Bombay High Court
Chutararam S/O Nemaram Gehlot And ... vs The State Of Maharashtra on 28 September, 2016
Bench: V.K. Jadhav
1 CRI APPLN NO.3956.2015.odt
IN THE HIGH COURT OF JUDICATURE OF BOMBAY
BENCH AT AURANGABAD
CRIMINAL APPLICATION NO. 3956 OF 2015
1. Chutararam S/o Nemaram Gehlot,
Age. 43 years, Occu. Business,
R/o. Village Panchuda Kala,
Taluka Sojat city, District Palli,
Rajasthan.
2. Jetharam S/o Nemaram Gehalot,
Age. 33 years, Occu. Business,
R/o. Plot No. 2 & 3, First Floor,
Survey No. 148/2,
H No. 194 & 1950, Kishor Bhavan,
Opposite to Heera Pipes,
Sadoba nagar, Ajintha Chowk,
Jalgaon. ...Applicants..
(orig accused)
VERSUS
State of Maharashtra,
Through Drug Inspector,
Food and Drug Administration,
Maharashtra,
Tal. & District Jalgaon. ..Non-Applicant...
(orig complainant)
...
Advocate for applicant: Shri V.J. Dixit, Senior Counsel
i/b Mr. H.H.Padalkar
A.P.P. for respondent No.3: Mr A.R. Kale
...
CORAM : V. K. JADHAV, J.
Dated: September 28, 2016.
...
JUDGMENT :-
1. Rule. Rule made returnable forthwith. With the
consent of learned counsel for respective parties, heard
2 CRI APPLN NO.3956.2015.odt
finally at admission stage.
2. The petitioner original accused is seeking
quashment of criminal proceeding bearing R.C.C. No.
487 of 2006 pending before the Chief Judicial
Magistrate, Jalgaon.
3. Brief facts, giving rise to the present application,
are as under:-
a) The applicant is proprietor of of "Prem Mehandi
Center" having its office at Plot Nos. 2 and 3 as detailed
in the title cause at Jalgaon, Maharashtra. The said
establishment "Prem Mehandi Center" is a small
manufacturer of Heena/Mehandi Powder and Mehandi
cone products on household basis. The applicant No.1
has started the business at Jalgaon in the year 2006
and also engaged few persons on daily wages basis. The
applicant No.1 had also obtained manufacturing
cosmetic licence for Mehandi products at the said
premises under the provisions of Drugs and Cosmetics
Act 1940 (hereinafter for the sake of brevity referred to
as the "Act of 1940") and also renewed the same
3 CRI APPLN NO.3956.2015.odt
regularly.
b) Respondent No.1 on 22.5.2006 visited the
premises of "Prem Mehandi Center" at Jalgaon. The
applicant No.2 was present at the time in the said
premises. Respondent No.1 Drug Inspector had taken
two samples of Mehandi cone and three samples of
Mehandi powder from the premises of the "Prem
Mehandi Center", Jalgaon. Those samples were further
sent to the Government analyst for analysis and to
ascertain whether the said product contains any Para
Phenyl Diamine (PPD) or Ammonia. However, after
detail analysis by the Government Analyst it was found
that the said samples were of standard quality and does
not contain any hazardous or harmful substance for
human use. The said samples also did not contain any
material/chemical etc. However, according to the
respondent Drug Inspector, the said samples did not
contain labels in the prescribed manner and there was
no valid licence at the relevant time. Consequently, the
respondent Drug Inspector filed a complaint against the
applicants original accused which is numbered as
4 CRI APPLN NO.3956.2015.odt
R.C.C. No. 487 of 2006. The learned Judge of the trial
court was pleased to issue process by order dated
7.10.2006 for the offence punishable under sections
18(a) (ii) and Section 17(c) r.w. Rules 146, 148 and
Section 18(c) of the Drugs and Cosmetics Act 1940 and
the Rules thereunder and punishable under Section 27-
a (ii) of the Act of 1940. Hence, this Criminal
Application.
4. Learned counsel for the applicants submits that,
no manufacturing licence is required for manufacture of
the Mehandi products under the provisions of the Act of
1940. Therefore, there is no question of manufacturing,
sale and distribution of the misbranded cosmetics.
There is no obligation to specify in the label date of
packing and manufacturing of the article made or food
or period within which the article has to be utilized.
