that almost 60% of the population in India is vegetarian, over 50% of it is illiterate and over 90% public cannot read English. The Public Interest Litigation for disclosure of the ingredients of the products was filed to safeguard the interest of such innocent consumers and to ensure that such products bear an easily recognizable symbol to know whether it has any animal ingredient. The consumers have a right of informed choice between the products made or derived from vegetarian and those made or derived from non-vegetarian ingredients.

11. The questions involved in this case are:

(i) Whether under Article 226 of the Constitution of India the High Court has jurisdiction to direct the manufacturers of drugs and cosmetics to display a particular symbol in their packages to identify the ingredients of ‘ non- vegetarian’ or ‘ vegetarian’ origin; and

(ii) Whether it is practicable and desirable to display any identification as to the origin of the non-vegetarian ingredients in the packages of drugs and cosmetics.

12. Before discussing the relevant provisions of the Drugs and Cosmetics Act, 1940 and the Rules framed thereunder, it is relevant to notice that with a view to prevent adulteration of food stuff and bringing uniformity of laws in the country, the Prevention of Food Adulteration Act, 1954 was enacted. Later on when it was felt that the “consumer of food products” should know whether any article of food contains whole or any part of animal including birds, fresh water or marine animals or eggs or product of any animal origin, the Government of India by notification dated 4th April, 2001 enacted the Prevention of Food Adulteration (Fourth Amendment) Rules, 2001 amending Rule 32 and Rule 42 of the Prevention of Food Adulteration Rules, 1955 and introduced symbol and colour code of vegetarian and non- vegetarian food products. Under clause (b) of amended Rule 32 of the Prevention of Food Adulteration Rules, 1955, it was made compulsory to make declaration whether article of food contains any non-vegetarian ingredients by a symbol and colour code so stipulated for the said purpose, to indicate that the product is a non-vegetarian food. The symbol of non-vegetarian food on every food product package was introduced by inserting clause (16) of sub-rule (ZZZ) of Rule 42 of the Prevention of Food Adulteration (Fourth Amendment) Rules, 2001. The amendment came into effect from 7th March, 2001.

But no such provision has been made to indicate whether any ingredient of any drug or cosmetics is of non-vegetarian origin.

13. “The Drugs and Cosmetics Act, 1940” was introduced to regulate the import, manufacture, distribution and sale of drugs and cosmetics including its package. “Drug” as defined in Section 3(b) of the Drugs and Cosmetics Act, 1940 reads as follows:

“3(b) “drug” includes—

i) all medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals, including preparations applied on human body for the purpose of repelling insects like mosquitoes;

ii) such substances (other than food) intended to affect the structure or any function of human body or intended to be used for the destruction of 6(vermin) or insects which cause disease in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette;

(iii) all substances intended for use as components of a drug including empty gelatine capsules; and

iv) such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette, after consultation with the Board ;

‘Cosmetic’ is defined in Section 3(aaa):

“3(aaa) “cosmetic” means any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied to, the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and includes any article intended for use as a component of cosmetic.”

14. Under Section 5 of the Drugs and Cosmetics Act, 1940 a “Drugs Technical Advisory Board” is to be constituted to advise the Central Government and the State Governments on technical matters arising out of the administration of the Act and to carry out other functions assigned to it by the Act. The Board consists of the Director General of Health Services; the Drugs Controller of India; the Director of the Central Drugs Laboratory; the Director of Central Research Institute; the Director of Indian Veterinary Research Institute, the President of the Medical Council of India; the President of Pharmacy Council of India; etc. The Central Government is also required to establish a ‘Central Drugs Laboratory’ under the control of a Director under Section 6 ‘for analysis and test of samples of drugs’. Under Section 7, the Drugs Consultative Committee is constituted to advise the Central Government, the State Governments and the Drugs Advisory Board on any matter tending to secure uniformity throughout India in the administration of the Act. Under Section 8 standards of quality in relation to drugs and cosmetics have been prescribed. Chapter III deals with the definition of ‘misbranded drugs’; ‘adulterated drugs’; ‘spurious drugs’; ‘misbranded cosmetics’; ‘spurious cosmetics’ etc.

