Overview of Medical Devices Regulations in India
The Medical Devices Rules of 2017 in India categorize medical devices into broad classifications, including electronics equipment, implants, consumables, IVD reagents, and surgical instruments. These rules apply to substances used for diagnosis, surgical dressings, contraceptives, disinfectants, and insecticides. The Indian medical device market is growing steadily, with an estimated market size of $11 billion and a global market share of 1.5%. The compound annual growth rate of the Indian medical device market is also discussed in the context of regulatory frameworks under the Drugs and Cosmetics Act.
Overview of Medical Devices Regulations in India
PowerPoint presentation about 'Overview of Medical Devices Regulations in India'. This presentation describes the topic on The Medical Devices Rules of 2017 in India categorize medical devices into broad classifications, including electronics equipment, implants, consumables, IVD reagents, and surgical instruments. These rules apply to substances used for diagnosis, surgical dressings, contraceptives, disinfectants, and insecticides. The Indian medical device market is growing steadily, with an estimated market size of $11 billion and a global market share of 1.5%. The compound annual growth rate of the Indian medical device market is also discussed in the context of regulatory frameworks under the Drugs and Cosmetics Act.. Download this presentation absolutely free.
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DRUGS AND MEDICAL DEVICES REGULATONS IN INDIA MEDICAL DEVICES RULES 2017 EFFECTIVE FROM IST JANUARY 2018 16-04-2024 HARNA 1
MEDICAL DEVICE A MEDICAL DEVICE IS DEVICE USED IN CURE MITIGATION TREATMENT, PREVENTION AND DIAGNOSIS OF DISEASES IN HUMAN BEINGS AND ANIMAL, BY NOTIFICATION UNDER SECTION 3 OF THE DRUGSA AND COSMETICS ACT AND MEDICAL DEVICES RULES 2017 THE MEDICAL DEVICE IS A MULTI-PRODUCT SECTOR, WITH THE FOLLOWING BROAD CLASSIFICATIONS: (A) ELECTRONICS EQUIPMENT; (B) IMPLANTS; (C) CONSUMABLES AND DISPOSABLES; (D) IVD REAGENTS; AND (E) SURGICAL INSTRUMENTS. 16-04-2024 HARNA 2
STATUTE DRUGS AND COSMETICS ACT 1940 AND RULES THERE UNDER DRUGS ACT 1940 + DRUG RULES MEDICAL DEVICES RULES 2017 COSMETICS RULES 2020 16-04-2024 HARNA 3
MARKET SIZE National Medical Device Policy, 2022 THE CURRENT MARKET SIZE OF THE MEDICAL DEVICES SECTOR IN INDIA IS ESTIMATED TO BE $11 bn AND ITS GLOBAL MARKET SHARE IS ESTIMATED TO BE 1.5% . INDIA IS COUNTED AMONGST TOP 20 GLOBAL MARKET OF MEDICAL DEVICES, AND 4THLARGEST MEDICAL DEVICES MARKET IN ASIA AFTER JAPAN, CHINA, AND SOUTH KOREA 16-04-2024 HARNA 4
INDIAN MEDICAL DEVICE MARKET COMPOUND ANNUAL GROWTH RATE 16-04-2024 HARNA 5
