Read:- 1. Application dated 20th September,
2005 of M/s. Neham International., holder of Registration
Certificate No. 400086/S/6724 dated 10.09.2004.
2. This office letter dated 16th January,
2006 calling the applicant for hearing on 18th January,
2006.
Heard:- Shri. Ratan Samal, Advocate attended on behalf of
the applicant.
PROCEEDINGS
(Under Section 56 of the Maharashtra Value Added Tax Act,
2002)
No.DDQ-11-2005/Adm-5/77/B-4
Mumbai, dt.10/04/2006
An application is received from M/s. Neham
International of 1/1, Swami Lila Shah, Garden Lane, L.B.S.
Marg, Ghatkopar (West), Mumbai-400 086, posing for
determination the question as regards the Schedule Entry and
rate of tax applicable to the following products :
1.
Stent
2.
Tracheostomy Tube, Endobronchial Tube, Performed
Tracheal Tube and other Anesthesia and critical care
products.
The applicant is of the opinion that with the
introduction of Maharashtra Value Added Tax Act, 2002 which
repealed the earlier Bombay Sales Tax Act, 1959, there are a
lot of changes in respect of the definitions and schedule
rates under the new Act. Hence to have a confirmed view, he
has presented this application for determination.
02. DETAILS SUBMITTED ALONG WITH THE APPLICATION
1.
Copy of Sale Invoice No. 117 dt. 9.5.2005.
2. A detailed written submission.
3. Proof of payment of fees.
4. Letter of authority authorising Shri Ratan Samal,
Advocate to attend on behalf of the applicant.
5. An order by the Food & Drugs Administration in
respect of the product “Drug Eluting Stent”.
6. Copies of the various judgments on which the
applicant relies in support of his claim for the schedule
entry applicable to his products :
03. BACKGROUND OF THE CASE
The applicant is a registered dealer under the
Maharashtra Value Added Tax Act, 2002. The applicant
carries on the business of importing and reselling of
various types of drugs including Stent, Anesthesia and
critical care products. The applicant holds valid licenses
under the Drugs & Cosmetics Act, 1940 for the above
products. Considering the introduction of Value Added Tax
with effect from 1.4.2005, the applicant is in a dilemma as
regards the rate of tax applicable to the products mentioned
hereinabove. The products are sold to different hospitals
and medical stores. The products could be discussed as
follows :
1.
Stent : The applicant in his submission states
that the use of the stent reduces incidents of restonsis
(recurrence of blockages in artery due to clotting of
blood). The stent is implanted inside the artery during the
angioplasty procedure. In the procedure, the catheter is
used to infuse the implanted stent inside the artery with a
drug called Pacitaxel. Some stents are also coated with
Sirolimus and Pacitaxel drugs.
2. Tracheostomy Tube, Endobronchial Tube,
Performed Tracheal Tube and other Anesthesia and critical
care products : These products are used to connect the
oxygen cylinders on the one side and the other end is
connected to the patients. They are either put into the nose
or the trachea. The applicant submits that these products
help the patients in breathing as well as to control cough
inflation. They are critical care products.
The applicant submits that various
brands of the above products are available in India. The
price range of Stent varies from Rs. 35,000/- to Rs.
1,25,000/-. The physicians who handle these equipments have
received appropriate training to perform such
implantations.
The applicant is of the view that the products are drugs as
understood by Schedule Entry C-29/C-29(a) of the Maharashtra
Value Added Tax Act, 2002.
04. CONTENTION AND HEARING
The applicant submits that in view
of the legal position and judicial pronouncements so far,
the products may be treated as drugs falling under Schedule
Entry C-29/C-29(a) of Maharashtra Value Added Tax Act, 2002,
thereby attracting tax @ 4%. The applicant also submits that
the products can alternatively be classified as devices
under Schedule Entry C-29A (a) or C-107(8) of the
Maharashtra Value Added Tax Act, 2002.
Shri Ratan Samal, Advocate attended on behalf of the
applicant on 18th January,
2006. He contended that cardiac stent should be classified
as a drug and medicine as per Schedule Entry C-29/C-29(a)
and not as device as per the Entry C-29A (a). In respect of
the product “Anesthetic Mask”, he stated that the same is
covered by the notification to the Schedule Entry 107(8) of
the Maharashtra Value Added Tax Act, 2002.
