14 January 2011
Supreme Court
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MADLEY PHARMACEUTICALS LTD. Vs COMMNR OF CENTRAL EXCISE&CUSTOMS, DAMAN

Bench: D.K. JAIN,H.L. DATTU, , ,
Case number: C.A. No.-003626-003626 / 2005
Diary number: 10955 / 2005
Advocates: K J JOHN AND CO Vs B. KRISHNA PRASAD


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REPORTABLE

IN THE SUPREME COURT OF INDIA

CIVIL APPEALATE JURISDICTION

CIVIL APPEAL NO. 3626 OF 2005

Medley Pharmaceuticals Ltd.     ……….. Appellant

Versus

The Commissioner of Central Excise  & Customs, Daman                                 …………..Respondent

WITH

CIVIL APPEAL NOS.1354-1355 OF 2010

Medley Pharmaceuticals Ltd.    ………….. Appellant

Versus

The Commissioner of Central Excise, Gujarat …………..Respondent

J U D G M E N T

H.L. Dattu, J.

1) A  group  of  three  appeals  is  filed  by  the  appellant  –  Medley  

Pharmaceuticals Ltd., under Section 35 L  (b) of the Central Excise  

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Act,  1944  (hereinafter  referred  to  as  ‘the  Act’).   In  Civil  Appeal  

No.3626 of 2005, the appellant  calls  in question the correctness  or  

otherwise  of  the order  passed by Customs Excise and Service Tax  

Appellate Tribunal (CESTAT) (in short, “The Tribunal”) in  Appeal  

No. E/549 to E 551/2003-Mum, dated 3.12.2004.  By the impugned  

order, the Tribunal has confirmed the order passed by Commissioner  

of  Customs  and Central  Excise,  Valsad  dated  30.12.2002.   In  this  

appeal, the appellant has raised the following question of law for our  

consideration and decision:-

“Whether  Physician samples  manufactured and distributed as  

free samples have to be assessed on the basis of cost of manufacture  

plus normal profits, if any, earned on the sale under Rule 6(b)(ii) of  

the Central  Excise Valuation Rules, 1975 (for short, “Rules 1975”)  

upto 1st July, 2000 and thereafter, on application of Rule 8 of Central  

Excise Valuation Rules, 2000 (for short, “Rules 2000”) i.e. on cost of  

manufacture plus 15% profit basis and not on pro-rata basis as has  

been done by the Revenue?”

2) The  Commissioner,  while  passing  the  order  in  Original  No.  

01/MP/Valsad/2002 dated 30.12.2002, has held that the value should  

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be determined under Rule 4 of Rules 1975.  In the appeal filed by the  

appellant, the Tribunal, following the judgment in the case of  Mayo  

India Ltd.  and  Cheryl Laboratories (P) Ltd., held that the value of  

Physician  samples  should  be  determined  in  accordance  with  the  

principle laid down in Rule 6(b)(i) read with Rule 7 of the Rules 2000.  

After coming to the aforesaid conclusion, the Tribunal has accepted  

the method of assessable value adopted by the Commissioner, though  

it was under Rule 4 of the Rules 1975.   

3) In Civil Appeal Nos. 1354-1355 of 2010, the appellant is aggrieved by  

the  final  order  passed  by  the  Tribunal,  bearing  No.A/490/WZB  

/AHD/2009  dated  27th February,  2009  and  the  order  

No.H/853/WZB/AHD/2009  dated  4th August,  2009  passed  on  the  

rectification application in Appeal No. E/384/2005.  By the impugned  

order, the Tribunal dismissed the appellant’s appeal and upheld the  

order passed by the Commissioner of Central Excise (Appeals) dated  

24th November,  2004  holding  that  for  the  purpose  of  payment  of  

Excise duty, Physician samples have to be valued for the period post  

1st July, 2000 upto December, 2001 on pro-rata basis on the value of  

trade packs under Rule 4 read with Rule 11 of  the Central  Excise  

Valuation (Determination of Price of Excisable Goods) Rules 2000.  

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The Tribunal, while rejecting the application filed for rectification of  

the  order  dated  27th February,  2009,  held  that  merely  because  a  

product is statutorily prohibited from being sold, would not mean that  

the product is not capable of being sold. In this appeal, the appellant  

has raised the following questions of law for our consideration and  

decision. They are:-  

(A)Whether “Physician Samples” are excisable goods in view of the  

fact that they are statutorily prohibited from being sold under the  

Drugs and Cosmetics Act, 1940 (in short, “Drugs Act”) and the  

Rules made thereunder?

(B)If physician’s samples are held to be excisable,  then what is the  

appropriate method of valuing physician samples for the purpose  

of excise duty?  