MEDICAL DEVICES RULES 2017 DEFINITION OF MEDICAL DEVICES::devices notified from time to time under sub-clause (iv), of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940) APPLICATION: These rules shall be applicable in respect of,- (i) substances used for in vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood and blood component collection bag with or without anticoagulant covered under sub- clause (i); (ii) substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings), disinfectants and insecticides notified under sub-clause (ii); AND as defined under section 3(b)(iv) of the Drugs and Cosmetics Act 1940 16-04-2024 HARNA 6
NOTIFICATION OF MEDICAL DEVICE MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) NOTIFICATION New Delhi, the 11th February, 2020 S.O. 648(E). In pursuance of sub-clause (iv) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with the Drugs Technical Advisory Board, hereby specifies the following devices intended for use in human beings or animals as drugs with effect from the 1st day of April, 2020, namely: All devices including an instrument, apparatus, appliance, implant, material or other article, ..ans, but which may assist in its intended function by such means for one or more of the specific purposes of 1. (i) diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder; 2. (ii) diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability; 3. (iii) investigation, replacement or modification or support of the anatomy or of a physiological process; 4. (iv) supporting or sustaining life; 5. (v) disinfection of medical devices; and 6. (vi) control of conception. 16-04-2024 HARNA 7
CLASSIFICATION OF MEDICAL DEVICES (UNDER MDR 2017. IT IS MATRIX) EVERY MEDICAL DEVICE GETS CATEGORIZED IN TO CLASS A, B, C OR D DEPENDING UPON RISK INVOLVED IN ITS USE WHEN INTER-CONNECTED THEN THE CLASS OF CONNECTION END DECIDES AS PER FIRST SCHEDULE AND SECOND SCHEDULE 1. BASED ON BEING INVASIVE OF NOT OR CONTACT WITH HUMAN BODY 2. LONG TERM RETENTION OR SHORT TERM RETENTION 3. MEDICATED OR NOT 4 CONTAINS INACTIVATED ISSUES OR CELL OR ACTIVE TISSUE OR CELL 3. WHETHER IT IS AN ACTIVE DEVICE OR NOT 4. WHETHER IT IS TO STORE LIQUIDS TO BE INFUSED OR FOR CHANNELISATION 5. IF IT IS IMPLANT ETC. 16-04-2024 HARNA 8
CERTAIN DEFINITIONS PREDICATE DEVICE ( RULE 3 zm) : means a device, first time and first of its kind approved for manufacture for sale or for import by The Central Licensing Authority and has the similar intended use, material of construction, and design characteristics as the which is proposed for licence in India SHORT TERM USE RULE 3zr;continuous useNLT 60 min andNMT30Day LONG TERM USE RULE3za; continuous use for more than 30 days. ACTIVE MEDICAL DEVICE; RULE3d; IT OPERATES ON ELECTRICAL SOURCE OR ENERGY DERIVED FROM SOURCE OTHER THAN DERIVED FROM HUMAN OR ANIMSL BODY ACTIVE THERAPEUTIC MEDICAL DEVICERULE3e; USED IN TREATMENT OR ALLEVATION OF ILLNESS, INURY OR HANDICAP, TO SUPPORT MODIFY, REPLACE OR RESTORE BILOGICAL FUNCTIONS OR STRUCTURES 16-04-2024 HARNA 9