In the alternative, it is prayed that if the
products are not determined to be either drugs or medical
devices and subjected to tax @ 12.5% by virtue of falling
under the residuary Entry E-1, the applicant's past
liability may be protected till the date of the
determination order.
05. OBSERVATIONS
The applicant has contended that the products
get classified as drugs and therefore fall under Schedule
Entry C-29/C-29(a) of the Maharashtra Value Added Tax Act,
2002 which is for drugs. The applicant also prays that if
the products are classified as devices falling under
Schedule Entry C-29A (a) or C-107(8) then, this
determination may be given a prospective effect.
I propose to go through the case as follows :-
[A] Ascertaining the meaning
of the three schedule entries.
[B] Ascertaining the nature
and use of the products.
[C] Ascertaining the
connecting link, if any between the Schedule entries and
the impugned products.
[A] SCHEDULE ENTRIES
Let me reproduce the relevant schedule entries
under the Maharashtra Value Added Tax Act, 2002 before
proceeding with the discussion on the same.
|
Schedule entry No. |
Description |
Rate of Tax |
Date of Effect |
|
C-29 |
Drugs (including
Ayurvedic, Sidha, Unani, spirituous Medical Drugs and
Homoeopathic Drugs), being formulations or preparations
conforming to the following descriptions:-
Any medicinal
formulation or preparation ready for use internally or
on the body of human beings, animals and birds for
diagnosis, treatment, mitigation or prevention of any
diseases or disorders, which is manufactured or imported
into India, stocked, distributed or sold under licence
granted under the Drug and Cosmetic Act,1940, and
includes devices notified by the Central Government
under sub-section (iv) of clause (b) of section 2 of the
said Act, but does not include mosquito repellants in
any form. |
4% |
1-4-2005 to
30-4-2005. |
|
C-29 |
Drugs (including
Ayurvedic, Sidha, Unani, spirituous Medical Drugs and
Homoeopathic Drugs), being formulations or preparations
conforming to the following descriptions:-
Any medicinal
formulation or preparation ready for use internally or
on the body of human beings, animals, and birds for
diagnosis, treatment, mitigation or prevention of any
diseases or disorders, which is manufactured or imported
into India, stocked, distributed or sold under licence
granted under the Drug and Cosmetic Act,1940 but does
not include mosquito repellants in any form. |
-d0- |
1-5-2005 to 31-01-2006 |
|
C-29 |
29(a) Drugs
(including Ayurvedic, Sidha, Unani,
spirituous
Medical Drugs and Homoeopathic
Drugs),
being formulations or preparations
conforming
to the following description:-
Any medicinal
formulation or preparation ready for use internally or
on the body of human beings, animals, and birds for
diagnosis, treatment, mitigation or prevention of any
diseases or disorders, which is manufactured or imported
into India, stocked, distributed or sold under licence
granted under the Drug and Cosmetic Act,1940 but does
not include mosquito repellants in any form.
(b)
Medical Oxygen and Nitrous Oxide
manufactured under licence granted under the Drug and
Cosmetic Act, 1940. |
-d0- |
01.02.06 till date |
|
C-29A |
(a) Devices
notified from time to time by the Central
Government
under sub-clause (iv) of clause (b) of
Section 3 of
the Drugs and Cosmetics Act, 1940.
(b) Bandages
and dressings manufactured or imported
into India,
stocked, distributed or sold under licence
granted under
the Drugs and Cosmetics Act,1940.
(c) Syringes. |
-d0- |
1-5-2005 to till
date.
|
|
C-107 |
(8) Medical
devices and implants as may be notified
from time to
time by the State Government in the
Official
Gazette; |
-do- |
1-5-2005 to
31-01-2006 |
|
C-107 |
(8) Medical
devices and implants as may be notified
from time to
time by the State Government in the
Official
Gazette; |
-do- |
01-02-06 till date. |
Now entries C-29[1-4-2005 to 30-4-2005], C-29A
(a) and C-107(8) speak of notification to be issued for the
purpose of the said entries. It is thought unnecessary to
reproduce the said notifications herein. A mere mention of
the fact, as regards, whether the impugned products are
included in the said notification or not would be
sufficient.
Let me discuss the Schedule entries in the order as
reproduced above.
[1] Schedule Entry C-29/C-29(a) : The entry
pertains to Drugs fulfilling the conditions as laid out in
the said entry itself.
