Requirements And Guidelines For Permission To Import / or Manufacture of New Drugs For Sale or To Undertake Clinical Trials
Schedule Y was introduced under the Drugs and Cosmetics Act 1940, to
introduce requirements for countries to get permission for:
Importing
Manufacturing new drugs
Conducting Clinical Trials.
Application for permission
Clinical Trial
Studies in specific population
Post marketing surveillance
Special studies: BA/BE studies
Concept of Pharmacovigilance, history and development of pharmacovigilance, WHO International drug monitoring programme, Pharmacovigilance programme of India
For better understanding of students. This will give you a detailed explanation of IND APPLICATION. Contact me through comment section if you need any assistance in understating this topic.
Establishment of Pharmacovigilance ProgrammeNipun Gupta
1. Pharmacovigilance
2. Pathway of PvPI
3. Establishment of PV Programme
in Hospital
4. Establishment of PV Programme
in Industry
5. Contract Research Organization
6. Establishment a National Programme
The Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product (IB) obtained during a drug trial.
Clinical study on human subjects according to all guidelines to form a ideal protocol and requirement to conduct clinical trial with very efficient way mainly considering to India and ICH associated countries
Organization and objectives of ICH, expedited reporting, ICSR, PSURs, post approval expedited reporting, pharmacovigilance Planning, good clinical practices
detection methods of Adverse drug reactions, postal survey method, Reporting of Adverse drug reactions, Preventability assessment, predictability assessments
ICH: Introduction, objectives & guidelines: A brief insight.RxVichuZ
This is my 44th powerpoint........deals with ICH guidelines.....
Deals with brief introduction, precise objectives, organization(in short) & guidelines (in precise), based on SAFETY, EFFICACY, QUALITY & MULTIDISCIPLINARY guidelines.
Happy reading!!
:)
Concept of Pharmacovigilance, history and development of pharmacovigilance, WHO International drug monitoring programme, Pharmacovigilance programme of India
For better understanding of students. This will give you a detailed explanation of IND APPLICATION. Contact me through comment section if you need any assistance in understating this topic.
Establishment of Pharmacovigilance ProgrammeNipun Gupta
1. Pharmacovigilance
2. Pathway of PvPI
3. Establishment of PV Programme
in Hospital
4. Establishment of PV Programme
in Industry
5. Contract Research Organization
6. Establishment a National Programme
The Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product (IB) obtained during a drug trial.
Clinical study on human subjects according to all guidelines to form a ideal protocol and requirement to conduct clinical trial with very efficient way mainly considering to India and ICH associated countries
Organization and objectives of ICH, expedited reporting, ICSR, PSURs, post approval expedited reporting, pharmacovigilance Planning, good clinical practices
detection methods of Adverse drug reactions, postal survey method, Reporting of Adverse drug reactions, Preventability assessment, predictability assessments
ICH: Introduction, objectives & guidelines: A brief insight.RxVichuZ
This is my 44th powerpoint........deals with ICH guidelines.....
Deals with brief introduction, precise objectives, organization(in short) & guidelines (in precise), based on SAFETY, EFFICACY, QUALITY & MULTIDISCIPLINARY guidelines.
Happy reading!!
:)
IIMPORT AND REGISTRATION AS PER DRUG AND COSMETIC ACT Sagar Savale
The drug and cosmetic act was passed on 10th April, 1940.
Objective : To regulate the import, manufacture, distribution, and sale of Drug and Cosmetics.
All classes of the drugs and cosmetics imported into India, shall comply with the prescribed standards and labels.
Manufacture of all classes of drug require prior license.
Biosimilars
A biosimilar is a biological medicine highly similar to another already approved biological medicine (the 'reference medicine'). (A medicine whose active substance is made by a living organism.)
Biologicals
Biological medicines contain active substances from a biological source, such as living cells or organisms and are often produced by cutting-edge technology.
Biological medicinal product
Biological Medicinal Products, also known as biologics or biologicals, are medicinal products that are manufactured using biotechnology processes and derived from living organisms or their products. They can include vaccines, blood products, gene therapies, monoclonal antibodies, recombinant proteins, and other complex biological substances.