CLASSIFICATION OF MEDICAL DEVICES UNDER THE RULES 2017 CLASSIFICATION OF MEDICAL DEVICES UNDER THE RULES 2017 CHAPTER II RULE 4 : (1) MEDICAL DEVICES OTHER THAN IN VITRO DIAGNOSTIC MEDICAL DEVICES SHA CLASSES GIVEN IN First Schedule PARAMETERS SR RISK CLASS THE MEDICAL DEVICE ON BASIS ON ITS MEDICAL USE (i) LOW RISK NON INVASIVE NO BREACH OF SKIN. ONLY SUPPORT. SELF HEALING. FOR STORAGE AND CHANELLING OF FLUIDS . OR IF DOES NOT COME IN CONTACT WITH PERSON OR IT IS INVASIVE UPTO ORAL ,PHARYNGEAL ,EXTERNAL AND MIDDLE EAR ,AND NASAL CAVITY CLASS A (ii) LOW MODERATE RISK NON INVASIVE IN CONTACT WITH BREACHED SKIN, OR IF CONNECTED TO CLASS B, OR C OR D FOR CHANNELING CLASS B (ii) MODERATE HIGH RISK NON INVASIVE PRINCIPALLY IN CONTACT WITH WOUND CANNOT HEAL BY ITSELF WITHOUT TREATMENT OR IF IT IS BLOOD BAG WITHOUT MEDICINES INCORPORATED, MECHANICAL CONTRACEPTIVES NOT MEANT TO BE LEFT IN BODY CAVITY CLASS C (iv) HIGH RISK CLASS D INVASIVE, MEDICINAL,LONG TERM RETENTION IMPLANTS 16-04-2024 HARNA 10
SCHEDULES (total eight) UNDER MDR 2017 SCHEDULE CONTENTS FIRST SCHEDULE PART I PART II PARAMETERS FOR CLASSIFICATION INTO CLASS A,B,C & D OF MD & IN VITRO DIAG.MD MD AND IN VITRO-DIAGNOSTIC AGENTS, AND IN VITRO-DIAGNOSTIC MEDICAL DEVICES SECOND SCHEDULE FEES PAYABLE FOR LICENCE, PERMISSION AND REGISTRATION CEERTIFICATE THIRD SCHEDULE PART I I PART II DOCUMENTS REQUIRED FOR REGISTRATION OF NOTIFIED BODY, its duties and functions DOCUMENTS FOR APPLICATION IN Form MD-1, GRANT OF CERT.OF REGISTRATION DUTIES AND FUNCTIONS OF NOTIFIED BODY FOURTH SCHEDULE DOCUMENTS REQUIRED FOR GRANT OF LICENCE TO MANUFACTURE FOR SALE OR FOR DISSTRIBUTION OR IMPORT POWER OF ATTORNEY MD CLASS A :DOCUMENTS FOR GRANT LIC: IMPORT OR MFR for sale OR DISRTIBUTION CONTENTS OF A SITE OR PLANT MASTER FILE DEVICE MASTER FILE FOR MD OTHER THAN IN VITRO DIAGNOTIC MEDICAL DEVICES DEVICE MASTER FILE FOR IN VITRO DIAGNOTIC MEDICAL DEVICES IFORMATION WITH APPLICATION FOR IMPORT OR MFR OF MD WITHOUT PREDICTE MD PART I PART II PART III APPENDIX I PART III APPENDIX II PART III APPEND III PART IV 16-04-2024 HARNA 11
SCHEDULES (total eight) UNDER MDR 2017 SCHEDULE CONTENTS FIFTH SCHEDULE QUALITY MANAGEMENT SYSTEM APPLICABLE TO MFR FINISHED DEVICES: IN VITRO DMD, CONDOMS, INTRAUTERINE DEVICES, TUBAL RINGS, SURGICAL DERESSINGS, SURGICAL BANDAGES, SURGICAL STAPLERS, SUTURES AND LIGATURES, BLOOD AND BLOOD COMPONENT COLLECTION BAGS WITH OR WITHOUT ANTICOAGULANTS. QUALITY MANAGEMENT SYSTEM EXPLAINED AND DEFINED ENV REQUIREMENT FOR IN VITRO DIAGNOSTIC MEDICAL DEVICES (DMD) AND ISO CLASS FOR THE INVIRONMENT) AND ANNEXURE A SIXTH SCHEDULE POST APPROVAL CHANGES: MAJOR DESIGN,QUALITY, SPECIFICATION & MO AND MINOR DEFINED SECONDARY PACKAGING SEVENTH SCHEDULE REQUIREMENTS FOR PERMISSION TO IMPORT OR MANUFACTURE INVESTIGATIONAL MEDICAL DEVICES FOR CONDUCTING CLINICAL INVESTIGATIONS EIGHTH SCHEDULE EXEMPTIONS; FORM APLICATION OF CERTAIN PROVISIONS OF APPLICABILITY OR SALE LICENCES AND OTHER PROVISIONS DEPENDING UPON THE PURPOSE STATED THEREIN. 16-04-2024 HARNA 12
