Need for special statute on Medical Devices in India

Dr. Ravishankar K. Mor, Asst. Prof., Dept. of Law, Yeshwant Mahavidyalaya, Wardha

Use of technology and computer science is extensive in the field of Life sciences. Life is most precious to human being and therefore whatever development took places it always revolve around life comforts and protection, and protection of life necessarily involves maintenance and restoration of health. In last a few years technological developments have shown a ray of hope for the patients of many deadly diseases, what was presume to be incurable or impossible now seems to be within reach of human being. Use of technology in medical sciences is extensive, for the purpose of clarity and brevity, following chart is used to show the different areas where technology is used in medical sciences.

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From the above flow chart, it can be seen that use of technology is widespread so far as medical sciences are concerned. Now the quality, safety and efficacy of these medical devices need to be regulated and standardised. For this purpose we need to look into the Regulations in India for Medical devices.

National Legal regime for Medical Devices

In order to regulate the import, manufacture, distribution and sale of drugs and cosmetics, the Drugs and Cosmetics Act, 1940 (“D&C, Act”) was introduced in India in 1940. However, no separate legislation/regulation has been enacted for regulating the import, manufacture, distribution or sale of medical devices in India till date by the Government of India1.

Undoubtedly, the medical devices and surgical instruments are currently not covered under the regulatory framework in India. However, any device which is intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified by the Central Government by notification in the Official Gazette would be considered as a drug under the D&C Act and provisions of D&C Act and Rules made therein would be applicable on such device. From time to time, Ministry of Health and Family Welfare, Government of India vide gazette notifications has notified certain medical devices as drugs under the D&C Act.

Prior to 2005, only medical devices such as disposable hypodermic syringes, tubal rings, condoms, metered dose inhalers, were required to be registered in India. In 2005, the Ministry of Health and Family Welfare (MOHFW) vide gazette notification dated 6 October 2005 further notified 10 sterile devices (“Notified Medical Devices”) to be considered as drugs and consequently regulated their import, sale and manufacture under Section 3(b) (iv) (defined below) of the D&C Act.

Regulatory Overview of the Notified Medical Devices

The main regulation regulating Notified Medical Devices in India has been the Drugs and Cosmetics Act, 1940(‘Act’) and the Drugs and Cosmetics Rules, 1945 (‘Rules’). Notified Medical Devices are currently covered under the definition of Drugs under the Act Section 3 (b) (iv) which reads as follow:

b) “drug” includes—

(iv) such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette, after consultation with the Board ;]

The provisions of the Rules also deal with Notified Medical Devices and as they are currently defined as drugs and import and/or manufacture of them requires licenses to be obtained from the appropriate licensing authority as laid down under the Rules.

Rule 22 of the D&C Rules states that the licensing authority may with the approval of the Central Government by an order in writing delegate the power to sign licenses and Registration Certificate and such other powers as may be specified in the order to any other person under his control.’

Rule 109A deals with labelling of medical devices and states that: “The labelling of Medical Devices shall conform to the Indian Standards Specifications laid down from time to time by the BIS in addition to any other requirement prescribed under the said rules.

Rule 125A states that the standard for medical devices is stated in Schedule R1 namely, Sterile Disposable Perfusion sets for single use only (Sections 2 and 3 of item 1 of IS 9824:1981 read with the Amendment number 1); Sterile Disposable Hypodermic syringes for single use only (IS 10258:1982) and Sterile Disposable Hypodermic needles for single use only (IS 10654:1991) must conform to the Indian Standards specification laid down by the Bureau of Indian Standards (‘BIS’).

According to the BIS, the BIS product certification scheme is essentially voluntary in nature, and is largely based on ISO Guide 28, which provides general rules for third party certification system of determining conformity with product standards.

The Medical Equipment and Hospital Planning Division Council (MHDC) of BIS deals with Medical Devices

The Programme of Work prepared & updated Sectional Committee wise as on 1 March 2012 deals with Standardization in the field of Surgical Instruments, Medical Equipment, Surgical Dressings, Artificial Limbs, Rehabilitation Equipment, Diagnostic Kits, Veterinary Surgery Instruments, Dental Equipment, Laboratory Instruments & Equipment, Hospital Planning and Healthcare Services”. It is stated that this publication will provide the community of Standards users a convenient tool for obtaining the latest information about all the published new and upcoming Standards in the field of Medical Equipment & Hospital Planning. List of Indian Standards under BIS Certification Scheme along with list of licensees, ISS wise, is also given in this programme of work.

