QCI reveals its plans to increase lab capacities to test medical devices

New Delhi: Speaking at a webinar, Mr Adil Zainulbhai, Chairperson, Quality Council of India mentioned, “India is the pharmacy of the world but not in medical technology which is a sunrise sector with a lot of opportunities to be recognized and tapped during this transition period. He also said that many Indian companies are meeting International standards for the betterment of quality & safety and the government should also support Medtech Industry for its growth and expansion. He said, QCI also focuses on improving standards in India as per the vision of the Prime Minister of India about Aatma Nirbhar Bharat.”

Zainulbhai further stated that QCI looks forward to collaborating 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 providing a better and faster quality of certification. He also mentioned that we need different acts for the 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 on moving faster towards improving standards & making testing capacity cheaper for the MSMEs sector in India.

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

While welcoming all the panelists, 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 that 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 devices 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 the last few years and urged that all safety standards must be very high for all medical devices as it deals with patient lives.”

Mr. Sumit Kumar, Scientist-C- Medical Equipment & Hospital Planning Department, Bureau of Indian Standards explained the role of BIS to ensure the availability of Indian standards and harmonization of Indian standards at the International level. He further mentioned that BIS has pleased to announce that they have developed more than 250 standards in the 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.

Mr. Manish Airan, AVP- Quality & Regulatory, Transasia Bio-medicals Limited said that better Coordination and co-operation is expected among all the three bodies, CDSCO, BIS, and QCI. This will help reducing redundancy, ease the adherence & effective implementation of regulations to all medical device manufacturers. 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.

While mentioning that the industry has expectations to augment a policy roadmap for catalyzing the MedTech sector and make it self-sustainable to achieve the ‘Atmanirbhar Bharat’ call by the Prime Minister, Dr Rajiv Chhibber, Vice President External Affairs at Sahajanand Medical Technologies, “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 the 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.”

Dr. Harvinder Popli, Director, Delhi Pharmaceutical Science & Research University gave a formal vote of thanks to all the panelists 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.