Learned counsel submits that the Government Analysis
report also supports the case of the applicants as
nothing contrary to the provisions of the Act of 1940
found in the drawn sample. On the other hand, it
reveals from the report that, samples are of the
5 CRI APPLN NO.3956.2015.odt
standard quality and does not contain any hazardous or
harmful substance for human use and are free from any
chemical i.e. PPD and ammonia. Even Government
Analysis has not declared said Mehandi product as mis-
branded. Learned counsel submits that, as per the
provisions of Rule 138 of the Drugs and Cosmetics
Rules, 1945 (hereinafter for the sake of brevity referred
as Rules of 1945), application for grant or renewal of the
licence to manufacture cosmetics for sale or for
distribution shall be made up to ten items of each
category of cosmetics categorized in Schedule M-II to the
Licensing Authority appointed by the State Government
in form No.31 and it shall be accompanied by a
prescribed licence fee. In view of the provisions of Rule
138 of Rules 1945, in the category of cosmetics as
categorized in Schedule M-II, the product Mehandi is
not mentioned. Chapter 15 of Rules of 1945 and most
particularly, Rule 146 to 148 contends the provisions of
manner of labelling and prohibition of sale or
distribution. In rule 146 it has stated that, no person
shall sell or distribute any cosmetic unless the cosmetic
is manufactured by a licenced manufacturer and
6 CRI APPLN NO.3956.2015.odt
labelled and packed in accordance with these Rules.
Learned counsel submits that, if no licence is required
for manufacturing the Mehandi, then the provisions of
Rule 148 containing the manner of labelling does not
apply to the Mehandi Product. Section 17-C
particularly clause (b) says that a cosmetic shall be
deemed to be misbranded, if it is not labelled in the
prescribed manner. The learned counsel submits that,
even accepting the allegations made in the complaint as
it is, the charges levelled against th applicants in the
complaint are not at all attracted. Learned counsel
submits that, same is also evident from the circular
dated 16.8.2010 issued by the Jt. Commissioner (Head
Quarter), Controlling Authority, Food and Drugs
Administration, wherein, it is stated that, so far as
Mehandi Cone product is concerned, as per the
provisions of the Drugs and Cosmetics Act and the
Rules of 1945, the manufacturer thereof shall not be
directed to obtain the licence, however, if any colour is
used in the said Mehandi cone, they should be in
conformity with the standard prescribed as per the
annexure Q and further the PPD die should not be used
7 CRI APPLN NO.3956.2015.odt
in such a Mehandi Cone. It has stated in the said
circular that such a manufacturer should be given
understanding to that effect.
5. The learned A.P.P. submits that, during the raid in
the premises of the applicants, it was found that the
applicants were manufacturing and selling Mehandi
Cone and Mehandi Powder and on the said product the
batch number and manufacturing dates are not
mentioned. It has mentioned on the Mehandi Cone that
said product being manufactured at Nashik and thus it
was the case of misleading information printed on the
Mehandi Cone label. In response to the notice issued to
the applicants, it has stated that said Prem Dulhan
Mehandi Cone is being manufactured by him at Jalgaon
by using raw materials like Mehandi Powder, Eucalyptus
Oil, clove oil and water etc. Thus, the petitioner was
manufacturing Mehandi Cone which was a cosmetic and
there is a clear cut violation of section 17-C of the Act of
1940. The learned APP submits that, Prem Dulhan
Mehandi Powder and Prem Dulhan Mehandi Cone is a
cosmetic as per the provisions of Section 3 (aaa) of the
8 CRI APPLN NO.3956.2015.odt
Act of 1940 and Rules thereunder. The learned APP
further submits that, so far as circular issued by the Jt.
Commissioner (Head Quarter) and Controlling
Authority, Food and Drugs Administration, Maharashtra
State dated 16.8.2010 is concerned, this is a internal
letter which cannot over ride the provisions of the Act.
Further, the complaint is of the year 2006 where as the
said circular is issued in the year 2010. The learned
APP submits that the applicants violated the provisions
of Section 18-C of the Act of 1940 by manufacturing the
cosmetics by using chemicals and further carried out
manufacturing activities without license and also
misbranded the cosmetic articles.
6. The learned APP further submits that, as per the
provisions of Rule 150-A of the Rules of 1945 and
appended Schedule S, requirement of obtaining licence
for cosmetic is made mandatory. As per the status of
Heena Powder at Sr. No.28 in Schedule S, it is clear that
Mehandi Cone is nothing but a cosmetic product. The
learned APP further admits that, said circular issued by
the Jt. Commissioner (Head Quarter) and Controlling
9 CRI APPLN NO.3956.2015.odt
Authority, Food and Drugs Administration, Maharashtra
State dated 16.8.2010 is still in existence. In reply to
the query of this Court, Additional Affidavit in reply was
submitted by Shri Vijay S/o Tanaji Jadhav, Assistant
Commissioner, Food and Drugs Administration,
Jalgaon, wherein it is stated that, in view of the said
circular issued by the Jt. Commissioner, Food and Drug
Department, State of Maharashtra, dated 16.8.2010, the
department of Food and Drugs Administration do not
insist anybody to obtain license under the provisions of
Drugs and Cosmetics Act, 1940 for manufacturing of
Mehandi Cone.
