New Drug, Cosmetic and Medical Devices

1. ROLL NO – 69
Present by – Suvarnsing Pardeshi

2. A) NEW DRUG –
Regulatory guidelines
Steps in new drug development
Basic research
B) COSMETICS -
Definition
Classification of cosmetics
C) MEDICAL DEVICES BILL -
Regulation in india
IMRDA objectives
2
New drug

3. New drug: Definition under Schedule Y -
New substance, which except during local clinical trials,
has not been used ever before in the country.
Drug already approved for certain claims but which is now
proposed to be marketed with modified or new claims
(indications, dosage, dosage form, route of administration).
FDC of two or more drugs, proposed to be combined for
first time in a fixed ratio.
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NEW DRUGS

4. • Authority to grant permission for New Drug to test & market
new drug in India rests with "Drugs Controller General of India
(DCGI)", and is given as per Drugs & Cosmetic rules.
• Schedule Y of Drugs & Cosmetic Rules, regarding investigation
of new drug (NDA) gives details of preclinical (animal) data
required as also issues guidelines on clinical trials which are
required to be carried out for import &/or manufacture of new
drug in India.
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New
drug
s

5. A. Idea or Basic Research
B. New drug discovery
C. Screening
D. Preclinical studies
E. Formulation development
F. IND application
G. Clinical studies
H. Official license / Regulations/Marketing
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New drugs

6. 1.Start by studying normal & abnormal body functions.
2.Investigation of each component of the disease (pathophysiology).
3. Look up information obtained in previous research and publication.
4. Find out at which stage we can stop disease progression or
development (OUR TARGET!).
5. Search for targeted drug.
6. Isolate the index compound.
7. Perform animal testing to obtain safety data.
8. Approval to test in humans.
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Ipqc test for gel

7. • Cosmetic it is derived from Greek word 'kosmeticos' which means to adorn
(According to D & C act 1940 and rule 1945,
• "Cosmetic is defined as any article intended to be rubbed, poured, sprinkled or
sprayed on, or introduced into or otherwise applied to, the human body or any
part therefore cleaning, beautifying, promoting attractiveness or altering the
appearance and includes any article intended for use as a component of
cosmetic".
• Cosmetics are substances used to enhance or alter the appearance of the face
fragrance & texture of the body .
• Many cosmetics are designed for the use of applying to the face, hair & body.
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cosmetics

8. Classified into three main categories-
1) According to their use.
2) According to their function.
3) According to their physical nature.
A) Cosmetics according to their Use
for the Skin:-
Cream
Powder
Lotion
Deodorants Antiperspirants
B) Use for the nails:-use-
Nail polish
Nail polish remover
C) Use for the eye:-
Eye cream
Eyeliner
D) Use of hair:-
Shampoo
Hair dyes
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cosmetics

9. A medical device is an instrument, apparatus, in vitro reagent,
implant or other similar or related article, which is intended for use in the
diagnosis of disease or other condition , or in the cure, mitigation,
treatment, or prevention of disease or intended to affect the structure or
any function of the body and which does not achieve any of its primary
intended purposes through its chemical action within or on the body.
Example – Glucometer , Oximeter , Thermometer , Nebulizer , Hearing
aid, etc.
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Medical devices bill

10. In India medical devices are governed by CDSCO(Central
Drugs Standard Control Organization) which is regulated by
Directorate General of Health Services, Ministry of Health
and Family Welfare, Government of India.
CDSCO is the only government body which regulate the
medical devices.
All these are now being taken into to form the India
Medical Device regulatory Act (IMRDA).
Indian Medical Devices Regulatory Act come in force
December 31, 2009
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Medical devices bill

11. • Provide notification of essential principles
• Provide for risk based classification of devices
• Notify standards and guidelines
• Provide mechanism of conformity
• Provide a post market surveillance system
• Provide for enforcement
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MEDICICAL DEVICES BILL
IMRDA OBJECTIVES