It can be seen that for the period
1-4-2005 to 30-4-2005, the entry on drugs specifically
included devices notified by the Central Government under
sub-section (iv) of clause (b) of section 2 of the Drugs and
Cosmetics Act, 1940. The same was excluded w.e.f 1/5/2005
and a new entry C-29A (a) was formed with the same wording.
Again w.e.f 01.02.06 the entry on drugs was amended. With
this amendment the sub-entry (a) of this entry [C-29] on
drugs pertains to only definition of drugs and the sub-entry
(b) pertains to Medical Oxygen and Nitrous Oxide
manufactured under licence granted under the Drug and
Cosmetic Act, 1940. It can be thus seen that even Medical
Oxygen and Nitrous Oxide had to be specifically mentioned in
the form of a sub-entry to the main entry which pertains to
only definition of drugs.
To qualify as a drug, a product should
satisfy all the five conditions simultaneously:-
1.
It should be a medicinal formulation or preparation
ready for use internally or externally on human beings,
animals and birds.
2.
It is used for diagnosis, treatment, mitigation or
prevention of any disease or disorder.
3.
It should be manufactured or imported into India.
4.
It should be stocked, distributed or sold under
license granted under the Drugs and Cosmetics Act, 1940.
5.
It does not include mosquito repellents in any form.
Of the five conditions, the condition
No. 2 pertaining to diagnosis, treatment, mitigation or
prevention of any disease or disorder is the most important
and decisive test.
During the period 1-4-2005 to 30-4-2005, the entry
on drugs had sought to include devices also by the words
“and includes devices notified by the Central Government
under sub-section (iv) of clause (b) of section 2 of the
said Act”.
The entry was split into two different entries and a
new entry 29A(a) was introduced w.e.f. 01/05/2005 to
specifically include the devices notified by the Central
Government.
The Bombay High Court had an occasion to
interprete the word “including” in case of M/s. Afson
Industrial Corporation, 78 STC 383, and, therein it is
observed that “ The normal function of the word
“including” in an entry, is to indicate that though the
items following the word “including” are of the type of the
main item in the entry, there could be some doubt as to
whether the main entry covered them or not and, therefore,
the legislature specifically mentioned those items in the
entry to remove scope for any doubt.”
The Allahabad High Court in case of Ashoka Dairy, 53 STC
239, had observed that, the word “including” is to be
interpreted as “and”. It is thus clear that whenever word “including”
is used in the Schedule Entry or in notification, it is used
in restrictive sense, so as to specifically include only
those goods which are mentioned therein. The word
“including” in the Schedule Entry leaves no scope to expand
the ambit of the Schedule Entry. In interpreting the
Schedule Entry, one has to look merely at what is clearly
said and there is no scope for any intendment.
The intention of the legislature as reflected in the
Schedule entry appears very distinct and unambiguous. A
product to qualify as a drug has to pass all the five
specifications simultaneously as mentioned in the schedule
entry only. A product to be declared a drug has to be
interpreted only in terms of the Schedule Entry C-29/C-29(a)
of the Maharashtra Value Added Tax Act, 2002.
[2] Schedule Entry C-29A : The Schedule entry has
sub-entries which could be seen
separately as follows :-
i] The sub-entry (a) which came into effect from
1/5/2005 pertains to devices notified from time to time by
the Central Government under sub-clause (iv) of clause
(b) of Section 3 of the Drugs & Cosmetics Act, 1940.
Thus this sub-entry (a) depends on the Drugs &
Cosmetics Act. It does not lay down any specifications
as to the type, nature or category of devices to be
included for the purpose of the entry. It just
notifies only those devices which are notified by the
Central Government for the purpose of the Drugs & Cosmetics
Act, 1940.
ii] The sub-entry (b) which came into effect from
1/2/2006 pertains to Bandages & Dressings which are
manufactured or imported into India and stocked,
distributed or sold under license granted under the Drugs
and Cosmetics Act, 1940. The discussion on this
sub- entry is not relevant in the present case.
iii] The sub-entry
(c) which came into effect from 1/2/2006 pertains to
syringes. Again it is not necessary to discuss this entry
as it is not relevant in the present context.
[3] Schedule Entry C-107(8) : The Schedule entry
speaks of medical devices
and implants notified by the
State Government from time to time in the Official Gazette.
The difference between Schedule Entry C-29A (a)
and C-107(8) is that in the case of the
former the devices are notified by the Central Government
while in the case of the latter, the devices are
notified by the State Government.