AUTHORITIES OFFICERS AND BODIES (total eight) NAME MODE FUNCTION SR 1. LICENSING AUTHORITIES CLA OR HIS DELEGATE ENFORCEMENT OF MDR wrt IMPORT,MFR of Class C &D, CLINICAL INV. AND THEIR APPROVAL, EVALUATION AND THAT OF NEW INVITRO DMD 2. STATE DRUGS CONTROLLER STATE LLICENSING AUTHORITY ENFORCEMENT OF MFR FOR SALE AND DISTRIBUTION OF CLASS A & B MD SALE STOCK AND EXHIBIT OR OFFER FOR SALE OR DISTRIBUTION OF ALL CLASSES OF MD 3 CONTROLLIN AUTHORITY ADC OR ABOVE SUBJECT TO ORDER OF DCGI OR SDC OVER SUBORDINATE OFFICER ENFORCEMENT 4 NATIONAL ACCREDITION BODY (NAB) INSTITUTE, FIRM , GOVT. ORGANIZATION OR GOVT AIDED ORG. NOTIFICATION BY CENTRAL GOVERNMENT 16-04-2024 HARNA 13
AUTHORITIES OFFICERS AND BODIES (total seven) SR NAME MODE FUNCTION 5 NOTIFIED BODY ANY INSTITUTE meeting with criterion TO SATISFACTION OF NAB WHO WILL NOTIFY 6 MEDICAL DEVICE OFFICER (INSPECTOR) CENTRAL GOVERNMENT OR STATE GOVERNMENT APPOINTS AND NOITFIES UNDER SECTION 21 OF THE ACT. Central Govt Notification No. S.O. 2572 (E) dt. 25.07.2021, notified 172 as Medical Device Officers. TO CARRY OUT DUTIES GIVEN UNDER RULE 70 TO 80 7 MEDICAL DEVICE TESTING OFFICER (GOVT. ANALYST) CENTRAL GOVERNMENT OR STATE GOVERNMENT APPOINTS AND NOITFIES UNDER SECTION 20 OF THE ACT TO CARRY OUT DUTIES GIVEN UNDER RULE 66 TO 69 16-04-2024 HARNA 14
STANDARDS OF MEDICAL DEVICES CHAPTER II RULE 7 PRODUCT STANDARDS FOR MEDICAL DEVICES 1. SECTION 3 OF BUREAU OF INDIAN STANDARDS ACT , 1985 2. AS MAY BE NOTIFIED BY THE CENTRAL GOVERNMENT 3 ISO 4. INTERNATIONAL TECHNO COMMISSION 5. BY ANY OTHER PHARMACOPOEIAL STANDARDS 6. IN CASE NONE OF ABOVE STANDARDS ARE AVAILABLE THEN VALIDATED STANDARDS OF ITS MANUFACTURER 16-04-2024 HARNA 15
LICENSING UNDER MDR 2017 S R NATUR E OF LIC NATURE OF MD FORM OF APP FORM OF LIC INSPECTION LICENSING AUTHORITY 1 MFG CLASS A CLASS B CLASS C CLASS D MD CL INVST CLASS ABCD MD-3 MD-3 MD-7 MD-7 MD-5 MD-5 MD-9 MD-9 NONE NPNE YES YES LICENSING REPLACED WITH REGISTRATION FOR A & B CLA CLA MD-12 MD-13 NO CLA 2 IMPORT CLASS A MD-14 MD-14 MD-14 MD-14 MD-27 ------ MD-27 MD-15 MD-15 MD-15 MD-15 MD-29 ----- MD-29 NONE BUT HAVE MD-5 /-9 NONE BUT HAVE MD-5 /-9 NONE BUT HAVE MD-5 /-9 NONE BUT HAVE MD-5 /-9 NONE CLA CLA CLA CLA CLA CLASS B CLASS C CLASS D INVG MD NEW IN VIT DMD NONE CLA 3 SALE ONLY REGISTRATION ON SUGAM PORTAL OF DCGI IS REUIRED. 16-04-2024 HARNA 16
QUALITY MANAGEMENT SYSTEM FOR MANUFACTURE OF MD AND IN VITRO DMD FIFTH SCHEDULE OF MDR2017 : QMS 4.1 GENRAL: ESTABLISH, DOCUMENT, IMPLEMENT AND MAINTAIN ITS EFFECTIVENESS 4.2 DOCUMENTATION: QUALITY POLICY, QUALITY MANNUAL, DOCUMENTED PROCEDURE, QUALIFIED STAFF, MANUFACTURING PROCESS AS PER WRITTEN SOP AND PROCEDURES 4.2.3 CONTROL OF DOCUMENTS: ALL DOCUMENTS USED IN PRODUCTION WILL BE APPROVED SIGNED AND DATED BY AUTHORISED PERSON. 4.2.4 CONROL OF RECORDS: TO BE PRESERVED FOR AT LEAST ONE YEAR AFTER THE DATE OF EXPIRY OF SHELF LIFE OF MD AND AT LEAST TWO YEARS AFTER THE DATE OF PRODUCT RELEASE IN CASE OF INVITRO DIAGNOSTIC MEDICAL DEVICE. 5. MANAGEMENT COMMITMENT TO QMS 6. RESOURCE MANAGEMENT 7, PRODUCT REALIZATION 8. MEASUREMENT, ANALYSIS AND IMPROVEMENT 16-04-2024 HARNA 17
