Annexure A – Comments by AIMED on D&C Amendment Bill 2015 MEDICAL DEVICES : SAFETY AND PERFORMANCE Fundamental Principles of Medical Device Regulation BACKGROUND: Advances in science, technology and medicine have produced a huge variety and number of Medical Devices, which have become an important part of healthcare delivery today. The term “Medical Devices” as generally defined, covers very simple, low risk ones like spectacles and hearing aids to critical life-saving and life-supporting devices like artificial heart valves and hemodialysers; the numbers are increasing rapidly every year, with the development of new advanced materials and technologies. However, poorly designed or manufactured devices have the potential to cause harm and injury to patients and care givers. Current international experience in the use of medical devices has clearly shown, that the optimum assurance of medical device safety has several essential elements: • Absolute safety cannot be guaranteed • It is a risk management issue • It is closely aligned with device design and performance • It must be considered throughout the life span of the device • It requires shared responsibility amongst the stakeholders – the Users, the Regulated Suppliers and the Regulators Based on the international experience in the regulation of medical devices over the last 4 decades, the following PRINCIPLES and REQUIREMENTS clearly stand out as the basic fundamentals and building blocks of any National Medical Device Regulatory System, some of which have been again missed in the Proposed Bill. 1. DEFINITIONS of other related Terminology related to Medical Devices which are relevant to Medical Devices regulation - missing. 2. ESSENTIAL PRINCIPLES OF MEDICAL DEVICE PATIENT SAFETY AND PERFORMANCE a. Essential principles of safety and performance - missing b. Design and Manufacturing Requirements - missing 3. PRINCIPLES OF RISK BASED REGULATION – Proportionate control - missing 4. CONFORMITY TO ESSENTIAL PRINCIPLES OF SAFETY AND APPLICATION OF STANDARDS - missing 5. RESPONSIBILITIES OF THE PRIMARY MANUFACTURER - missing a. Responsibility of the Manufacturer to demonstrate conformity b. Technical documentation requirements c. System for post-market surveillance and Adverse event reporting d. Declaration of conformity by Manufacturer e. Registration and placing the device on the market f. Records of manufacture and tracking of devices g. Code of advertising / Claims to performance or efficacy Page 2 of 11 6. CONFORMITY ASSESSMENT PROCEDURES & APPLICATION OF QUALITY MANAGEMENT SYSTEMS - missing a. Conformity assessment procedures and application of quality management systems to manufacture b. Clinical Investigation c. Marking of conforming medical devices 7. RESPONSIBILITIES OF THE INDIAN HEALTHCARE PRODUCTS REGULATORY AUTHORITY a. TIME LIMITS FOR COMPLETION OF REGISTRATION BY IHPRA - missing b. VIGILANCE BY IHPRA on Adverse events & advertising - missing c. Coordinating and Proactively initiating Product Recalls & adequacy of Field Corrective Actions by IHPRA - missing d. For ensuring Publics ready accessibility to innovative Medical Devices and limiting Publics access to Potential unsafe Devices - missing 8. REVIEW OF FUNCTIONING OF IHPRA BY PARLIAMENT - missing 9. MEDICAL DEVICE SAFETY APPELLATE TRIBUNAL - missing 10. TRANSITIONAL ARRANGEMENTS - missing You may kindly consider to include these key vital elements as part of the Law as much as possible and then Rules for implementation and Guidelines may follow subsequently. Our specific suggestions to amend the bill are: 1) The Drugs and Cosmetics Bill 2015 may be preferably named as “Medical Devices & Patient Safety Bill 2015” and to be presented as entirely separate regulations from Pharmaceuticals to encourage investment in this segment. We recommend the regulatory body may be called IHPRA – Indian Healthcare Products Regulatory Authority under MOH with separate divisions for Drugs , Cosmetics, Medical Devices & Diagnostics. A medical device manufacturer may not be expected to pick up and study the entire D&C Act or the D&C rule book. 2) REF. : (Page #6) S# 7 (y) The term “New Medical Device” has been defined but the definition is very much confusing and impractical and does not serve its intention, so not acceptable. We suggest amending the definition as follows: New Medical device means a device not approved by Central Licensing Authority or by any other International Regulatory Authority. 3) REF.: (Page #3) S#7 (g) (iii) The word “Effectiveness” needs to be replaced by the word “Performance” in this clause and everywhere else in the Act when it refers to Medical Devices. Explanation: Unlike Drugs where their effectiveness is measured, for Medical Devices it is performance that is evaluated and compared. Drug Efficacy is dosage dependent where as performance of Medical Devices depends also on usage and user skills. Page 3 of 11 Provision of performance evaluation need to be incorporated for medical devices/ Invitro diagnostic medical devices. 