[B] NATURE AND USE OF THE PRODUCTS
The products as mentioned in the application are :
1] Stent 2] Tracheostomy Tube 3]
Endobronchial Tube 4] Performed Tracheal Tube 5]
Other Anesthesia & Critical Care products
The products as mentioned in the Invoice put up for
determination are :
1] Coronary Stent Vision 2] Inflation Device
3] Cross it PTCA guidewire 4] Connector Kit
5] Y Connector 6] Manifold Kit
It is informed that the above products fall under two
categories -
1. Stent
2. Anesthesia & Critical Care products
I would discuss the products as follows :
The drug eluting stent was developed to
address the problem of in-stent blockage. The drug embedded
in the stent is released into the lining of the artery,
preventing the growth of scar tissue around the stent, the
primary cause of re-blockage. Coronary stents are often
used with traditional PTCA (balloon angioplasty) to prevent
restenosis and improve the functioning of the coronary
arteries. Thus it goes without saying that the product is a
device.
The other products are of the nature of
anesthesia and critical care products. Their very names such
as connector, wire, etc. suggest their use as a device.
[C] LINK BETWEEN THE SCHEDULE ENTRIES AND
THE PRODUCTS
It needs to be determined whether the
product description matches the description of the Schedule
entry. This being the most essential part of the
observations, I hereby proceed to examine the links, if any.
[1] Stent :
Having discussed the schedule
entries and the products let me have a look at the arguments
and judgments cited by the applicant in support of his claim
of the products being drugs.
[i] The applicant in his written
submission has pointed out the definition of drug under the
Drugs & Cosmetics Act, 1940. The entry C-29 or as the case
may be C-29(a) of the Maharashtra Value Added Tax Act, 2002
is not a referential entry. The entry itself defines the
meaning of the word “drug” for the purposes of this schedule
entry. The entry does not convey that the meaning of the
word “drug” is to be derived from the Drugs Act & Cosmetics
Act, 1940. Thus, the reliance of the applicant on the
meaning of ‘drug’ as per the Drugs Act & Cosmetics Act, 1940
is irrelevant, as far as, the interpretation of schedule
entry C-29 / C-29(a) is concerned.
The applicant further stresses
the point that since the product 'stent' cures diseases like
blockage of artery which helps to avoid heart attacks, the
product gets squarely covered by the definition of ‘drugs’.
[ii] The applicant in his written submission
has mentioned the dictionary meaning of medicine. I do not
feel the need to discuss the definition of medicine as
per the dictionary, the reason being that a product to
be qualified as a drug needs to fulfill the conditions and
specifications as laid down in the schedule entry
C-29/C-29(a) on drugs. Since a specific definition is
provided by the Act itself, the resort to any other means of
interpretation for the product “Drug” in considering the tax
aspect is totally uncalled for.
[iii] The applicant has also submitted a
copy of an order by the Commissioner, Food & Drugs
Administration, Mumbai stressing the mention of the word
“drug” used in relation to the product “drug eluting stent”.
This argument of the appellant also does not hold good as it
is an incorrect and incomplete interpretation of the said
order. The order pertains to obtaining the required
approvals of the Food & Drugs Administration, Maharashtra
and has nothing to do with taxation.
This clause regarding devices
notified by the Central Government was included in the entry
on drugs for the period 1-4-2005 to 30-4-2005. However,
during that period, the product “stent” was not notified by
the Central Government. The product “stent” is notified as a
“Sterile device” only w.e.f. 6.10.2005 for the purpose of
sub-clause (iv) of clause (b) of Section 3 of the Drugs &
Cosmetics Act, 1940.
Hence the argument of the
applicant as regards the tax rate only .for the product
“stent” holds goods for the period from 6.10.2005 onwards
and not the earlier period.
[iv] The applicant has placed reliance on
the following judgments in support of his claim of the
products being “drugs”. I would discuss each one of the
judgments separately as follows :-
[1] M/s. Merind Ltd V/s. State of Maharashtra
[30 STC 11]
It was held by the Bombay High Court that
Diagnostic Kits are medicinal formulations/preparations
taxable under Schedule Entry C-II-37 of the Bombay Sales Tax
Act, 1959 which pertains to Drugs. A Diagnostic Kit
comprises of different types of reagents and solutions which
are assembled and kept in the kit. These reagent and
solutions were medicinal formulations or preparations.