Regulating Authority for Notified Medical devices

In India, the Central Drugs Standard Control Organization (‘CDSCO’) is the main regulatory body currently regulating import, sale and manufacture of medical devices which have been notified as drugs by virtue of Section 3(b) (iv) of the D&C Act. The CDSCO lays down standards of drugs, cosmetics, diagnostics and devices and issues licenses to drug manufacturers and importers. It also lays down regulatory measures, amendments to Acts and Rules and regulates market authorization of new drugs, clinical research in India and standards of imported drugs etc. The CDSCO has setup a separate division which is called Medical Device Division in order to facilitate mattes related to Notified Medical Devices.

Notifications/guidelines of CDSCO with respect to Notified Medical Devices

CDSCO vide gazette notifications issued on 5 September, 2007 has notified  that Free Sale Certificate in country of origin issued by the Ministry of Health/National Regulatory Authority is a pre-requisite for the registration. Any change in the Design and/or change in material and/or change in composition of an already approved/ registered medical device will require prior approval of Drugs Controller General of India (“DCGI”).

Based on large number of requests seeking clarity on issues relating to registration, manufacture and import of Notified Medical Devices, from both manufacturers of Medical Devices and their representatives from India and abroad, CDSCO has time and again come up with clarifications & explanations on the guidelines. It has stated vide Notification dated June 2008 that for the purpose of registration of medical devices and in order to calculate the fees required to be deposited with the application, a group or family of devices manufactured by or for the same manufacturer and which has the same basic design, performance characteristic relating to device safety, effectiveness of the device and its intended use (which includes variation in sizes and shapes) would be considered one single device. It was also clarified that a device may also include package of various devices or sub systems that are required to be used together as a single functioning device.

On 20 March 2009, the Central Drugs Standard Control Organization (CDSCO) clarified that sterile medical devices such as spinal needles, insulin syringes, endotracheal tubes, cardiac patches, and extension tubes were also required to be registered.

On 4 August 2010 CDSCO released new guidelines for document submission for medical device product registration. Under CDSCO’s current system, medical devices requiring registration need approval from the DCGI. After receipt of the application with fees, evaluation begins. DCGI may require clinical testing in India or request information on clinical trials performed abroad.

In light of developing clearer provisions with regard to regulation of Medical Devices, the Government upon the recommendation of the DCGI and examination by the Expert Committee, has further confirmed 11 devices such as Spinal needle, Insulin syringes, three way stop cock as an accessory of I.V. Cannula/Catheter/Perfusion Set, Introducer sheath, Cochlear implant, Close wound drainage set, AV fistula needle, Extension line as an accessory of Infusion set, ANGO kit/PTCA/ Cath Lab kit, Measure volume set and Flow regulator as an accessory of Infusion set as drugs vide notification dated 5 March, 2012.

As of now, only 21“notified” categories of devices are required to register prior to sale, this includes  disposable hypodermic syringes and needles, disposable perfusion sets, in-vitro diagnostic devices for HIV, HBSAG and HCV, cardiac and drug-eluting  stents, catheters and IV cannulas, bone cements, intra-ocular lenses, orthopedic implants, prosthetic replacements, and heart valves. Devices not under the notified categories can be sold without registration. Also, devices already approved in their home countries by the U.S. FDA, the European CE, Australian, Canadian, or Japanese regulators are readily importable with limited paperwork2.

WHO guidelines on Medical Devices

After understanding National regulatory measures for medical devices this will not be out of context to know that WHO has also attempted to improve the situation in this direction worldwide. Let us have a look on the WHO initiative in this direction.

WHO has a mandate, as outlined in the World Health Assembly Resolution 60.29 “to encourage member states to draw up national or regional guidelines for good manufacturing and regulatory practices, to establish surveillance systems and other measures to ensure the quality, safety and efficacy of medical devices and, where appropriate, to participate in international harmonization”. Furthermore, WHO’s Strategic Objective 11 states that it is necessary for WHO: “to ensure improved access, quality and use of medical products and technologies3.” WHO has published a document called Development of Medical Device Policy4in the year June 2011 to assist the member countries in framing their national medical device policy, as on today as per the records of WHO only 9% countries out of 145 countries have independent medical device policy.

In the light if WHO guidelines attempts have been made in India to have specific legislation for regulating all medical devices rather than treating them as drugs and then applying a legislation meant for regulating drugs.

Bills introduced in Parliament for Regulating Medical Devices.