4) Shri  S.  Ganesh,  learned senior counsel for the appellant,  submitted  

that the Physician Samples of Patent and proprietory medicines come  

into  existence  as  a  manufactured  product  only  when  the  same  are  

labeled  and  packed  for  the  purpose  of  sale  and  distribution.   Our  

attention is invited to Note 5 of Chapter 30 of Central Excise Tariff  

Act,  1985,  wherein  it  is  provided that  packing  and labeling would  

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amount to manufacture. Therefore, it is contended that the Physician  

Samples of Patent and proprietary Medicines become manufactured  

goods  only  when  the  same  are  packed  and  labeled.   It  is  further  

contended  that  the  physician  samples  of  patent  and  proprietory  

medicines,  at  the  time  they  are  manufactured,  are  statutorily  

prohibited from being sold by virtue of Section 18 of the Drugs Act  

read with Rule 65(18) of the Drug Rules and the breach of the Drug  

Rules invites prosecution under Section 27(d) of the Drugs Act, and  

also invites penalty under Section 27(c) of the Drugs Act.  It is further  

submitted that the two conditions that require to be satisfied for levy  

of excise duty are existence of manufacturing process and as a result  

of  such  process,  goods  are  produced  which  are  capable,   in  the  

ordinary course, of being taken to the market for being bought and  

sold.  It is further submitted that the word ‘excisable goods’ has been  

construed to mean not only goods specified in the Schedule to the  

Central Excise Tariff Act, 1985, but also goods which are capable of  

being  sold  i.e.  marketable.   In  the  present  case,  the  ‘Physician  

Samples’ are statutorily prohibited from being sold and therefore, do  

not satisfy the twin test required to make physician samples excisable  

goods.   

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5) Shri R. P. Bhatt, learned senior counsel for the Revenue, justifies the  

reasoning and conclusion reached by the Tribunal.

6) In pith and substance, the submission of learned senior counsel Shri  

Ganesh  is  that  the  physician  samples  of  patent  and  proprietary  

medicines are statutorily prohibited from being sold by virtue of Rule  

65(18)  and Rule 95 and Rule 96 (1) (ix) of the Drugs Rules.  It is  

contended  that  every  drug  intended  for  distribution  as  physicians  

sample while complying with the labeling provisions under Drugs and  

Cosmetic Rules further bear on the label of the container the words  

“Physician’s Sample- Not to be Sold”  requires to be over printed and  

further,  the  sale  of  such Physician  samples  is  expressly  prohibited  

under Rule 65 (18) of the Drug Rules. He contends that patent and  

proprietory  drugs are  excisable  only after  the  labeling is  complete.  

Since these physician samples cannot be sold in the market after the  

completion of the labeling in view of the statutory prohibition,  the  

physician samples are not  marketable and hence,  no excise duty is  

leviable on their manufacture.

7) The  Central  Excise  Act,  apart  from  others,  provides  for  

charging of duty, valuation etc. Section 3 of the Act is the charging  

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provision.  It  states,  there  shall  be  levied  and  collected  in  such  a  

manner  as  may be prescribed duties  on excisable  goods which are  

produced  or  manufactured  in  India.  Basic  excise  duty  and  special  

excise  duty  are  levied  under  the  charging  provision  at  the  rates  

specified in First and Second Schedule to Central Excise Tariff Act,  

1985.   The duty is  on excisable  goods which are  manufactured  or  

produced  in  India.   This  Court  in  Shinde  Brothers  vs.  Deputy  

Commissioner, AIR  1967  SC  1512  has  held  that  excise  duty  is  

imposed on goods, and the taxable event for the levy is manufacture  

or production of the goods.  A duty of excise is a tax upon the goods  

and not upon sales or proceeds of sale of goods.  In terms of Entry 84,  

List I of Seventh Schedule to the Constitution, taxable event in respect  

of excise is manufacture or production (See CCE vs. Acer India Ltd.,  

2004 AIR SCW 5496).  The levy is on the manufacture or production  

of goods.  The collection is shifted to stage of removal.  Since excise  

is a duty on manufacture, duty is payable whether or not goods are  

sold.  Therefore, sale is not necessary condition for charging excise  

duty.  This Court in the case of Ram Krishna Ramanath Agarwal Vs.   

Secretary,  Municipal  Commissioner,  Kamptee   1950 SCR 15,  has  

referred to the distinction made by the Federal Court between the duty  

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of excise and a tax on sale in Province of Madras vs. Boddu Paidanna  

and Sons (1942) FCR 90, wherein it is observed:

“ Plainly, a tax levied on the first sale must, in the nature   of  things,  be a  tax  on  the  sale  by  the  manufacturer  or   producer; but it is levied upon him qua seller and not qua   manufacturer  or  producer.   It  may  well  be  that  a  manufacturer or producer is sometimes doubly hit... If the   taxpayer  who pays  sales  tax  is  also  a manufacturer  or   producer  of  commodities  subject  to  a  central  duty  of   excise, there may no doubt be overlapping in one sense,   but there is no overlapping in law.  The two taxes which   he is called on to pay are economically two separate and   distinct imposts. There is, in theory, nothing to prevent the   Central Legislature from imposing a duty of excise on a  commodity as soon as it comes into existence no matter   what  happens  to  it  afterwards,  whether  it  be  sold   consumed,  destroyed,  or  given  away...  It  is  the  fact  of   manufacture which attracts the duty even though it may be  collected later.  In the case of a sales tax, the liability to  tax arises on the  occasion of  a sale  and a sale  has no   necessary  connection  with  manufacture  or  production.”   ...” [emphasis supplied]  

8) The consistent view of this Court is that for the purpose of levy of  

excise duty, an article must satisfy two requirements to be ‘Goods’ i.e.  

