S. ATHILAKSHMI Versus THE STATE REP. BY THE DRUGS INSPECTOR
S. ATHILAKSHMI Versus THE STATE REP. BY THE DRUGS INSPECTOR
Landmark Cases of India / सुप्रीम कोर्ट के ऐतिहासिक फैसले
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REPORTABLE
IN THE SUPREME COURT OF INDIA
CRIMINAL APPELLATE JURISDICTION
CRIMINAL APPEAL NO. OF 2023
(@ SPECIAL LEAVE PETITION (CRL.) No.9978 OF 2022)
S. ATHILAKSHMI ……Appellant(s)
Versus
THE STATE REP. BY THE DRUGS ..…Respondent(s)
INSPECTOR
J U D G M E N T
SUDHANSHU DHULIA, J.
Leave granted.
2. The Appellant before this Court is a registered medical
practitioner who is presently working as an Associate Professor
and the Head of Dermatology Department, in the Government
Omandurar Medical College, Chennai. In the past, she has held
the post of Assistant Professor and Civil Surgeon at Royapettah
Medical College. It is permissible for her under the law to
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practice medicine when she is not performing her official duties.
The Appellant, in her individual and independent capacity was
carrying on her medical practice at a premises which is No. 87,
Red Hills Road (North), Villivakkam, at Chennai. It is here that
she could be consulted and where she meets and examines her
patients.
3. An inspection was made on the above premises by the
Drugs Inspector, Villivakkam Range on 16.03.2016. As per
inspection report, the Drugs Inspector found the following
medicines in the inner room of her premises.
S No. Name of Drug Quantity M.R.P (Rs.)
1. Denidol Lotion
50ml
1 No. 198.50
2. Salico Lotion 30ml 4 Nos. 75/30 ml.
3. ACN Gel 20 gms 1 No. 98/20gms
4. Tebir Gel 10 gms 9 Nos. 47.90/10gms
5. SoltopS.6% Lotion (30ml) 4 Nos. 125/30ml
6. Mycotin Cream 15 gms 3 Nos. 115/15gms
7. Mopry 2% Ointment 4 Nos. 75.60/5gms
8. MomtopS Ointment
(10gms)
1 No. 145/10gms
9. ESM Cream (10gms) 4 Nos. 76/10gms
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10. NuWhitified Ointment
(20gms)
7 Nos. 40/20gms
11. Momesone Cream (15gms) 3 Nos. 82/15gms
12. Sudif Cream (10gms) 4 Nos. 99/10gms
13. CAP Gel (15gms) 1 No. 156/15gms
14. Kenozole Cream (30gms) 2 Nos. 130/30gms
15. SoltopS 3% Ointment 1 No. 125/30gms
16. Zylo AC gel 2.5% (20gms) 1 No. 99.74/30gms
17. Ketzi cream (30gms) 1 No. 99.47/30gms
18. Ketoff lotion (60ml) 2 Nos. 150/60ml
The Drugs Inspector also referred to certain sale bills of
medicines which are as follows:
Sr.
No.
Bill No. & Date Name of the Drug Qty. Sold
1 409 dated
24/02/2016
Mycotin Cream
Nufoce Power
Certrezol – L tablets
1 No.
1 No.
10 Tablets
2 423 dated 9/03/2016 Certivera Lotion
ESM Cream
ILor or Tablets
Cetrezol L Tablets
1 No.
1 No.
10 Tablets
10 Tablets
3 426 dated
11/03/2016
Adixied Tablets
CAP Gel
AFK Lotion
CAN Soap
Zit care Tablets
2 Strips
1 No.
1 No.
1 No.
2 strips
4 424 dated 9/03/2016 P Scab Lotion
1 for Tablets
Loxip Tablets
1 No.
10 Tablets
10 Tablets
5 428 dated
11/03/2016
Cultivera Location
Momesone Cream
Cetrezol – L tablets
1 No.
1 No.
10 Tablets
4. The Drugs Inspector thereafter moved an application for
obtaining sanction from the office of the Director of Drugs
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Control, Tamil Nadu, Chennai06 on 22.09.2016 which was given
to him on 23.01.2018. Consequently, the Drugs Inspector filed a
complaint before the Court of X Metropolitan Magistrate, Egmore,
for prosecuting the Appellant under Section 18(c) of the Drugs
and Cosmetics Act, 1940 punishable under Section 27(b)(ii) of the
Act.
