Regulations For 3D Printing – Analysis
By Ambika Khanna*
3D printing (3DP), a critical emerging technology, has come into the limelight in the last decade. Industries such as pharmaceuticals, bio-medicine, aviation and automobiles have rapidly adopted 3D printing. Space agencies such as NASA and India’s ISRO have been using 3DP components in spacecrafts. Its use is becoming so pervasive, that the 3DP industry is expected to grow dramatically from $9.9 billion in 2018 to $42.9 billion by 2025.[1]
However, in spite of its huge potential and significance for the digital economy, there is no global policy on 3DP. While it has mostly escaped relevant regulation in countries such as India, in some countries the regulation is centered only around singular sectors such as medical devices. Now, industries across the board and round the world are looking at 3DP to define the future of technology, and governments must focus their attention on regulating 3DP as a whole, and sector-wise wherever the need arises. This is especially relevant as different countries are at different stages of adoption of 3D technology, greatly varying from sector to sector.
The countries leading in the implementation and regulation of 3DP are China, the U.S. and the EU. China, has been working extensively to develop its 3DP market and the regulations to govern it. In 2017, it formulated an action plan for the development of the 3DP industry ‘Additive Manufacturing Industry Development Action Plan (2017-2020)’.[2] A year later, China’s Center of Medical Device Evolution, issued guidelines[3] for the regulation and registration of 3DP medical devices including custom-built additive-produced medical devices. China has since released several guidelines for different 3DP medical devices including a 2020 technical guidance for 3D printed artificial vertebrae[4] and an acetabular cup.[5]
The US government too is keeping pace. In 2017, the Food and Drug Administration (FDA) issued guidance for additive manufactured medical devices, including recommendations for testing of devices that include at least one additively manufactured component or additively fabricated step. In the aerospace industry, the Federal Aviation Administration (FAA) has developed an eight-year Additive Manufacturing Roadmap which will cover manufacturing and certification policies.[6] FAA has also approved the manufacturing of 3D printed components for commercial engines.[7] The US, through the introduction of several bills before the Congress, has tried to curb and control the misuse of 3D printing of firearms.[8] However, none of these have seen the light of day yet.
The EU has specific legislations for the use of 3DP for manufacturing of medical devices.[9] During COVID-19, it issued special guidelines on using 3D printing for providing COVID-19 relief.[10] In fact, the pandemic has accelerated the importance and implementation of 3DP. In March this year, an Italian start-up, Issinova, used 3D printing to manufacture respiratory valves to swiftly meet a supply shortage, arising out of increased demand, in a hospital.[11] These were made under the EU COVID-19 guidelines for 3DP medical devices. Recently, US’ FDA allowed 3D manufacturing of ventilator tubes and other accessories.[12] So did the U.K.[13]
With 3DP set to dominate the future of manufacturing, standardisation is a key concern. Therefore, the International Standards Organization (ISO) is currently developing a standard on 3D printing: IEC CD 23510.[14] ASTM International and ISO set up a working group in 2016 which has been recommending standards on additive manufacturing.[15] It has created a framework on 3DP called theAdditive Manufacturing Standards Structure. ISO already has various standards on additive manufacturing, some of which have been developed while others are under development.[16]
Where does India fit in? Just two states, Maharashtra and Rajasthan[17] recognise the importance of smart manufacturing in their industrial policies, yet do not provide policy guidelines required for 3DP, an important component of smart manufacturing. One of the salient features of the National Policy on Electronics, 2019 is to promote R&D and start-ups in emerging areas of technology including additive manufacturing.[18] However, domestic manufacturing has yet to realise the full potential of 3DP.
Currently, India has only some sector specific laws, such as in medicine, which can be interpreted to include 3DP. In the medical/ pharmaceutical field, where 3DP is most used, 3D printed objects include:
a) Anatomical elements of the human body (organs, bones, glands, etc.);
b) Pharmacological, immunological or metabolic in nature (eg. medicines like tablets, capsules, etc.) and;
c) Those that assist in the treatment, monitoring, alleviation, etc. (eg. ventilators, scanning machines, medical instruments like forceps, scalpels, protective gear, etc.).
