Association of Indian Medical Device Industry (AIMED)

Mr. Rajiv Nath
Forum Coordinator,
Association of Indian Medical Device Industry (AIMED)

AI-MED is an Umbrella Association of Indian Manufacturers of Medical Devices covering all types of Medical Devices including consumables, disposables, equipments of diagnostics representing the interest of over 700 Manufacturers of Medical Devices to cover issues and address the manufacturer’s problem.

The aim behind forming AI-MED is allow the Government to access a single point of contact and provide various services to the manufacturers like Advocacy on policy issues, Information services, Regulations for medical devices, Education and Training, services, Testing Assistance and guidance for Quality Certification (ISO, CE, GMP), Lobbying for funding for R&D from the Government, encourage innovations from member units, Improve clinician and patient access to the modern, innovative and reliable medical device technologies through organizing Meeting, Seminars, Symposia, Exhibitions and Demonstrations and also, to promote global harmonization of Indian device industry.

AI-MED will ensure convergence at a one common platform, when needed, for ensuring overall growth of Indian Medical Devices Industry and further address the needs of all members of the Medical Device Industry irrespective of their affiliation or their company size. It will also help in wider dissemination of information to each player of the industry. AI-MED would be horizontally divided into common groupings like – Legal Issues, Tax Issues, Export Related Issues, Medical Device Regulatory Issues common to all vertical groups of different families of product lines with Zonal Representations.

AI-MED has initiated the formation of the IMDRRG (Indian Medical Device Regulatory Review Group) This is an open informal forum – broad based consisting of Regulators, the Regulated Industry, the conformity assessment quality system auditing bodies like SGS/TUV/Intertek/UL/DNV/BSI, Testing Facilities and other Stake Holders – Consultants/Doctors/Nurses/Patients to review proposed regulations on ongoing basis and ensure that these are aligned to the GHTF (Global Harmonization Task Force) Guidelines - AI-MED wishes to collaborate with the Government. Currently we have over 400 individuals and organization representatives receiving e-mails with opportunity to use this forum for informal and candid e-mail exchange as well as pass on information to members of their organizations.

Mr. M. M. Saiyed
President

We are an Association of Medical Disposable Manufacturers popularly known as MDMA [Medical Disposable Manufacturers;' Association] in Gujarat. We have more than 40 members. The Medical Disposable Manufacturing Industry is in existence for the last more than 30 years and many of our units are major suppliers of Disposable Medical Devices like Intravenous Infusion Sets [I.V. Sets], Blood Transfusion Sets [B.T. Sets] to the local regions, export markets and central government for tender supply.

Most of the unit members hold approved Drug Manufacturing License, GMP, ISO & CE certifications with product barcodes. Our main objective is to contribute to the development and growth of the inter-disciplinary areas of Medical Devices Industries in all aspects and specialties.

Main Activities of the Association:

• Organizing Meetings, Seminars, Symposia, Exhibitions & Demonstrations
• Conducting Training Programs for Skill Development, Management & Marketing
• Training Man Power [Technical, Non-Technical]
• Exchange information between the Members regarding changing Government policies & regulations
• Representation of the issues with Government Authorities like FDA, Excise, VAT
• Assistance and Guidance to the Members for quality certifications like ISO, CE, and GMP.

INDIA is one of the fastest growing health care markets in the world. The current estimate of health care device market is about $1billion with a projected growth rate of 18%. Realizing this huge potential, Indian industry as well as academician has started showing keen interest in biomaterials and medical devices research. As a result, establishments like National Laboratories, Indian Institutes of Technology and other leading Universities have started research as well as teaching programs. Many of the establishments work in close association with the industry also. As an outcome of this, apart from the ongoing research activities, indigenously developed implants and devices like artificial heart valve, hydrocephalus shunt, blood oxygenator etc. are also available in the Indian market.

In order to develop coherence among the scientists and engineers working in this field, way back in 1986 Dr. Chandra P. Sharma along with his colleagues founded the society, Society for Biomaterials and Artificial Organs - India.

Founded in 1978, the National Bio-Medical Engineering Society is carrying out various activities for the development, growth and popularity in the interdisciplinary areas of Medicine, Engineering and Bio-Medical Engineering. These include efforts to improve education technical information, organising meetings, work-shops, seminars etc.

The Society has created a very effective platform for bringing professionals from Medicine, Engineering academics and industry together.

