Qualis BioMed : Science & Regulation of Medical Products

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Full Acts and Rules related to Drugs, Cosmetics, Medical Devices, other pharmaceutical Products etc

Last post by QualisBioMed « Fri Sep 30, 2022 12:56 am

by QualisBioMed » Fri Sep 30, 2022 12:56 am » in General » Announcements

You can access full Acts and Rules related to Drugs, Cosmetics, Medical Devices, other pharmaceutical Products etc. on

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Last post by QualisBioMed
Fri Sep 30, 2022 12:56 am
Instruction before you start using this forum - Must Read for New User.

Last post by QualisBioMed « Fri Sep 30, 2022 12:52 am

by QualisBioMed » Fri Sep 30, 2022 12:52 am » in General » Welcome

This is a 24x7 discussion Forum for Pharmaceutical Professionals looking to share their knowledge. As together we can achieve better and also try to...

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Last post by QualisBioMed
Fri Sep 30, 2022 12:52 am
Regulation of all class A & B Medical Devices in India from 01 Oct 2022.

Last post by QualisBioMed « Fri Sep 30, 2022 12:38 am

by QualisBioMed » Fri Sep 30, 2022 12:38 am » in Acts & Rules » Rules » Medical Devices Rules, 2017

From 01 Oct 2022 onward all manufacturers / importer of Class A & Class B Medical Devices in India will need license, as they will come under...

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Last post by QualisBioMed
Fri Sep 30, 2022 12:38 am
Section 3 (f) : manufacture

Last post by QualisBioMed « Tue Aug 17, 2021 10:42 pm

by QualisBioMed » Tue Aug 17, 2021 10:42 pm » in Acts & Rules » Acts » Drugs & Cosmetics Act, 1940

“manufacture” in relation to any drug or cosmetic includes any process or part of a process for making, altering, ornamenting, finishing, packing,...

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Last post by QualisBioMed
Tue Aug 17, 2021 10:42 pm
Section 3 (e) : “Inspector” means -

Last post by QualisBioMed « Tue Aug 17, 2021 10:41 pm

by QualisBioMed » Tue Aug 17, 2021 10:41 pm » in Acts & Rules » Acts » Drugs & Cosmetics Act, 1940

“Inspector” means -

(i) in relation to Ayurvedic, Siddha or Unani drug, an Inspector appointed by the Central Government or a State Government under...

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Last post by QualisBioMed
Tue Aug 17, 2021 10:41 pm
Section 3 (aaa) : cosmetic

Last post by QualisBioMed « Tue Aug 17, 2021 10:40 pm

by QualisBioMed » Tue Aug 17, 2021 10:40 pm » in Acts & Rules » Acts » Drugs & Cosmetics Act, 1940

“cosmetic” means any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied to, the human body or...

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Last post by QualisBioMed
Tue Aug 17, 2021 10:40 pm
Section 3 (aa) : “the Board” means -

Last post by QualisBioMed « Tue Aug 17, 2021 10:39 pm

by QualisBioMed » Tue Aug 17, 2021 10:39 pm » in Acts & Rules » Acts » Drugs & Cosmetics Act, 1940

“the Board” means -

(i) in relation to Ayurvedic, Siddha or Unani drug, the Ayurvedic, Siddha and Unani Drugs Technical Advisory Board constituted...

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Last post by QualisBioMed
Tue Aug 17, 2021 10:39 pm
Section 3 (b) "drug"

Last post by QualisBioMed « Mon Aug 16, 2021 11:05 pm

by QualisBioMed » Mon Aug 16, 2021 11:05 pm » in Acts & Rules » Acts » Drugs & Cosmetics Act, 1940

drug includes

(i) all medicines for internal or external use of human beings or animals and all substances intended to be used for or in the...

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Last post by QualisBioMed
Mon Aug 16, 2021 11:05 pm
How New Drugs are defined in India?

Last post by QualisBioMed « Sun Aug 08, 2021 10:35 pm

by QualisBioMed » Sun Aug 08, 2021 10:35 pm » in Pharmaceuticals » Drugs

In India, New Drugs are defined in The Drugs & Cosmetics Rules, 1945 as :

Rule 122E. Definition of new drug.-
For the purpose of this Part, new...

