As India already exports more than 40 per cent of its generics to the western markets like USA and Europe, it is high time that the Indian manufacturers explored other regions of the globe to supply high quality generics at affordable prices. Keeping this in view, IPHEX has been made a platform for national and international companies, regulators, exhibitors and other related service providers to utilize it and build business relations and improve their exports to the global markets , says Dr. P. V. Appaji, Director General, Pharmexcil, while sharing his views about the event with Amguth Raju in an exclusive interview.
What is the theme of IPHEX 2016 and how different is this event going to be from the earlier editions?
The theme for IPHEX 2016 is ‘Brand India Pharma’. We are continuing this theme to promote Indian pharmaceutical sector in the global markets since its inception. In fact, IPHEX was launched way back in the year 2013 with an aim to promoting Indian system of medicines and the country’s pharmaceutical strength and generic capabilities to the world. As already India exports more than 40 per cent of its generics to the western markets like USA and Europe, it is high time that the Indian manufacturers in the country also explored other regions of the globe and continue supply of high quality generics at affordable prices. Keeping all this in view, we have instituted India’s international pharmaceutical and healthcare exhibition (IPHEX) as a platform for national and international companies, regulators, exhibitors and other related service providers to utilize it and build business relations and improve their exports to the global markets.
Who are major participants in this year’s IPHEX and the delegates, exhibitors and visitors expected?
Our major focus has been to attract the Small and medium entrepreneurs (SMEs) and accordingly we have invited all the SMEs in the country to take part in this event. However, coming to international clients we have categorised the invitees on region basis as LAC (Latin American Countries), CIS (Common wealth independent states), USA, EU and Rest of the World (ROW). Accordingly we have extended our invitations and are expecting more than 600 overseas delegates from across 100 countries.
Coming to the domestic front, unlike from the earlier occasions, for the first time, we have extended the state governments to take part in IPHEX to promote their states for investments. Already about 300 exhibitors from India and elsewhere have confirmed their participation for IPHEX 2016.
What are the steps taken to promote the Indian System of Medicine (ISM) and are there any AYUSH exhibitors participating during this year’s IPHEX?
Of course, apart from promoting generic pharma manufacturing capabilities, we have also exclusively focusing on promoting the ISM. As a part of this, we have invited about 20 AYUSH (Ayruveda, Unani, Siddha and Homeopathic) product manufacturers and exporters to exhibit their products and services at IPHEX.
As far as the government is concerned, there are many initiatives to protect and improve ISM systems at global standards. Some of these initiatives include documentation of existing knowledge available in public domain on AYUSH system and to safeguard the sovereignty of traditional knowledge and to protect it from being misappropriated in the form of patients on non-original innovations. Recently a collaborative project has been established between ministry of AYUSH and CSIR for setting up Traditional Knowledge Digital Library (TKDL).
Central Council of Indian Medicine and Central Council for Homoeopathy have notified relevant regulations pertaining to quality of education with prior approval of Ministry of AYUSH.
For the development of quality standards of Ayurveda, Siddha and Unani & Homoeopathy (ASU &H) drugs, Pharmacopoeia Commission for Indian Medicine and Homoeopathy (PCIM&H) has been set up as an independent autonomous organization under Ministry of AYUSH. Ministry of AYUSH has launched National AYUSH Mission (NAM) whose objective is to promote AYUSH medical systems through cost effective AYUSH services, strengthening of educational systems, facilitate the enforcement of quality control ASU & H drugs and sustainable availability of raw materials.
Tell us about the technical seminars and related programmes being organized as part of IPHEX?
As part of the three- day event, we have planned to organize technical seminars focusing on international drug regulatory environment and pharmacopeia standards. During the technical seminar, the presenters will discuss various regulatory standards and issues relating to international regulations. We are also taking this as an opportunity to promote the Indian Pharmacopeia to the world. We are planning to conduct exclusive seminars on various pharmacopeias where presenters will deliberate and what we expect is a common book of standards could be evolved for implementation of the developed countries which will help us reduce the cost and improve availability of essential medicines.
What initiatives are being taken to promote Indian Pharmacopeia and how will it benefit the Indian pharma manufacturers and exporters?
With an aim to promoting the Indian pharmacopeia to the world, this time we have invited a high level official delegation from Ghana. This is our first attempt in this direction. Pharmexcil along with senior officials from Ministry of commerce, DGCI, Indian pharmacopeia commission and health ministry will meet and discuss on various bilateral issues. The high level parliamentary delegation from Ghana and other senior officials will visit the Indian pharmacopeia commission and will discuss issues relating to recognition of Indian pharmacopeia.
If we succeed in getting the Indian pharmacopeia recognized by the world, it will ease our export problems.
At present , our manufacturers are finding it difficult to comply with the standards imposed by various countries for supplying medicines to their country. If our pharmacopeia is recognized, then our manufacturers will not have to follow different standards for different countries and thus help us increase our exports.
Tell us about your recent visit to USA and meeting with USFDA officials?
Before going to USA, we had a meeting with Mathew T Thomas, Director USFDA India in Hyderabad, where in leading members from industry and senior officials along with Pharmexcil discussed issues relating to regulatory compliance and mutual cooperation by understanding each other’s needs and requirements. In continuation to this a three- member delegation visited USA and met senior USFDA official Dr. Robert Cliff, Managing Director and commissioner of USFDA and other regulators. This was a fruitful tour for Pharmexcil as the USFDA has recognized the council as an important government agency to be relied on data relating to Indian industries. Our focus was to chalk out plans to organize workshops between officers of USFDA and Indian regulators and industry players for mutual understanding and improve standards for drug development.