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Combinational products & medical devices
1. REGULATION FOR COMBINATION OF PRODUCTS &
MEDICAL DEVICES
PRESENTED BY GUIDE
MR. SHUBHAM GAJANAN WAGH PROF. DR.S.D.PANDE
M.pharm (pharmaceutics)
VIDYA BHARATI COLLEGE OF PHARMACY, AMRAVATI-444602
2021-22
2. INDEX
Sr. No. Contents Page No.
1 Introduction 3
2 Types of combination products 4
3 Examples of combination products 5
4 Regulatory authorities 6
5 Medical devices 7
6 Regulation of medical devices in India 8
7 Indian Medical Device Regulatory Act (IMRDA) 9
8 I.M.R.D.A. essential principles & objectives 10
9 I.M.R.D.A. regulation 11
10 I.M.R.D.A. Classification of medical devices 12
11 The Drug and Cosmetic Act 13
12 Significance & role of pharmacist in use of medical devices 14
13 Latest development in medical device regulation 15
14 References 16
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3. INTRODUCTION
Definition of a combination product
A combination product is a product composed of two or more different types of medical
products (i.e. a combination of a drug, device, and/or biological product with one
another). The drugs, devices, and biological products included in combination products
are referred to as “constituent parts” of the combination product.
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4. TYPES OF COMBINATION PRODUCTS
Under 21 CFR 3.2(e), a combination product includes:
A product comprised of two or more regulated components ( i.e. drug/device, biologic/device, drug/biologic, or
drug/device/biologic)that are physically, chemically, or otherwise combined or mixed and produced as a single
entity (often referred as to “single entity” combination product)
Two or more separate products packaged together in a single package or as a unit and comprised of drug and
device products, device and biological products, or biological and drug products (often referred as to “co-
packaged” combination product)
A drug, device, or biological product packaged separately that according to its investigational plan or proposed
labeling is intended for use only with an approved, individually specified drug, device, or biological product
where both are required to achieve the intended use, indication, or effect and where upon approval of the
proposed product the labeling of the approved product would need to be changed (e.g., to reflect a change in
intended use, dosage form, strength, route of administration, or significant change in dose) (often referred as
“cross-labeled” combination product); or
Any investigational drug, device, or biological product packaged separately that according to its proposed
labeling is for use only with another individually specified investigational drug, device, or biological product
where both are required to achieve the intended use, indication, or effect (another type of cross-labeled
combination product).
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5. EXAMPLES OF COMBINATION PRODUCTS
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Examples of single-entity combination products (where the components are physically, chemically or
otherwise combined) (21 CFR 3.2(e)(1)):
Monoclonal antibody combined with a therapeutic drug
Device coated or impregnated with a drug or biologic
(Drug-eluting stent, pacing lead with steroid-coated tip, catheter with antimicrobial coating, condom with
spermicidal, transdermal patch)
Prefilled drug delivery systems
(Syringes, insulin injector pen, metered dose inhaler)
Examples of co-packaged combination products (the components are packaged together) (21 CFR
3.2(e)(2)):
Drug or vaccine vial packaged with a delivery device
Surgical tray with surgical instruments, drapes, and anesthetic or antimicrobial swabs
First-aid kits containing devices (bandages, gauze), and drugs (antibiotic ointments, pain relievers)
Example a of product that may be cross-labeled combination products (components are separately
provided but specifically labeled for use together) (21 CFR 3.2(e)(3) or (e)(4)):
Photosensitizing drug and activating laser/light source
6. REGULATORY AUTHORITIES
The regulatory authorities in India are as follow:
Drugs Controller General of India (DCGI). This is part of the Ministry of Health and Family Welfare.
Central Drugs Standard Control Organization(CDSCO). This is part of the Ministry of Health and Family
Welfare.
State drug licensing authorities.
Gazetted officers authorized by the state governments to enforce drug advertising regulations.
National Pharmaceutical Pricing Authority (NPPA). This is part of the Ministry of Chemicals and
Fertilizers.
Department of Pharmaceuticals (DOP). This is part of the Ministry of Chemicals and Fertilizers.
Department of Biotechnology (DBT). This is part of the Ministry of Environment and Forests.
Review Committee on Genetic Manipulation (RCGM). This is part of the Ministry of Science and
Technology.
Genetic Engineering Appraisal Committee (GEAC). This is part of the Ministry of Environment and
Forests.
National Medical Commission (NMC). The NMC regulates healthcare professionals practicing modern
(allopathic) medicine.
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7. MEDICAL DEVICES
Definition
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.
According to Therapeutics Goods Act 1989, it is defined as any instruments, apparatus, appliances,
material or other article (weather used alone or in combination and including software necessary
for its proper application) intended to be used for human being for:
Diagnosis, prevention, monitoring, treatment or alleviation of diseases.
Investigation, replacement or modification of the anatomy or of a physiological processes.