4) REF. : (Page #6) The following Definitions related to regulating Medical Devices may also be included in S#7 - Accessories: An article intended specifically by its manufacturer to be used together with a specific medical device(s), to enable the medical device to be used in accordance with its intended use. - Abnormal Use: Act or omission of an act by the operator or user of a medical device as a result of conduct that is beyond any reasonable means of risk control by the manufacturer. - Clinical Evaluation: The assessment and analysis of clinical data pertaining to a medical device to verify the clinical safety and performance of the device when used as intended by the manufacturer. - Custom made Device : Custom made Device means any Medical Device specifically made in accordance with a written prescription given by a Person authorized for the same by virtue of his professional qualifications, or by a duly qualified Medical Practitioner, under his responsibility, and in accordance with the specific design characteristics and is intended for the sole use of a particular Patient or Patients. Explanation : Mass produced Devices which only need adaptation to meet the specific requirements of the Medical Practitioner or any other professional user are not considered to be custom made Devices. - Quality Management System : Quality Management System means a set of Policies, Processes and Procedures required for planning and execution (production / development / service) in the manufacture of Medical Devices. - Performance evaluation : Review of the Performance of a Medical Device or In-Vitro Diagnostic Medical Device based upon data already available, scientific literature and, where appropriate, laboratory, animal or Clinical Investigations - Notified Body : Notified Body means a body corporate or other legal entity with suitable expertise, Notified by the Central Government as competent to carry out Conformity Assessment of Medical Devices as per the requirement of this Act and Prescribed Rules 5) REF.: (Page #5) S#7 (v) The definition of manufacturer is not appropriate in Indian context & can be misused. We would suggest the following definition Manufacturer' in respect of Medical Devices means the natural or legal person with responsibility for the design, manufacture, packaging and labeling of a device before it is placed on the market under his own name. The obligations of this Act to be met by manufacturer also apply to the natural or legal person who assembles packages, processes, and with a view to their being placed on the market under his own name. Page 4 of 11 We caution Govt. to kindly be wary of a hidden agenda of some of the US / European MNC’s who are increasingly dominating the Indian Market and have lobbied for Policy changes in past and have already made India over 70% dependent on import of Medical Devices rather than establishing factories here to help India be self reliant. The definition proposal of “ manufacture through another Person on his behalf” will allow Importers & MNC’s to claim Made in China Products ti be labeled as Made in India and Manufacture by them (?) (!) MNC’s are keen for India to adopt the definition of ‘Legal’ manufacturer as is used in Europe under the ruse of offering to the Regulators a single Company to target and hold responsible for regulatory issues. Under the European Law Manufacturer is defined as :- ‘Manufacturer’ means the natural or Legal Person with responsibility for the design, manufacture, packaging and labeling of Device before it is placed on the market under his own name, regardless of whether these operations are carried out by that Person himself or on his behalf by a third party. If original proposed definition is allowed by Law by oversight by our Law Makers :- a) It will be in conflict with Labeling requirement of the Indian Consumers Protection Act and the Packaging Rule. b) It will be misused and misrepresented by Trading Companies especially international MNC Traders who will pass of the Product as if manufactured by them – as a legal manufacturer – rather than as ‘Marketed by’ them or ‘Manufacture for’ them in their Brand Name on the Labels. c) It will hurt the interest of the Domestic Industry. Many World Bank financed Tenders and State Govt. Tenders have a Clause of giving a 10 to 15% price benefit to the indigenous Company to encourage a local long term supply source. If a Trader is going to be allowed to print his Name as ‘Manufacturer’ of Product this will take away the competitive benefit being given to Domestic Producer. d) It will further discourage green field investment Projects by MNC or Indian Industrialists in Medical Devices – simply more convenient to get complete Product imported / outsourced rather than making efforts and huge Capital investments of putting up a New facility and having Operational headaches. We would therefore request you to kindly revise the definition with due caution if you wish to achieve the objective “Make in India” Medical Devices. 