Schedules – Drugs and Cosmetics Act 1940 and Rules 1945

Schedules – Drugs and Cosmetics Act 1940 and Rules 1945 including schedules of Cosmetics Rules 2020

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Schedules – Drugs and Cosmetics Act 1940 and Rules 1945

Rules Law
Picture: Pixabay

As per Drugs and Cosmetics Act 1940 and Rules 1945 we have provided some important Schedules for drugs relevant to the above said topic, Click below links for more information:

Schedule-B: Fees for test or analysis by the Central Drugs Laboratories or State Drugs Laboratories
Schedule-B

Schedule-C-C1: Biological and special products
Schedule-C-C1

Schedule-D: Class of drugs and Extent and conditions of exemption
Schedule-D

Schedule-D1: Information and undertaking required to be submitted by the manufacturer or his authorized agent with the Application Form for a Registration Certificate
Schedule-D1

Schedule-DII: Information required to be submitted by the manufacturer or his authorized agent with the Application Form for the registration of a bulk drug / formulation / special product for its import into India
Schedule-D-II

Schedule-G: List of drugs falls under Schedule-G
Schedule-G

Schedule-H: List of drugs falls under Schedule-H
Schedule-H

Schedule-H1: List of drugs falls under Schedule H1
Schedule-H1

Schedule-K: Class of drugs and Extent and Conditions of Exemption
Schedule-K

Schedule-L1: (GLP) Good laboratory practices and requirements of premises and equipment
Schedule-L1

Schedule-M: (GMP) Good manufacturing practices for premises and materials
Schedule-M

Schedule-O: Provisions applicable to Black Fluids and White Fluids
Schedule-O

Schedule-P: Storage conditions of drugs
Schedule-P

Schedule-P1: Pack size of drugs
Schedule-P1

Schedule-T: (GMP) Good manufacturing practices for Ayurvedic, Siddha and Unani medicines
Schedule-T

Schedule-T-A: Form for record of utilizaion of raw material by Ayurveda or Siddha or Unani licensed manufacturing units during the financial year
Schedule-T-A

Schedule-X: List of drugs falls under Schedule-X
Schedule-X

Schedule-Y: Requirements and guidelines for permission to import and / or manufacture of new drugs for sale or to undertake clinical trials
Schedule-Y

How to obtain retail drug license, click here

How to obtain Jan Aushadhi License, click here

How to change pharmacist at medical store, click here

Good storage practice of medicines at Medical Store, click here

Record keeping for Medical Store / Pharmacy, click here

Self inspection of Medical Store :105 points, click here

Licensing procedure for manufacturing of Drugs

Latest Notifications: D&C Rules 1945

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Schedules – Cosmetics Rules 2020

Rules Law
Picture: Pixabay

As per Cosmetics Rules 2020 we have provided all the Schedules introduced in these rules, Click below links for more information:

First Schedule – Authorisation from manufacturer
First-Schedule-Cosmetics

Second Schedule – Part-I – Information and undertaking required to be furnished by the manufacturer or his authorised importer or distributor or agent with the application form for import registration certificate
Second-Schedule-Part-I-Cosmetics

Second Schedule – Part-II – Information and undertaking required to be furnished by the manufacturer with the application form for grant of manufacturing licence or loan licence
Second-Schedule-Part-II-Cosmetics

Third Schedule – Fee payable for licence, permission and registration certificate
Third-Schedule-Cosmetics

Fourth Schedule – List of categories of cosmetics for import
Fourth-Schedule-Cosmetics

Fifth Schedule – Fee for test or analysis by the Central cosmetics laboratories or by the state laboratories
Fifth-Schedule-Cosmetics

Sixth Schedule – Undertaking for the import of cosmetics to be submitted by the importer with application form for Import Registration Number
Sixth-Schedule-Cosmetics

Seventh Schedule – (GMP) Good manufacturing practices and requirements of premises, plants and equipment for manufacture of cosmetics
Seventh-Schedule-Cosmetics

Eight Schedule – Particulars to be shown in the manufacturing raw material records
Eighth-Schedule-Cosmetics

Ninth Schedule – Standards for cosmetics
Ninth-Schedule-Cosmetics

Tenth Schedule Part-I – List of colourants allowed for use in cosmetic products as given under IS: 4707 (Part 1) as amended by the Bureau of Indian Standards from time to time.
Tenth-Schedule-Part-I-Cosmetics

Tenth Schedule Part-II – List of colours permitted to be used in soaps
Tenth-Schedule-Part-II-Cosmetics

Eleventh Schedule – (GLP) Good laboratory practices and requirements of premises and equipment
Eleventh-Schedule-Cosmetics

Twelfth Schedule – Class of cosmetics and Extent and conditions of exemption
Twelfth-Schedule-Cosmetics

Thirteenth Schedule – Substitutions in the Rules
Thirteenth-Schedule-Cosmetics


Cosmetics – Manufacturing License

Latest Notifications: Cosmetics

FAQs on – Cosmetics Rules 2020

FAQs – on Cosmetics (Series-1)

FAQs on Pollution in Drug, Cosmetics & Homeopathic Industries


Schedules – Medical Devices

Rules Law
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As per Medical Devices Rules 2017 we have provided all the Schedules introduced in these rules, Click below links for more information:

First Schedule – Parameters for classification of medical devices and in vitro diagnostic medical devices
First-Schedule

Second Schedule – Fee payable for licence, permission and registration certificate
Second-Schedule

Third Schedule – Documents required for registration of Notified Body, its duties and functions.
Third-Schedule

Fourth Schedule – Documents required for grant of licence to manufacture for sale or for distribution or import
Fourth-Schedule

Fifth Schedule – (QMS) Quality Management System for medical devices and in vitro diagnostic medical devices
Fifth-Schedule

Sixth Schedule – Post approval change
Sixth-Schedule

Seventh Schedule – Requirements for permission to import or manufacture investigational medical device for conducting clinical investigation
Seventh-Schedule

Eight Schedule – Exemptions
Eighth-Schedule

Licensing procedure for Medical devices

Latest Notifications: Medical Devices


Schedules: Clinical Trials

Rules Law
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As per New Drugs and Clinical Trials Rules 2019 we have provided all the Schedules introduced in these rules, Click below links for more information:

First Schedule – Clinical Trial – General principles and practices for Clinical Trial
First-Schedule-Clinical-Trials

Second Schedule – Clinical Trial – Requirements and guidelines for permission to import or manufacture of New Drug for sale or to undertake clinical trial
Second-Schedule-Clinical-Trials

Third Schedule – Clinical Trial –Conduct of Clinical Trial
Third-Schedule-Clinical-Trials

Fourth Schedule – Clinical Trial – Requirements and guidelines for conduct of bioavailability and bioequivalence study of New drug or investigational new drug
Fourth-Schedule-Clinical-Trials

Fifth Schedule – Clinical Trial – Post market assessment
Fifth-Schedule-Clinical-Trials

Sixth Schedule – Clinical Trial – Fee payable for licence, permission and registration certificate
Sixth-Schedule-Clinical-Trials

Seventh Schedule – Clinical Trial – Formulae to determine the quantum of compensation in the cases of Clinical Trial related injury or death
Seventh-Schedule-Clinical-Trials

Eight Schedule – Clinical Trial – Application Forms
Eighth-Schedule-Clinical-Trials

Notifications: New Drugs, FDC, Clinical Trial

Other details about New Drugs, FDCs, Clinical trial


Compiled by:
Rakesh Dahiya, SDCO cum Licensing Authority, FDA Haryana

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