Guest author: Anuvrat Singal | Executive Director | Glatt (India) Engineering Pvt. Ltd.

Being an economy of world reckoning, India is poised to become the ‘pharmacy of the world’. We are the fastest growing and leading pharma producers having one of the highest exports of generics in the world. Advantage India lies in its cost efficiency, diversified portfolio, economic prosperity, well-trained work-force and policy support by local government. By 2020, India is likely to be among the top three pharmaceutical markets by incremental growth and sixth largest market globally in absolute size. It will cross US$ 80 billion and have a CAGR of approx. 20%. As of today, the top 5 firms account for nearly 20% of the market share which would gradually change over this decade when SME players revamp/re-engineer their existing sites to cater to the growing need for quality products.

Overall, there is a trend in the Indian pharma industry to continuously increase – R&D spending, export revenues, joint ventures and expansions abroad. Between 2012-2016, patent drugs worth US$ 170 billion are estimated to go off-patent, leading to a huge surge in generic products. This newly available market will be filled mainly by generics, which would provide great opportunities to Indian companies. The Indian Government is also very proactive for boosting growth and investment in the Indian pharmaceutical sector. The Department of Pharmaceuticals (DoP) has prepared a Pharma Vision 2020’ document for making India one of the leading destinations for end-to-end drug discovery and innovation. Also, under the government’s Make in India program it has been decided to declare 2015 as ‘Year of Active Pharmaceutical Ingredients (API)’. Under this initiative, the government will introduce industry friendly policies and incentives to give a major thrust to the growth of the Indian bulk drug industry to make it a formidable force globally and reduce the dependency on Chinese manufactured API’s. This initiative has come after decades of incentives and advantages given to generic manufacturers in the country.

However, “With great power comes great responsibility”…The Indian pharma industry has been riddled by various issues like data integrity, GMP (good manufacturing practices), the export of counterfeit products, IPR issues & drug quality to name a few. There have been recent bans on sites of major pharma producers due to GMP issues. There is an urgent need for improvement in pharmaceutical manufacturing practices across the country, irrespective of what the regulator says.

The pharma industry being a highly monitored/stringent/innovative sector requires a lot of care and foresight in the design philosophy. The guidelines vary from facility to facility and from country to country. Different manufacturing practices are to be followed depending upon the product portfolios. WHO / UK MHRA / US FDA / PICS / ICH etc. are all important to follow, but it all trickles down to GxP – Good Manufacturing / Engineering / Design / Lab / Construction / Consultation / Documentation / Business – Practices and the list goes on. The new mantra from US FDA is QbD (Quality by design) i.e. systematic approach that begins with analysing, understanding and pre-defining the objectives, process and product parameters and quality risk management.

All this has increased the need to involve professional engineering experts (like Glatt Engineering) with in-depth technology expertise to develop, implement and deliver state-of-the-art designed and engineered manufacturing facilities. A systematic planning approach needs to be deployed during the life cycle of the projects which also ensures that GMP & QbD norms are followed, till the end. In the end the customer must be sure that his investment is safe in the hands of the Engineering consultant.

As promising as the future looks, care must be taken that India is able to continuously improve in manufacturing practices in order to keep its market position and not lose it to other developing markets. “We have promises to keep and miles to go before we sleep”….

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