Telangana High Court
Swiss Gamier Life Sciences A Registered ... vs Drugs Inspector, Abids Zone Sales, on 11 June, 2025
1
THE HONOURABLE SRI JUSTICE E.V. VENUGOPAL
CRIMINAL PETITION No.4186 OF 2023
O R D E R:
This Criminal Petition is filed seeking to quash the
proceedings against the petitioners/accused Nos.1 to 3 in
C.C.No.3855 of 2019 on the file of the learned X Additional Chief
Metropolitan Magistrate, at Secunderabad (for short, "the trial
Court") registered for the offences under Section 18(a)(iv) r/w.
Rule 106 and Sl.Nos.42 & 51 of Schedule 'J' punishable under
Section 27(d) of the Drugs and Cosmetics Act, 1940 (for short,
"the Act").
2. Heard Mr.Dammalapati Srinivas, learned senior counsel
representing Mr.Karan Talwar, learned counsel for the petitioners
and Mr.E.Ganesh, learned Assistant Public Prosecutor appearing
for respondent No.2-State.
3. The brief facts of the case are that on 07.12.2015
respondent No.1/complainant received credible information that
the firm of M/s.Mankind Pharma Limited, D.No.1-3-
183/40/21/63/A & 62/2 & 62/2A, (Ground Floor) and III Floor,
P & T District has stocked Pilorute cream labeled with indication
of "Varicose veins and Haemorrhoids (Piles)" for sale; that LW1
along with LWs.2 and 3 proceeded to the premises of LW4. Upon
search in the above shop, the drug 'Pilurute cream (Troxerutin,
Calcium Dobesilate, Zinc, Phenylephrine, Legnocaine with
Hydrocortisone Cream), Batch No.B1CTO027, Mfg.date:08/2015,
Expiry Date:10/2016, Manufactured in India by: Swiss Garnier
Life Sciences, 21 to 23, Industrial area, Mehatpur, Distt.UNA (HP)
-174315 labelled with indication of 'Varicose veins and
Haemorrhoids (Piles)' was found stocked in the premises for sale
along with other saleable drugs thereby contravening Section
18(a)(iv) r/w Rule 106 r/w Sl.No.42 & 51 of Drugs & Cosmetics
Act, 1940 & Rules 1945. Hence, LW1 seized the subject drug, 20
x 30 gms of Pilorute cream, from the premises of LW4 by enlisting
the details of subject drug in Form-16 under the cover of
panchanama. Basing on the said facts, the present crime is
registered.
4. Learned counsel for the petitioners submitted that in
similar circumstances, this Court vide order dated 02.03.2023 in
Crl.P.No.2502 of 2021 and order dated 06.04.2006 in
Crl.R.C.No.1121 of 2002 quashed the proceedings against the
petitioners therein. Relying on the aforesaid decisions, learned
counsel seeks to allow the Criminal Petition.
5. Learned Assistant Public Prosecutor submits that the
matter requires to be tried and seeks to dismiss this Criminal
Petition.
6. The basis on which the prosecution is launched by the
Drug Inspector is that the said Drug Pilorute cream is labeled
with an indication of "Varicose veins and Haemorrhoids (Piles)"
and such indication would amount to violation of 18(a)(iv) r/w
Rule 106(1) r/w Sl.No.42 and 51 of Drugs & Cosmetics Act, 1940
(for short 'the Act') & Rules 1945.
7. For the sake of convenience Section 18(a)(iv) of the Act and
Rule 106 of Drugs Rules, 1945 are extracted hereunder:
"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 on this behalf_
(a) manufacture for sale [or for distribution], or sell, or stock or
exhibit [or offer] for sale, or distribute___
(i).....
(ii)...
(iii)...
(iv). Any drug which by means of any statement, design or devise
accompanying it or by any other means, purports or claims [to
prevent, cure or mitigate] any such disease or ailment, or to have
any such other effect as may be prescribed;"
"106. Diseases which a drug may not purport to prevent or
cure.(1) No drug may purport or claim to prevent or cure or may
convey to the intending user thereof any idea that it may prevent
or cure, one or more of the diseases or ailments specified in
Schedule J.
(2) No drug may purport or claim to procure or assist to procure,
or may convey to the intending user thereof any idea that it may
procure or assist to procure, miscarriage in women."
8. For the sake of convenience, the words in label is also
extracted which is as follows:
"Troxerutin, Calcium Dobesilate, Zinc, Phenylephrine,
Lignocaine with Hydrocortisone Cream"
9. To attract an offence under Section 18(a)(iv) of the Act, a
statement must have been made or designed in such manner or
any devise accompanying the drug or by any other means, claims
or purports to prevent, cure or mitigate (lessening pain etc) any
disease or ailment, amounts to an offence, which is made
punishable under Section 27(d) of the Act. It is necessary that
either the labelling or in any manner manufacturer must have
claimed that the drug prevents or cures or mitigates any disease.
10. The basis for prosecution is 'indication' of varicose vein and
piles. Indication means 'to point out' according to the dictionary.
As seen from the label, there is nothing pointing to Varicose veins
and Haemorrhoids (Piles) specifically. However the label gives the
details of the contents of the drug and its trade name as 'Pilorute'
A normal person cannot infer that the label claims to prevent,
cure or mitigate/lessen the problem of either Varicose veins or
Haemorrhoids (Piles).
11. It is not the case that the drug is of either sub-standard
quality or there are contents which have any kind of adverse
effect on the health of a person if used, the claims made on the
label are prima-facie not violative of section 18(a)(iv) of Drugs Act.
12. Learned counsel appearing for the petitioners relying on the
judgment of this Court in Criminal Petition No.1128 of 2018,
dated 29.11.2018; ii) Chennakeshava Bandage and Gauge Cloth
Manufacturing Unit, Tadiparthi v. State of Andhra Pradesh 1; iii)
judgment of this Court in Criminal Revision Case No.1121 of
2002 dated 06.04.2006; iv) State of Maharashtra v.
R.A.Chandawarkar 2, argued that the Drug Inspector has no
authority to file the Complaint.
13. According to Schedule J of Drugs Rules 1945, a drug may
not purport, or claim to prevent or cure or make false claim to
prevent or cure or may convey to the intending user any idea that
it may prevent or cure, one or more of the diseases or ailments
specified therein.
(2010) 1 ALD (Crl) 24
2 1999 Law Suit (Bom) 116
14. As already discussed above, the label which is extracted
above does not make a mention about either Piles, Haemorrhoids
or Varicose veins. This Court in the case of 'USV Private Limited
v. State of Telangana' in Criminal Petition No.1128 of 2018 by
order dated 29.11.2018 quashed the proceedings when the drug
'Anovate' claimed on the cover as 'for the treatment of external &
internal piles'. In the present case no such mention of any
disease or ailment is made on the label.
15. Having regard to the submissions of both the learned
counsel and in view of the above discussion, the proceedings in
so far as the petitioners/accused Nos.1 to 3 in C.C.No.3855 of
2019 on the file of the learned X Additional Chief Metropolitan
Magistrate, at Secunderabad are hereby quashed.
16. Accordingly, Criminal Petition is allowed.
Miscellaneous Petitions, pending if any, shall stand closed.
_____________________
E.V.VENUGOPAL, J
Date: 11.06.2025
ESP
THE HON'BLE SRI JUSTICE E.V. VENUGOPAL
CRIMINAL PETITION No.4186 OF 2023
Dated: 11.06.2025
ESP
