In order to address the needs of the Rs 5000 crore unorganised bulk drugs process equipment market, experts suggest automation with the help of latest integrated technologies like micronizing, containment and integrated granulation line to meet quality standards of potent drugs like APIs, critical pharmaceutical excipients and dry product ingredients (DPIs).
These technologies are relevant to India as there is a growing need for proper handling of bulk drugs through safe human interfacing systems and solutions to prevent any metal contamination in dry product ingredients.
Says V Manjula, Managing Director, Hosokawa Micron India Pvt Ltd, Chennai, "Increasingly exacting occupational safety requirements and the use of highly active pharmaceutical substances pose a compelling need for manufacturers to reassess their system components and put an integrated containment milling system, which the company has been providing for the past 15 years to the Indian market."
Experts pinpoint that the market in India is at a nascent stage and is poised not only towards embracing new technologies but also indigenization to bring about affordability and availability of products in India. Companies in process equipment segment has done indigenisaion in 30 to 50 per cent of the products over the past nine years.As imports are expensive, experts say there is an evolving market for indigenous products in certain core areas.
Talking about the challenges in bulk drugs process handling and processing, Naresh Hingorani, Sales Director, Haver Ibau India Pvt Ltd, a leading wholesaler and trader of filling packing machines says "Indian manufacturers need to embrace technologies which are available in India for size reduction to make fine powder in the pharma industry for various requirements."
There are around six foreign companies in India providing customized products and services for bulk drugs processing and powder manufacturing. The number of potent pharmaceutical compounds requiring solid dosage development and subsequent manufacture at clinical and commercial scale is growing at a rapid pace. This process calls for contained environments to protect machine operators and products from cross contamination.
A containment system prevents biological agents from escaping either into the working surroundings or the external environment. Containment requires closed containers or biological cabinets and the use of rooms with specially designed air handling units and secures operating procedures.
Glaxo meets its requirement for micronized APIs and DPIs with the help of micronizer. Micronizer is equipped with a static classifier or an integrated dynamic classifier which offers precise cut points. Similar kind of systems are also with Cipla, Sun Pharma and Ranbaxy. Micronizer helps produce powder in dry form below five microns for special applications.
There is a niche market for such machines mostly imported from Germany to cater generics and NDDS. Export oriented companies form 20 per cent of this market.
Machines like Fluid Bed Dryer are ideal for drying, sizing, agglomerating and spray coating of delicate substances in powder form, with quick drying time, gentle product handling combined with intensive mixing and proven batch to batch quality and reproducibility.
Rapid mixing granulator is a versatile machine developed for homogeneity of dry and wet powders, de-agglomeration of wet mass and fast dispersion of binding or granulating ingredients. Machines are also available to handle critical pharmaceutical excipients and ingredients used for unique applications like inhaler drugs.
Automation
Companies are moving towards automation to cater to the cleaning issues, human error and increasing capacities of pharma manufacturing. Leading manufacturer of pharmaceutical process equipment Bectochem Consultants & Engineers Pvt Ltd which boasts of 200 clients globally caters to pharma companies like Pfizer, Aurobindo and Dr Reddy. It provides single- window solution to put in place integrated systems in the area of closed or contained granulation line. Automation offers good scope in terms of return on investments and hence cost gets recovered in a few months time.