India’s Drugs and Cosmetics Act, 1940 does not specifically include such 3D printed objects but the Ministry of Health and Family Welfare expanded the definition of ‘drugs’ under the Act in February 2020[19] to include appliances whose function is the diagnosis, prevention or treatment of a disease. However, there is lack of clarity on the applicability of this legislation to 3D printed devices.
Similarly, while the Transplantation of Human Organs and Tissues Act, 1994 deals with transplantation of organs from a person-donor, transplanting a 3D printed organ/gland is beyond the scope of this legislation.[20] These laws must be amended to include 3D printed devices and organs, or separate policy guidelines must be established for these.
The COVID-19 pandemic will certainly boost the use of 3DP. Any relief material, cure or preventive vaccine or drug that is discovered can quickly go into mass production using 3DP.
This is an opportune moment for India to consider a comprehensive policy on 3DP, or even the principles that should govern 3D printing. It can be the model for global guidelines. The comprehensive policy should address:
a) purchase of 3D printers and scanners;
b) manufacturing processes using 3D printers;
c) quality of input material and final product;
d) classification of computer-aided design (CAD)/digital file, and whether it is a good or a service, which will determine its sale, distribution and taxation;
e) product sale and distribution, including intermediary liability;
f) Governing body and single window clearance for businesses;
g) Standardisation:
i) 3DP should be explicitly included under Bureau of Indian Standards (BIS), the nodal standards body in India, BIS’ compulsory registration scheme for printers.[21]
ii) BIS should consider establishing separate standards for input units used in 3DP, in addition to standards for the final product;
iii) Central Drugs Standard Control Organisation, which sets the standards for drugs that are manufactured in and imported into India, should set standards for 3D printed medical devices and drugs.
While policy and standards will create a conducive framework for the regulated growth of 3DP in India, the government needs to supplement this impetus with fiscal and tax incentives for those businesses adopting 3DP. There are examples to follow, For instance Australia, to promote advanced manufacturing including 3DP, created an ecosystem which included different funds for R&D and capital investments in emerging tech companies, and innovation labs that support new ventures in this sector.[22] Recently, India announced production-linked incentives for electronics manufacturing and for the domestic manufacture of medical devices and drugs. The government is also in the process of considering similar schemes for other sectors such as auto components. Such incentives should be considered for 3D printing, across sectors.
With India’s increased focus on self-reliance, 3DP can be a game changer especially in critical sectors where India is heavily reliant on raw material or final product from countries such as China. Sectors such as electronics, pharma, aviation or defence, can all be developed at home with a focus and clear policy on 3DP, with enormous benefit to the economy.
*About the author: Ambika Khanna is Senior Researcher, International Law Studies Programme, Gateway House.
Source: This article was written by Gateway House: Indian Council on Global Relations. You can read exclusive content here.
References
[1] Markets and Markets, “3D Printing Market worth $42.9 billion by 2025 with a growing CAGR of 23.3%”. https://www.marketsandmarkets.com/PressReleases/3d-printing.asp
[2] “Multi-departmental joint publication to support the development of additive manufacturing industry”, December 14, 2020. http://www.gov.cn/xinwen/2017-12/14/content_5246754.htm
[3] Centre for Medical Device Evaluation, National Medical Products Administration, People’s Republic of China, “Guidelines for the Technical Review of Custom Additive Manufacturing Medical Device Registration”, February 26, 2018. https://www.cmde.org.cn/CL0063/6954.html.