Under Section 16, it is mandated that the quality of a drug should comply with the standard as set out in the Second Schedule. Similarly, the quality of a cosmetic should comply with such standard as may be prescribed by the Central Government.

The Act deals with disclosure of the name of the manufacturer of a drug, cosmetic and its agent under Section 18A. The Central Government is also empowered under Section 26A to prohibit manufacture, etc., of drug and cosmetic in public interest. The conditions to be observed in the packing in bottles, packages, and other containers of drugs or cosmetics including regulating the mode of labelling of packed drugs or cosmetics prescribed by the Central Government by framing a Rule under Section 33 which reads as follows:

“33.Power of Central Government to make rules. —(1) The Central Government may after consultation with, or on the recommendation of, the Board and after previous publication by notification in the Official Gazette, make rules for the purposes of giving effect to the provisions of this chapter:

Provided that consultation with the Board may be dispensed with if the Central Government is of opinion that circumstances have arisen which render it necessary to make rules without such consultation, but in such a case the Board shall be consulted within six months of making of the rules and the Central Government shall take into consideration any suggestions which the Board may make in relation to the amendment of the said rules.

(2) Without prejudice to the generality of the foregoing power, such rules may—

xxx xxx xxx

xxx xxx xxx

(i) prescribe the conditions to be observed in the packing in bottles, packages, and other containers of drugs or cosmetics, including the use of packing material which comes into direct contact with the drugs]and prohibit the sale, stocking or exhibition for sale, or distribution of drugs or cosmetics packed in contravention of such conditions;

(j) regulate the mode of labelling packed drugs or cosmetics, and prescribe the matter which shall or shall not be included in such labels;”

15. Part XV of the Drugs and Cosmetics Rules, 1945 relates to labelling, packing and standards of cosmetics. The list of ingredients, present in concentration of more than one per cent is required to be listed in the descending order of weight or volume under sub-rule (7) of Rule 148. Rule 149A is a special provision relating to toothpaste containing fluoride whereunder it is mandatory to mention the content of fluoride on the tube and the carton apart from the date of expiry.

Rule 97 relates to ‘labelling of medicines’ :

“97. Labelling of medicines— (1) The container of a medicine for internal use shall—

(a) if it contains a substance specified in Schedule G, be labelled with the words ‘Caution: it is dangerous to take this preparation except under medical supervision’ – conspicuously printed and surrounded by a line within which there shall be no other words;

(b) if it contains a substance specified in Schedule H be labelled with the symbol Rx and conspicuously displayed on the left top corner of the label and be also labelled with the following words:-

Schedule H drug-Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only’;

(c) if it contains a substance specified in Schedule H, and comes within the purview of the [Narcotic Drugs and Psychotropic Substances Act, 1985 (61 of 1985)] be labelled with the symbol NRx which shall be in red and conspicuously displayed on the left top corner of the label, and be also labelled with the following words:-

Schedule H drug -“Warning:– To be sold by retail on the prescription of a Registered Medical Practitioner only’;

(d) if it contains a substance specified in Schedule X, be labelled with the symbol XRx which shall be in red conspicuously displayed on the left top corner of the label and be also labelled with the words : –

Schedule X drug -“Warning:– To be sold by retail on the prescription of a Registered Medical Practitioner only’;

(2) The container of a embrocation, liniment, lotion, ointment, antiseptic cream, liquid antiseptic or other liquid medicine for external application shall be labelled with the word in capital ‘For External use only’.

(3)The container of a medicine made up ready only for treatment of an animal shall be labelled conspicuously with the words ‘Not for human use; for animal treatment only’ and shall bear a symbol depicting the head of a domestic animal.

(4) The container of a medicine prepared for treatment of human ailments shall if the medicine contains industrial methyllated spirit, indicate this fact on the label and be labelled with the words :-

“For External Use only”.

(5) Substances specified in Schedule X in bulk form shall bear a label wherein they symbol as specified in sub-rule (1) shall be given conspicuously in red letters.”

Whereas Rule 105 relates to packing of drugs, including sizes meant for retail sale as prescribed in ‘Schedule P’. For other drugs, a separate packing has been prescribed under Rule 105A read with ‘Schedule X’.