Aims & Objectives :

• To contribute to development, growth & popularity of the interdisciplinary area of Bio-Medical Engineering in all aspects and specialty in India
• To review & strive to improve education in this field at all levels
• To undertake, promote, encourage or sponsor studies and research projects in the field of Bio-Medical Engineering with the ultimate aim of making high quality medical care available to lowest echelon of society with the help of modern engineering technology
• To establish research centers pertaining to Bio-Medical Engineering.

Shri H.G. Koshia
Commissioner
Food & Drug Control Administration, Gujarat

Drugs Control Administration (DCA), Gujarat came into existence on 1st May 1960 after separation of Gujarat State from Greater Bombay State and Mr. B.V. Patel became the first director of DCA, Gujarat.

DCA, Gujarat was entrusted implementation of Drugs & Cosmetics Act – 1940 & Rules 1945 and Drugs Magic Remedies (Objectionable Advertisement) Act – 1954. Mr. B.V. Patel played a vital role in establishing well defined administrative structure, policies and procedures of DCA, Gujarat. He seeded the present culture of this department - industry friendly, prompt & strict action against law breakers. He also took initiative to establish state of art Drug Laboratory equipped with latest equipments at Vadodara.

Dr. M. A. Patel was followed by SHRI A. G. Shah, Shri G. R. Bhagat, Dr. S. P. Adeshara, Mona Khandhar, (I.A.S.), DR. S. Murlikrishna, ( I.A.S. ) & Dr. H. G. Koshia as Commissioners of FDCA, Gujarat. Since, 22nd January 2009 Dr. H. G. Koshia is Commissioner, FDCA, Gujarat.

With effect from 5th August 2011, PFA and seven other acts related to food have been repealed by “The Food Safety and Standards Act, 2006” (FSSA).

Dr. H.G. Koshia, Commissioner, Food & Drugs Control Administration, Gujarat His Key Responsibilities are Enforcement of “Drugs & Cosmetic Act, 1940 and Rules” & Enforcement of “Food Safety & Standard Act, 2006” and rules, in Gujarat State. He is actively representing nine national and state level committees. He is Chairman of the very important committee “Track & Trace”, for preparation of guidelines to prevent of menace of spurious drugs.

Dr. Koshia regularly interact with officials of US FDA, Health Canada, MHRA, DCGI, technocrats, academicians, IDMA, Chemists & Druggists Association etc. to ensure a consultative approach towards inclusive development and growth.

He has played a pivotal role in transformation of pharma sector in Gujarat to emerge as a favorable investment destination with proactive & pragmatic approaches.

He has played a vital role in the implementation of e-governance in FDCA and is winner of one state level and three national level awards.

FDCA implementing various Acts and rules related to Drugs, Cosmetics, Medical Devices, Food & Safety, Cigarettes & other tobacco products etc.

Medical Device Industry In Gujarat:

Gujarat State has the largest number of licensed Medical Devices Companies which are nurtured by Gujarat FDCA Dept. with an exemplar nary approach and has been receiving recognition in the country. The present culture of this department is industry friendly, prompt & still known for taking strict action against law breakers.

Testing Laboratories:

Food & Drug Laboratory (FDL), Vadodara is the first NABL accredited Government laboratory in the country. In addition to FDL, Vadoadara, FDCA has two other Regional Food Laboratories for testing of food samples, one at Rajkot and one at Bhuj. FDCA is also setting up one more state of art Food & Drug Laboratories in the state.

Training :

Training of FDCA officers of both cadres, Drug & Food, has been a regular practice. It includes induction training of newly appointed officers and in service training as well. The objective of training is to sharpen their knowledge not only to maintain performance of FDCA but also to achieve newer landmarks.

e-Governance :

FDCA, Gujarat makes optimum use of information technology for achieving excellence in performance.

FDCA, Gujarat is the first State to initiate online software for sales & manufacturing licenses.

After successful implementation of Sales Licensing Software since 1st January 2007 and with proven sustainability of the software, Drugs Controller General India (DCGI), Government of India praised and recommended this software to all State Drugs Controllers at several occasions.

ADMI is a non-profit making company, incorporated in the year of 2002 with its registered office in the State of Gujarat. The management of the business affairs and control of the company are rested with the Managing Committee, which is elected based on the tenets as enshrined in the constitution of ADMI. The office bearers are elected every three years.