7. On careful perusal of the complaint, it appears
that, the charges levelled against the applicants in the
complaint are mainly divided into two parts i.e. 1] -
there is no valid license and 2]- said Mehandi Cone and
Mehandi Powder was a misbranded cosmetic.
8. In view of the above, the provisions of Rule 138 of
the Rules of 1945 are relevant. Rule 138 of the Rules
1945 reads as under :-
10 CRI APPLN NO.3956.2015.odt
138.Application for licence to manufacture
cosmetics [for sale or for distribution] :-
[(1) Application for grant or renewal of
[licence to manufacture cosmetics for sale or
for distribution] [shall be made up to ten items
of each category of cosmetics categorized in
schedule M-II to the Licensing Authority
appointed by the State Government for the
purpose of this part (hereinafter in this Part
referred to as Licensing Authority) in Form 31
and shall be accompanied by a licence fee of
rupees two thousand and five hundred and an
inspection fee of rupees one thousand for every
inspection thereof or for the purpose of renewal
of licence.
(2) If a person applies for the renewal of
licence after expiry but within six months of
such expiry, the fee payable for the renewal of
such licence shall be [rupees two thousand and
five hundred plus an additional fee at the rate
of rupees four hundred per month or part
thereof in addition to an inspection fee of
rupees one thousand].
(3) Application by a licensee to manufacture
additional items of cosmetics shall be
accompanied by a fee of rupees [one hundred
for each item subject to a maximum of rupees
three thousand for each application].
[(4) A fee of rupees [two hundred and] fifty
shall be paid for duplicate copy of a licence
issued under sub-rule (1), If the original is
defaced, damaged or lost.]
9. Condition for grant or renewal of the licence in
form No.32 are laid down in Rule 139 of Rules of 1945.
Rule 139 reads as under :-
11 CRI APPLN NO.3956.2015.odt
139. Condition for the grant or renewal of a
licence in Form 32. :-
Before a licence in Form 32 is granted or
renewed, the following conditions shall be
complied with by the applicant :
(1) The manufacture shall be conducted
under the direction and personal
supervision of a competent technical staff
consisting of at least one person who is a
whole-time employee and who possesses any
one of the following qualification-
(a) hold a Diploma in Pharmacy approved
ig by the Pharmacy Council of India under
the Pharmacy Act, 1948 (8 of 1948), or
(b) is registered under the Pharmacy Act,
1948 (8 of 1948), or
(c) has passed the Intermediate
Examination with Chemistry as one of the
subjects or an examination recognized by
the Licensing Authority as equivalent to
it.
(d) (omitted).
[(2) The factory premises shall comply
with the requirements and conditions
specified in Schedule M-II.]
(3) (omitted)
(4) (omitted)
(5) The applicant shall either-
(i) provide and maintain adequate staff,
premises and laboratory equipment for
testing the cosmetic manufacture, and the
raw materials used in the manufacture, or
(ii) make arrangements with some
institution approved by the Licensing
12 CRI APPLN NO.3956.2015.odt
Authority [under Part XVI(A) of these Rules]
for such tests to be regularly carried out in
this behalf by the institution.
10. In Rule 138 of the Rules of 1945, the application
for grant or renewal of licence to manufacture cosmetics
for sale or for distribution shall be made up to ten items
of each category of cosmetics categorized in Schedule M-
II to the Licensing Authority appointed by the State
Government and as per the provisions of Rule 139 of the
Rules 1945 the conditions as laid down in the Rules are
required to be fulfilled before a licence is granted. Those
conditions as laid down in Rule 139 of the Rules 1945
are mainly in respect of qualification of a competent
technical staff and also certain requirements are to be
fulfilled in the factory premises including laboratory
equipment for testing the cosmetic manufacture, and
the raw materials used in the manufacture etc. On
careful perusal of the Schedule M-II I do not find the
Mehandi Product categorized in Schedule M-II.
11. Further, in view of the Rule 142 of the Rules
1945, a licence shall be subject to the conditions stated
13 CRI APPLN NO.3956.2015.odt
therein and to the other conditions as mentioned in the
Rules. Rule 142 reads as under :-
142. Conditions of licence. -
A licence in form 32 shall be subject to the
conditions stated therein and to the following
other conditions, namely-
(a) The licensee shall provide and maintain
staff, premises and equipment as
specified in Rule 139.
(b) The licensee shall comply with the
provisions of the Act and the rules
made thereunder and with such
ig further requirements, if any, as may be
specified in any rules to be made
hereafter under Chapter IV of the Act.