(a)  it  must  be movable   and  (b)  it  must  be marketable.   In  these  

appeals,  we  are  primarily  concerned  whether  the  ‘Goods’  namely  

Physician samples of patent and proprietory medicines intended for  

distribution to the medical practitioner as free samples, satisfies the  

test  of  ‘Marketability’.   Marketability  is  an  essential  criteria  for  

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charging duty.  The test of marketability is that the product which is  

made liable to duty must be marketable in the condition in which it  

emerges. The word ‘Marketable’ means saleable or suitable for sale.  

It need not in fact be marketed.  The article should be capable of being  

sold to consumers, as it  is without anything more.  The essence of  

marketability  of  goods  is  neither  in  the  form nor  in  the  shape  or  

condition  in  which  the  manufactured  article  is  found.   It  is  the  

commercial  identity  of  the  article  known  to  the  market  for  being  

bought and sold.  The fact that the product in question is generally not  

being  bought  or  sold  or  has  no  demand  in  the  market,  would  be  

irrelevant.  [See  Indian  Cable  Co.  Ltd.  vs.  CCE,  1994(74)  ELT  

22(SC)].  We will now refer to some of the decisions of this Court,  

which have explained the concept of ‘Marketability’ for the purpose  

of the Act.

9)   The Constitution Bench of this Court, in the case of  Union of   

India  vs.  Delhi  Cloth and General  Mills, AIR 1968 SC 922,  after  

referring to definition of ‘excisable goods’, stated:

“These  definitions  makes  it  clear  that  to  become  goods  an  article  must  be  something  which  can  ordinarily come to the market to be bought or sold”.  

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10)    A three Judge Bench of this Court in the case of Union Carbide  

India Ltd.  v.  Union of  India,  (1986)  2  SCC 547 has discussed the  

concept of ‘marketability’ in order for the Revenue to impose excise  

duty as under:

“6. It does seem to us that in order to attract excise duty the   article manufactured must be capable of sale to a consumer.   Entry  84  of  List  I  of  Schedule  VII  to  the  Constitution   specifically speaks of “duties of excise on tobacco and other   goods manufactured or produced in India....”, and it is now  well accepted that excise duty is an indirect tax, in which the   burden  of  the  imposition  is  passed  on  to  the  ultimate   consumer.  In  that  context,  the  expression  “goods   manufactured or produced” must refer to articles which are   capable of being sold to a consumer. In Union of India v.   Delhi Cloth & General Mills, AIR 1963 SC 791, this Court   considered the meaning of the expression “goods” for the   purposes  of  the  Central  Excises  and  Salt  Act,  1944  and  observed  that  “to  become  ‘goods’  an  article  must  be  something which can ordinarily  come to the market  to be  brought and sold”, a definition which was reiterated by this   Court in South Bihar Sugar Mills Ltd. v. Union of India, AIR   1968 SC 922”.

11)     In  Bhor Industries  Ltd.  vs.  Collector  of  Central  Excise,  Bombay,  

(1989) 1 SCC 602, it was held:

“Excise  is  a  duty  on  goods  as  specified  in  the   Schedule.  The taxable event in the case of excise   duties  is  the  manufacture  of  goods.   Under  the   Central Excise Act, as it stood at the relevant time,   in order to be goods as specified in the entry, it   was essential that as a result manufacture goods  

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must come into existence.  For articles to be goods   these must be known in the market as such or these  must  be  capable  of  being  sold  in  the  market  as  goods.  Actual sale in the market is not necessary,   user  in  the  captive  consumption  is  not   determinative but the articles must be capable of   being sold in the market or known in the market as  goods.   It  is,  therefore,  necessary  to  find  out   whether there are goods, that is to say, articles as   known  in  the  market  as  separate  distinct   identifiable  commodities  and  whether  the  tariff   duty levied would be as specified in the Schedule.   Simply  because a certain article  falls  within  the   Schedule it would not be dutiable under excise law  if  the  said  article  is  not  `goods’  known  to  the   market.   Marketability,  therefore,  is  an essential   ingredient  in  order  to  be  dutiable  under  the   Schedule to Central Excise Tariff Act, 1985.”

12)      In  Hindustan  Polymers v.  CCE (1989)  4  SCC 323,  this  Court  

observed:  

“11.  Excise  duty  is  a  duty  on  the  act  of  manufacture.   Manufacture under the excise law, is the process or activity   which  brings  into  being  articles  which  are  known  in  the  market  as goods and to be goods these must  be different,   identifiable  and  distinct  articles  known  to  the  market  as  such. It is then and then only that manufacture takes place   attracting duty. In order to be goods, it was essential that as   a result of the activity, goods must come into existence. For   articles to be goods, these must be known in the market as   such and these must be capable of being sold or are being  sold  in  the  market  as  such.  In  order,  therefore,  to  be   manufacture,  there  must  be  activity  which  brings   transformation to the article in such a manner that different   and distinct article comes into being which is known as such   in the market.”