6) REF. : (Page #7) S #4A Chapter IA This chapter requires Clinical Trials of a new Medical Device or Investigational New Medical Device to be conducted only after- a) Permission from the Central Licensing Authority b) Approval from Ethics Committee Page 5 of 11 We would suggest incorporating the provision in the Bill to exempt such nature of Clinical low risk assessments and initially consider to apply some measures of Regulatory control and discipline only on Clinical investigation solely on Class D level of high risk Medical Devices. The provisions for this may be made under Chapter IIA which could be limited to approval from a Hospital Ethics Committee and submission of an online registration with the Medical Division of the IHPRA (Indian Healthcare Products Regulatory Authority). There should be no need for a Medical Device manufacturer to refer to Regulatory controls of Drugs or Cosmetics stated elsewhere in the Act. At the same time punishing a licensed Manufacturer with minimal 2 years imprisonment term for conducting an assessment without 100% Compliance of the stated Clinical Trial procedure is highly draconian / punitive and overkill. We are unaware of any country which warrants such punishments for Medical Devices as if it is a serious crime. REF.: (Page #13) S#4V In light of above, we would therefore suggest removal of all reference of Medical Devices from Chapter IA of Clinical Trials is being done for Ayurvedic, Sidha or Unani drugs. REF. : (Page #13) S#9 to S#13 : These clause may be shifted to appropriate chapter as they are not related to clinical trial. 7) REF.: (Page #18) S# 13 (2) Drugs, Cosmetics & Medical Devices Consultative Committee: There is no representative included from the Medical Device Industry in the Consultative Committee. We would propose to include “One representative of the Medical Device Industry” and one Representative from the National Accreditation Board of Confirmatory Assessment Bodies (NABCB). We would also recommend that the Consultative Committees for Drugs, Cosmetics & Devices needs to be separate from each other as experts of Drugs may not be experts on Medical Devices and vice versa. 8) REF.: (Page #18) S#7B(1) Regulations are needed to bring in a disciplined approach in manufacturing Medical Devices as per a formally Structured Quality Management System so that they are safe. Medical Devices need not necessarily conform to a Product Standard of Quality as for over 95% of thousands of Medical Devices which have been recently developed there are no Product Performance Standards. Instead the approach of regulations and the prescribed Quality Management System that manufacturer needs to adopt is to demonstrate whether they meet certain Principles of Essential Requirements for ensuring Safety & Performance during manufacturing and designing of Medical Devices. Medical Devices are not Drugs so unlike a Pharmacopeia they are usually not having Standards of Quality Compliance. Leaving this part undefined by use of Term “Standard Quality” as being prescribed by a Regulator from time to time, will only give a very wide grey area open to multiple interpretation by different groups – the IHPRA, the State Regulatory Authorities, the Medical Device Officers and the Auditors with only a Big Stick to beat the industry all the time and lead to corruption. We recommend the following for substitution : Page 6 of 11 All Medical Devices placed on the Indian market must meet the following 6 requirements of the ESSENTIAL PRINCIPLES of SAFETY AND PERFORMANCE, namely : a. Use of Medical Devices should not compromise health and safety b. Design and manufacture of medical devices must conform with safety principles c. Medical devices should be suitable for the intended purpose and achieve the performance intended d. Long-term safety must be assured e. Medical Devices should not be adversely affected by transport or storage f. Benefits of medical devices must outweigh the risks associated with the use of the Device The Central Govt. should be empowered to prescribe Rules for: a. General requirements that manufacturers must meet so that devices achieve the performance intended by them during the lifetime of their use, so as to satisfy the requirements of Essential principles of Safety and Performance as laid in the clauses above. b. Design and Manufacturing requirements bearing in mind the following: i) Chemical, physical and biological properties ii) Infection and microbial contamination iii) Manufacturing and environment properties iv) Devices with a diagnostic or measuring function v) Protection against radiation, including ionizing, non-ionizing radiation and covering electromagnetic compatibility requirements to ensure overall safety in the environment and also complying with the national laws relating to electromagnetic