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Licenses Required for Manufacturing Hand-made Soaps
in India
Posted by: Guest Post in Al July 12,2015 9
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This article is written by Rimjhim Vaishnavi, a student of NUSRL, Ranchi.
Introduction
Among increasing demand for different goods, there is also an increase in demand for
hand soap. People now a days not only require hand soap for just washing their hands,
but they want more in it, they require that it should kill 100% bacteria or should make
their hand feel soft, or make their hand smell good or for any other reason. The scenario
is same for all other cosmetics also. These all demand shows that the people are
becoming more conscious about how they look, towards their health and all of these are
making them more brand conscious. Westernization can also be considered as a reason
behind it. And hence to fulfil the entire requirement more and more production and
manufacturing houses are being established.
http:/blog.ipleaders jiviicenses-for-hand-made-soaps-in-indialThere is no particular or separate legislation relating to the manufacturing of hand
soap. The Drugs and Cosmetics Act 1940 and Rules 1945 in India regulate all the
manufacturing process relating cosmetics and drugs and under which manufacturing of
hand soap is covered.
Does hand soap come under the ambit of cosmetics?
As per the definition of cosmetic under Sec. 3 (aaa) of Drugs and Cosmetics Act 1940
and Rules 1945, which includes any article which is intended to be rubbed, poured,
sprinkle or sprayed on or has been introduced into, or otherwise applied to, human
body or any part either for the purpose of cleansing, beautifying, promoting
attractiveness or for altering the appearance.
As hand soap is used for the purpose of cleaning hands, it comes under the ambit of
cosmetics under this act.
Manufacturing of hand soap under Drugs and cosmetics Act and
Aue
As defined under the Drugs and Cosmetics Act manufacturing includes many stages like
the process of making, altering, ornamenting, finishing, packing, labelling and breaking
up or treating or adopting any drug or cosmetic with view of its sale or distribution. But
the manufacturing proces
course of retail business. But the foremost thing which is required for manufacturing
hand soap is to get a manufacturing licence, for which the procedure and the grounds
for acquiring a licence has been mentioned in part XIV of Drugs and Cosmetics Rule.
After acquiring a licence the other thing which has to be determined is the area or place
where the manufacturing process should be done.
How to get a manufacturing licence for hand soaps?
s does not include the compounding or dispensing in ordinary
As per the Drugs and Cosmetics Act and Rule, the Central Government and the State
Government makes rule regarding issuance of licence to a person for manufacturing
cosmetics. Basi
it is the State Drug Authorities of respective States, who are
authorized to issue manufacturing licenses.
+ Firstly, a person applying for a manufacturing licence for hand soap needs to fill the
application form 31 along with it; the person is required to pay an amount of Rs 3,500
and Rs 2,500 as a government and inspection fee of 2500 respectively.
* Secondly, the cosmetics for which the licence is being acquired should be specified
into classes of cosmetics, as has been mentioned under Schedule M-II, where the
cosmetics have been classified into 10 categories.
+ A person applying for the license of manufacturing hand soap or any other
cosmetics should have passed intermediate exam with Chemistry as one of its subject
or any examination which is recognised by the Licensing authority.
+ Apart from it to get a license it is required to hold a diploma in Pharmacy which
should be certified and approved either under the Pharmacy Council of India under
the Pharmacy Act, 1948 or under the Pharmacy Act, 1948
+ At the time of applying for the licence it is required to mention other information
like the lists of equipment, manufacturing facility details with minimum area required
for manufacturing, Technical Competent personnel details, etc.
* Apart from those details the licencing authority also considers before approving the
licence that whether the cosmetic
misbranded or is a spurious cosmetic.
http://blog.pleaders.inVlicenses-for-hand-made-soaps-in-india/* For renewal also the manufacturer is required to categorise the cosmetics as per
Schedule M-II, apart from it Rs. 1000 has to be paid as a charge for every inspection
for renewal
It is mandatory for the Licensing Authority to direct an inspection of the area where
manufacturing will take place, before approving or rejecting the application of license.
After the inspection a report is send to the Licensing Authority on the basis of which
they either approve the licence application or reject it.