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13)        In  A.P. State Electricity Board vs. CCE, Hyderabad, (1994) 2  

SCC 428, this Court stated:

“Marketability is an essential ingredient in order to   be  dutiable  under  the  Schedule  to  the  Act.......The   `marketability’ is thus essentially a question of fact to   be decided in the facts of each case.  There can be no   generalization.  The fact that the goods are not in fact   marketed is of no relevance.  So long as the goods   were marketable, they are goods for the purposes of   Section 3.  It is not also necessary that the goods in   question should be generally available in the market.   Even if the goods are available from only one source   or from a specified market, it makes no difference so  long  as  they  are  available  for  purchasers.....   The   marketability  of  articles  does  not  depend  upon  the  number of purchasers nor is the market confined to   the territorial limits of this country.”

14)      In  Indian Cable Company Ltd.., Calcutta vs. Collector of Central   

Excise and Others, (1994) 6 SCC 610, this Court has stated:

“Marketability is a decisive test for dutiability.  It only  means `saleable’ or “suitable for sale”.  It need not be   in fact `marketed’.   The article should be capable of   being sold or being sold, to consumers in the market, as   it is ---- without anything more.”

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15)   In Triveni Engineering & Industries Ltd. v. CCE, (2000) 7 SCC  

29, this Court, while demonstrating the attributes of excisable goods  

under the excise law, has observed that:   

“13. … The article in question should be capable of being   brought and sold in the market — a test which is too well   established  by  a  series  of  decisions  of  this  Court  to  be  elaborated here.”

16)        In Union of India v. Sonic Electrochem (P) Ltd., (2002) 7 SCC  

435, this court has held:  

“9. … It is difficult to lay down a precise test to determine  marketability of articles. Marketability of goods has certain  attributes. The essence of marketability is neither in the form  nor  in  the  shape or  condition  in  which  the  manufactured  articles are to be found, it is the commercial identity of the   articles known to the market for being bought and sold. The   fact  that  the  product  in  question  is  generally  not  being   bought and sold or has no demand in the market would be   irrelevant.”

17) In the case of ITC Ltd. v. Collector of Central Excise, Patna, (2003) 1  

SCC 678, this Court while applying the test of marketability for the  

purpose of levy of excise duty on the manufacture of the cigarette, has  

observed:  

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“17. From a conspectus of the aforesaid decisions, it would  be clear that for the purposes of levy of excise duty, the test   to  be  applied  is  whether  the  goods  manufactured  are  marketable or not. In the present case, the cigarette, which is   the end product of tobacco, is fit for consumption before the   same is removed for test. Packing of the cigarettes cannot be   said  to  be  incidental  or  ancillary  to  the  manufacturing   process, but the same may be incidental or ancillary to its   sale only. In case it is laid down that packing of cigarettes is   incidental  or  ancillary  to  the  completion  of  manufactured   products, the same may result in evasion of excise duty as   before  packing  the  cigarettes  the  same  may  be  regularly   supplied  to  each and every  employee for  his  consumption   without  payment  of  excise  duty  thereon.  The  definition  of   “manufacture”  under  Section  2(f)  very  clearly  includes  process which is incidental or ancillary to the completion of   manufactured  product.  Manufacture  of  cigarette  is   completed when the same emerges in the form of sticks of   cigarettes  which  are  sent  to  the  laboratory  for  quality   control  test.  Sticks  of  cigarettes  can  be  consumed  and  manufacture  of  the  end  product  i.e.  cigarette,  which  is   commercially  known  in  the  market  as  such,  is  completed   before its removal for test and after testing only packing of   the same, which is the requirement of Rule 93 of the Rules, is   done.  Thus,  we  hold  that  sticks  of  cigarettes  which  are   removed  for  the  purpose  of  test  in  the  quality  control   laboratory  located  within  the  factory  premises  of  the   appellant Company are liable to excise duty.”

18)  In the case of Cadila Laboratories (P) Ltd v. CCE, Vadodara, (2003)  

4 SCC 12, this Court has held:  

“9. Thus the law is that in order to be excisable, not only  goods must be manufactured i.e. some new product brought   into  existence,  but  the  goods  must  be  marketable.  By   marketable it does not mean that the goods must be actually   

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bought  and  sold  in  the  market.  But  the  goods  must  be  capable of being bought or sold in the market. The law also  is that goods which are in the crude or unstable form and   which  require  a  further  processing  before  they  can  be  marketed,  cannot  be  considered  to  be  marketable  goods  merely because they fall within the Schedule to the Excise   Act”.

19)       In  Hindustan Zinc Ltd.  v.  CCE,  (2005) 2 SCC 662, this  Court  

observed:  

“5. Excise  duty  is  levied  under  Section  3  on  goods   manufactured or produced in India. Thus, before excise duty  is levied on an item, even if it is mentioned in the tariff, two  conditions have to be cumulatively satisfied, namely, that the   process  by  which  an  item  is  obtained  is  a  process  of   manufacture and that the item so obtained is commercially   marketable and bought and sold in the market or known to   be so in the market.”  