compatibility and ionizing radiation vi) Requirements for Medical Devices connected to or equipped with an energy source vii) Protection against Mechanical risks viii) Protection against the risks posed to the patient by supplied energy or substances ix) Protection against the risks posed to the patient for devices for self testing or administration x) Information supplied by the manufacturer xi) Performance evaluation including, where appropriate, Clinical investigation and evaluation Note: the manufacturer can select the design and manufacturing requirements that are relevant to the Device, documenting the reasons for excluding the others. This shall be verified during the conformity assessment process. Regulatory controls will be proportionate to the level of risk associated with a Medical Device. The level of Regulatory control exercised for Medical Device can increase with increasing degree of risk, taking account of benefits offered by use of the device. At the same time the imposition of regulatory controls may not place an unnecessary or unrequired burden on Regulators & Manufacturers. The IHPRA may work towards the establishment of a classification system to cover Medical Device in Four Risk categories and have the power to define the Rules of Classification and for making exceptions to that Rule. These 4 Risk categories can be of : Page 7 of 11 (a) Low Risk (b) Moderate Risk (c) Moderate to High Risk (d) High Risk Examples of Medical Device for Low Risk are Tongue Depressors and Thermometer, for Moderate Risk are Hypodermic Needles and I V Catheters, for Moderate to High Risk are Lung Ventilator and Bone Fixation Plate and for High Risk are Heart Valves and Pace Makers. Given the vast diversity of Technologies and varying risk profile of Medical Devices, Regulatory Controls may be shared and split, the IHRA for Policy, Licensing & Registration of Manufacturers/Importers/Exporters for enabling a single window and harmonized controls ; Utilization of specialist CAB's ( Conformity Assessment Bodies)with domain specific knowledge for delegating the task of factory audits of Indian and Overseas Manufacturers for Compliance to Good Manufacturing Practices/ Quality Management Systems and the State Regulatory Authority for Licensing and Registration of Traders/Distributors/Dealers/Warehousing Sub Contractors/Retailers etc for regulating Logistics and Sales. Keeping in mind the need for Risk Proportionate Regulatory Controls, the Act may prescribe the rules for Registration of Class (a) Devices and the rules for Conformity Assessment by CAB’s of Class (b), (c) & (d) Devices and the rules for Licensing for Class (c) & (d) Devices. The NABCAB (National Accreditation Board of Conformity Assessment Bodies) may create a formal review mechanism of the audit quality of CAB’s and for supervision of these CAB’s to ensure harmonized quality of evaluations. 9) REF.: (Page #18) S#7C Medical Devices are not Drugs. (a), (b) & (c) may be replaced to read as : a) if it is made to appear of better or superior functional or performance value than it really is or b) if its label or container or anything accompanying the Medical Device bears any statement, design or c) Device which make any false claim. 10) REF.: (Page #12) Chapter IIA S#7D A Medical Device shall be deemed to be adulterated, “if it consists in whole or in part, of rusted or corroded or filthy or putrid or decomposed substance”. In this regard we would like to submit that above definition of adulterated medical device does not fit well with the construction and nature of most of the medical devices which are engineered products made under a tolerance where the storage, usage conditions and usage skills need to be considered before putting a criminal insinuation on a manufacturer For example, a Device made of standard stainless steel (e.g. SUS 304 grade) can get rusted / corroded in case it is exposed to acidic or corrosive fumes (during transportation or storage) or with anaesthesia fluids during usage / surgery which may not be in control of the manufacturer. By application of above definition { Section 7D(a)} the device manufacturer can be held responsible and be punished upto 7 years imprisonment for a defect which is beyond his control (!) and not done willfully. The Law needs to be fair and not punish innocent well meaning law abiding licensed manufacturers. Page 8 of 11 We would like to add that provision of adulterated Medical Device are not there in European and most Countries Regulations .We would suggest removal of Section 7(D) of Bill and to be replaced with Mis Labelled Devices as follows : 7(D) for the purpose of the Chapter any Medical Device may be deemed to be Mis Labelled if it is not labeled in the prescribed manner. 