Biological Investigational Medicinal Product
Refer to biological products that are being investigated in clinical trials or research studies to evaluate their safety, efficacy, or pharmacokinetic properties. These products have not yet received marketing authorization and are still in the experimental phase.
In the European Union, A biological substance is referred as the active ingredient in biological products.
A "biological substance" is defined as "a substance that is produced by or extracted from a biological source
That requires a combination of physico-chemical-biological testing, along with the production process and its control, for its characterization and the determination of its quality.“
Examples: Immunologic medicines
Medicines derived from human blood and plasma
Medicines developed by means of recombinant DNA technology
Hybridoma and mAb methods
Advanced therapy medicinal products
The requirements of the EU centralized procedure.
The approval standards for biotechnology products are the same as for chemically synthesized medicines.
Both types of products must be safe and effective and have appropriate quality.
MAA for a biotechnology product must meet the standard dossier submission requirements
MAA must generally comply with the CTD format, including with respect to
Module I (administrative information, including labelling)
Module 2 (various summaries)
Module 3 (chemical, pharmaceutical, and biological information)
Module 4 (nonclinical reports)
Module 5 (clinical study reports)
The EU has approved the highest number of biosimilars worldwide, and consequently has the most extensive experience of their use and safety.
EMA has issued scientific guidelines to help developers conform to the strict regulatory requirements for approving biosimilars.
The guidelines have evolved to keep pace with rapid advances in biotechnology and analytical sciences, and they take on board increasing experience of clinical use.
All medicines produced using biotechnology and those for specific indications must be approved in the EU through EMA
Some biosimilars may be approved at national level, such as some low-molecular weight heparins derived from porcine intestinal mucosa.
Introduction
Definition
Classification
Regulatory registration procedure
Quality system requirements
Clinical evaluation
Investigation of medical devices
Summary
Medical devices are regulated by the National Medical Product Administration (NMPA), formerly the China Food and Drug Administration (CFDA)
Manufacturers must register their devices with the NMPA before selling or distributing in China.
The NMPA reviews all device applications and has strict requirements for submission documentation, testing, and clinical data.
Any instrument, apparatus, appliance, material, or other article whether used alone or in combination, including the software necessary for its proper application.
Diagnosis, prevention, monitoring, treatment or alleviation of disease
Diagnosis, monitoring, treatment, alleviation of compensation for an injury or handicap conditions
Investigation, replacement or modification for anatomy or a physiological process
Control of conception
The Chinese authorities (CFDA/NMPA) have their own quality management system requirements.
However, these “GMP requirements” are very similar to ISO 13485.
Therefore, manufacturers usually submit the ISO 13485 certificate.
However, the audit will review this certificate against the Chinese GMP requirements.
These audits are regularly carried out during the approval procedure and/or after a recall.
NMPA issued and implemented the "Guideline on Inspection of Quality Management System for Medical Device Registration" on October 10, 2022.
Product Life-cycle Process
The guideline specifies the basic requirements for registration inspection, self-inspection, commissioned inspection, and extended inspection, etc. Applicant needs to:
Ensure the design, development, production, and other process data to be true, accurate, complete, and traceable, and consistent with the registration application materials.
Carry out the registration QMS inspection in reference to the registration application materials, and focus on the design, development, procurement, production management, and quality control of the product.
For lower-risk medical devices (Class I and Class II), clinical evaluation may not always be required. However, higher-risk devices (Class III and implantable devices) generally require clinical evaluation.
The evaluation involves reviewing existing clinical data, scientific literature, and relevant clinical research to assess the safety and performance of the device.
All clinical trials for medical devices must follow China Good Clinical Practices
Clinical investigations are required if no equivalent devices can be found and safety and efficacy cannot be proven with other clinical and non-clinical data.
For certain medical devices, the NMPA may require clinical investigations, especially for novel devices or those with significant risk.
Clinical investigations involve conducting studies on human subjects to generate clinical data on the safety and effectiveness of the device.