In 2006, the Medical Devices Regulation Bill (MDRB) was proposed by the Ministry of Science and Technology. The MDRB was designed to consolidate laws related to medical devices and establish the Medical Device Regulatory Authority of India (MDRA). This proposal was aimed at establishing and maintaining a national system of controls for the quality, safety and availability of medical devices in India. If enacted, the MDRB will govern all medical devices throughout India. Companies wishing to import devices into India or manufacture products locally will have to comply with the design, manufacturing, packaging, labelling, import, sale, use, and disposal requirements of the MDRB. Also the bill will expand the list of products requiring registration.

The Bill provides for the creation of a Medical Device Regulatory Authority which has been empowered with extensive powers relating to fining and imprisoning defaulters. Besides looking to harmonize the standards in accordance with the global norms to push the export potentials, the Bill also seeks to lay down concrete norms on import of devices and their conformity with the Indian standards. Standards notified by the Bureau of Indian Standards or other international standards making bodies like International Organization for Standardization (ISO), may be incorporated for harmonization. The Bill seeks to regulate the design, manufacture, packaging, labelling, import, sale, usage and disposal of medical devices in India.

With a view to raise the level of control on Medical Devices, the Drug Technical Advisory Board (DTAB) in India has submitted the final draft of the guidelines on medical devices and has recommended strict implementation of Indian Conformity Assessment Certificate (ICAC) for the medical devices manufactured, imported and marketed on Indian market under Schedule M III of Drugs & Cosmetics Rules 1945. The Medical Devices have been classified into Class A, B, C & D as per their level and intended use. It is provided that all Medical Devices sold in India (except for custom made devices, meant for a particular patient use) should, as a general rule, bear the Indian Conformity Assessment Certificate mark (ICAC) to indicate their conformity with the provisions of this schedule.

Proposed New Clinical Trial Regulations

Additionally, the MDRB discusses clinical trials and Clinical Research Organizations (CROs) in India. If the bill is approved, some high-risk medical devices will require local clinical trials in India in addition to foreign clinical data. In general, more-stringent regulations will apply to CROs and clinical trials.

In January 2011, the Ministry of Health and Family Welfare issued a notification to amend the Drugs and Cosmetic Rules with some minor proposals (draft rules) on clinical trial establishments. There are also proposed additions that stress the quality of clinical trials, the need for proper procedures and requirements for skilled CRO staff.

On 11 May 2011, CDSCO released draft guidelines on reporting serious adverse events (SAEs) for medical devices in clinical trials. At present, CROs and medical companies are using multiple different formats to report SAEs. CDSCO is trying to standardize the reporting procedure.

The Health Ministry is planning to amend the Drugs and Cosmetics Rules to introduce certain provisions relating to medical devices and diagnostic reagents. As per media reports, the Ministry will frame draft rules in respect of labelling, manufacturing, shelf life and other matters relating to medical devices and publish them for seeking feedbacks from the stakeholders, before making effective the same.

The Drugs and Cosmetics (Amendment) Bill, 2013

  • The Drugs and Cosmetics (Amendment) Bill, 2013 was introduced in the Rajya Sabha on August 29, 2013. The Bill amends the Drugs and Cosmetics Act, 1940 and changes the name of the Act to the Drugs, Cosmetics and Medical Devices Act, 1940.
  • The Bill proposes changes in the regulation of the import, export, manufacture, distribution and sale of drugs, cosmetics and medical devices and to ensure safety, efficacy, quality and conduct of clinical trials.
  • The definition of drugs is changed to include new drugs that are (i) not in significant use in India and are not recognised as effective and safe by the Drugs Controller General of India (DCGI);(ii) approved by the DCGI for certain claims but are being marketed with modified/new claims; (iii) a fixed dose combination of two or more drugs, which are individually approved but are being combined for the first time in a fixed/changed ratio; and (iv) all vaccines, Recombinant Deoxyribonucleic Acid derived products, Living Modified Organisms, stem cells, gene therapeutic products etc. which are intended to be used as drugs.
  • Under the Act, medical devices were covered under the definition of drugs. The Bill changes this by adding a definition of medical devices to include any instrument, implant, material or other article, including the software, intended to be used specially for human beings or animals for the specific purposes of diagnosis, prevention, treatment or alleviation of any disease or, injury, modification of the body’s anatomy and sustaining life.
  • Clinical trials are defined in relation to drugs, cosmetics and medical, and involve their systematic study with the objective of determining their safety, efficacy, performance or tolerance. Anyone initiating a clinical trial has to register with the Central Drug Authority (CDA) and get approval from an Ethics Committee registered with it. The Bill creates  provisions for the medical treatment and compensation in case of injury or death of a person during participation in a clinical trial or due to it.
  • The Central Government shall establish a CDA to subsume the existing Central Drugs Standards Control Organisation. The CDA will be composed of representatives from the Ministries of Health and Family Welfare, Law, Commerce and Industry, Science and Technology, Chemicals and Fertilisers, DCGI, Indian Council of Medical Research, Directorate General of Health Services, and other experts nominated by the central government, including those from state licensing authorities.
  • The CDA shall among others, specify guidelines, structures and requirements for the effective functioning of the central and state licensing authorities; review, suspend or cancel any licence or permission issued by them; and decide on disputes between two or more state licensing authorities relating to the provisions of the Act and rules and regulations made under it
  • The DCGI is the central licensing authority that has the power to issue, renew, suspend or cancel licences for import, export or manufacture of drugs, cosmetics or medical devices or permission for conducting clinical trials. The DCGI also has the sole power to issue licenses for the manufacture, sale, and export of 17 categories of drugs.

