3rd Annual Conference – ‘PharmaMed 2014: Healing the World’ on 20th November 2014 at PHD House, New Delhi

New Delhi, Jan 31, 2015 – Health Committee PHD Chamber organized its 3^rd National Conference PharmaMed: Healing the World on November 20, 2014 at PHD House, New Delhi.

The conference was inaugurated by Dr. V K Subburaj, Secretary, Ministry of Chemicals and Fertilizer.

Mr. Pradeep Multani , Chairman Health, PHD Chamber delivered the welcome address at the inaugural wherein he welcomed Dr. V K Subburaj, Secretary, Ministry of Chemicals and Fertilizer to inaugurate the conference and also covered the current scenario of the export issues faced by both Pharmaceutical & Medical Devices industry. He highlighted the concern areas of the Indian regulatory regime in both Pharmaceutical & Medical Device Industry is currently facing.

Mr. Himanshu Baid , Co- Chairman, PHD Chamber gave the introductory remarks on the Medical Devices. He talked about the tremendous export potential and added that the basic perplexity the industry is facing due to The Drugs & Cosmetics Act. Mr. Himanshu Baid appreciated the new release of 4^th Amendment to the Drugs & Cosmetics Rules, 2014 – G.S.R. 690(E) “Amended Rules” and added that some fundamental changes to the regulatory framework for medical devices, including the introduction of a definition of competent staff for medical device manufacturing and testing, labeling requirements for both domestic use and export, shelf life, exemptions for custom made devices, and adoption of certain standards has really helped the industry to specify certain standards in Medical Device Industry .

Mr. Berlia gave the theme presentation wherein he focused on the mission of Hon’ble Prime Minister Mr. Narendra Modi Swach Bharat. According to him Swacch Bharat mission of “A CLEAN NATION” can only be achieved through a disease free society. Mr. Berlia also added the challenges Indian Health set up faces is the accessibility to remote areas, maintaining proper standards and a regulatory body to maintain them. In the current scenario Communicable Diseases, Non- Communicable Diseases and Injuries are the major health risks. However, India’s major shortcoming is the poor spending on Public funded health i.e. India spends 1.04% of its GDP on health services which is one of the lowest in the world.

Mr. Berlia also shared his vision of Make in India. The Make in India vision aims to facilitate investment, foster innovation, enhance skill development and strengthen IPR. Make in India vision will also cover the aspect of building up export of both Pharmaceutical and Medical Devices Industry, he added.

Dr. V K Subburaj, Secretary, Ministry of Chemicals and Fertilizer in his inaugural address congratulated PHD Chamber for its 3^rd National Conference PharmaMed: Healing the World. Dr. Subburaj appreciated initiative taken by PHD Chamber and said that India being a dominant player in export of Pharmaceuticals has a responsibility of Healing the world. Currently, Indian Healthcare industry is in the position where it can globally offer better healthcare products. Dr. Subburaj mainly focussed preventive measures than curing the diseases, especially the life style diseases/ Non communicable which can be prevented/ cured upto 100% through life style changes though, difficult to implement.

Dr. V K Subburaj stated that India has a growing Pharma sector of the country and out of many challenges skilled manpower is one of them. Pharmaceutical Science and allied courses are not taken as the first career options by youth as Engineering and Medical Science are given major emphasis. He also added that strengthening NIPER National Institute Pharmaceutical Education and Research as IITs & IMSs in India is the prime focus of the Department of Pharmaceutical.

He concluded by announcing that the Hon’ble Minister Mr. Narendra Modi will rollout the new bulk drug pharma policy in next 10-15 days which will be industry friendly and the existing irritants and prevailing ills that will take care of pharma sector restricting its growth.

Panel Discussion on Leveraging the Export Potential in Pharma & Medical Devices Industry: Issues of Certifications & Standardization

The panel discussion which was chaired by Dr. G N Singh, Drug Controller General of India and includedDr. Jitendar Sharma, Head, Health Technology Department, NHSRC, Ministry of Health & Family Welfare, Govt of India , Mr. Anil Khaitan, Chairman, Sunil Healthcare, Mr. Himanshu Baid, Chairman PolyMed & Co- Chairman, PHD Chamber, Mr. Nishant V Berlia, Co- Chairman, PHD Chamber, Mr. Anil Jauhri, CEO, National Accreditation Board for Certification Bodies, Dr. Ghulam Moinuddin, Head Regulatory Affairs & Quality Centre, LG Life Sciences.