DIETARY SUPPLEMENT
The purpose of dietary supplements, is to enhance or supplement the diet. Even though a product is marketed as a dietary supplement, it is still considered a medicine to the extent that it is meant to treat, diagnose, cure, or prevent diseases.
Tablets, capsules, soft gels, powders, bars, gummies, and liquid supplements are just a few of the many different forms that supplements can take.
It is a product that is intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid.
A dietary substance use by human to supplement the diet by increasing the total daily intake, or a concentrate, metabolite, constituent, extract, or combinations of these ingredients.
FDA Role
Companies can often introduce a dietary supplement to the market without notifying FDA.
FDA’s role in regulating dietary supplements primarily begins after products enter the marketplace.
If a product is found to be unsafe or not otherwise in compliance with the law, FDA can work with the company to bring the product into compliance or possibly remove it from the market.
FDA regulates both finished dietary supplement products and dietary ingredients.
FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods (edible fruits and vegetables) and drug products.
Role of DSHEA
Manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing products that are adulterated or misbranded.
That means that these firms are responsible for evaluating the safety and labelling of their products before marketing to ensure that they meet all the requirements of the Federal Food, Drug, and Cosmetic Act (FFDCA) as amended by DSHEA and FDA regulations.
FDA has the authority to take action against any adulterated or misbranded dietary supplement product after it reaches the market
The Dietary Supplement Health and Education Act of 1994 was enacted to prohibit
Dietary supplement manufacturers and distributors from making false claims (such as "natural" and "therapeutic," on supplement labels)
The law also prohibits the manufacture and sale of adulterated dietary supplements.
Aim of these act:
To make dietary supplements safer by forbidding manufacturers and distributors from producing and selling mislabelled or adulterated products.
Act requires that the manufacturer of the dietary supplement ensures their product meets DSHEA and FDA regulations.
Table of Contents
Short Title Reference Table Of Contents
Findings
Definitions
Safety of Dietary Supplements and Burden of Proof on FDA
Dietary Supplement Claims
Statements of Nutritional Support
Dietary supplement ingredient labeling and nutrition information labeling
New dietary ingredients
Good manufacturing practices
Conforming amendments
Withdrawal of the regulations and notice
Commission on dietary supplement labels
GCC countries, Drug registration regulations of Saudi Arabia, Medicinal Product Registration process (SA), Drug Registration Requirement (SA), Post Registration Requirements in (SA), Drug registration regulations UAE Medicinal Product Registration process (UAE), Drug Registration Requirement (UAE).
Since 2003, The Saudi Food and Drug Authority (SFDA) is the competent authority for registrations, maintenance, quality, pharmacovigilance and import of medicinal products.
SFDA is responsible for handling and licensing the manufacture, import, export, distribution, promotion, and advertising of medicinal products.
The SFDA is also responsible for assessing the safety, efficacy, and quality of medicinal products, issuing marketing authorizations, and monitoring the quality & safety of the marketed medicinal products.
SFDA prefers the drug dossier submission in electronic format (eCTD).
It is an independent authority from the Ministry of Health.
Market Authorization
The process of submitting a new Marketing Authorization Application (MAA) consists of the following phases:
Phase 1
Step 1: Online Registration on the Drug Establishments National Registry (DENR)
The applicant register online on the DENR to get a username and password, which enables the applicant to log in and avail all the electronic services of the drug sector.
Step 2: Marketing Authorization Application (MAA) Submission:
The applicant shall apply through the Saudi Drug Registration (SDR) system to fill out the application form and pay the fees.
Upload the eCTD file to the system through the SDR system portal.
A soft copy of the eCTD should be submitted labelled as per the SFDA guideline, along with the hard copies of the original documents.
Phase 2
Step 1: Validation
The product file will be validated on technical and business bases to ensure that the applicant fulfils the requirement.
Step 2 - Assessment, Testing and Inspection
The relevant departments will evaluate the MAA to assess quality, safety, and efficacy, along with the onsite GMP inspection and sample analysis by the SFDA central laboratories.
Step 3 - Pricing
The Pricing Department will review the product’s price according to the “SFDA's pricing rules.”