5. Aggrieved by these proceedings, the Appellant filed an
application under Section 482 of the Code of Criminal Procedure,
1973 before the High Court of Madras for quashing the criminal
proceedings. Her petition was dismissed by the Ld. Single Judge
on 21.06.2022. Aggrieved by this, the Appellant has filed Special
Leave Petition before this Court against the order of the Single
Judge.
6. Under Section 18 of Drugs and Cosmetics Act 1940, a
prohibition has been imposed as to the manufacture, sale etc. of
certain drugs and cosmetics. Section 18 reads as follows:
18. Prohibition of manufacture and sale of certain drugs
and cosmetics. — From such date as may be fixed by the
State Government by notification in the Official Gazette in this
behalf, no person shall himself or by any other person on his
behalf—
(a) …………………………………..
(b) [sell or stock or exhibit or offer for sale,] or distribute
any drug [or cosmetic] which has been imported or
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manufactured in contravention of any of the provisions
of this Act or any rule made thereunder;
(c) [manufacture for sale or for distribution, or sell, or
stock or exhibit or offer for sale,] or distribute any drug
[or cosmetic], except under, and in accordance with the
conditions of, a licence issued for such purpose under
this Chapter:
Provided that nothing in this section shall apply to the
manufacture, subject to prescribed conditions, of small
quantities of any drug for the purpose of examination,
test or analysis:
Provided further that the [Central Government] may,
after consultation with the Board, by notification in the
Official Gazette, permit, subject to any conditions
specified in the notification, the [manufacture for sale or
for distribution, sale, stocking or exhibiting or offering
for sale] or distribution of any drug or class of drugs not
being of standard quality.
The punishment for contravention of Section 18(c) is provided
under Section 27(b)(ii) which reads as follows:
27. Penalty for manufacture, sale, etc., of drugs in
contravention of this Chapter— Whoever, himself or by any
other person on his behalf, manufactures for sale or for
distribution, or sells, or stocks or exhibits or offers for sale or
distributes—
(a) xxxxxxxxxxxxxxxxxx
(b) any drug –
(i) xxxxxxxxxxxxxxxxxx
(ii) without a valid licence as required under clause (c) of
section 18, shall be punishable with imprisonment for a term
which shall [not be less than three years but which may
extend to five years and with fine which shall not be less than
one lakh rupees or three times the value of the drugs
confiscated, whichever is more]:
Provided that the Court may, for any adequate and
special reasons to be recorded in the judgment, impose a
sentence of imprisonment for a term of [less than three years
and of fine of less than one lakh rupees];
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7. As we can see the prohibition under Section 18(c) is on the
manufacturing, distribution, stocking or exhibition of medicines
for the purposes of sale. The charge in the present case is that
the Appellant had “stocked” medicines for “sale”. The entire
emphasis is on “sale” of these medicines. This is evident from the
sanction being sought by the Drug Inspector from the office of the
Director, Drugs Control, Tamil Nadu wherein as per the sanction
letter dated 23.01.2018, he had said that the Appellant be
prosecuted for the contravention of:
“Section 18(c) of Drugs and Cosmetics Act 1940 for having ∙stocked
drugs for sale and sold the drugs without having a valid drug
license, which is punishable under section 27(b)(ii) of the said Act”.