QUALITY SURVEILLANCE IN THE MFG SITE MARKET OR HOSPITALS BY MEDICALL DEVICE OFFICER RULE 70:THE MEDICAL DEVICE OFFICER APPOINTED UNDER SECTION 21 OF THE ACT AND NOTIFIED FOR SPECIFIC AREA OF JURISDICTION CAN 1. INSPECTION OF MFG UNITS AT LEAST ONCE AYEAR 2. VERIFICATION OF CONDITIONS OF MFG 3. TAKE SAMPLES FROM MFG SITE, IMPORTED MD, BEING SOLD IN MARKET 4. TO SEND ALL INFORMATION TO CLA AND OR SLA 5. TO DETECT CONTRAVENTION 6. INVESTIGATE COMPLAINTS 7. INSTITUTE PROSECUTIONS FOR CONTRAVENTION IN COMPETENT COURT 8. TO REVIEW TECHNICAL DOSSIER AS ASKED BY CLA 16-04-2024 HARNA 18
MEDICAL DEVICE TESTING OFFICER RULE 66: MEDICAL DEVICE TESTING OFFICER APPOINTED U/S 20 OF THE ACT AND NOTIFIED SO WITH RESPECT TO CLASS AND TYPE OF THE MD AND FOR THE TESTING LAB NOTIFIED UNDER MDR 2017 1. RECEIVE SAMPLES FOR TEST OR EVALUATION SENT BY MDO ON FORM MD-38 2. ISSUE REPORT OF TEST OR EVALUATION OF MD ON FORM MD-32 IN TRIPLICATE TO MEDICAL DEVICE OFFICER WHO SENT THE SAMPLE 3. RECEIVE REQUEST FROM PURCHASER ON FORM MD-33 ALONG WITH SAMPLE AND ISSUE TEST OR EVALUATION REPORT IN FORM MD-32 16-04-2024 HARNA 19
CENTRAL MEDICAL DEVICE TESTING LABORATORY RULE 67 TO RECEIVE SAMPLE OF MD FORM MAGISTRATE COURT ON FORM MD-30 TO ISSUE CRETIFICATE OF TEST OR EVALUATION ON FORM 31 TO THE MAGISTRATE COURT WHO SENT THE SAMPLE ON FORM MD-30 SUCH A TESTING IS UNDER S25(4) OF THE DRUGS AND COSMETICS ACT 1940 WHEN THE COURT ON ITS OWN DISCRETION OR ON THE REQUEST OF ACCUSED INTEND SO 16-04-2024 HARNA 20
PROCEDURE TO BE FOLLOWED BY MDO FOR SAMPLING THE NOTIFIED MDO TAKES SAMPLE ON FORM MD-36. DEVIDES INTO 3 OR 4 POTIONS, SUIATABLE PACKS AND SEALS WITH SEAL IMPRESSION COPY OF FORM MD-36 IS GIVEN TO THE PERSON IN CHARGE FROM WHOSE PREMISES THE SAMPLE IS BEING TAKEN ALONG WITH A PORTION OF THE SAMPLE MDO TENDERS FAIR PRICE UNDER SECTION 23 OF THE ACT. IF THE PRICE IS REFUSED THEN HE ISSUES A RECEIPT OF THE SAMPLED QUANTITY ON FORM 37 MDO SENDS ONE PORTION OF THE SAMPLE TO MDTO BY REGISTERED PARCEL OR BY SPECIAL MESSANGER. MDO RECEIVES TEST AND EVALUSTION REPORT ON FORM MD-32 16-04-2024 HARNA 21
OFFICIAL WEBSITE OF THE INTERNATIONAL TRADE ADMINISTRATION Policy and Regulatory Environment To ensure quality healthcare, the Indian government increased the list of medical devices covered under the Drugs and Cosmetics Act of 1940, bringing several categories of implantable devices under the provision of the Medical Device Rules (MDR) 2017. Medical devices in India are classified according to the risk to patient health. The current risk classifications are Class A: devices with the lowest risk (e.g., surgical dressings and alcohol swabs); Class B: devices with low to moderate risk (e.g., needle kits and cervical drains); Class C: devices with moderate to high risk (e.g., bone cement, bifurcation stents and catheters); and Class D: devices with high risk (e.g., coronary stents and cardiac catheterization kits). 16-04-2024 HARNA 22