Step 4 - Product Licensing
The Registration Committee will review the registration request for approval.
Verification and Abridged Procedure
Verification Process
This process will be applicable if the product has been approved and marketed by both the European Medicines Agency (EMA) and the United States Food and Drug Administration (USFDA).
For all pharmaceutical items, even those that are not intended to be used as medicines, such as nutritional supplements and cosmetics, to be registered with the Ministry of Health & Prevention (MOHAP) in the United Arab Emirates.
The UAE government takes all necessary measures to ensure that safety standards and procedures are followed in cases of import, export, trade, and sale of products, which are consumed or used by the people.
Patents are a type of techno-legal document that describes novel, unique, and industrially applicable inventions. A request for the issuance of a patent for an invention created and detailed in the patent specification is known as a patent application.
a) Novelty: Before submitting the patent application in India, the subject matter specified in the specification was not published in India or anywhere else.
b) Inventive Step: A person who is experienced in the art would not recognize the invention in light of the earlier publication, knowledge, or document.
c) Industrial Applicability: In order to be produced or used in the industry, an invention must have some sort of utility.
DOCUMENTS REQUIRED FOR PATENT REGISTRATION:
1. (Form 1) Application form for the grant of patent in India.
2. (Form 2) If a provisional specification is submitted, it must be followed within a year by a complete specification. Provisional or complete specification of patent in duplicate.
3. (Form 3) Information and undertaking listing each foreign patent application's number, filing date, and current status in duplicate.
4. Priority document (if the priority date is claimed) in convention application, when directed by the Controller
5. (Form 5) When a complete specification follows a provisional specification, or in the event of a convention or PCT national phase application, an inventor declares their invention
ADVANTAGES OF REGISTERING A PATENT
1. A patent serves as a means of supporting innovations and inventions. The invention or concept belongs to the applicant after they receive the patent.
2. A business must register for a patent because a patent prevents competitors from stealing, selling, or importing the intellectual property without authorization.
3. In support of the current legislation, the patent holder can thereby defend his patent rights.
a) Like other types of property, patents can be bought, sold, or licensed.
b) Ownership of the patent may also be transferred by the inventor.
c) A patented product enhances brand recognition and can allow the company to charge more.
d) With exclusive patent rights, the inventor has long-term control over how the innovation is used.
e) Under the International Patent Protection Scheme, the government would cover up to Rs. 15 lakhs (or 50% of the total cost) of an MSME's international patent filing.
TRADEMARK: 1. A trademark is a symbol that can be used to separate the products or services of one company from those of other companies. Intellectual property rights provide protection for trademarks.
2. A trademark registration grants the owner of the trademark the sole right to use it. This suggests that the trademark may be used solely by its owner or may be licensed to a third party for use in exchange for payment.
COPYRIGHT: 1. The legal term "copyright" (sometimes known as "author's right") is used to refer to the ownership rights that authors and other artists have over their creative works.
DOCUMENT
A DOCUMENT is a piece of written, printed, or electronic matter that provides information or evidence or that serves as an official record.
WHY DOCUMENTATION
Documents and products are produced in pharmaceuticals but regulatory bodies are interested to see documents first.
Due to the importance given to documentation in pharma "good documentation practices" is required.
Good documentation is a systematic procedure of preparation, checking, verifying, issuing, storing and reviewing of any documents.
Clearly written documents prevent errors of various activities in Pharma.
PURPOSE OF DOCUMENTATION:
Defines specifications and procedures for all materials and methods of manufacture and control.
Ensures that all personnel knows what to do and when to do it.
Ensure that authorized persons have all information necessary for release of product.
Ensures documented evidence, traceability, provide records and audit trail for investigation.
Ensures availability of data for validation, review and statistical analysis.
Drug substance :
Drug substance is an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient.
Drug product :
Drug product is a finished dosage form, e.g., tablet, capsule, or solution, that contains a drug substance, generally, but not necessarily, in association with one or more other ingredients.
Exploratory Product Development Brief
Many companies today utilize some form of a traditional phased-and-gated product development process, which originated more than 50 years ago. It hasn’t changed substantially since then.