Thus, as per the prosecution she had stocked the drugs and sold
them. What the Director of Drugs Control and the High Court lost
sight of is the fact that the Appellant is a registered medical
practitioner, her area of specialization being dermatology. She
has an M.D. (DVL) degree in this specialisation. It is not a case
that she had opened a shop in her premises from where she was
selling drugs and cosmetics across the counter! It is possible that
she was distributing these drugs to her patients for emergency
uses and thus she is protected by the Act itself. Schedule (K)
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which is a part of the Drugs and Cosmetics Rules, 1945 provides
an exemption which we shall examine hereafter.
8. Under Section 33 of the Act, the Central Government can
make rules which have to be laid before the Parliament for its
ratification under Section 38 of the Act. These rules have been
framed which is known as Drugs and Cosmetics Rules, 1940.
Rule 123 of the rules exempts certain drugs from the provisions
of Chapter IV of the Act (which includes both Section 18 and
Section 27 referred above, which are penal provisions), under
certain conditions Rule 123 reads as under:
“123. The drugs specified in Schedule K shall be exempted from
the provisions of Chapter IV of the Act and the rules made
thereunder to the extent and subject to the conditions specified in
that Schedule.”
Entry No. 5 under Schedule (K) are the drugs which are supplied
by a registered medical practitioner with which we are presently
concerned. The relevant provision of Schedule (K) reads as
under:
Schedule K
(See Rule 123)
Class of Drugs Extent and Conditions of
Exemptions
1.xxxxxxxxxxxx xxxxxxxxxxxxxxxxx
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2. xxxxxxxxxxx xxxxxxxxxxxxxxxxx
3. xxxxxxxxxxx xxxxxxxxxxxxxxxxx
4. xxxxxxxxxxx xxxxxxxxxxxxxxxxx
5. Drugs supplied by a registered
medical practitioner to his own
patient or any drug specified in
Schedule C supplied by a registered
medical practitioner at the request of
another such practitioner if it is
specially prepared with reference to
the condition and for the use of an
individual patient provided the
registered medical practitioner is not
(a) keeping an open shop or (b)
selling across the counter or (c)
engaged in the importation,
manufacture, distribution or sale of
drugs in India to a degree which
render him liable to the provisions of
Chapter IV of the Act and the rules
thereunder.
All the provisions of Chapter
IV of the Act and the Rules
made thereunder, subject to
the following conditions:
[1. The drugs shall be
purchased only from a dealer
or a manufacturer licensed
under these rules, and
records of such purchases
showing the names and
quantities of such drugs,
together with their batch
numbers and names and
addresses of the
manufacturers shall be
maintained. Such records
shall be open to inspection by
an Inspector appointed under
the Act, who may, if
necessary, make enquiries
about purchases of the drugs
and may also take samples
for test.]
2. In the case of medicine
containing a substance
specified in [Schedule G, H or
X] of the following additional
conditions shall be complied
with:
a. the medicine shall be
labelled with the
name and address of the
registered medical
practitioner by whom it is
supplied;
b. if the medicine is for
external application, it shall
be labelled with the words
[***] “For external use only” ―
or, if it is for internal use with
the dose;
c. the name of the medicine or
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ingredients of the preparation
and the quantities thereof,
the dose prescribed, the name
of the patient & the date of
supply and the name of the
person who gave the
prescription shall be entered
at the time of supply in
register to be maintained for
the purpose;
d. the entry in the register
shall be given a number and
that number shall be entered
on the label of the container;
e. the register and the
prescription, if any, on which
the medicines are issued shall
be preserved for not less than
two years from the date of the
last entry in the register or
the date of the prescription,
as the case may be.
3. The drug will be stored
under proper storage
conditions as directed on the
label.]
4. No drug shall be supplied
or dispensed after the date of
expiration of potency recorded
on its container, label or
wrapper or in violation of any
statement or direction
recorded on such container,
label or wrapper.]