20)         In Dharampal Satyapal v. CCE, (2005) 4 SCC 337, it was held by  

this Court:  

“18. … Marketability is an attribute of manufacture. It is an   essential criteria for charging duty. Identity of the product   and  marketability  are  the  twin  aspects  to  decide  chargeability. Dutiability of the product depends on whether   the product is known to the market. The test of marketability   is  that  the  product  which  is  made  liable  to  duty  must  be   marketable in the condition in which it emerges. Marketable  means  saleable.  The  test  of  classification  is,  how are  the   goods known in the market. These tests have been laid down   by  this  Court  in  a  number  of  judgments  including  Moti   

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Laminates (P) Ltd. v. CCE (1995) 3 SCC 23, Union of India   v. Delhi Cloth & General Mills Co. Ltd. (1997) 5 SCC 767  and Cadila Laboratories (P) Ltd. v. CCE  (2003) 4 SCC 12”

21)   In Gujarat Narmada Valley Fertilizer Co. Ltd. vs. Collector of   

Excise and Customs, (2005) 7 SCC 94,  it was held that unless the  

product is capable of being marketed and is known to those who are in  

the  market,  as  having  an  identity  as  a  distinct  and  identifiable  

commodity, that the article is subject to excise duty.   Simply because  

certain  articles  fall  within  the  Schedule  does  not  make  them  

marketable.  Actual sale in market is not necessary, but the articles  

must be capable of being sold in the market or known in the market as  

goods.    

22)          In Moriroku UT India (P) Ltd. vs. State of Uttar Pradesh and Ors.,  

(2008) 4 SCC 548, it  was observed that excise duty is a levy on a  

taxable event of ‘manufacture’.  Liability under excise law is event  

based on manufacture and irrespective of whether the goods are sold  

or captively consumed.  Excise duty is not concerned with ownership  

or sale.   

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23)        Having said so in so far as exciseability of Goods for the purpose of  

duty under the Act, we may notice the purpose and object of Drugs  

Act.  In our opinion, the main object or real purpose of the Drugs Act,  

1940 and Rules made thereunder,  is to regulate the manufacture of  

drugs in order to maintain the standard or quality of drugs for sale and  

distribution  as  a  drug.  This  Court  in  State  of  Bihar  v.  Shree  

Baidyanath Ayurved Bhawan (P) Ltd., (2005) 2 SCC 762, has held:  

“14. … The object of the Drugs Act is to maintain the quality   of  drugs as  drugs.  Its  use as  any other  commodity  in  the  hands of the consumer is not regulated. Hence, the Drugs  Act  is  relatable  to  Entry  19  of  List  III,  which  deals  with   drugs and poisons, subject to Entry 59 of List I regarding   opium. Lastly, the said Act regulates the manufacture of drug  for sale and distribution as a drug.”  

24)        Therefore, any requirement or condition imposed by the Drugs Act  

and Rules made thereunder, is in furtherance of its above stated object  

of regulating and maintaining the quality of Drugs.  

25)        The primary object of the Act is to raise revenue by imposing duty  

on  goods  that  are  manufactured  as  mentioned  above  (see  Kedia  

Agglomerated  Marbles  Ltd.  v.  CCE,  (2003)  2  SCC 494).  In  other  

words, the scope of the Act extends to the event of manufacture of  

goods, for the levy of excise duty. These two Statutes and the Rules  

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made  thereunder,  operate  in  entirely  two  different  fields  having  

different objects, purposes and schemes. The conditions or restrictions  

contemplated by one statute should not be lightly and mechanically  

imported  and  applied  to  fiscal  statue  for  non  levy  of  excise  duty,  

thereby  causing  a  loss  of  revenue.  This  Court  in CCE  v.  Shree  

Baidyanath Ayurved Bhavan Ltd., (2009) 12 SCC 419 has held:

“55. True it is that Section 3(a) of the Drugs and Cosmetics   Act,  1940 defines  “Ayurvedic,  siddha or  unani  drug” but   that  definition is  not  necessary to be imported in the new  Tariff  Act.  The  definition  of  one  statute  having  different   object, purpose and scheme cannot be applied mechanically   to another statute. As stated above, the object of the Excise   Act  is  to  raise  revenue  for  which  various  products  are   differently classified in the new Tariff Act.”

26)       Therefore, the prohibition on the sale of Physician Samples intended  

for distribution to medical practitioners as free samples by Rule 65  

(18) of the Drugs Rules shall have no bearing or effect upon the levy  

of excise duty under the Act, since excise is a duty on manufacture,  

duty is payable whether or not goods are sold.  Excise duty is payable  

even in case of free supply, since sale is not a necessary condition for  

charging duty under the Act.   