A phased-and-gated system creates multiple batches that slows down the overall speed of a product development project.
When companies try to maintain a traditional phased- and-gated process in a changing environment, the product development team is unable to manage to the scope, timeline and budget approved at the outset.
The result usually includes changing product requirements, unexpected problems, rework, schedule delays, breaking the budget and commercial failure.
GOAL
Develop Exploratory PD® (ExPD), which help companies achieve growth and improve product development success through an adaptive system.
The primary goal of ExPD is to reduce uncertainty and risk by reducing the unknown.
When organizations adapt quickly to the changing environment (market, technology, regulations, globalization, etc.), they reduce uncertainty and risk leading to product success.
APPROACH
The product development team needs an approach that allows them to adapt to change in customer needs, markets, competition, technology and more.
ExPD proposes a new approach to developing products, using a two-pronged solution:
1) Treating product development from a comprehensive systems perspective
Animal Testing: Rationale for conducting studies, CPCSEA Guidelines
The use of animals in research is currently an essential component of the drug discovery process.
Animals help us advance our scientific understanding, serve as models to study disease, help us develop and test potential new medicines and therapies.
Animal testing has benefited researchers in understanding how to treat and prevent various conditions such as high blood pressure, diabetes, tuberculosis, polio, muscular dystrophy, and Parkinson's disease.
Education:
Undergraduate teaching to demonstrate effects of various drugs although this has been phased out in most institutes.
Postgraduate teaching to demonstrate the effects of various drugs, to determine the nature of an unknown drug for bioassay, screening methods and to learn skills e.g. administering drugs.
Research:
A larger number and a greater variety of animals are used in pure research than in applied research. This usually involves studies on embryogenesis, developmental biology, behaviour and breeding in Fruit flies, nematodes, mice and rats.
INTRODUCTION
The motto of Prevention of Cruelty to Animals (PCA) Act 1960 as amended in 1982 is to prevent infliction of unnecessary pain or suffering on animals.
The Central Government has constituted a Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA), which is duty bound to take all such measures as may be necessary to ensure that animals are not subjected to unnecessary pain or suffering before, during or after the performance of experiments on them.
The goal of these guidelines is to promote the human care of animal used in biomedical and behavioural research and testing.
To avoid/minimize pain and suffering inflicted on experimental animals
Inspection of animal house facilities
It provides guidelines for -
Proper care, housing, breeding, maintenance, handling and use of experimental animals.
Source of experimental animals
Acceptable experimental procedures for anaesthesia and euthanasia.
Registration of establishments conducting animal experimentation or breeding of animals for this purpose.
Selection and assignment of nominees for the Institutional Animal Ethics Committees (IAEC) of the registered establishments.
Approval of Animal House Facilities on the basis of reports of inspections conducted by CPCSEA.
Permission for conducting experiments involving use of animals.
Recommendation for import of animals for use in experiments.
Action against establishments in case of established violation of any legal norm/stipulation.
Conduct of Training Programmes for the Nominees of CPCSEA.
Conduct/Support of Conference/Workshop on Animal Ethics.
To assure quality maintenance and safety of animals used in laboratory studies while conducting biomedical and behavioural research and testing of products.
Quarantine
2. Personal hygiene
3. Environment
4. Physical facility
5. Animal husbandry
6. Animal disposal
7. Documentation
This presentation contain introduction to Good Distribution Practices Guideline. and Legal GDP requirements put worldwide.
Good distribution practice (GDP) describes the minimum standards that a wholesale distributor must meet to ensure that the quality and integrity of medicines is maintained throughout the supply chain
Each participant in the distribution chain must agree by the relevant requirements in order to retain the original quality of pharmaceutical products.
Each activity in the distribution of pharmaceutical products shall be carried out according to the principles of Good Distribution Practices (GDP) as applicable.
The risks involved are likely to be of a nature comparable to those that are present in the industrial environment, such as mix-ups, adulteration, contamination, cross-contamination, and spurious.
