Health and Pharmaceutical Manufacturing & Medical Devices Committee, PHDCCI in association with Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers, Govt. of India organized fourth series of Self Sufficiency in Medical Technology on Optimum Regulations, Quality Standards, Controls for MedTech” on 12th March 2021

The webinar was graced with the presence of Dr. N. Subramanian, Chair, Health Committee, PHDCCI & Director, Medical Services, Indraprastha Apollo Hospitals, Dr. Sameer Gupta, Co-Chair, Health Committee, PHDCCI& Dr. Harvinder Popli, Director, Delhi Pharmaceutical Science & Research University.

The other eminent panelists present were Mr. Anil Zainulbhai, Chairperson, Quality Council of India, Mr. Sumit Kumar, Scientist-C- Medical Equipment & Hospital Planning Department, Bureau of Indian Standards, Mr. Manish Airan, AVP- Quality & Regulatory, Transasia Bio-medicals Limited and Dr. Rajiv Chhibber, Vice President, External Affairs, Sahajanand Medical Technologies Pvt. Ltd.

The session was moderated by Mr. Vivek Seigell, Assistant Secretary General, PHDCCI.

Mr. Adil Zainulbhai, Chairperson, Quality Council of India said that India is the pharmacy of the world but not in medical technology which is a sunrise sector with lot of opportunities to be recognised and tapped during this transition period. He also said that many Indian companies are meeting International standards for the betterment of quality & safety and government should also support Medtech Industry for its growth and expansion. He said, QCI also focus on improving standards in India as per vision of our Hon’ble Prime Minister of India about ‘Aatma Nirbhar Bharat’. He said, QCI look forward to collaborate and work together with CDSCO and BIS for further standardization for the Medtech Industry. He further mentioned that as we are in a digital world today we need to look forward to provide a better and faster quality of certification.

He also mentioned that we need different act for medical technology sector and also asked industry, industry associations to get together and make their points visible to QCI to make the process faster and smoother. He said QCI is currently focusing in moving faster towards improving standards & making testing capacity cheaper for the MSMEs sector in India.

While welcoming all the panellists, industry leaders and delegates, Dr. N Subramanian said that defects or disturbances in the functions of medical devices may expose patients to serious risks which is particularly true for devices which transfer energy or pharmaceuticals to patients; hence the safety standards must be high for all medical devices and the devices shall be safe, reliable and well suited for their intended purposes. He further mentioned that The notification of the new (and comprehensive) definition of medical device has brought finality to the issue of regulation of all medical devices that has haunted the government and Indian consumers for a long time.

Dr. Sameer Gupta, Co-Chair, Health Committee, PHDCCI said that the emphasis should be on quality and ease of getting regulatory approvals. India is the Pharmacy & vaccine provider to the world but there are still some gaps in the demand and supply chain side. He further mentioned that the most expensive and dangerous drugs are those which are not working in their efficacy level like substandard and counter freight drugs. He mentioned that Medtech has shown very tremendous growth in last few years and urged that all safety standards must be very high for all medical devices as it deals with patient life.

Mr. Gupta mentioned that government and other policy makers should define guidelines for the Medical device Industry. He said the domestic Indian companies are also dealing with cost pressure and India need proper regulatory mechanism so that patient should have access for superior products. He further mentioned that India has potential of becoming an export nation for medical devices.

Mr. Sumit Kumar, Scientist-C- Medical Equipment & Hospital Planning Department, Bureau of Indian Standards explained about the role of BIS as to ensure about the availability of Indian standards and harmonization of Indian standards at International level. He further mentioned that BIS has pleased to announce that they have developed more than 250 standards in last 2 years itself with all stakeholders and more 90 standards are in pipeline. BIS has also developed more than 200 standards for assistive devices and also developing standards for cold chain vaccine. He further mentioned that development of standardisation cells within the industry & government, creating closure association with medical start-ups and consulting them for developing new ideas based on their requirements. He further mentioned that BIS is in closure association with other standards developing organizations to make one nation one standard.

Mr. Manish Airan, AVP- Quality & Regulatory, Transasia Bio-medicals Limited said that better Co-ordination and co-operation is expected among all the three bodies, CDSCO, BIS and QCI. This will help reducing the redundancy, ease the adherence & effective implementation of regulations to all the medical device manufactures. The standard development process by BIS to include more stakeholders from users, public purchasing departments, CDSCO and QCI apart from industry experts.  This will create more buy-in from the stakeholders and will improve the acceptance of standards. The QCI involvement in developing reliable testing infrastructure & approval process will make the standards more trustworthy.

He further mentioned that public procurement agencies including GEM, need to be educated on the Indian standards so that the need of CE and USFDA to be eliminated. Also important to educate them on CE and USFDA regulation process so that only applicable certificates from those regulations are asked. The standards must be developed keeping public health and safety in mind so that the best product is available at the optimum cost. The standards must be constantly upgraded on the quality and performance expectations, this will help Indian manufacture to become more competitive and the product more export worthy.”

While mentioning that the industry has expectations to augment a policy roadmap for catalysing the MedTech sector and make it self-sustainable to achieve the ‘Atmanirbhar Bharat’ call by the Hon’ble Prime Minister, Dr Rajiv Chhibber, Vice President External Affairs at Sahajanand Medical Technologies Pvt Ltd said “The Indian government has announced several initiatives and policy measures to boost the medical devices sector, however, there is more potential to build policy certainty to accelerate growth of the devices sector. The need is to be looking at harmonizing Indian standards and International standards for ease of doing business, focus on developing domestic prowess in key areas like laboratory infrastructure, innovation, R&D and manufacturing, and lastly, through a collaborative approach within key departments like QCI, ISO, CDSCO and efforts by related ministries, boost a facilitative environment for domestic industries by expanding the market and position India to be a big consumption hub with sufficient sales and preferential purchase procurement for Make-in-India goods that would further push the ongoing drive towards accomplishing the ‘Vocal for Local’ call.

Dr. Harvinder Popli, Director, Delhi Pharmaceutical Science & Research University gave a formal vote of thanks to all the panellists for sparing their valuable time and sharing their views on this platform on the very important topic of quality which directly exposes patients to serious risks. She further mentioned that the State Government should also set up a funding scheme to support the industry.