Hence they were drugs.
But in the present case, the products are notified
as devices and not drugs i.e. medicinal formulations or
preparations. Hence the reliance on this case is not of any
help to the applicant.
[2] M/s. TTK Pharma Ltd V/s. The State of
Maharashtra [11 STC 730]:
In this case, it was held that the products such
as micro-porous paper surgical tape, fibreglass casting
tape, dressings, pregnancy test cassette/kit were held as
falling under the Schedule entry C-II-37 of the Bombay Sales
Tax Act, 1959. It was held that the definition of “drugs”
is comprehensive enough to take in not only medicines but
also substances intended to be used for or in the treatment
of diseases of human beings or animals. The view of the
Commissioner as regards pregnancy not being a human disorder
was disagreed by the Tribunal.
In the said judgment, the Tribunal has
interpreted the words ‘treatment’ and ‘diagnosis’ as
appearing in the schedule entry C-II-37. The ratio of this
judgment is not applicable to the facts of this case as the
impugned products are not medicinal formulations and also
they do not satisfy the criterion for a product to be
termed as a medicine.
[3] Determination Order by the Commissioner,
Maharashtra State, in the case of M/s. Boehringer
Mannheime India Ltd (dated 4.3.2000):
It was held that “Radiopaque
Bone Cement” is covered by the Schedule Entry C-II-37 of the
Bombay Sales Tax Act, 1959. In this case it was not
disputed that the product is a medicinal formulation since
it had all the characteristics of any ordinary drug and it
was not an implant.
In the present case, the product “stent” is
notified as a “sterile device” by the Central Government
itself in the notification for the purposes of the Drugs &
Cosmetics Act, 1940.The other products are also devices and
not drugs.
[4] [a] Commissioner of Sales Tax, Uttar Pradesh,
Lucknow V/s. Allied Surgical Emporium (Agencies) (63 STC
221) :
It was held by the Allahabad High Court that
Catguts-sutures used for stitching wounds fall under
category of medicine and pharmaceutical preparations and not
under surgical goods. It was held that drugs include all
medicines and also substances used for treatment of human
beings or animals.
[b] Rashtra Deep Laboratory V/s. Commissioner of
Sales Tax, U.P. (53 STC 419):
It was held that “water for injection” falls under
the entry on medicine and pharmaceutical preparations. It
was held that the term “medicine” cannot be confined within
the traditional concept of an article which, by itself, is
enough to cure a human ailment.
The Schedule entry on drugs as per the Uttar
Pradesh Act & Maharashtra Act is structured differently. The
entry under the Uttar Pradesh Act is worded as “medicines
and pharmaceutical preparation”. To interpret a product as
regards, its being a drug, the same has to be interpreted in
terms of the entry as per the relevant Act only. Hence,
this judgment would not be applicable to the present case.
In the present case, the product “stent” is notified as a
“sterile device” by the Central Government itself in the
notification for the purposes of the Drugs & Cosmetics Act,
1940.The other products are also devices and not drugs. The
ratio of both the above cases 4(a) and 4(b) would not apply
to the present case as the impugned products are devices and
not drugs. The other products are also devices and not
drugs.
[5] Commissioner of Income Tax, Lucknow V/s.
Madho PD Jatia (In the Supreme Court of India dt. August 17,
1976) :
The following was observed:
“It is well settled that there
is no equity about tax. If the provisions of a taxing
statute are clear and unambiguous, full effect must be given
to them irrespective of any consideration of equity. Where,
however, the provisions are couched in language which is not
free from ambiguity and admits of two interpretations, a
view which is favourable to the subject should be adopted.
The fact such an interpretation is also in consonance with
ordinary notions of equity and fairness would further
fortify the Court in adopting such a course”.
The facts of the present case are different. Here
the wording of the Schedule Entry on drugs is very clear and
unambiguous. There are no two schedule entries and no two
views involved in the present case. Also the products are
recognized as devices which further dispels of any confusion
or misinterpretation.
[6] Bharat Vijay Mills Ltd V/s. Commissioner of
Commercial Taxes (and another case) (85 STC 23) :
It was held that” if an article is to be taxed
and may fall within two entries , the entry which is more
beneficial to the assessee will have to be accepted as
applicable to the article in question “.
Such is not the case in the present dispute. The
wording of the entry is clear. There are no two entries
which are applicable. The product is recognized as a device
and not as a drug.