16. The Drugs and Cosmetics Act, 1940 or the rules framed thereunder do not mandate mentioning or displaying symbol of ingredients of non- vegetarian or vegetarian origin. The manufacturer or others are not required to mention ‘vegetarian’ or ‘non-vegetarian’ on the label of drugs or cosmetics.

The Central Government is vested with the power under the Drugs and Cosmetics Rules, 1945 to amend the ‘label of the drugs and cosmetics’ in consultation with the Drugs Technical Advisory Board. Without fruitful consultation with the Drugs Technical Advisory Board, no amendment can be made or suggested to change the label of the drugs and cosmetics.

17. Earlier a proposal was made by certain persons to amend ‘the Drugs and Cosmetics Rules, 1945’ so as to mention the words “vegetarian” and “non- vegetarian” on the labels of the drugs and cosmetics. After fruitful deliberations, the Drugs Technical Advisory Board in its 48th Meeting held on 8th July, 1999 rejected the proposal as quoted hereunder:

“AGENDA ITEM NO.3

PROPOSAL TO AMEND DRUG & COSMETIC RULE

1945 TO REQUIRE MENTION OF WORDS

V(VEGITAIAN) AND NV(NON VEGITARIAN) ON

LABELS OF DRUGS/COSMETICS

Ministry of Social Justice and Empowerment nominated Shri Devdas Chhotray, Joint Secretary, Ministry of Food Processing and Shri S.R. Khanna, representative from an NGO, VOICE for acquainting the Board Members with their views on this subject. Sh. Chhotray, explained regarding his Ministry’s concern about the killing of animals and consumer’s right for information. He stated that some consumers may like to avoid use of any product containing material from animal source if they have recourse to such information and this need of consumer requires to be respected. It was, therefore, proposed that the provision for labelling V and NV on every food/drug product depending on its vegetarian or non vegetarian aspects may be introduced in the Drugs & Cosmetics Rules.

Dr. S.R. Khanna, also, in detail stressed upon consumers rights to such information and desired a mandatory provision to indicate the source of drug in terms of V and NV.

The Chairman explained that while respecting the consumers rights to information the issue of V & NV markings need to be examined in wider perspectives of medical treatment an critical importance of certain drugs products like vaccines, harmones, Biotech products etc. which are of life saving nature and could be traced to animal origin. (Unlike food, drugs are not taken by choice or for the purpose of gratification). He, however, suggested that in the context of general understanding of vegetarianism such drugs where macroscopic portion of animal tissues like animal blood, liver extract etc. are present in oral preparations may be considered by the Board for marking NV on the label of such drugs.

1. Prof. Jindal opined that the drugs may be labelled to indicate their source i.e. synthetic source, Bio Source and animal source. This suggestion was, however, not found practicable.

2. Prof. Kokato and Mrs. Muthuswamy representatives of ICMR felt that what may be appropriate in case of food may not necessarily be appropriate in case of drugs which are prescribed for relief from disease conditions and many a times in life threatening situation. To introduce the concept of Vegetarian and Non Vegetarian by marking V or NV in drugs may not be in the overall interest of the consumers.

3. Sh. Praful Seth agreed with the views of Chairman about the possibility of considering the proposal for a limited number of non critical drugs that is oral tonics etc. having obvious animal tissues. He also explained that alternate formulations are also available and the physician may advice/educate consumers about it.

4. Prof. S.D. Seth, and Sh. R.Anand Raj Sekhar, opined that if at all proposals to mark NV has to be considered it may be discussed only for non-essential drugs.

5. Dr. Prem Agarwal, representative of IMA opposed any move to bring in the concept of V/NV in the field of medicines and also stated that it would not be rational to further classify drugs essential or non-essential for the purpose of marking NV on the labels.

6. The Drugs Controller, Karnataka, was in agreement to the extent of marking NV on non-essential drugs taken orally and containing obvious animal tissues but did not favour the concept of making V or NV in the field of drugs.

7. The president MCI, Dr Ketan Desai was of opinion that marking products as NV is not relevant for medicines and no attempt should be made to differentiate them as essential and non-essential once. The proposal may be considered for food products and not for drugs.