(b-1) The licensee shall keep records of the
details of each batch of cosmetic
manufactured by him and of raw
materials used therein as per
particulars specified in schedule U(1)
and such records shall be retained for a
period of three years.
(c) The licensee shall test each batch or lot
of the raw materials used by him for the
manufacture of the cosmetics and also
each batch of the final product and
shall maintain records or registers
showing the particulars in respect of
such tests. The records or
registers shall be retained for a period
of three years from the date of
manufacture.
(d) The licensee shall allow any [Inspector
appointed under the Act] to enter with
or without prior notice any premises
where the manufacture of a substance
in respect of which the licence is issued
is carried on, to inspect the premises
and to take samples of the
manufactured products under a receipt.
14 CRI APPLN NO.3956.2015.odt
(e) The licensee shall allow an Inspector to
inspect all registers and records maintained
under these rules and shall supply to the
Inspector such information as he may require
for the purpose of ascertaining whether the
provisions of the Act and the rules made
thereunder have been complied.
(f) The licensee shall maintain an
Inspection Book in Form 35 to enable an
Inspector to record his impression and the
defects noticed:
[Provided that clauses (b-1) and (c) shall not
apply to the manufacture of soap and the
procedure for testing of raw materials and the
records to be maintained by a manufacturer of
ig soap shall be such as are approved by the
Licensing Authority.]
12. Thus, the conjoint reading of Section 138, 139, 142
and Schedule M-II, it is clear that, no licence is required
to manufacture Mehandi Cone or Mehandi Powder for
sell or for distribution. The Jt. Commissioner, Head
Quarters and Controlling Authority, has, thus issued
the Circular to that effect in the year 2010 which still
holds the field, wherein, it is stated unequivocally that
no manufacturing licence is required for the
manufacturing of Mehandi Products under the
Provisions of Act of 1940. It is not the case that prior to
issuance of the said circular, there were different
provisions in the Act of 1940 and Rule of 1945 and in
view of the certain amendments subsequently in the
15 CRI APPLN NO.3956.2015.odt
year 2010, the Jt. Commissioner constrained to issue
the said circular dated 16.8.2010.
13. In Rule 150-A standard of Cosmetics is prescribed.
As per Schedule S and in Schedule S item No.28 is
Heena Powder. It is stated in the Schedule S that,
cosmetic as listed in the Schedule in finished form shall
conform to the Indian Standards specifications laid
down from time to time by the Bureau of Indian
Standards (BIS). So far as entry no.28 Heena Powder is
concerned, specifications as per the Indian Standard is
mentioned as 11142.
14. In the Government Analysis report it has not
mentioned that sample shall not conform to the Indian
Standard Specifications. On the contrary, it has clearly
mentioned in the report that, sample gives T.L.C.
Identification test for the presence of Principal
ingredients of genuine Heena Powder namely lawsone
and chlorophyl (reference is:11142:1984) Heena Powder.
It has also stated in the report that, sample does not
give identification test for the presence of ammonia,
16 CRI APPLN NO.3956.2015.odt
Para Phenyl Diamine (PPD), Turpine Oil and Clove oil. It
has only stated in the report that, N.B. details such as
manufacturing licence number, batch number are not
stated in the label.
15. Rule 146 and 148 specifically speaks about the
labelling, packing and standard of Cosmetics. Rule 146
of the Rule of 1945 reads as under :-
146.Prohibition of sale or distribution -
Subject to the other provisions of these
rules, no person shall sell or distribute any
cosmetic unless the cosmetic, if of Indian
origin, is manufactured by a licensed
manufacturer and labelled and packed in
accordance with these rules.
16. Bare reading of Rule 146 makes it clear that, no
person shall sell or distribute any cosmetic unless
cosmetic, if of Indian Origin, is manufactured by a
licensed manufacturer and labelled and packed in
accordance with these Rules.
17. Thus, as discussed in the foregoing paragraphs by
referring the provisions of Rule 138 of Rules 1945, if the
Product Mehandi is not categorized in Schedule M-II,
17 CRI APPLN NO.3956.2015.odt
there is no question of obtaining any license for
manufacturing the same for sell or for distribution.
Consequently, for such a product there is no question of
following the conditions of license as provided under
Rule 142 of the Rules 1945 and the manner of labelling
as prescribed under Rule 148 of the Rules of 1945.
18. In the light of the above discussion, continuation
of the proceedings in RCC No.487 of 2006 pending
before the Chief Judicial Magistrate, Jalgaon would be
gross abuse of the process of the Court. In the result, I
proceed to pass the following order.
O R D E R
I. Criminal Application is hereby
allowed in terms of prayer clause 'C'.
II. Rule is made absolute in the above
terms. Criminal Application is
accordingly disposed of.
sd/-
( V.K. JADHAV )
JUDGE
....
aaa/-
Authenticated copy