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27)     Even assuming that Shri. Ganesh is correct, when he contends that  

physician samples are not allowed to be sold in the open market in  

view  of  the  statutory  prohibition  on  their  sale,  and  hence  are  not  

marketable; the Revenue is only concerned with the manufacture of  

the goods and the possibility of marketability of the goods. When the  

product is manufactured by a Pharmaceutical Company, it is for the  

purpose of sale i.e., every such product including Physician Sample is  

capable  of  being  sold  in  the  open  market,  but  the  pharmaceutical  

company makes the choice to distribute the same as a free sample. In  

other words, it is not mandatory for the pharmaceutical company to  

distribute free physician samples of every drug they manufacture. This  

choice made by the pharmaceutical companies in terms of Rule 96 (1)  

(ix) of the Drugs Rules by overprinting words ‘Physician’s sample-

Not to be sold’ on the label of the drugs will not come in the way of  

the Revenue from levying excise duty on the drugs so manufactured.

28)      We agree with Shri Ganesh, learned senior counsel for the appellant,  

that the manufacture of patent and proprietary drugs is completed only  

after the labelling is completed, for the purpose of levy of excise duty.  

However, on a perusal of the labelling provisions in the Drug Rules,  

we find that they deal with the name of drug, contents of the drug,  

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name and address of manufacturer, a distinctive batch number (details  

of manufacture of drug is recorded and available for inspection as a  

particular batch), preparation of drug, date of manufacture and date of  

expiry of drug,  its  storage conditions,  etc.,  which are in aid of the  

object of the Act, viz. promoting the use of good quality drugs, and  

ensuring that drugs that do not live upto quality do not find their way  

into the market.  Rule 96 (1) (ix) of the Drug Rules on which Shri  

Ganesh heavily relies in support of his submission, states that while  

complying with the labelling provisions under clauses (i) to (viii) of  

Rule  96  (1),  the  manufacturer  must  further  overprint on  the  label  

‘Physician’s  Sample  –  Not  to  be  Sold’,  in  case  they  are  to  be  

distributed  free  of  cost  as  physicians  samples.  Further,  the  bare  

perusal of Rule 96 shows that its heading bears ‘Manner of Labelling’  

and  clause  1  of  this  Rule  contemplates  or  govern  the  manner  of  

labelling in a way that the particulars on the label of the container of a  

drug shall be either printed or written in indelible ink and shall appear  

in conspicuous manner. This gives ample clarification that the process  

of labelling is distinct or different from the overprinting on the label  

of a physician’s sample, and hence we are unable to agree with him  

that the manufacture for the purpose of the Central Excise Tariff Act  

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is not completed until ‘Physicians Sample – Not to be Sold’ is printed  

on the label.  

29)     The primary reason of distributing free physician samples by the  

manufacturer of pharmaceutical drugs to us appears to be only for the  

purpose of advertising of the product and thereby enhancing the sale  

of the product in the open market. It has been shown by research that  

the market of a pharmaceutical company is enhanced substantially by  

the  distribution  of  free  physician  samples.  In  other  words,  the  

distribution of such physician samples serves as a marketing tool in  

the hands of the pharmaceutical companies [See Sarah L. Cutrona et  

al., Characteristics of Recipients of Free Prescription Drug Samples:   

A  Nationally  Representative  Analysis,  98  Am.  J.  Pub.  Health  284  

(2008)].

30)     Before we conclude, in our view, the issue raised in these appeals is  

no more res-integra.  This issue came up for consideration before this  

Court in the case of Ranbaxy Laboratories Ltd. Vs. Commissioner of   

Central Excise, Pune, (2003) 9 SCC 199, wherein it was held:  

“1. In these appeals,  the question is whether free medical   samples supplied to the doctors are liable to excise duty. In   our  view,  this  question  is  answered  by  a  decision  of  this   Court rendered today in Civil Appeal No. 3643-44 of 1999.

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2. However, in these matters one further question arises i.e.   how are the samples to be valued. The question arises as to   whether the price of physician samples are to be worked out   on pro-rata basis for the samples as per Section 4(1)(b) of   the  Central  Excise  Act  read with  Rules  7 and 6(b) of  the  Central  Excise  (Valuation)  Rules,  1975  or  on  some other   basis. The Tribunal has not decided this question even after   holding that the goods were excisable. We, therefore, remit   these  matters  back  to  the  Tribunal  for  a  decision  on  this   point. The appeals stand disposed of accordingly. No order   as to costs.”

31)       This Court, while passing the aforementioned order, has relied on the  

judgment and order passed in the case of  Bharat Heavy Electricals   

Ltd. v. Commissioner of Customs & Central Excise, (2003) 9 SCC 185  

[referred to as Civil Appeal No. 3643-44 of 1999], in which this Court  

held:

“4. It is next submitted that the value of an assessable goods   can be  zero.  It  is  submitted  that  when a part  is  replaced  under  a  warranty  to  the  assessee  the  value  is  zero.  It  is   submitted that as the value is zero, no excise duty should be  payable  on  that  part.  We  are  unable  to  accept  this   submission  also.  In  order  to  promote  sales  manufacturers   and dealers very often offer incentives e.g. supply of free TV   or  some other  equipment  or  goods.  One  of  the  incentives   offered, is a warranty to replace a part within a particular   period. Merely because manufacturers and dealers choose to   offer  such incentives  does not  mean that  goods which are  otherwise excisable, should be exempted from paying excise   duty.  When  offering  the  incentive,  the  manufacturer  or   dealer  is  choosing  to  take  upon himself  the  cost  of  those   goods.  So  far  as  the  Revenue  is  concerned,  those  goods   remain excisable.”