[4] Centre for Medical Device Evaluation, National Medical Products Administration, People’s Republic of China, “3D printing artificial vertebrae registration technical review guidelines (No. 36 of 2020)”, June 5, 2020. https://www.cmde.org.cn/CL0112/21043.html
[5] Centre for Medical Device Evaluation, National Medical Products Administration, People’s Republic of China, “3D printed acetabular cup product registration technical review guidelines (No. 36 of 2020)”, June 5, 2020. https://www.cmde.org.cn/CL0112/21042.html
[6] Martin, Nichols, “FAA Drafts Plan to Regulate Additive Manufacturing of Aerospace Components”, October 23, 2017. https://www.executivegov.com/2017/10/faa-drafts-plan-to-regulate-additive-manufacturing-of-aerospace-components/
[7] General Electric, “The FAA Cleared the First 3D Printed Part to Fly in a Commercial Jet Engine from GE”, April 14, 2015. https://www.ge.com/news/reports/the-faa-cleared-the-first-3d-printed-part-to-fly-2
[8] H.R.7115 – 3-D Firearms Prohibitions Act, 115th Congress (2017-2018), https://www.congress.gov/bill/115th-congress/house-bill/7115/text?r=1&fbclid=IwAR2ara4EL2d6RHk5M_hNXHOKLaYlPcYmAScl_hBgTIV0unCw_dk5VPPGO4E. ;
S.1831 – 3D Printed Gun Safety Act of 2019, 116th Congress (2019-2020), https://www.congress.gov/bill/116th-congress/senate-bill/1831/text
[9] Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:01993L0042-20071011&from=EN
[10] Conformity assessment procedures for 3D printing and 3D printed products to be used in a medical context for COVID-19.
[11] Zarzalegos, Ana; Moynihan, Ruqayyah, “A startup in Italy used 3D printing to make valves for COVID-19 patients”, World Economic Forum, March 18, 2020. https://www.weforum.org/agenda/2020/03/3d-printed-emergency-breathing-valves-covid-19/
[12] U.S. Food and Drug Administration, “3D Printing of Medical Devices, Accessories, Components, and Parts During the COVID-19 Pandemic”, https://www.fda.gov/medical-devices/3d-printing-medical-devices/faqs-3d-printing-medical-devices-accessories-components-and-parts-during-covid-19-pandemic.
[13] Medicine and Healthcare products Regulatory Agency, Guidance, “3D printing (additive manufacturing) of medical devices or component parts during the coronavirus (COVID-19) pandemic”, June 4, 2020, https://www.gov.uk/guidance/3d-printing-additive-manufacturing-of-medical-devices-or-component-parts-during-the-coronavirus-covid-19-pandemic.
[14] ISO/IEC CD 23510, Information technology — 3D Printing and Scanning — Framework for Additive Manufacturing Service Platform (AMSP), https://www.iso.org/standard/75842.html
[15] Naden, Clare, “ISO AND ASTM INTERNATIONAL UNVEIL FRAMEWORK FOR CREATING GLOBAL ADDITIVE MANUFACTURING STANDARDS”, October 7, 2016. https://www.iso.org/news/2016/10/Ref2124.html.
[16] https://www.iso.org/ics/25.030/x/p/1/u/1/w/0/d/0
[17] Rajasthan Industrial Development Policy 2019, Government of Rajasthan. http://industries.rajasthan.gov.in/content/dam/industries/pdf/bip/home/downloads/policies%26schemes1/Industrial%20Policy%202019.pdf
[18] Press Information Bureau, “Cabinet approves the proposal of National Policy on Electronics 2019”, February 19, 2019. https://pib.gov.in/PressReleaseIframePage.aspx?PRID=1565285.
[19] Department of Health and Family Welfare, Ministry of Health and Family Welfare, Government of India, Notification, February 11, 2020. https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTU0OA
[20] The Transplantation of Human Organs Act, 1994. https://main.mohfw.gov.in/sites/default/files/Act%201994.pdf
[22] Department of Industry, Science, Energy and Resources, Government of Australia, “Supporting Advanced Manufacturing”. https://www.industry.gov.au/funding-and-incentives/supporting-advanced-manufacturing
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