Dr Ashes Ganguly, Director, Cryogen Instruments India Pvt Ltd, is the founder secretary of Indian Analytical Instruments Association (IAIA). The association was formed in 1996, and is the only body in the country representing analytical instruments manufacturers. In an interview with Kavita Tate from Pharmabiz, Dr Ganguly spoke on the recent trends in the analytical instrumentation (AI) market in the country.
How are the implementation of GMP, GLP and increased activity in R&D getting reflected in analytical instrumentation sector?
Previously, in manufacturing a product, purity was the matter of concern. But, the product manufacturers today are keen to know how impure the sample is rather than how pure it is. With the advancement in technology, more sophisticated instruments to check impurities even at a nano level have come into the market. In general, the impurity estimation today is done at Parts Per Billion level (PPB). As a result, purity is not only the concern for pharmaceutical sector. Controlling the contamination in the process is important. The real concern in GLP and GMP is to follow the system and monitor the right process with proper validation.
Analytical instrumentation is becoming the utmost tool in any pharmaceutical process for quality monitoring. Bio-equivalence, Stability study and High Throughput (HTS) Studies cannot be concluded with out analytical instruments. Magentic Resonance and X-ray diffraction studies are the integral part of structural elucidation or to target a molecule.
How do analytical instrument manufacturers in India manage to supply cost effective instruments without compromising on quality?
Quality and performance cannot be compromised for any reason. Market in the Asian countries like India, China, Malaysia etc. and also in Japan and Australia, is growing at a faster rate. There is a minimum 15-20% growth in the analytical market in pharmaceutical and biotech industry. Large numbers of units have come up and this has inspired the foreign countries (USA and EU) to give third party contracts to the Asian countries. They also provide guidance on design, drawing and other requirements to the contract manufacturers or their subsidiaries. Also, the cost of labour in Asian countries is low. Thus, it is possible for the Asian manufacturers to supply cost-effective instruments without compromising on the quality.
But, as far as the total instrumentation is concerned, Indian manufacturers are far behind other leading countries in analytical instrumentation and related software. We fall short of the reference system.
Import dependency on analytical instruments is going up. How do you think the Indian instrumentation sector can attract more investors?
To attract something, quality manpower is essential and that is available in our country in abundance. As a country, India is trying to take a lead in lot of sectors. Industry here is doing well and the investors with capacity of 50 million- 100 million dollars may take interest in the industry.
But, analytical market in India is low as compared to the global market. It may not exceed 1.5%. If investors are interested, they have to consider the global market. Since the domestic market is too small, it does not interest many local investors.
How does the existing regulatory mechanisms aid the growth of the sector?
Growth is a natural process. Therefore, regulatory mechanism cannot stop it. It can remain as a checkmate but cannot hinder the growth. But, it is advisable to follow the regulatory mechanism for better quality, safety, health and environment.
What are the new trends in analytical instrumentation sector?
Hypernated technique in spectroscopy and chromatography, product specific detectors and micro and nano analysis are the new trends in the analytical industry. Nano technology and imaging are becoming popular day by day.
Chromatography is a broad range of physical methods used to separate and or to analyze complex mixtures. The components to be separated are distributed between two phases: a stationary phase and a mobile phase that percolates through the stationary bed whereas, Spectroscopy is the study of the way in which atoms absorb and emit electromagnetic radiation. Nanotechnology is advancing. It comprises any technological developments on the nanometre scale, usually 0.1-100nm. One nanometer equals one thousandth of a micrometer or one millionth of a millimeter.
Outlook of Indian analytical instrumentation sector. Your comments.
We are in the bank of world-class market. Today, any global manufacturing company launches its product in India on the same day or within a week as it is launched globally. The end users and service providers are equally exposed and knowledgeable as those in the frontline countries. Indian scientists and technocrats are regulars in global seminars and deliver lectures on various subjects. Hundreds of seminars and product presentations of international standard take place every year in India.
Therefore one can say that analytical sector is growing. For example, IAIA in combination with Messe Munichen (Founder of Analytica Conference in Germany) is doing an international seminar in Banglore on November, 2006. Also, ISAS is having a Satellite seminar in Dubai on February, 2006.