Pharmaceutical manufacturing has undergone considerable change over the last few years. Major industry restructuring and consolidation has increased pressures on pharmaceutical companies to lower costs, increase utilization of processes and meet the ever-increasing demand for new drugs. Many of the pharmaceutical companies are expanding manufacturing facilities by upgrading or re-structuring processes at the core level.

As an emerging hub for major multinationals to outsource their production of bulk generic drugs, India is in the midst of a major revolution. The pharmaceutical business scene is witnessing a rapid change. In addition to the process changes and embracement of technology to core process, the companies also resort to the inorganic expansions by means of acquisitions.

Industry challenges

Contrary to popular beliefs, the pharmaceutical manufacturing industry is very competitive when compared to other industries. This phenomenon can be attributed to the quick technological advances as a result of big investments in R&D.

With stringent regulatory norms, pressure to have faster time to market and huge R&D costs, the pharmaceutical sector is poised to benefit a lot from high-end automation and instrumentation solutions being offered in the process and related industry.

Investment trend

Like any other global industrial and process sectors, including oil, gas and steel, in India pharma sector also, the breakup of capital outlay for hi-tech automation and instrumentation has been less. In the current scenario, with pressure on margins and requirement of flexible manufacturing, the benefits of automation are far too many to neglect. It is evident from the investments in HMI/OCS, DCS, PLC and high-end instrumentation investments that have been made by the Indian pharmaceutical sector in the recent past. Manufacturing and R&D leaders in the field like Ranbaxy, Dr Reddy's have shown the path. New biotech majors like Reliance has made a sizeable investment.

Capital expenses are typically divided into hardware and software, which includes automation software, field instrumentation and sensors and the cost of control systems. Apart, there exist expenses on ERP, MES and advance process and batch control systems.

HMI/OCS, DCS, PLC

There is a clear trend in the Indian pharmaceutical industry to invest in to HMI/OCS, DCS and PLC category. The benefits include higher productivity and ease of compliance to regulation. The traditional DCS solutions have clearly moved towards HMI+PLC kind of solutions, with technological advancements making PLC versatile, flexible and more powerful. Also hybrid systems are popular, which provide the benefit of both. Sector specific features like audit trails, electronic signatures and clauses out of the part 11 of 21 CFR regulations have clearly laid down key CTQs for these products.

Software - Batch control & planning / MES

Most of the batch software solutions and packages are bundled with the HMI/PLC solutions. However, higher end MES solutions may be required to put on top. The IT technology and automation technology have practically converged, leading to seamless data exchange and interfacing simple.

The high-end batching solutions and MES solutions in this sector are yet to pickup momentum in India. Considering that automation maximizes only through the high-end batching solutions and MES solutions, it is expected to gain popularity in the future. Some companies also follow the nomenclature of Enterprise Production Management systems (EPM) instead of MES.

Field instruments / sensors

Traditionally, companies have been investing on transmitters, flowmeters and control valves. However, during the past 3 years, the Indian pharmaceutical industry has shifted its focus to high-end instrumentation with profibus / foundation fieldbus backbones. This has in turn led to the convergence of field instruments and control room devices. The pharma industry has adopted higher end valves, SMART transmitters and new technology flowmeters, including coriollis and ultrasonic. Inherent non-intrusive characteristics of ultrasonic flowmeters make it an ideal choice for FDA norms compliance.

Automation in process validation

Instrumentation and automation have converged with high technology products to provide a plethora of process validation systems, including wired and wireless thermal validation systems and ion trap based cleaning validation systems. Indian pharmaceutical majors like Ranbaxy, Orchid, Aurobindo, Wockhardt, Zydus and Cipla have invested huge amounts in high-end thermal validation products in the last 3 years.
Almost all the major players in the HMI/PLC, DCS & OCS market, including Siemens, Emerson, Rockwell, ABB, Invensys and GE Fanuc have a base in the Indian market. While, some of them are aggressive players currently, others are poised for an entry quickly. These companies manage production and MES solutions.

Traditional instrument brands like Emerson, E+H, ABB and Panametrics provide good solutions to all instrumentation needs, while process validation systems are available from GE Kaye.

In general, considering the industry trends, wireless technologies are expected to play a major role in IT and automation in the pharmaceutical industry. It is evident from the trends that by 2012 all the best automation and instrumentation concepts with state of the art enterprise software solutions would be deployed in all the major pharmaceutical manufacturing facilities in India.

(The author is marketing director with GE Sensing India)