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32)        This Court has consistently held that the medical supplies supplied  

to the Doctors are liable to excise duty.  Elaborate consideration may  

not  be forthcoming in these judgments,  but,  in our view, the issue  

stands concluded.  We say so for the reason that this Court, in catena  

of cases, has opined that in case, the appeal has been dismissed in the  

absence of detailed reasons or without reasons, such order will entail  

the application of the doctrine of merger, wherein the superior court  

upholds the decision of the lower court from which the appeal has  

arisen.  In  the  case  of  V.M.  Salgaocar  & Bros.(P)  Ltd.  Vs.  C.I.T.,  

(2000) 5 SCC 373, this Court held:

“8. Different  considerations  apply  when  a  special  leave  petition  under  Article  136  of  the  Constitution  is  simply   dismissed  by  saying  “dismissed”  and  an  appeal  provided   under  Article  133  is  dismissed  also  with  the  words  “the   appeal is dismissed”. In the former case it has been laid by  this Court that when a special leave petition is dismissed this   Court does not comment on the correctness or otherwise of   the order from which leave to appeal is sought. But what the   Court means is that it does not consider it to be a fit case for   exercise  of  its  jurisdiction  under  Article  136  of  the  Constitution. That certainly could not be so when an appeal   is  dismissed  though  by  a  non-speaking  order.  Here  the   doctrine of merger applies. In that case, the Supreme Court   upholds the decision of the High Court or of the Tribunal   from which the appeal is provided under clause (3) of Article   133. This doctrine of merger does not apply in the case of   dismissal of a special leave petition under Article 136.”

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33)         In the case of Kunhayammed v. State of Kerala, (2000) 6 SCC 359,  

it was held:  

“41. Once  a  special  leave  petition  has  been  granted,  the   doors for the exercise of appellate jurisdiction of this Court   have been let open. The order impugned before the Supreme  Court becomes an order appealed against. Any order passed  thereafter would be an appellate order and would attract the  applicability  of  doctrine  of  merger.  It  would  not  make  a  difference  whether  the  order  is  one  of  reversal  or  of   modification  or  of  dismissal  affirming  the  order  appealed   against. It would also not make any difference if the order is   a speaking or non-speaking one.  Whenever this Court has  felt inclined to apply its mind to the merits of the order put in   issue before it though it may be inclined to affirm the same, it   is customary with this Court to grant leave to appeal and   thereafter  dismiss  the  appeal  itself  (and  not  merely  the   petition  for  special  leave)  though  at  times  the  orders   granting  leave  to  appeal  and  dismissing  the  appeal  are   contained in the same order and at times the orders are quite   brief. Nevertheless, the order shows the exercise of appellate   jurisdiction  and therein  the  merits  of  the  order  impugned  having been subjected to judicial scrutiny of this Court.

42. “To merge” means to sink or disappear in something  else; to become absorbed or extinguished; to be combined or   be swallowed up. Merger in law is defined as the absorption  of  a thing of  lesser importance by a greater,  whereby the   lesser ceases to exist,  but the greater is not increased; an  absorption  or  swallowing  up  so  as  to  involve  a  loss  of   identity and individuality. (See Corpus Juris Secundum, Vol.   LVII, pp. 1067-68.)”

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34)        It is settled law that this Court should follow an earlier decision  

that has withstood the changes in time, irrespective of the rationale of  

the view taken.  It was held by a Constitution Bench in the case of  

Waman Rao v. Union of India, (1981) 2 SCC 362:

“40. It is also true to say that for the application of the rule   of stare decisis, it is not necessary that the earlier decision   or  decisions  of  longstanding  should  have  considered  and  either accepted or rejected the particular argument which is   advanced  in  the  case  on  hand.  Were  it  so,  the  previous   decisions  could  more  easily  be  treated  as  binding  by   applying the law of precedent and it will be unnecessary to   take resort to the principle of stare decisis. It is, therefore,   sufficient for invoking the rule of stare decisis that a certain   decision was arrived at on a question which arose or was  argued, no matter on what reason the decision rests or what   is the basis of the decision. In other words, for the purpose of   applying the rule of stare decisis, it is unnecessary to enquire   or  determine  as  to  what  was  the  rationale  of  the  earlier   decision which is said to operate as stare decisis. …”

35) Now we may notice the decisions on which reliance placed by  

learned senior counsel Shri Ganesh.  In  Delhi Cloth and General   

Mills Vs. Joint Secretary, 1978(2) ELT (J121) (Delhi High Court),  

the question before the court was whether calcium carbide, which  

does not comply with regard to purity and packaging with statutory  

rules answers the test of ‘Marketability’.   The Court on facts has  

found that the calcium carbide manufactured by the company was  

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for further utilization in the production of acetylene gas was not of  

purity that rendered it marketable nor was it packed in such a way as  

to make it  marketable  that  is  to say,  in air  tight containers.   The  

Court  has  further  noticed  that  the  commodity  in  question  would  

require further processing to make it marketable and therefore, the  

commodity in question is not marketable and hence, not excisable.