8. Dr. Bhargava, representatives of Medical Council of Indian, Dr. Gupta, Director, CDR Lucknow and Mr. M.V. Kumar, expressed strong views against, introducing the requirement for marking drugs products with NV.

9. The mailer was discussed in great details and the other members did not favour any labelling of NV or V on the medicines.

In view of the above labelling of drugs “V/NV” or “from animal source” as proposed in the Agenda, was not accepted.” (Emphasis supplied).

18. A citizen has the right to expression and receive information under Article 19(1)(a) of the Constitution. That right is derived from freedom of speech and expression comprised in the Article. The freedom of speech and expression includes the right to receive information. [Refer : The State of U.P. vs. Raj Narain and othersl, (1975) 4 SCC 428; Secretary, Ministry of Information &Broadcasting, Govt. of India and others vs. Cricket Association of Bengal and others, (1995) 2 SCC 161; P.V. Narasimha Rao vs. State (CBI/SPE), (1998) 4 SCC 626)]. But such right can be limited by reasonable restrictions under the law made for the purpose mentioned in the Article 19(2) of the Constitution.

19. It is imperative for the State to ensure the availability of the right to the citizens to receive information. But such information can be given to the extent it is available and possible, without affecting the fundamental right of others.

20. In the present case the appellant-Union of India had taken a plea that information relating to the ingredients of drug particularly those ingredients of non-vegetarian origin should not be given “in the interest of general public”. A specific plea has been taken that it is not possible to distinguish the drugs whether these are life saving or otherwise.

21. In the given circumstances the condition of a patient may be such that a drug which is ordinarily not treated as a life saving drug may be essential to save the life. In such a case when drug becomes a life saving drug, it may not be desirable for the patient or his attendant to know the origin of the ingredients of the drug i.e. whether ‘vegetarian’ or ‘non- vegetarian’. Such option cannot be left on the patient or his attendant if required to save the life or eradicate a disease.

22. The information about the origin of the ingredients of a drug or cosmetic, if claimed as a matter of right, a vegetarian can also claim information about the origin of a vegetarian ingredient, depending upon his food habit.

23. Food habit in India varies from person to person and place to place. Religion also plays a vital role in making such habit. Those who follow ‘Jainism’ are vegetarian but many of them do not eat some of the vegetarian food such as potato, carrot, onion, garlic etc. which are grown below the earth. Majority of Indians treat ‘honey’ and ‘lactose’ (milk derived sugar) as vegetarian but scientists treat them as ‘non-vegetarian’ products.

Amongst the non-vegetarians a number of persons are ‘eggetarian’ i.e. those who only take one non-vegetarian product–egg. They do not eat other non-vegetarian food like animal, fish or birds. There are number of persons who treat egg as vegetarian food. Even amongst non-vegetarians, a large number of persons do not take beef or ham/pork because of religious belief. Many of the non-vegetarians do not eat snakes, insects, frog or bird. In individual case, the Central Government may feel difficulty in specifying the origin of a ‘vegetarian’ or ‘non-vegetarian’ ingredient, if a person wants to know the definite origin of such ‘vegetarian’ or ‘non- vegetarian’ ingredient on the basis of his food habit.

24. ‘The Drugs and Cosmetics Rules’ can be amended by the Central Government after taking into consideration any suggestion which the Drugs Technical Advisory Board may make in relation to the amendments of the said Rules. Earlier on a reference the Drugs Technical Advisory Board has already opined that the labelling of drugs as ‘vegetarian’ or ‘non- vegetarian’ or ‘from animal sources’ is not desirable and such proposal was not accepted.

25. The question arises as to whether in facts and circumstances noted above, the High Court was justified in issuing a writ of mandamus calling upon the Central Government to discharge its duty by amending rules. In A.K. Roy v. Union of India and others, (1982) 1 SCC 271, this Court considered the question whether the Court should issue a mandamus calling upon the Central Government to discharge its duty without any further delay and held:

“The Parliament having left to the unfettered judgment of the Central Government the question as regards the time for bringing the provisions of the 44th Amendment into force, it is not for the court to compel the government to do that which, according to the mandate of the Parliament, lies in its discretion to do when it considers it opportune to do it. The executive is responsible to the Parliament and if the Parliament considers that the executive has betrayed its trust by not bringing any provision of the Amendment into force, it can censure the executive,…..”