11) REF.: (Page #20) S#7F (I) (iii) The word ‘software’ is very wide. It includes all types of software to be included under this Act. Standalone software has not been included in the definition of medical device. Under this section, standalone software is being included (?). Clarity is required if it is intended to be introduced in the Act. Similarly, the word ‘component’ has a very wide meaning. A component of a medical device may have other uses too. Hence the part may be imported or procured for general use, and specific use for a Medical Device may be a decision of the manufacturer rather than the importer. Similar provisions are applicable for exports. Illustrations include resistors, capacitances, isolation transformers, etc. Hence “or part or Components” may be deleted. 12) REF.: (Page #21) Chapter IIA S#7H (I) The provision of Medical Device Officers should be there and the qualification for such officers to include Trained & Certified Auditors. 13) REF.: (Page #15) Chapter IIA S#7H (2) The provision for medical device officer should be included. “The power for prescribing or recommending corrective actions by a Medical Officer and the duties which may be performed by him after evaluating the associated risk and the profile of class of Medical Devices in relation to which and the conditions, limitations or restrictions subject to which, such powers and duties may be exercised or performed shall be such as may be prescribed in the Act”. 14) REF.: (Page #22) S#7J to 7L The punitive and criminal judicial action may be maintained only for any Non Licensed or Non Registered manufacturing facility of Medical Devices and which has not even applied for registration / licensing compliance. Explanation : Any person who is a regulated / licensed manufacturer / exporter / importer / reseller of Medical Device is to be considered as willing to subject himself to conform and abide with prescribed regulations and regulatory process and needs to be disciplined by the regulatory authority through an administrative process. This willingness to abide and be disciplined can be part of the Licensing procedures as an undertaking. Reliance needs to be of Correction and Improvement of Processes and Controls at the manufactures / logistics / warehousing / retailing /final utilization for ensuring Patient Safety through administrative methods before using the Judiciary which is already overburdened with pending cases. The IHPRA should have Administrative Powers for putting things Right e.g. Suspension of License, Recall of Goods, Field Corrective Action, Levying a Fine, etc. If it’s a mislabeling issue e.g. mismatching of a letter of a Batch No. of a Unit Pack or Shelf Box it should not warrant Jail Terms for Managing Directors ! You do not need to kill a fly with a machine gun. Page 9 of 11 15) REF.: (Page #22) S#7J to 7M These all sections provide penalty and punishments for all levels of nonconformance i.e. minor, moderate and major. We suggest that there should be scope of Corrective / Preventive action and progressive penalties starting with commercial punishments by the Regulatory Authority for Licensed & Registered Manufacturer rather than considering each case by the Judiciary which is over burdened already. Other Countries do not send Managing Directors of Licensed companies to jail for general Non Compliance but demand corrective / preventive action and stiff commercial penalties if they are at fault. . We would strongly urge that Reliance on Judiciary and Police force as a criminal action should be restricted only to non Registered Units or for very exceptional cases where risk to patient safety is high and there is evidence of blatant violation and willful and wide spread non compliance to multiple Rules without scant regard to Patient Safety. May we suggest that any Regulatory administrative action against a licensed manufacturer should be on the basis of proportionate degree of potential risk / safety of non conformity classification which is to followed by all the Confirmatory Assessment Bodies . Generally the classification of non-conformities is as follow: - a) Observations = No non-conformance against the defined system but pointed out as scope for improvements. b) Minor = infrequent or lesser deficiency which is unlikely to affect functional quality or safety. c) Moderate = General or combined deficiency which could or does affect quality with a moderate probability or seen infrequently or is considered controlled elsewhere in the system. d) Major = systems deficiency which could or does affect product quality with a high level of probability. 