OFFICIAL WEBSITE OF THE INTERNATIONAL TRADE ADMINISTRATION In July 2017, the Indian government introduced price controls on cardiac stents, capping the selling price up to 70 percent lower than the prevalent market rate. That order was followed by a similar cap on knee implants later in the year. The devices were price capped after inclusion in the National List of Essential Medicines. In January 2020, the Indian government categorized all medical devices (including instruments, implants, and software intended for human or animal medical use) as drugs, bringing them under the purview of the Drugs & Cosmetics Act, 1940. 16-04-2024 HARNA 23
OFFICIAL WEBSITE OF THE INTERNATIONAL TRADE ADMINISTRATION Currently, 37 medical devices are classified as drugs and regulated under the Drugs and Cosmetics Act. Of these, cardiac stents, drug- eluting stents, knee implants, condoms, and intra-uterine devices are included in the National List of Essential Medicines and are subject to price caps. In February 2020, the Indian government levied a five percent ad-valorem health tax on imports of a variety of medical, dental, surgical, and veterinary devices. Several medical device segments (such as orthopedic knee implants) that were previously exempt from customs duties were withdrawn from the duty exemption. 16-04-2024 HARNA 24
OFFICIAL WEBSITE OF THE INTERNATIONAL TRADE ADMINISTRATION In June 2020, the Department for Promotion of Industry and Internal Trade amended its 2017 Public Procurement Order, giving priority to Indian companies whose products contain 50 percent or more local content. Products with less than 20 percent local content are categorized as non-local suppliers and cannot participate in government tenders. Effective June 2021, the National Pharmaceutical Pricing Authority issued orders to impose price controls on oxygen concentrators in line with the Trade Margin Rationalization (TMR) approach, which is the difference between the price at which manufacturers sell to the trade and the price to patients. National Pharmaceutical Pricing Authority had initially introduced the Trade Margin Rationalization policy for medical devices and drugs in 2018 to help improve patient access to affordable and accessible healthcare. 16-04-2024 HARAN 25
OFFICIAL WEBSITE OF THE INTERNATIONAL TRADE ADMINISTRATION In June 2021, the Quality Council of India and the Association of Indian Medical Device Industry added new features to the Indian Certification for Medical Devices Scheme of 2016. This new scheme, called Indian Certification for Medical Devices Plus (2021), was designed to verify the quality, safety, and benefits of medical devices and help government agencies identify counterfeit products and falsified certifications. In addition, the new rules eliminated the need for re-approval of manufacturing and import licenses. 16-04-2024 HARAN 26