The guideline addresses
Personnel
Quality System
Premises Warehousing and Storage
Documentation
Traceability
Complaints and Returns
Transportation
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1. Clinical Research Regulation
in India: Schedule Y
Presented by:
Vanshika Gupta
1st sem M.Pharm (RA)
CRR (MRA103T)
1
PARUL INSTITUTE OF PHARMACY
PARUL UNIVERSITY
2. Content
Schedules under D&C Act 1940
Rules under Schedule-Y
Amendments in 2013 & 2014
Introduction to Schedule Y
Schedule Y
1. Application for permission
2. Clinical Trial
3. Studies in special populations
4. Post Marketing Surveillance
5. Special studies: Bioavailability / Bioequivalence Studies
2
3. Schedules under Drugs and
Cosmetics Act 1940
Schedule A: Describes application forms and licenses types.
Schedule-B: Fees for test or analysis by the Central Drugs
Laboratories or State Drugs Laboratories.
Schedule-C: Contains various biological products and their
regulation. Examples: Serums, Adrenaline, Vitamins etc.
Schedule-D: List of drugs exempted from the provision of
import of drugs.
Schedule-E: List of poisonous substances under the Ayurvedic,
Siddha and Unani systems.
Schedule-F: This contains regulations and standards for
running a blood bank.
3
4. Cont...
Schedule-F I: Provisions applicable to the production of
bacterial vaccines
Schedule-F II: Standards for surgical dressings
Schedule-F III: Standards for umbilical tapes
Schedule-FF: Standards for ophthalmic preparations
Schedule-G: List of drugs falls under Schedule-G (taken only
under the supervision of a Registered Medical Practitioner)
Most of these drugs are hormonal preparations.
Schedule-H: List of drugs falls under Schedule-H (sold by
retail only on the prescription of Registered Medical
Practitioner)
4
5. Cont...
Schedule-J: Contains a list of various diseases and conditions
that cannot be treated under any drug currently in market and
No drug may legally claim to treat these diseases
Schedule-K: Contains various substances and drugs and their
corresponding regulation.
Schedule-L I: It prescribes list of drugs to be sold on
prescription only- omitted.
Schedule-M: (GMP) Good manufacturing practices
requirements of factory premises, plant, equipments, etc for
manufacturing of drugs.
Schedule-N: List of minimum equipment for the efficient
running of a pharmacy
5
6. Cont...
Schedule-O: Contains various regulations and requirements
for disinfectant fluids.
Schedule-O I: Provisions applicable to Black Fluids and White
Fluid (disinfectants)
Schedule-P: Storage conditions of drugs
Schedule-P I: Pack size of drugs
Schedule-Q: List of dyes, colours and pigments permitted to
be used in cosmetics and soaps.
Schedule-R: Standards for condoms made of rubber latex
intended for single use and other mechanical contraceptives
Schedule-S: Standards for cosmetics
6
7. Cont...
Schedule-T: The requirements of factory premises, plant,
equipments and hygienic conditions for manufacture of
Ayurvedic, Siddha, and Unani
Schedule-U: Particulars to be shown in manufacturing records
Schedule-V: Standards for patent or proprietary medicines
Schedule-X: List of drugs falls under Schedule-X (Narcotic
drugs and Psychotropic)
Schedule-Y: Requirements and guidelines for permission to
import and / or manufacture of new drugs for sale or to
undertake clinical trials.
7
8. Rules under Schedule-Y
8
Section 122A: Application for Permission to import new drug
Section 122B: Application for approval to manufacture new drug
Section 122D: Permission to import or manufacture fixed dose
combination
Section 122DA: Application for permission to conduct clinical trials
for New Drug/ Investigational New Drug.
Section 122DAA: Definition of Clinical trial.
Section 122DB: Suspension or cancellation of permission/approval
Section 122-E: Definition of new drug
9. Amendments in 2013 & 2014
Rule 122DAB – Compensation in case of injury or death
during clinical trial
Rule 122DAC – Condition of clinical trial permission and
inspection.
