REGULATORY PROVISION RELATING TO MANUFACTURING OF COSMETICSourav Mohanto
REGULATORY PROVISION RELATING TO MANUFACTURING OF COSMETIC.
Minimum requirement of space, equipment and machinery for manufacturing of cosmetic have been prescribed under M II to the Drugs and Cosmetics Rule,1945
The Cometic registration and Import registration process as per regulations in India. CliniExperts Services Pvt. Ltd. provides consultation services in Cosmetic Registration since the import registration of cosmetics came into existence and became mandatory. For further assistance or queries please contact us at contact@cliniexperts.com or visit our website www.cliniexperts.com
REGULATORY PROVISION RELATING TO MANUFACTURING OF COSMETICSourav Mohanto
REGULATORY PROVISION RELATING TO MANUFACTURING OF COSMETIC.
Minimum requirement of space, equipment and machinery for manufacturing of cosmetic have been prescribed under M II to the Drugs and Cosmetics Rule,1945
The Cometic registration and Import registration process as per regulations in India. CliniExperts Services Pvt. Ltd. provides consultation services in Cosmetic Registration since the import registration of cosmetics came into existence and became mandatory. For further assistance or queries please contact us at contact@cliniexperts.com or visit our website www.cliniexperts.com
Import of drugs - Drugs and cosmetic Act 1940 and rules 1945Swarna kumari S
Drugs and cosmetic Act 1940 and rules 1945. How drugs can be imported. Licensing procedure in India. Prohibited drugs for Import. classes of drugs allowed to import.
This presentation will give General overview about Indian Regulatory Requirements for cosmetics.
This ppt contains information about latest cosmetics rules 2020 and D& C Act 1940
Drugs and Cosmetics Act 1940, 1945 Unit-I as per B. Pharm Pharmaceutical Juri...Sagarpamu123
This PPT covers the B. Pharm, Pharmaceutical Jurisprudence Unit-I topics with Objectives, Definitions, Legal definitions of schedules to the Act and
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Import of drugs – Classes of drugs and cosmetics prohibited from import, Import under
license or permit. Offences and penalties.
Manufacture of drugs – Prohibition of manufacture and sale of certain drugs,
Conditions for grant of license and conditions of license for manufacture of drugs,
Manufacture of drugs for test, examination and analysis, manufacture of new drug, loan
license and repacking license.
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India has the 4th largest market for drugs and medical devices in Asia. The industry has been predicted to grow to be a $ 50 billion industry in less than 5 years by 2025.
Laws Regulating Drugs and Medical DevicesAshish vishal
This is the umbrella legislation which deals with regulation of drugs and medical devices in India. It is from Section 12 of this Act that the Central Government derives the power to make rules and as a result the Drugs and Cosmetics Rules, 1945 were formulated. https://www.rickychopra.co/
This PPT Covers Pharmacy Act –1948: Objectives, Definitions, Pharmacy Council of India; its
constitution and functions, Education Regulations, State and Joint state pharmacy
councils; constitution and functions, Registration of Pharmacists, Offences and Penalties
Import of drugs - Drugs and cosmetic Act 1940 and rules 1945Swarna kumari S
Drugs and cosmetic Act 1940 and rules 1945. How drugs can be imported. Licensing procedure in India. Prohibited drugs for Import. classes of drugs allowed to import.
This presentation will give General overview about Indian Regulatory Requirements for cosmetics.
This ppt contains information about latest cosmetics rules 2020 and D& C Act 1940
Drugs and Cosmetics Act 1940, 1945 Unit-I as per B. Pharm Pharmaceutical Juri...Sagarpamu123
This PPT covers the B. Pharm, Pharmaceutical Jurisprudence Unit-I topics with Objectives, Definitions, Legal definitions of schedules to the Act and
Rules
Import of drugs – Classes of drugs and cosmetics prohibited from import, Import under
license or permit. Offences and penalties.
Manufacture of drugs – Prohibition of manufacture and sale of certain drugs,
Conditions for grant of license and conditions of license for manufacture of drugs,
Manufacture of drugs for test, examination and analysis, manufacture of new drug, loan
license and repacking license.
Laws regulating drugs and medical devices Ashish vishal
India has the 4th largest market for drugs and medical devices in Asia. The industry has been predicted to grow to be a $ 50 billion industry in less than 5 years by 2025.
Laws Regulating Drugs and Medical DevicesAshish vishal
This is the umbrella legislation which deals with regulation of drugs and medical devices in India. It is from Section 12 of this Act that the Central Government derives the power to make rules and as a result the Drugs and Cosmetics Rules, 1945 were formulated. https://www.rickychopra.co/
This PPT Covers Pharmacy Act –1948: Objectives, Definitions, Pharmacy Council of India; its
constitution and functions, Education Regulations, State and Joint state pharmacy
councils; constitution and functions, Registration of Pharmacists, Offences and Penalties
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3.
The Government of India through the Drug and Cosmetic
act 1940 and rules 1945 has made stringent provisions
regarding import, Manufacturing, Sale and Distribution of
Cosmetics.
These provisions mainly cover the licensing for the
import, manufacturing of cosmetics and also the GMPs
for the manufacturing of cosmetics.
These guidelines have also listed the 28 cosmetics whose
import is allowed only on to the conformance to the
Indian standards.
4.
These guidelines have also covered the offences and penalties in case of
contravention of the provisions of the Drug and Cosmetic Act 1940.
Bureau of Indian standard sets the standard for cosmetic products
listed under the schedule S of the Drugs and Cosmetics Act 1945.
The Government of India in Feb 2007, the Ministry of Health and
Family Welfare has bring amendment in Drug and Cosmetic Rule, 1945
according to which a cosmetic to be imported into the India has to be get
registered under Rule 129D by licensing authority appointed by Central
Government under Rule 21.
5.
Usually Drug controller General of India is the Licensing Authority. There
should be a single Application made for one or more cosmetic which are
manufactured by same manufacturer.
The registration Certificate which is provided is valid for 3 years if it is
not cancelled.
The application for the registration should be made either by manufacturer
or his agent or importer in India.
6.
Application
form no 31A Fees 3500/- State regulatory
authority
• A person not having his own manufacturing facility can get cosmetic manufacture
form a license cosmetic manufacture under loan license system.
• Application for loan license is prescribed form no 31A along with the fees of
3500/- together with other documents should be submitted to the state regulatory
authority.
7.
• A qualified person can make sure use of approved facility of
manufacturing provided by any other person obtain a loan license for
manufacturing of drugs other than C, C1 and X.
8.
Here are some offences and penalties which are important aspect of regulatory
provision for cosmetic in India-
• For Spurious, adulterated cosmetic imprisonment up to 3 years and fine.
• For not keeping records for cosmetic properly imprisonment up to 3 years
and fine up to 5000/- for manufacture and wholesaler.
9.
CONTRAVENTION IN
BRIEF
PENALTY
Import of spurious cosmetic or
cosmetic containing any ingredient
which harmful for use.
Imprisonment for term of 3 years which
may extends to 5 years with fine of five
thousand rupees.
Import of cosmetic whose import is
prohibited under section 10-A.
Imprisonment for term of 3 years which
may extends to 5 years with fine of five
thousand rupees.
Repeated offence of above two. Imprisonment for term of 5 years and
fine which may extend to 10 thousand
rupees