36) Reliance is placed on the decision of CESTAT in Amar Lal Vs.   

CCE,  (2004)  172  ELT  466.   That  was  a  case  where  assessee  

manufactured a new drug for trial  which were supplied for clinical  

trials.   In  view  of  the  Drugs  Control  Act  and  the  Rules  framed  

thereunder, any drug could be marketed only after successful clinical  

trials and after approval and licence from Drugs Controller.  Hence,  

the Tribunal held that the drug supplied free for clinical trials is not  

excisable Goods as it cannot be bought and sold at that stage.

37) In  Pfizer vs. Commissioner of Central Excise 2002 (146) ELT  

477,  the  question  before  the  Tribunal  was,  whether  excise  duty  is  

leviable on ‘Sugar syrup’ manufactured by the assessee for use in the  

manufacture by it  for cough syrup. The Tribunal, while answering the  

issue, has stated that since the sale of Sugar Syrup containing artificial  

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sweetener  sodium  saccharin  would  contravene  the  provisions  of  

Prevention  of  Food  Adulteration  Rules,  the  Goods  cannot  be  

considered as marketable.

38)    In  Hindustan Petroleum Corporation Ltd. vs. CCE, (2007)  

210 ELT 407 (CESTAT), it was a case where assessee manufactured  

‘diesel stem’ by refining the sour crude for captive consumption and  

sale in the market.  The sale of ‘diesel stem’ containing high sulphur  

content was prohibited by Ministry of Petroleum and Natural Gas in  

the light of the notification issued by Ministry of Environment and  

Forest  for preventing environmental  pollution caused by emission  

due  to  burning  of  sulphur   along  with  fuel.   In  the  light  of  the  

notification issued by Ministry of Environment & Forest, the ‘diesel  

stem’ in its high content of sulphur is incapacitated from being sold  

in  the  market.   In  other  words,  this  inherent  incapability  in  the  

ingredients of the Goods, from being sold in the market  makes it  

non-marketable and hence not excisable.

39)       In Himalaya Drug Company vs. C.C.E., (2005) 187 ELT 427, the  

question  before  the  Tribunal  was,  whether  the  excise  duty  is  

leviable on ‘vegetable extracts’ manufactured by the assessee for  

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use in the manufacture of Ayurvedic, Unani or Siddha Medicines.  

The  Tribunal,  while  answering  the  issue,  concluded  that  such  

vegetable extracts,  unless subjected to  preservative process, are  

not liable to be considered as Goods attracting  excise duty and  

such Goods should be considered  as  only intermediary  Goods.  

Further,  in view of the fact  that the licence issued by the Drug  

Controller  prohibits  assessee  from  selling  such  semi  finished  

products. Therefore, the Tribunal concluded that such intermediary  

or  semi  finished  Goods  manufactured  by  assessee  cannot  be  

compared with the products manufactured by others for sale, for  

the purpose of ‘marketability’.

40)   In our considered view, the reliance placed by the learned  

senior counsel for the appellant on some of the decisions of the  

Tribunal would not assist him in support of his submission for  

the reason that the goods therein were not marketable and hence,  

excise  duty  was  not  leviable,  not  because  of  any  statutory  

prohibition for the sale of the goods, but because they had not  

reached the stage of  satisfying the  test  of  marketability  of  the  

goods.   

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41) Now coming to the valuation of the physician samples for  

the purpose of levy of excise duty, in our view, this issue need  

not detain us long in view of the decision of this Court in the case  

of Commissioner of Central Excise vs. M/s. Bal Pharma [Civil  

Appeal No. 1697 of 2006].  This Court has upheld the conclusion  

of the Tribunal that the physician’s samples have to be valued on  

pro-rata  basis.   The  Tribunal,  while  arriving  at  the  aforesaid  

conclusion,  had  relied  upon its  earlier  decision  in  the  case  of  

Commissioner  of  Central  Excise,  Calicut  vs.  Trinity   

Pharmaceuticals Pvt. Ltd., reported as 2005 (188) ELT 48, which  

has been accepted by the department.  Therefore, we hold that  

physician  samples  have to be valued on pro-rata  basis  for  the  

relevant period.   

42)   In view of the above discussion, we pass the following order:-

a) Civil Appeal No. 3626 of 2005 is allowed and the matter  

is  remitted to the Adjudicating Authority with a direction to  

value the goods in question on pro-rata basis for the relevant  

period.    

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b) We dismiss Civil Appeal Nos. 1354-1355 of 2010.  Parties  

to bear their own costs.

 …………………

………J.                                                                                     [ D.K. JAIN ]

          ....………………………J.  [ H.L. DATTU ]

New Delhi, January 14, 2011.

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