26. The aforesaid decision was noticed and reiterated by this Court in Supreme Court Employees’Welfare Association v. Union of India and another, (1989) 4 SCC 187, and held:

“51. There can be no doubt that no court can direct a legislature to enact a particular law. Similarly, when an executive authority exercises a legislative power by way of subordinate legislation pursuant to the delegated authority of a legislature, such executive authority cannot be asked to enact a law which he has been empowered to do under the delegated legislative authority.”

27. In Bal Ram Bali and another vs. Union of India, (2007) 6 SCC 805, this Court discussed the separation of powers while dealing with the question of total ban on slaughter of cows, horses, buffaloes and chameleon. This Court held that it is a matter of policy on which decision can be taken by the appropriate Government and the Court cannot issue any direction to Parliament or to the State Legislature to enact a particular kind of law. The writ petition was held to be not maintainable with the following observation:

“3. It is not within the domain of the Court to issue a direction for ban on slaughter of cows, buffaloes and horses as it is a matter of policy on which decision has to be taken by the Government. That apart, a complete ban on slaughter of cows, buffaloes and horses, as sought in the present petition, can only be imposed by legislation enacted by the appropriate legislature. Courts cannot issue any direction to the Parliament or to the State legislature to enact a particular kind of law. This question has been considered in Union of India v. Prakash P. Hinduja and Anr.,(2003) 6 SCC 195, wherein in para 30 of the reports it was held as under:

“30. Under our constitutional scheme Parliament exercises sovereign power to enact laws and no outside power or authority can issue a direction to enact a particular piece of legislation. In Supreme Court Employees’ Welfare Assn. v. Union of India, (1989) 4 SCC 187, it has been held that no court can direct a legislature to enact a particular law. Similarly, when an executive authority exercises a legislative power by way of a subordinate legislation pursuant to the delegated authority of a legislature, such executive authority cannot be asked to enact a law which it has been empowered to do under the delegated legislative authority. This view has been reiterated in State of J and K v. A.R. Zakki, (1992) Supp.1 SCC 548. In A.K. Roy v. Union of India (1982) 1 SCC 271, it has been held that no mandamus can be issued to enforce an Act which has been passed by the legislature….”

4. In view of the aforesaid legal position, we are of the opinion that this Court cannot grant any relief to the petitioners, as prayed for, in the writ petition. The writ petition is accordingly dismissed.”

28. Learned counsel for the respondent-writ petitioner relied on the decision of this Court in Union of India vs. Association for Democratic Reforms and another, (2002) 5 SCC 294, and submitted that the “field has remained unoccupied this Court can issue such direction under Article 32 of the Constitution of India”, but such submission cannot be accepted as it cannot be said that field has remained unoccupied as under the Drugs and Cosmetic Rules it is the Central Government which in consultation with the Drug Technical Advisory Board is empowered to decide whether any amendment is to be made in the relevant Rules showing the ingredients of vegetarian or non-vegetarian origin or to provide a symbol. In fact the issue in question was deliberated by the Central Government when such matter was referred to the Drug Technical Advisory Board which in its 48th Meeting on 8th July, 1999 rejected such suggestion.

29. In view of the discussions above, we hold that the High Court under Article 226 of the Constitution of India has no jurisdiction to direct the Executive to exercise power by way of subordinate Legislation pursuant to power delegated by the Legislature to enact a law in a particular manner, as has been done in the present case. For the same reason, it was also not open to the High Court to suggest any interim arrangement as has been given by the impugned judgment. The writ petition filed by Respondent being not maintainable for issuance of such direction, the High Court ought to have dismissed the writ petition in limine.

30. In the result, both the appeals are allowed and the order and directions issued by the High Court are set aside but there shall be no orders as to costs.

…………………………………………………………………….J.

( G.S. SINGHVI )

…………………………………………………………………….J.

( SUDHANSU JYOTI MUKHOPADHAYA)

NEW DELHI,

MARCH 07, 2013.