[7] Southern Gas Ltd. v/s. State of Kerala
(139 STC 504] :
Medical Oxygen and Nitrous Oxide
were held to be taxed as ‘medicine’ and not under ‘liquefied
gases’ under the Kerala General Sales Tax Act.
The wording of the entry on drugs is
different under the Kerala General Sales Tax Act. Hence,
the ratio of the above case cannot be made applicable to the
present case.
The product 'stent' does not in the first place satisfy the
four fold test of diagnosis, treatment, mitigation or
prevention. Hence, it cannot be said to be a drug as
understood by the entry C-29/C-29(a).
In pursuance of sub-section (iv) of clause (b)
of Section 3 of the Drugs & Cosmetics Act, 1940, the Central
Government has notified sterile devices intended for
internal or external use in human beings as drugs with
effect from 6.10.2005. This notification mentions at serial
nos. (i) and (ii) the following products namely
:
(i) Cardiac Stents (ii) Drug Eluting Stents
This notification having identified stent as a
device, the debate about whether stent is a drug or device
has been put down to rest.
Under the Maharashtra Value Added Tax Act,
2002, we have an independent entry w.e.f 1/5/2005 which
covers such devices notified by the Central Government for
the purpose of sub-clause (iv) of clause (b) of Section 3 of
the Drugs & Cosmetics Act, 1940. In view of the above
notification, with effect from 6.10.2005 the product 'stent'
gets covered by Schedule entry C-29A (a) of the Maharashtra
Value Added Tax Act, 2002 which pertains to devices notified
from time to time by the Central Government. The rate of
tax for the purpose of this entry is 4%.
Now, this product 'stent' has been notified as
a 'device' w.e.f. 6.10.2005. The earlier notification on
devices which was valid up to 5.10.2005 issued by the
Central Government did not include the product. Hence, now
the question arises as regards the schedule entry and rate
of tax for the period 1.4.2005 to 5.10.2005. The answer to
this question lies in the notification itself.
The product is notified as a device which in
other words means that the product is regarded as a device
and is not a drug in the form of a device. It is also
discussed in the earlier part of this order that the product
does not qualify for the test as laid down in the entry
C-29/C-29(a) of the Act. It can thus be safely said that
the product is not a drug. But it is a medical device.
Hence it will not fall under the entry on drugs.
The product gets covered by the Schedule entry
C-29A (a) only with effect from the date of notification
i.e. 6.10.2005. As regards the period prior to 6.10.2005,
the product not being so notified for the purpose of sub
clause (iv) of clause (b) of section 3 of the Drugs &
Cosmetics Act, 1940. It was also not notified by the State
Government, for the purposes of the schedule entry C-107(8)
which is for medical devices notified by the State
Government. This non inclusion in either the schedule
entry for drugs or the schedule entry for medical devices
for the period 1.4.2005 to 5.10.2005, places the product in
the residuary schedule entry E-1, thereby attracting tax @
12.5%.
[2] Other Products
Applying the same law as declared above,
the products such as Tracheostomy Tube, Endobronchial Tube,
Performed Trancheal Tube, Connector Kit, Y Connector,
Manifold Kit, etc. cannot be regarded as drugs.
The very names indicate their use as
devices. They cannot be said to be drugs. They may be sold
under a license granted under the Drugs & Cosmetics Act,
1940. But all the five conditions as put forth by the
schedule entry C-29/C-29(a) need to be fulfilled in order to
be placed in the category of drugs. The products do not
pass the four fold test of diagnosis, treatment, mitigation
or prevention of any disease or disorder. They cannot be
said to cure any disease or disorder.
The products are medical devices or aids
and implants. This fact is not disputed. Thus as regards
the other products, the applicant’s claim of “drugs” does
not hold merit. The products do not qualify the test of a
“drug” as specified in the schedule Entry C-29/C-29(a) of
the MVAT Act, 2002. The use of the products is obvious as a
device and not as a drug. Further to being devices, their
non inclusion in the notification on medical devices and
implants by both the Central and State Governments places
the products out of the coverage of the entries C-29
[1-4-2005 to 30-4-2005] /C-29A (a) and C-107 (8) .In absence
of any mention in either the schedule 'A' or 'C', the
products get automatically placed in the residuary entry
E-1 attracting tax @ 12.5% from 01/04/2005 itself.
