In order to gain greater market access, Indian pharma companies are looking at strengthening drug pipeline, intellectual property (IP) competence, scientific pool, regulatory expertise and faster turnaround. Vishnukant Bhutada, MD, Shilpa Medicare Ltd states that it is the comprehensive and reliable expertise that has helped Indian pharma companies to succeed in the international arena, in an interview with Nandita Vijay. Excerpts:
Would you please throw light on the pharma scene in the country?
Indian pharma sector continues to show sterling performance and is expected to register growth at 12 to 14 per cent over the next 3 to 5 years. Domestic market performance is a justification of the strong regulatory and scientific skills, with patent filings and larger pipeline across all markets. Apart, it has a relatively resilient cost structure, which should enable the sector to strengthen its presence as a globally competitive generics major.
What are the trends you observe in Indian pharma sector?
There is a solid presence of the Indian pharma companies in the international arena in the area of contract research and manufacture. The trends include adherence to highest quality standards and the importance given to product development, ensuring US and EU dependence on India for scientific strength and infrastructure. India has the highest number of US FDA approved plants outside the US. Also, India is known for its accurate and systematically documented dossiers for international submissions.
What are the challenges before the companies?
Key challenges are to maintain the pace of new drugs in pipeline, ensure economies of scale, IP competence, capability of scientific pool, regulatory expertise and faster turnaround. All these factors are the major drivers of contract research business in India.
China has been exporting APIs to India at lower price. Will the presence of low cost advantage prove detrimental and a threat to Indian APIs in the long run?
China is successful only because of its proactive and protective government polices in industrial development. Exports are encouraged and imports are discouraged. Industries are offered ample subsidies for utilities. The basic and industrial infrastructure is far superior giving the country an edge in volume production. The dragon land is known for its high competence in large-volume, efficient and cost-effective production processes making the end-product offer at an attractive price. It also has a huge talent pool with sound knowledge of chemistry, strong arithmetic reasoning and analytical abilities. The scientific expertise at universities works in close coordination with the pharma industry to focus on innovative research. The competition from China could only affect small companies.
As a two-decade old co in APIs and intermediates space, could you identify the Shilpa Medicare's key strengths?
We are one of the low cost oncology API manufacturers in the country and globally. The present facility at Raichur has a WHO GMP certification for 20 APIs. Since 1999 we have been bagging awards for our services. These include the best entrepreneur award from Govt. of India and Karnataka. We also received the Star Export House status from Govt. of India in 2004. From 2005 to 2008, we received the Certificate of Suitability from EDQM for Ambroxol HCl, Ticlopidine, Carboplatin, Buflomedil HCl and a Korean FDA approval for Gemcitabine HCl & Ambroxol HCl. We have the leadership ability in terms of quality and cost to continue the focus onto oncology, develop products with high technology, apart from a strong penetration into the regulated markets and sound customs research/manufacturing (CRAMS) expertise. We have successfully procured CRAMS business with top MNCs. We can offer the entire supply chain from APIs, intermediates to multi-market finished packs.
Shilpa's vision statement indicates that you intend to become a leading supplier in the formulations space. When do you intend to enter this arena and what are your initiatives?
We have a total of 18 API oncology drugs and therefore we will do well in formulations. We are one of the few dedicated oncology product manufacturers in the country along with Intas, Venus Remedies and Biocon. Of course they have other therapies in the cartel. There is a constant demand for oncology APIs from leading formulation producers. We have the largest facility in API and therefore formulation is only an extension.
Is oncology API production the forte of Shilpa?
We have already invested Rs 100 crore for the API facility, which is an EOU (export oriented unit) and Rs 50 crore is slated for the formulation unit, which will start construction in mid 2008 and be commissioned in 2009. We are looking at parenteral injectables and tablets for all oncology APIs.
How do you propose to become a leading global supplier in pharma by 2010?
Our proposed oncology manufacturing facility is one of the largest dedicated oncology API manufacturing facilities in world, which will become operational by mid-2008. It will have five dedicated oncology production blocks, high containment facility with cGMP along with highest level of efficiencies and will be for multinational companies. Recently we acquired Loba Finechemie in Austria and are looking for opportunities in US market to enter at right time.
Would you please brief us about your goals?
The company will have a strong oncology presence offering highest global quality products at lean cost structure. There will be backward integration into key intermediates. Our focus is on the economies of scale and manufacturing process improvements. By 2010, estimated oncology turnover target is around US $100 million. We have chalked out strategies to build a robust pipeline and consolidate our offerings to the regulated markets. Going forward, we will be into finished dosage forms. Our blueprint for next five years is to become a dependable company with non-infringing processes in place to bring innovative products to the market and create value for stakeholders through innovation and quality.