(emphasis supplied)
It is not the case of the prosecution that the Appellant was selling
drugs from an open shop across the counter. She is a senior
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doctor who is engaged as an Associate Professor and Head of
Department, Dermatology in a Government Medical College, and
being a medical practitioner, under certain conditions, she is also
protected under the law which has been referred to above.
9. Considering the small quantity of medicines, most of which
are in the category of lotions and ointments, it cannot be said by
any stretch of imagination that such medicines could be ‘stocked’
for sale and would come in the category of stocking of medicines
for the purpose of sale. When small quantity of medicine has
been found in the premises of a registered medical practitioner, it
would not amount to selling their medicines across the counter
in an open shop. In fact, this is not even the allegation against
the Appellant. Undoubtedly, the provisions of Section 18 and 27
are relevant provisions under the law, which have a social
purpose, which is to protect ordinary citizens from being
exploited inter alia, by unethical medical practitioners, and for
this reason the punishment under Section 27 can extend up to 5
years under the law, and has a minimum punishment of 3 years.
But given the facts and circumstances of the case and
considering that the Appellant is a registered medical
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practitioner, along with the fact that the quantity of medicines
which have been seized is extremely small, a quantity which can
be easily found in the house or a consultation room of a doctor,
in our considered view no offence is made out in the present
case. In fact, an exception has been created under Schedule ‘K’
read with Rule 123 to the rules, the appellant ought to have been
given the benefit of these provisions and such a registered
medical practitioner should not have been allowed to face a trial
where in all likelihood the prosecution would have failed to prove
its case beyond reasonable doubt. The learned single judge while
dismissing the application under Section 482 Cr.P.C of the
appellant has relied upon a decision of this Court:
"9. It is too late in the day to seek reference to any authority for
the proposition that while invoking the power under Section
482 Cr.P.C. for quashing a complaint or a charge, the Court
should not embark upon an enquiry into the validity of the
evidence available. All that the Court should see is as to
whether there are allegations in the complaint which form the
basis for the ingredients that constitute certain offences
complained of The Court may also be entitled to see {i) whether
the preconditions requisite for taking cognizance have been
complied with or not; and {ii) whether the allegations contained
in the complaint, even if accepted in entirety, would not
constitute the offence alleged
…….
13. A look at the complaint filed by the appellant would show
that the appellant had incorporated the ingredients necessary
for prosecuting the respondents for the offences alleged. The
question whether the appellant will be able to prove the
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allegations in a manner known to law would arise only at a
later stage ... ... ........ ..... "
10. But what the High Court failed to consider, however, is the
provisions contained in Rule 123 read with Schedule ‘K’ to the
1945 Rules and when admittedly it is not the case of the
prosecution that the drugs which were seized were being sold in
an open shop across the counter. Since this was not being done
as visualized above, and an exception is created under the law in
favour of the medical practitioner where the drugs given in
Schedule ‘K’ would be exempted from the purview of Chapter 4 of
the Act, we are of the considered view that prosecution against
the Appellant is unwarranted.
11. The backbone of the Respondent’s case is the sales bills
with the list of 18 drugs seized from the premises of the
Appellant. However, the details of the sales bills and seized drugs
in the Show Cause Notice issued by the Respondent it is seen
that the sales bills are not even for the medicines which have
been seized by the Respondent.
12. On the contrary, upon being served with the Show Cause
Notice, the Appellant was directed, under Section 18A, to reveal
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the name and addresses of persons from whom she obtained the
drugs which were seized. In compliance with the same, Appellant
has produced multiple invoices from pharmaceutical shops to
show her bonafides. Further, upon inspection of the drugs by the
Drugs Testing Laboratory, Tamil Nadu they returned a finding
that the drugs were of ‘standard quality’ which indicates it is not
a case where the Appellant was operating a shop to sell spurious
medicines over the counter.