Place of Manufacturing
While determining the place for manufacturing the hand soap it has to be seen that the
manufacturing house should work in a manner it benefits the public at the same time it
should not affect the environment adversely. Also there has been rule laid down relating
to the factory premises which have been mentioned in the Schedule M-II of the Drugs
and Cosmeti
Act and Rule. The manufacturer has to comply with those requirements
and conditions.
* Location and surroundings— The production house or factory should not be
established near residential areas, Also it should have measures to avoid risk of
contamination from the external environment including open sewage, drain, and
public lavatory.
* Building and premise:
Apart from it the factory should have proper sanitation facilities, hygiene should be
maintain in the manufacturing building, for that it has to be ensured that the workers
are provided and are using hand gloves and masks. They shall also conform to the
conditions laid down in the factories Act, 1948. They should design, construct and
maintain to prevent the entry of insects, pests, birds and rodents.
ventilation openings and similar lines shall be designed
+ Waste disposal- Proper arrangement should be made for disposal of solid waste
well as liquid waste. All bio-medical waste shall be destroyed as per the provisions of
the Bio-Medical
and si
ste Rule, 1996. Apart from it provision should be made for proper
storage of waste material waiting for dispo
* Health, clothing and sanitation of workers- prior to employment all personnel shall
undergo medical examination including eye examination. It should be ensured that
any of the working staff is not suffering from any communicable diseases. Also all the
employ should be required to report about their illness or abnormal health condition
to their immediate supervisor.
Drugs Controller General is appointed by the Central Government as a head of the
Central Drug Standard Control Organization who is authorised to regulate the
cosmetics and drugs in India.
Action which can be taken when the manufacturing of hand soap
is against the provisions of Drugs and Cosmetics Acts and Rules
The act provides provisions for penalising the manufacturer who does not comply with
the Act, which has been dealt under Sec.26 to Sec.29 of the Act, by manufacturing
cosmetics which are prohibited by the Act, or is not disclosing the name of
manufacturer, place of manufacturing, any other records or documents prescribed by
the legitimate authority. The person may either be imprisoned or may be fined or both.
The fine may exceed upto Rs. 5000. Also a person is penalised if uses any report of a
test or analysis which the Central Drugs Laboratory or Government Analyst has given.
http://blog.pleaders.inVlicenses-for-hand-made-soaps-in-india/Import and export of the hand soap
For a manufacturer to import it hand soap has to fill form 10. As per the new
amendment 2010, it i
required to have prior registration before importation of any
cosmetic to India, which includes hand soap. The Central Government has the power to
smetics
prohibit the import of
in public inte
only. If the Central Government is
satisfied that the use would harm the public then it can prohibit the import of the
cosmetics.
The Central Drug Standard Control Organization also controls the import of cosmetics
and drugs at the same time regulate the approval of new drugs. The basic requirement
for the import and export of the hand soap are Manufacturing license, good
Manuf (GMP), Free sale Cert
for bot importing and exporting of a cosmetic. Labelling should be done as per the
ring Practici
cates, labelling of a cosmetic
s required
methods prescribed under Rule 148 of the Drug and Cosmetic Act, the product should
ribed by the Act and the hand
comply with the Bureau of Indian Standards or of the International Cosmetics
Standards.
Conclusion
not contain prohibited items
s pres
ap should either
Increas
in manufacturing house for hand soaps on one hand fulfils the demand of the
public and on the other hand it also generates employment opportunities. The Act not
only deals with the licencing process but also deals with import and export of the hand
soap; it also looks into the working of the manufacturing department, The Act gives
power to the Central and State Government to check the working these manufacturing
after they get li
ce. Hence, the Central government establishes different
s the Central
Government as well as the State Government on matters arising out of the
Administration of the Act. A Central Drugs Laboratory is also established by the Central
committees under this Act like Drug Technical Advisory Board who advi:
Government in order to determine the working of the manufacturing company that they
comply with the Act or not.
1 P, “Provisions Relating to Manufacture of Cosmetics”
2. “Basic Guidelines for manufacturing Cosmetics in India”,June 13, 2011,Bussiness
and Employment.
3.“The Soap and Others Detergents manufacturing Industry: trends and
Characteristics: Trends and Characteristics”-A report of the Center for Competitive
Analysis, May 2000 .
4. Drugs and Cosmetics Act,1940 and Rule,1945.
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