Dr. G N Singh, Drug Controller General of India started with the current scenario of National and International trend of Pharmaceutical Industry. India’s Pharmaceutical industry is the third fastest growing export industry – which grew 10.55 per cent to $14.65 billion during 2012-13.

He also mentioned the major reason for inaccessibility of the medical facilities is the illiteracy in the rural areas of the country. On exports he added that pending issues hanging on the wall since 1940 will be simplified and will be reflected in the forthcoming policies.

Dr. G N Singh concluded his address by saying he is open for recommendations from the industry and would consider the same in future polices.

Dr. Jitendar Sharma, Head, Health Technology Department, NHSRC, Ministry of Health & Family Welfare, Govt of India started with the point that policies should be based on patient’s perspective. Standardization specification on Medical Devices should be made in a way that domestic suppliers can qualify them. PHD Chamber has been actively contributing to these specifications as an Industry partner, he added.

Dr. Sharma said that 72% of the manufacturers don’t have their own testing laboratories and they send their products to Singapore or any other Asian countries which is an extra expense for them. Therefore, it entails that Government should set-up such facilities where the domestic manufacturer’s product can get tested and standardized. Lastly, he added that public health facility lacks in a designated policy for maintenance for biomedical equipment. Thus, there is an important need to develop biomedical equipment maintenance model for which the industry is being invited to tap up the 350 Crores opportunity in the public Health system.

Dr. Sharma also raised an important point setting up Vigilance in Medical Device Industry i.e. the industry should have their own vigilance for reviewing/ examining their products.

Mr. Anil Khaitan, Chairman Industry Affair Committee and Chairman, Sunil Healthcare talked about the liberalization in the export policy of pharmaceutical and medical devices. He also requested the government to financially support which will encourage MSMEs flourish and penetrate into the domestic market. He concluded the Brand India has already made a mark globally but there are issues related to IPR which need to be resolved.

Mr. Anil Jauhri , CEO, National Accreditation Board for Certification Bodies discussed that with the increasing penetration of chemists, especially in rural India, OTC drugs will be readily available. Pharma companies have increased spending to tap rural markets and develop better infrastructure. The market share of hospitals is expected to increase from 13.1% in 2009 to 26% in 2020. Following the introduction of product patents, several multinational companies are expected to launch patented drugs in India. Also, the rise of lifestyle diseases in India is expected to boost industry sales figures.

Dr. Ghulam Moinuddin, Head Regulatory Affairs & Quality Centre, LG Life Sciences talked about the challenges and future growth opportunities in Pharmaceutical & Medical Device Industry. Some of the key challenges highlighted include effects of new product patent, drug price control, regulatory reforms, infrastructure development, quality management and conformance to global standards.

Mr. Vivek Tiwari , Zonal Manager- North, Ortho Clinical Diagnostics (J&J) talked about the importance of the diagnostics tools. In Vitro Diagnosis (IVD) revenues in India is primarily driven by labs contributing 65% whereas hospitals contribute 35% and mainly Clinical Research Organizations, outsourcers Clinical Trials are into In Vitro diagnostic business.

He concluded by saying the future of IVD market is dependent on increased awareness, Health insurance privatization, Expansion of Clinical Testing, Evidence based medicine and Medical Tourism.

The meeting was concluded by Vote of Thanks by Mr. Vivek Seigell, Senior Secretary, PHD Chamber. He thanked Dr. V K Subburaj, Secretary, Ministry of Chemicals and Fertilizer for his continued support to the chamber and Industry and taking up the issues of the Industry.

Mr. Seigell also thanked Dr. G N Singh, Drug Controller General of India for asking for the recommendations of the chamber and the details of the deliberations to his office for the required actions.Mr. Seigell thanked Dr. Jitendar Sharma, Head, Health Technology Department, NHSRC, Ministry of Health & Family Welfare, Govt of India for the continued support of NHSRC especially while making the specification of the medical Device Industry for procurement in the Public Health System. CCI Newswire