Conclusion

India is a huge market for all kinds of medical devices, the production of low value medical supplies and disposables is dominated by domestic manufacturers, whereas the high end medical equipment is generally imported. In the future, due to the huge market opportunity in India, more and more foreign medical device companies are expected to explore Indian market for their products.

As we know technology can prove to be a bane of boon, though by complete tracing of human DNA we are much closer to have human clone, but this has been stop internationally but many technological implantations have been given green signals by medical and political bodies’ world over. In the matters of tale medicine, even government of India is running a program whereby doctors from well known institutions are made available for discussion and advice at district hospitals centre though video conferencing and expert advice of such doctors are sought in the complex cases. So also use of implantation of pace makers to monitor and maintain heart rate and implantation of Cochlear implants are allowed and practised on regular basis, these are instruments connected with the computer and can be given direction though the outside machine. These instruments if given wrong advice or any virus of wrong program is installed on such device one can imagine the destructive capacity of them.

Is there any special care taken in the matters of such application of technology which may have direct impact on human life?

Answer to this question is “No”, any ill consequences of such technological use shall be tried and taken cognizance of under the same provisions of IT act which are meant to protect the personal computers and information shared their upon. So also the Comprehensive Criminal Code of India IPC will take care of any wrong doing in this matter, but whether evidence act is in position to tackle such highly technological advancement is doubtful. In such circumstances having a separate statute to deal with all such technological applications which may have direct bearing on human life is necessary.

The Indian government is working on a comprehensive regulatory framework for the medical device sector. India’s health authorities plan to issue a set of guidelines to define and regulate medical devices as a separate category. But till the time these guidelines and law are not actualised, users of these devices in India more particularly the devices which are not notified by the CDSCO are vulnerable to the risk beyond compensable limits. These are devices implanted into the human body and are connected with outer devices and controlled by the computers, in case there is failure of such devices it require explants and re-implantation which involve high risk, can in the country like India we can afford the risk without being immediate regulation in this direction. In USA recently 54 medical devices are recalled for want of adequate standard and safety, when does we will evolve a system of standardisation manned with the expert in the field and not a general standardisation authority like BIS.   Moreover misuse of Information technology is also likely in the field of medical devices will it be sufficient to treat such instances as another cyber crime only or a distinct specialised regulation is to be there to tackle such life threatening cyber crimes in the field of medical sciences.

Process for having Medical devices regulatory authority in India is in limbo since 2006, it is 2014 and we are still awaiting nod of the parliament when parliament is in last session of the present government it is unlikely that they will get time to pass this Bill which will have minimum or no impact on upcoming general election.

It time to create public awareness and consequently public pressure on the government not only to pass the Bill for regulation of medical devices but also to established necessary administrative bodies for immediate implementation of the Bill.

  1. Singh & Associates, A brief overview of regulatory framework for medical devices in India, published on September 29, 2012 []
  2. Available at http://www.amritt.com/industries/medical-device-india/regulation-of-medical-devices-in-india/ visited on 02-06-13 at 13.11 []
  3. Available at http://www.who.int/medical_devices/safety/en/ visited on 02-06-14 at 12.00 Noon []
  4. Available at http://whqlibdoc.who.int/publications/2011/9789241501637_eng.pdf last visited on 02-06-13 at 13.19 []