This document discusses the requirements for manufacturing facilities and clinical trials in India according to Schedules M and Y of the Drugs and Cosmetics Rules. Schedule M outlines the good manufacturing practices and requirements for premises, plants, and equipment used in pharmaceutical production. It also discusses facility design aspects like clean surroundings, building facilities, lighting, ventilation, and storage areas. Schedule Y provides the guidelines for conducting clinical trials in India, including the various phases of trials from Phase 0 to Phase IV. It also discusses aspects like informed consent, ethics committee composition, and government facilities for expediting clinical trials.

1. SCHEDULE M
AND
SCHEDULE Y
By,
Joan Vijetha.R
M.Pharm(Pharmaceutics), I year, II sem
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2. CONTENT
•SCHEDULE M
•SCHEDULE M I
•SCHEDULE M II
•SCHEDULE M III
•GMP
•SCHEDULE Y
•CLINICAL TRIALS
•SUMMARY
•REFERENCES
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3. SCHEDULE M
GOOD MANUFACTURING
PRACTICES AND REQUIRMENTS OF
PREMISES, PLANT AND EQIPMENTS
FOR PHARMACEUTICAL PRODUCTS
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4. SCHEDULE M i
REQUIREMENTS OF FACTORY
PREMISES FOR MANUFACTURE OF
HOMOEOPATHIC PREPARATION.
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5. SCHEDULE M ii
REQUIREMENT OF FACTORY
PREMISES FOR MANUFACTURE OF
COSMETICS.
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6. SCHEDULE M iii
REQUIREMENTS OF FACTORY
PREMISES FOR MANUFACTURE OF
MEDICAL DEVICES.
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7. GMP
• GMP is a part of a quality system covering
the manufacturing and testing of active
pharmaceutical ingredients, diagnostics,
pharmaceutical products and medical
devices.
• According to rule 71 of drug and cosmetics
rules 1945- “THE LICENES SHALL COMPLY WITH THE REQUIRMENTS
OF GMP” as laid in schedule M.
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8. FACTORY PREMISES
• The surrounding of the factory should
be free from:
–Bad odour.
–Bad air.
–Water pollutants.
–Insects.
• There should be easy disposables of
waste and easy access to water and
electricity.
• Size should be adequate.
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9. 9CLEAN SURROUNDING UNCLEAN SURROUNDING

10. BUILDING AND FACILITES
• The wall, floor and ceiling should be
made up of non-porous, non-shedding
and should be free from cracks and
holes.
• Should have adequate space for
working and to allows orderly and
logical placement of equipment and
material to avoid the risk of mix up.
• Cleaning and maintenance facilitation
should be good
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11. LIGHTING, VENTILATION, AIR-FILTRATION,AIR-
HEATING AND AIR-COOLING
• Adequate lightening shall be provided to all
area.
• The required temperature and humidity
should be maintained.
• Air- filtration including pre and particulate
matter filters shall be provided.
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12. REQUIRMENTS FOR
STERILE PRODUCTS
• Should be carried in aseptic condition.
• High premises of air should be there than other
area.
• Laminar flow units should be used.
• Periodic monitoring for total particulates.
• The light should be mounted into the walls.
• Switch's should be placed outside the room.
• The mfg. area should be restricted with minimum
no. of persons.
• Written procedure must be displayed outside the
wall. 12