Rule 122DD – Registration of ethic Committee - Requirement
and guidelines for registration of ethic committee
9
10. Introduction
Requirements And Guidelines For Permission To
Import / or Manufacture of New Drugs For Sale or
To Undertake Clinical Trials
Schedule Y was introduced under the Drugs and Cosmetics Act
1940, to introduce requirements for countries to get permission
for:
1. Importing
2. Manufacturing new drugs
3. Conducting Clinical Trials.
10
12. SCHEDULE Y
(1) Application for permission:
- Application for permission to import or manufacture new
drugs for sale or to undertake clinical trials shall be made in
Form 44 accompanied with following data in accordance
with the appendices
It includes:
(i) Chemical and pharmaceutical information
(ii) Animal pharmacology data
(iii) Animal toxicology data
12
13. Cont...
(iv) Human Clinical Pharmacology Data
(v) Regulatory Status in other country
(vi) Prescribing Information
- Form 12 – To import study drug for examination, test or
analysis.
13
14. Cont...
2. Clinical Trial:
(i) Approval for clinical trial:
- Clinical trial on a new drug shall be initiated only after the
permission has been granted by the Licensing Authority
under rule 21 (b)
- All trial Investigator(s) should possess appropriate
qualifications, training and experience.
14
15. Cont...
- Protocol amendments if become necessary before initiation or
during the course of a clinical trial, all such amendments
should be notified to the Licensing Authority in writing along
with the approval by the ethics committee which has granted
the approval for the study.
(ii)Responsibilities of Sponsor: The clinical trial Sponsor is
responsible for implementing and maintaining quality
assurance systems to ensure that the clinical trial is conducted
and data generated, documented and reported in compliance
with the protocol
15
16. Cont...
- Standard operating procedures (SOPs) should be documented
to ensure compliance with GCP and applicable regulations.
- Sponsors are required to submit a status report on the clinical
trial to the Licensing Authority
- Any unexpected serious adverse event (SAE) occurring during
a clinical trial should be communicated promptly (within 14
calendar days) by the Sponsor to the Licensing Authority and
to the other Investigator(s) participating in the study.
16
17. Cont...
(iii) Responsibilities of the Investigator(s):
- Responsible for the conduct of the trial according to the
protocol and the GCP Guidelines
- SOP are required to be documented by the investigators for the
tasks performed by them.
- To ensure adequate medical care is provided to the subject.
- Investigator(s) shall report all serious and unexpected adverse
events to the Sponsor within 24 hours and to the Ethics
Committee that accorded approval to the study protocol within
7 working days of their occurrence
17
18. Cont...
(iv) Informed Consent:
- Informed consent should be Non-technical and in
understandable language.
- Investigator must provide information about the study verbally
and in written.
- The Subject’s consent must be obtained in writing using an
‘Informed Consent Form.
- Legally acceptable representative.
- The patient information sheet as well as the Informed Consent
Form should have been approved by the ethics committee and
furnished to the Licensing Authority.
18
19. Cont...
(v) Responsibilities of the Ethics Committee:
- The responsibility of the ethics committee that to reviews and
grant its approval to a trial protocol to safeguard the rights,
safety and well being of all trial subjects.
- Conduct ongoing review of the trial.
- Ethics committee(s) should get document ‘standard operating
procedures’ and should maintain a record of its proceedings.
(vi) Human Pharmacology (Phase I) :
- The objective of studies in this Phase is the estimation of safety
and tolerability with the initial administration of an
investigational new drug into human(s).
- Phase I trials should preferably be carried out by Investigators
trained in clinical pharmacology with access to the necessary
facilities to closely observe and monitor the Subjects.
19
20. Cont...
(vii) Therapeutic exploratory trials (Phase II) :
- The primary objective of Phase II trials is to evaluate the
effectiveness of a drug for a particular indication or indications
in patients with the condition under study and to determine the
common short-term side-effects and risks associated with the
drug.
- An important goal for this Phase is to determine the dose(s)
and regimen for Phase III trials.
(viii) Therapeutic confirmatory trials (Phase III) :
- Phase III are designed to confirm the preliminary evidence
accumulated in Phase II that a drug is safe and effective for use
in the intended indication and recipient population.