16) REF.: (Page #23) S#7J (d) This section requires that “Any Medical Device, other than a medical device referred to in Clause (a) and Clause (b) or clause (C), in contravention of any other provisions of this Chapter or any rule made there under ,shall be liable to pay penalty which shall not be less than one lakh rupees”. Chapter II A talks of import, manufacture, sale & distribution of medical devices and any violation will lead to a fine. This is deterrent to the establishment of a Domestic industry. Our suggestion is to remove this clause 7J(d). Page 10 of 11 17) REF.: (Page #25) S#7N (I) This clause authorize Central Government to make rules for classification, standards, manufacturing, testing, distribution, labeling, packaging, essential requirements for quality, safety and performance, adverse events, post marketing surveillance, conformity assessment bodies, exemptions and procedure to regulate notified category of medical devices under section 7B. This needs elaboration.Our suggestion is to include provision of key elements like a) Classification of Medical Devices (Risk based) b) Essential Requirements of Quality Safety & Performance, c) Role of Notified bodies in regulating the different classes of medical devices d) Confirmity assessment procedure and application of QMS e) Post marketing surveliance ,adverse event f) Responsibility of primary manufacturer in this Act.However provision for elements like Testing, Labelling, Packaging, Distribution can be included as rules. 18) Chapter IIA: The Bill should provide for a Transition Period as was done by Singapore & European Union for the new Regulatory provisions of the medical devices to be implemented and followed by manufacturer. Our Suggestion is to include a new clause under CHAPTER IIA for a 5 year initial Transition time for full compliance with the new law and thereafter the prescribed rules. For subsequent amendments to Law it may be considered for 2 years and for subsequent amendment to Rules it be considered for 1 year. 19) REF.: (Page #38 & 39) S#45 33T (1) & (2) and 33U (1) & (2) The provision for appeal added is as follows: Where any person is aggrieved by any action or decision of an officer to whom the powers under the provisions of the Act and rules made there under have been delegated, may prefer an appeal to the Central Licensing Authority in such manner as may be prescribed. Where any person is not satisfied with the decision of the Central Licensing Authority under sub-section (1), he may prefer an appeal to the Central Government in such manner as may be prescribed Where any person is aggrieved by any action or decision of an officer to whom the powers under the provisions of the Act and rules made there under have been delegated, may prefer an appeal to the State Licensing Authority in such manner as may be prescribed. Where any person is not satisfied with the decision of the State Licensing Authority under sub-section (1), he may prefer an appeal to the State Government in such manner as may be prescribed. We would suggest addition of an Appellate Authority or Tribunal to resolve disputes and address grievances, between the regulators and Manufacturer or Distributors Page 11 of 11 20) REF.: (Page #42) S#50 39(2) The current powers of the DCGI are limited and less than desired and Inspectors inversely enjoy excessive powers with relatively limited competencies. The proposed Amendment Bill is correctly addressing this area now. However Section 39 (2) requires every Rule and regulation to be laid before the Parliament for final Approval. We propose that there needs to be distinction of what nature of Rules and regulations needs to be laid before the Parliament. Example, historically, only a limited number of ports are designated points permitting import of Drugs into the country and if for enlarging even this list if approval is required by Parliament it is wasted time of Law Makers. 21) Note : Historically Indian Regulators have been visiting USA for getting acquainted with USFDA’s Regulatory Model for Pharmaceuticals and Medical Devices but seemingly have not been similarly exposed to the European Regulatory System eg UK’s MHRA which has proven to be more forward thinking, resilient and effective in converging the needs of Patients, the Industry and the Regulatory Government. The Canadian, Australian and ASEAN countries have already adopted the U.K /European Model. Indian Drug Regulatory Model has failed to check counterfeit Medicines and corruption of Drug Inspectors. The current Model needs a serious review. Increasing punishment may not be the answer. Assistance may be taken by Ministry Of Health from the European Commission through Ministry of Commerce under the CTBT arrangement for Developing and implementing a Regulatory framework on Medical Devices on the lines of:- a) The European M.D.D (Medical Devices Directive) – Law b) The European Guidance Documents (MEDDEV’s) on Regulating Medical Devices including IVD’s c) Notified Bodies Operations Group (NBOG) for promulgating Best Practices and Consistent levels of quality of audits by Accredited QMS (Quality Management System) Conformity Certifying Bodies. To achieve the objective of ensuring the highest level of Patient Safety while promoting Innovation and the competitiveness of this sector and enabling Regulatory convergence of Best International Practices based on the EU Model”. ----------------- x ------------------
Copyrights 2009. Association of Indian Medical Device Industry.