06. PROSPECTIVE EFFECT
The applicant has prayed that in case the
products are determined to be falling under neither drugs
nor devices, his liability may be protected by giving the
determination order a prospective
effect i.e from the date of the determination order.
This prayer of the applicant is not
acceptable as the schedule entries appear to me very clear
and self speaking. What is meant by drugs was to be
understood strictly in terms of the schedule entry on drugs.
Also as regards devices, only those devices which were
notified by the Central and State Government were to be
treated as taxable @ 4% for the purpose of the respective
schedule entry.
The criterion to decide a product as drug was
very well present in the schedule entry C-37 for medicine
under the Bombay Sales Tax Act,1959 also. The issue is
decided in a plethora of judgments and put to rest beyond
doubt by various judicial pronouncements. In the
determination order No.DDQ-11-2005/Adm-5/19/B-1 dt.
21/07/2005 in the case of M/s. Inox Products under the
Maharashtra Value Added Tax Act, 2002, the issue is
discussed in detail. In view of the above, I hereby reject
the applicant’s request for prospective effect.
07. CONCLUSION
In view of the elaborate discussion held herein above, I
have to decide that the products presently under
consideration are devices and not drugs within the meaning
of Schedule Entry C-29/C-29(a) of the Maharashtra Value
Added Tax Act, 2002.
The product “stent” being notified as a device under the
Drugs & Cosmetics Act, with effect from 6.10.2005, the same
gets covered by the schedule entry C-29A(a) of the
Maharashtra Value Added Tax Act,2002 attracting tax @ 4%
which is for such devices as notified for the purpose of the
Drugs & Cosmetics Act. But the said device being not
notified earlier to 6.10.2005, for the period starting from
1.4.2005 to 5.10.2005, it would get covered by the residuary
schedule entry E-1 attracting tax @ 12.5%. The coverage of
the said product under the entry on drugs is ruled out. For
the period 1.4.2005 to 5.10.2005, the said device was
neither notified for the purpose of schedule entry
C-29[1-4-2005 to 30-4-2005] which then included devices and
C-29A (a) nor for the purpose of schedule entry C-107(8) of
the Maharashtra Value Added Tax Act, 2002. Hence for the
period 1.4.2005 to 5.10.2005, the product falls under the
residuary Schedule entry E-1 of the Maharashtra Value Added
Tax attracting tax @ 12.5%.
As regards the other products, namely Inflation device,
Cross it. PTCA guide wire, Connector kit,Y Connector,
Manifold kit, the products definitely are not drugs but are
devices. Also they are not notified for the purposes of
Schedule entries
C-29[1-4-2005 to
30-4-2005] which then included devices and C-29A (a) and
C-107(8) which pertain to medical devices and implants.
Hence, they would fall under the residuary Schedule entry
E-1 of the Maharashtra Value Added Tax Act, 2002 attracting
tax @ 12.5% from 01/04/2005 itself.
In view of the deliberations held hereinabove, I propose to
pass an order as follows :-
ORDER
(Under Section 56 of the Maharashtra Value Added Tax Act,
2002)
No.DDQ-11-2005/Adm-5/77/B-04
Mumbai, dt. 10.4.2006
The application for determination as regards the
schedule entry and rate of tax applicable to the products
posed for determination is decided as in the table herein
below. The applicant's prayer for prospective effect is
rejected.
|
SR-NO
|
PRODUCT |
1.4.2005 to 5.10.2005 |
6.10.2005 ONWARDS
|
REMARKS |
|
Schedule entry |
Rate of Tax |
Schedule Entry |
Rate of Tax |
|
1. |
Coronary stent vision. |
E-1 |
12.5% |
C-29A(a) |
4% |
Notified as a device but it is
not a drug. |
|
2. |
Inflation Device |
E-1 |
12.5% |
E-1 |
12.5% |
Not drug but a device. |
|
3. |
Cross it PTCA guide wire. |
E-1 |
12.5% |
E-1 |
12.5% |
Not drug but a device. |
|
4. |
Connector Kit. |
E-1 |
12.5% |
E-1 |
12.5% |
Not drug but a device. |
|
5. |
Y-Connector. |
E-1 |
12.5% |
E-1 |
12.5% |
Not drug but a device. |
|
6. |
Manifold Kit. |
E-1 |
12.5% |
E-1 |
12.5% |
Not drug but a device. |
(B. C. KHATUA)
Commissioner of Sales Tax,
Maharashtra State, Mumbai.