Telangana High Court
Swiss Gamier Life Sciences vs State Of Telangana on 2 March, 2023
Bench: K.Surender
THE HONOURABLE SRI JUSTICE K.SURENDER
CRIMINAL PETITION No.2502 of 2021
ORDER:
1. This Criminal Petition is filed to quash the proceedings
against the petitioners/A1 to A3 in C.C.No.210 of 2017 on the file
of the VIII Metropolitan Magistrate, Cyberabad, now pending before
Principal Junior Civil Judge-cum-XIV Additional Metropolitan
Magistrate, Cyberabad at Rajendranagar according to the Counsel.
2. The petitioners are aggrieved by the complaint filed by the
Drugs Inspector for the offences under Section 18(a)(iv) r/w Rule
106(1) r/w Sl.No.42 and 51 of Drugs & Cosmetics Act, 1940 &
Rules 1945.
3. It is the case of the Drugs Inspector that the 1st petitioner is
manufacturing firm and petitioners 2 and 3 are the partners.
Company was selling the drug Pilorute cream (Troxerutin, Calcium
Dobesilate, Zinc, Phenylephrine, Lignocaine with Hydrocortisone
Cream), Batch No.B1CT0o17, Mfg. date 06/2015, Expiry Date
08/2016, Manufactured in India by Swiss Garnier Life Sciences, 21
to 23, Industrial Area, Mehatpur district, UNA (HP)-174315 labeled
with indication of "Varicose veins and Haemorrhoids (Piles)",
punishable under Section 27(d) of the Act.
4. 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.
5. 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."
6. For the sake of convenience, the words in label is also
extracted which is as follows:
"3way Action Active Treatment Vasoprotective
Local Anesthetic
Anti Inflammatory
Troxerutin, Calcium Dobesilate, Zinc, Phenylephrine, Lignocaine
with Hydrocortisone Cream
Pilorute Mankind"
7. 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 labeling or in any manner manufacturer must have
claimed that the drug prevents or cures or mitigates any disease.
8. 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' and
also states that 'three way action' and 'active treatment'. Such
claims of either 'active treatment' or 'three way action, cannot be
made on a drug, according to Public Prosecutor. A normal person
cannot infer that the label claims to prevent, cure or
mitigate/lessen the problem of either Varicose veins or
Haemorrhoids (Piles).
8. 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.
9. 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 Pradesh1; iii)
judgment of this Court in Criminal Revision Case No.1121 of 2002
dated 06.04.2006; iv) State of Maharashtra v. R.A.Chandawarkar2,
argued that the drug Inspector has no authority to file the
Complaint.
10. 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
1999 LawSuit(Bom) 116
11. 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 qushed 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.
12. In the result, Criminal Petition is allowed. Consequently,
miscellaneous applications pending, if any, shall stand disposed.
__________________
K.SURENDER, J
Date:02.03.2023
kvs
THE HON'BLE SRI JUSTICE K.SURENDER
CRIMINAL PETITION No.2502 of 2021
Dated: 02.03.2023
kvs