13. Another factor which must be considered is that the search
was carried out on 16.03.2016 and sanction for prosecution was
sought on 22.09.2016 and the sanction ultimately was given on
23.01.2018. There is no explanation which has been given for
this delay in getting the approval. In the recently decided case of
Hasmukhlal D. Vohra and Anr. v. State of Tamil Nadu1
,
criminal proceedings were quashed against a Petitioner on the
grounds that the substance in question was not a drug under
Indian Pharmacopoeia. One of the considerations was the delay
in the proceedings against which the following observations were
made,
1 2022 SCC OnLine SC 1732
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‘25. In the present case, the Respondent
has provided no explanation for the
extraordinary delay of more than four
years between the initial site inspection,
the show cause notice, and the complaint.
In fact, the absence of such an explanation
only prompts the Court to infer some
sinister motive behind initiating the
criminal proceedings.
26. While inordinate delay in itself may
not be ground for quashing of a criminal
complaint, in such cases, unexplained
inordinate delay of such length must be
taken into consideration as a very crucial
factor as grounds for quashing a criminal
complaint.
27. While this court does not expect a fullblown investigation at the stage of a
criminal complaint, however, in such cases
where the accused has been subjected to
the anxiety of a potential initiation of
criminal proceedings for such a length of
time, it is only reasonable for the court to
expect bareminimum evidence from the
Investigating Authorities.’
14. The sanction for prosecution given in the present case
appears, prima facie, to suffer from the vice of nonapplication of
mind. There is no reference to any of the documents, evidence or
the submissions submitted by either of the parties, no reasons
assigned or even an explanation pertaining to the delay which
indicates it has been passed in a mechani cal manner. This
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Court in the case of Mansukhlal Vithaldas Chauhan v. State
of Gujarat2
, highlighted the importance of a prior sanction
granted under Section 197 of the Code of Criminal Procedure,
1973 while quashing the criminal proceedings instituted against
a Divisional Accountant engaged with the Medium Irrigation
Project Division, Gujarat. It was observed as follows:
‘19. Since the validity of “sanction”
depends on the applicability of mind by
the sanctioning authority to the facts of
the case as also the material and evidence
collected during investigation, it
necessarily follows that the sanctioning
authority has to apply its own
independent mind for the generation of
genuine satisfaction whether prosecution
has to be sanctioned or not.’
15. The possession of the drugs is not disputed in this case by
either side. However, this Court in the case of Mohd. Shabir v.
State of Maharashtra3
while allowing an appeal in part and
directing the release of an Appellant who had been prosecuted
under the provision 18(c) of the 1940 Act, this Court observed
that possession simpliciter would not itself be an offence but the
prosecution had to prove the essential ingredient under Section
2 (1997) 7 SCC 622
3 (1979) 1 SCC 568
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27 which was that even a ‘stock’ of the medicine was for sale. It
was observed as follows:
‘4. …We, therefore, hold that before a
person can be liable for prosecution or
conviction under Section 27(a)(i)(ii) read
with Section 18(c) of the Act, it must be
proved by the prosecution affirmatively
that he was manufacturing the drugs for
sale or was selling the same or had
stocked them or exhibited the articles for
sale. The possession simpliciter of the
articles does not appear to be punishable
under any of the provisions of the Act. If,
therefore, the essential ingredients of
Section 27 are not satisfied the plea of
guilty cannot lead the Court to convict the
appellant.’
16. The sanctioning authority had not examined at all whether
a practising doctor could be prosecuted under the facts of the
case, considering the small quantity of the drugs and the
exception created in favour of medical practitioner under Rule
123, read with the Schedule “K”. All these factors ought to have
been considered by the sanctioning authority. Under these
circumstances we allow this appeal and set aside the order of
the learned Single Judge of the Madras High Court and quash
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the criminal proceedings in Criminal Case No. 7315 of 2018 on
the file of X Metropolitan Magistrate, Egmore, Chennai.
…....…...………….………………. J.
(Krishna Murari)
…………….....……………………. J.
(Sudhanshu Dhulia)
New Delhi,
March 15, 2023.
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