OFFICIAL WEBSITE OF THE INTERNATIONAL TRADE ADMINISTRATION: ISO 13484 Certification In January 2022, the Indian government issued a notification requiring all medical device companies to register their devices with the Central Drugs Standard Control Organization in compliance with a mandatory ISO 13485 certification. This requirement is designed to ensure the safe production and control of medical devices and in- vitro diagnostic products. Previously, medical devices were subject to a voluntary registration scheme. Starting in October 2021, Class A and B medical devices were subject to mandatory registration, and from September 2022, Class C and D medical devices will be subject to mandatory registration. When the mandatory registration period expires in September 2023, the medical device classes will transition to a licensing regime. 16-04-2024 HARAN 27
OFFICIAL WEBSITE OF THE INTERNATIONAL TRADE ADMINISTRATION In February 2022, the Department of Pharmaceuticals amended the list of medical devices exempted from India s Procurement Order 2017 to ensure patient access to critical medical technologies not currently produced in India. 16-04-2024 HARAN 28
LABELLING OF MD CHAPTER VII R-44 TO 48 1. NAME, UIDNo., Name of mfrer, address, quantity,Mfg date, B.No. Mfg Lic No. 2. Shelf life perod or Exp Dt. NOT TO EXCEED 60 MONTHS, Storage cond. 3. Status on sterility 4. Status on being medicated 5. If for single use 6. MD for Export to adapt to requirement of importing country 7. FOR NEW IN VITRO DIAGNOSTIC AGENTS BESIDES OTHER, USE BEFORE INFORMATION 16-04-2024 HARAN 29
OFFENCES AND PUNISHMENTS The offences and punishments are given in the DRUGS AND COSMETICS ACT 1940 UNDER R-76THE MD OFFICER WILL TAKE SAMPLES OF MD BY DIVIDING INTO 4 PORTIONS ON FORM- 36 UNDER R-78(1)HE WILL DISPATCH ONE SEALED PORTION TO MEDICAL DEVICE TESTING OFFICER ON FORM -38 UNDER R-74 ,MDO SIEZES STOCK OR DOCUMENTS ON MD-35 UNDER R- 68(2) MDTO ISSUES TEST REPORT ON FORM MD 32 MAGISTRATE U/S 25 SENDS SAMPLE TO CMDT LAB ON FORM MD-30 THE CMDTLAB SENDS TEST REPORT TO THE MAGISTRATE ON FORM-31 16-04-2024 HARAN 30
COURT PROCEDURE STANDARDS ARE GIVEN IN CHAPER II U/R7 SECTION 18(c) offence for manufacture for sale without lience and sale without licence unishable u/s 27(b)(ii) Section 36AB offence for MD which is likely to cause death of of patient which is punishable u/s 27(a) Section 17B offence for the Spurious MD, punishable under S.27 (c) Section 18(a)(i) , Not of standad quality, misbranded U/S 27(d) Punishment for any other contravention U/S 27(d) 16-04-2024 HARNA 31
COURT PROCEDURE COURT PROCEDURE IS GOVERNED BY CRIMINAL PROCEDURE CODE UNDER SECTION 32 ONLY MDO OR ANY OTHER OFFICER NOTIFIED OR THE CONSUMER CAN LAUNCH PROSECUTION IN THE COMPETENT COURT UNDER SECTION 32AB READ WITH 36AC AND READ WITH S 32(2) ALL OFFENCES FALLING UNDER SECTION 27(a) and section 27(c) can be tried by SPECIALLY NOTIFIED COURT OF SESSION UNDER THE ACT REST OF OFFENCES SHALL BE TRIES BY A MAGISTRATE IST CLASS, UNDER SECTION 36A AND 36. 16-04-2024 HARAN 32
THANK YOU VERY MUCH for PATIENT LISTENING RAJINDER KUMAR HARNA, M.PHARM, LLB RETIRED ASSISTANT STATE DRUGS CONTROLLER FDA, HARYANA 16-04-2024 HARNA 33