13. STORAGE AREA
• Storage area for material designated
as “UNDER TEST”, “APPROVED”, “REJECTED”.
• A room for finished product must be
provided.
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14. HEALTH AND CLOTHING
• The persons should be free form any
contagious diseases.
• The street cloths should be changed
and were clean appropriate cloths.
• Gloves, mask for nostrils and mouths,
footer cover, ect,.
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16. MASTER FORMULA
RECORDS
• Name of the product, strength and dosage form.
• Description of final container, packaging material
should be labeled.
• The identity, quantity and quality of each raw material
to be used.
• Description of all vessels, equipment with size used.
• Theoretical yield at different stages should be
recorded.
• In process quality control test and analysis to be
carried out during each stage of mfg.
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18. BATCH MANUFACTURING
RECORD
• Serial number
• Name of the product
• Lotbatch size
• Lotbatch number
• Date
• Name of ingredient and quantity used
• Actual production and packing particular including the size and
quantity of finished products.
• Quality control report for product.
• There should not be any overwriting or sticking.
• If any sticking is done it should be done diagonally.
• Date of release of finished packing for distribution and scale.
• Signature of respected staff should be done at each step.
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19. LABELLING AND
PACKING
• Unused coded, spotted label and
packaging material shall be destroyed
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20. SCHEDULE Y
Requirement and guidelines
on clinical trails for import and mfg. of
new drug.
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21. Clinical Trial
“Clinical trial” means a
systematic study of new drug(s) in
human subject(s) to generate data for
discovering and / or verifying the
clinical, pharmacological and /or
adverse effects with the objective of
determining safety and / or efficacy of
the new drug”.
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23. Timelines for Regulatory Approvals
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24. Phase 0 Clinical Trials
• This is a recent designation, also called as first in
human trials conducted by US Food And Drug
Administration’s.
• This phase is known as micro dosing studies and
are designed to speed up the development.
• This include administration of single sub-
therapeutic dose to a small group of 10-20
people.
• Does not give information about safety, efficacy,
but go/no-go decision can be taken.
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25. Phase I Clinical Trials
• Phase 1 Clinical Trial(Perform initial human testing in a small
group of healthy volunteers)
• In Phase 1 trials the candidate drug is tested in people for the first
• time. These studies are usually conducted with about 20 to 100
• healthy volunteers.
• The main goal of a Phase 1 trial is to discover if the drug is safe in
humans.
• Researchers look at the pharmacokinetics of a drug: How is it
absorbed? How is it metabolized and eliminated from the body?
They also study the drug’s pharmacodynamics: Does it cause side
effects? Does it produce desired effects?
• These closely monitored trials are designed to help researchers
determine what the safe dosing range is and if it should move on to
further development
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26. Phase II Clinical Trials
• Phase 2 Clinical Trial(Test in a small group of patients):
• In Phase 2 trials researchers evaluate the candidate
drug’s effectiveness in about 100 to 500 patients with the
disease or condition under study, and examine the
possible short-term side effects (adverse events) and
risks associated with the drug.
• They also strive to answer these questions: Is the drug
working by the expected mechanism? Does it improve
the condition in question?
• Researchers also analyze optimal dose strength and
schedules for using the drug.
• If the drug continues to show promise, they prepare for
the much larger Phase 3 trials.
• Phase 2 can be done more that one time .
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27. Phase III Clinical Trials
• Phase 3 Clinical Trial(Test in a large group of patients to show safety
and efficacy)
• In Phase 3 trials researchers study the drug candidate in a larger
number (about 1,000-5,000) of patients to generate statistically
significant data about safety, efficacy and the overall benefit-risk
relationship of the drug.
• This phase of research is key in determining whether the drug is safe
and effective.
• It also provides the basis for labeling instructions to help ensure proper
use of the drug (e.g., information on potential interactions with other
medicines).
• Phase 3 trials are both the costliest and longest trials.
• During the Phase 3 trial (and even in Phases 1 and 2), researchers are
also conducting many other critical studies, including plans for full
scale production and preparation of the complex application required
for FDA approval.
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28. Phase IV Clinical Trials
• Research on a new medicine continues even after
approval. As a much larger number of patients begin to
use the drug, companies must continue to monitor it
carefully and submit periodic reports,including cases of
adverse events, to the FDA.
• In addition, the FDA sometimes requires a company to
conduct additional studies on an approved drug in
“Phase 4” studies. These trials can be set up to evaluate
long-term safety or how the new medicine affects a
specific subgroup of patients.
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32. Format of informed consent form for Subjects participating in a
clinical trial
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34. Government is facilitating
Clinical trials
 No import duty on clinical trial supplies.
 Exemption from registration requirements for clinical
trial supplies.
 Export of clinical trial related biological specimens
allowed, based on protocol approval.
 Exemption from Service Tax on new Drug testing .
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35. Ethics Committee
 At least seven members
 Appropriate gender representation on the Ethics Committee.
 EC members who are independent of trial and sponsor
should vote / provide opinion in matters related to the study.
 Quorum at least 5 members with following representations:
1. Basic medical scientists (preferably one pharmacologist).
2. Clinicians
3. Legal expert
4. Social scientist / Representative of NGO voluntary agency
/Philosopher / Ethicist or a similar person
5. Lay person from the community.
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37. REFERENCE
1. SEMINAR ON Regulatory overview of clinical trials in
india by Dr.S.Priestly Vivekkumar, MD,Associate
Profess of Dept of Pharmacology, TAGORE
MEDICAL COLLEGE.
2. http://www.docstoc.com/docs/966956/Clinical-Trial-
Application-Form
3. http://www.docstoc.com/docs/966956/Clinical-Trial-
Application-Form
4. Textbook of pharmacuticals by Sanjay K Jain,
Vandana Soni, ed-2012,pg-739
5. Drug regulatory affairs by,V Sai Kishre. Ed-2012,
pg329-331
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