20
21. Cont...
- These studies should be intended to provide an adequate basis
for marketing approval.
- Studies in Phase III may also further explore the dose response
relationships (relationships among dose, drug concentration in
blood and clinical response)
- Use of the drug in wider populations, in different stages of
disease, or the safety and efficacy of the drug in combination
with other drug(s).
21
22. Cont...
(ix) Post Marketing Trials (Phase IV):
- Post Marketing trials are studies
- These trials go beyond the prior demonstration of the drug’s
safety, efficacy and dose definition
- Phase IV trials include additional drug-drug interaction(s),
dose-response or safety studies and trials designed to support
use under the approved indication(s), e.g. mortality/morbidity
studies, epidemiological studies etc.
22
23. Cont...
(3) Studies in Special Populations:
- The use of the drug in children, pregnant women, nursing
women, elderly patients, patients with renal or other organ
systems failure, and those on specific concomitant medication
is required to be submitted.
- Geriatrics- Geriatric patients should be included in Phase III
clinical trials in meaningful numbers, if-
- The disease intended to be treated is characteristically a disease
of aging.
- When there is specific reason to expect that conditions
common in the elderly are likely to be encountered.
- When the new drug is likely to alter the geriatric patient's
response compared with that of the non-geriatric patient.
23
24. Cont...
- Pediatrics: Studies in the new drug development program will
depend on the medicinal product
- The type of disease being treated
- Safety considerations, and
- The efficacy and safety of available treatments.
- Pregnant or nursing women
- Should be included in clinical trials only when the drug is
intended for use by pregnant/nursing women or
foetuses/nursing infants.
- Follow-up data (pertaining to a period appropriate for that
drug) on the pregnancy, foetus and child will be required.
24
25. Cont...
(4) Post Marketing Surveillance:
- Subsequent to approval of the product, new drugs should be
closely monitored for their clinical safety once they are
marketed.
- The applicants shall furnish Periodic Safety Update Reports
(PSURs). Submitted every 6 months for first 2 years.
(5) Special studies: Bioavailability / Bioequivalence Studies:
- For drugs approved elsewhere in the world and absorbed
systemically, bioequivalence with the reference formulation
should be carried out wherever applicable.
- All bioavailability and bioequivalence studies should be
conducted according to the Guidelines for Bioavailability and
Bioequivalence studies as prescribed.
25
26. Appendix
Some highlights of Schedule Y in terms of its appendices;
which provide the guidelines to conduct clinical trials are:
APPENDIX 1- Conduct clinical trials/import/manufacture of
new drugs
APPENDIX IA- For grant of permission to import and / or
manufacture a new drug
APPENDIX II- Structure, contents and format for clinical
study reports
APPENDIX III- Animal toxicology (non-clinical toxicity
studies)
26
27. Cont...
APPENDIX IV- Animal pharmacology
APPENDIX V- Informed consent
APPENDIX VII - Undertaking by the Investigator
APPENDIX VIII- Ethics Committee
APPENDIX X- Contents of Protocol
APPENDIX XI- Data elements for reporting SAE
APPENDIX XII- Compensation in case of injury or death
during clinical trial
27
28. Data To Be Submitted Along With The Application To Conduct
Clinical Trials / Import / Manufacture Of New Drugs For
Marketing In The Country.
1. Introduction
2. Chemical and pharmaceutical information
3. Animal Pharmacology (for details refer Appendix
4. Animal Toxicology (for details refer Appendix
5. Human / Clinical pharmacology (Phase I)
6. Therapeutic exploratory trials (Phase II)
7. Therapeutic confirmatory trials (Phase III)
8. Special studies
9. Regulatory status in other countries
10. Prescribing information
11. Samples and Testing Protocol/s 28
29. Reference
https://rgcb.res.in/documents/Schedule-Y.pdf
Schedule Y. Requirements and guidelines for permission to
import and/or manufacture of new drugs for sale or to
undertake clinical trials. New Delhi, India: Central Drug s
Standard Control Organization. 2013.
https://ccrps.org/clinical-research-blog/difference-between-ich-
gcp-and-schedule-y
29