Combinational products & medical devices

Regulation For Combination of 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 2

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. 3

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). 4

5. EXAMPLES OF COMBINATION PRODUCTS 5 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. 6

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. 7

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). 8 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 9

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. 10

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 11

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. 12

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 13 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 14 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. 15

16. Reference https://www.slideshare.net/bdvfgbdhg/medical-device-16068264 https://www.fda.gov/combination-products https://symbiosisonlinepublishing.com/pharmacy-pharmaceuticalsciences/pharmacy-pharmaceuticalsciences58.php 16