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Last post by QualisBioMed
Sun Aug 08, 2021 10:35 pm

General

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Welcome
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Last post Instruction before you start …
by QualisBioMed View the latest post
Fri Sep 30, 2022 12:52 am
Announcements
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Last post Full Acts and Rules related t…
by QualisBioMed View the latest post
Fri Sep 30, 2022 12:56 am

Acts & Rules

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Acts
Subforums: Drugs & Cosmetics Act, 1940 , Narcotic Drugs & Psychotropic Substances Act, 1985 , The Drugs & Magic Remedies (Objectionable Advertisement) Act, 1954 , THE CODE OF CRIMINAL PROCEDURE, 1973 ACT NO. 2 OF 1974
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Last post Section 3 (f) : manufacture
by QualisBioMed View the latest post
Tue Aug 17, 2021 10:42 pm
Rules
Subforums: Drugs & Cosmetics Rules, 1945 , Medical Devices Rules, 2017 , New Drugs & Clinical Trials Rules, 2019 , Cosmetics Rules, 2020 , Narcotic Drugs & Psychotropic Substances Rules, 1985 , The Drugs & Magic Remedies (Objectionable Advertisement) Act, 1955 , Drugs (Prices Control) Order, 1995
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Last post Regulation of all class A & B…
by QualisBioMed View the latest post
Fri Sep 30, 2022 12:38 am
Gazette Notifications

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Pharmaceuticals

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Drugs
Subforums: Investigational New Drugs (IND) and New Drugs , Subsequent New Drugs (SND) , Fixed Dose Combinations (FDC)
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Last post How New Drugs are defined in …
by QualisBioMed View the latest post
Sun Aug 08, 2021 10:35 pm
Biological Products

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Vaccines

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Phytopharmaceuticals

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Dosage Form
Subforums: Tablet , Capsule , Injection

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Pre-clinical Studies

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Clinical Studies

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Drugs Discovery

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Pharmaceutical Technology

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Quality Control

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Quality Assurance

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Quality Management System (QMS)

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Validation

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Clinical Trials

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Audits

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cGMP

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Water System

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Aseptic Processing

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SOPs

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GLP

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Stability Studies

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Instrument Calibration

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Production Facility

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Regulatory Approvals

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In-Vitro Diagnostics (IVD)

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In-Vitro Diagnostics

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In-Vitro Diagnostics (IVD) Classifications

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Quality Management System (QMS)

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Clinical Performance Study

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Quality Control

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Quality Assurance

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Engineering Design

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Software Validation

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Regulatory Approvals

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Medical Devices

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Medical Devices

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Medical Devices Classifications

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Quality Management System (QMS)

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Clinical Evaluation Reports

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Quality Control

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Quality Assurance

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Engineering Design

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Software Validation

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Regulatory Approval

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Cosmetics

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Cosmetics

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Regulatory Approval

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Manufacturing of Cosmetics

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Export / Import of Cosmetics

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Pre-Clinical Studies

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Clinical Studies

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Regulatory Updates from various National Regulatory Authorities

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Updates in Acts & Rules

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Draft Notifications

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National Regulatory Authorities (NRA)

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List of National Regulatory Authorities and their Role Healthcare

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List of Non-Statutory Agencies and their Role in HealthCare

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Intellectual Property Rights (IPR)

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Intellectual Property Rights

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Intellectual Property Rights classification

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Patent

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Miscellaneous

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Medical Products Guidelines from various Agencies

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World Health Organisation (WHO)

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International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

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Pharmacopoeia

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USP (United States Pharmacopeia )

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IP (Indian Pharmacopoeia )

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JP (Japanese Pharmacopoeia )

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EP (European Pharmacopoeia )

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Comparative topics across various Pharmacopoeia

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World Trade Organization (WTO)

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World Trade Organization and its role in the world economy

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Various treaties under WTO

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Artificial Intelligence and way ahead

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Artificial Intelligence

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Artificial Intelligence in Medical Products ( diagnostics and treatments)

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Challenges in Artificial Intelligence

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Products specific Artificial Intelligence (Case Studies)

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