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8. In India medical devices are governed by Central Drugs Standard Control Organization
(CDSCO) 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 regulates the medical devices.
Many committees had been setup and give their opinion and recommendation, like
Mahelkar Committee – Central Drug Standard Control Organization.
All these are now being taken into to form the Indian Medical Device regulatory Act
(IMRDA).
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REGULATION OF MEDICAL DEVICES IN INDIA
9. INDIAN MEDICAL DEVICE REGULATORY ACT (IMRDA)
Indian Medical Devices Regulatory Act come in force December 31,2009
Inputs to be sent to Dr.B.Hari Gopal , Adviser Department of Science and Technology,
New Delhi.
The composition of the Indian Medical Device regulatory Act (IMRDA) committee is
represented by:
Central Government
Eminent Jurist
Two eminent medical practitioners
Two eminent medical technologists
Secretary General Quality council
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10. I.M.R.D.A. ESSENTIAL PRINCIPLES & OBJECTIVES
Principles
Should not compromise health and safety.
Design and manufacture of devices must conform with safety principles.
Long term safety should be ensured.
Benefits of the devices must outweigh any side effects.
Medical devices should be useful for the intended purpose.
Objectives
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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11. I.M.R.D.A. REGULATION
Indian Medical Devices Regulatory Act (IMRDA) will issue:
Design and manufacturing requirements
Performance evaluation
Demonstration of device standards , testing and compliance
Regulation of post marketing follow up
Regulation of recalls
Legislate and punishment for non compliance
Principle of safety
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12. I.M.R.D.A. CLASSIFICATION OF MEDICAL DEVICES
IMRDA classifies the medical devices on the basis of risk level
Class A– Devices involving low risk levels
Class B– Devices involving low to medium risk
Class C – Devices involving moderate to high risk
Class D– Devices involving high risk.
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13. THE DRUG AND COSMETIC ACT
The Drug and Cosmetic Act regulates :
Covers the pharmaceutical products and cosmetic.
Added medical devices as early as1992(syringes , needles , etc.)
As per the latest list of regulated medical devices, issued on the 20/04/2010, listed following devices:
•Disposable hypodermic needles
•Disposable hypodermic syringes
•Disposable perfusion sets
•In vitro diagnostic devices for HIV, HbsAg.
•Cardiac stents
•Catheters
•Intra ocular lenses
Additionally following products are regulated as ‘Drugs’ under Drugs & Cosmetics Act & Rules there under:
•Blood grouping sera
•Ligatures, sutures & staplers
•Intra uterine devices
•Condoms
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•Drug eluting stents
•I.V. cannulae
•Bone cement
•Heart valve
•Scalp vein sets
•Orthopedic implant
•Internal prosthetic replacement
•Tubal rings
•Surgical dressings
•Umbilical cord
•Blood/blood related products
14. SIGNIFICANCE & ROLE OF PHARMACIST IN USE OF MEDICAL DEVICES
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Significance of medical devices
The medical development in terms of drugs and devices has brought about the robust change in
the life of the people. Medical devices have extended the ability of physicians to diagnose and
treat diseases, making great contributions to health and quality of life.
Like medicines and other health technologies, they are essential for patient care at the bedside,
at the rural health clinics or at the large, specialized hospitals.
Role of pharmacist in regulation and use of medical devices
Pharmacist should:
have proper understanding of medical device safety, risk involved, the degree of invasiveness,
duration of contact, the body system affected, and local versus systemic effects.
be actively involved in the regulation of effectiveness and performance of medical device.
15. LATEST DEVELOPMENT IN MEDICAL DEVICE REGULATION
There are only14 medical devices regulated by Drug Controller General of India (DCGI).
Currently, a number of specific medical devices are regulated as drugs and fall under India’s Drugs and Cosmetics Act (DCA).
Since 2008, both the Indian Department of Science and Technology and the Ministry of Health have sought to completely
restructure the regulations for medical devices.
Department of Science and Technology : proposed creation of a Medical Devices Regulatory Authority that would operate similar to
a division within the CDSCO.
Ministry of Health: proposed revision of the DCA that would create a Central Drug Authority to function similarly to the U.S.FDA.
The CDSCO is continuing to entrench its own medical device regulation standards. In June 2009, it seemed as if the CDSCO would
begin its own form of medical device regulations.
CDSCO: released schedule M-3 which provided an official definition for medical devices, outlined a four level medical device risk
classification scheme, created a body within the CDSCO to regulate medical devices in India.
Ministry of Health and Family Welfare, Government of India, with WHO funding, initiated a country wide National
Pharmacovigilance Program.
Central Drugs Standard Control Organization (CDSCO), New Delhi, coordinates the program. The Honorable Minister of Health,
Dr. Anbumani Ramadass at New Delhi, officially launched the program on November 23, 2004.
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