Peaks and Valleys of India’s Pharmaceutical Sector

India's pharmaceutical industry has demonstrated remarkable growth via both organic and inorganic routes. The issues encountered at each step have proved to be turning points that have changed the mechanisms and prevalent trends of the sector. India's pharmaceutical market is estimated to be the third largest globally in terms of volume and thirteenth largest in terms of value. Presently, the market size of India's pharmaceutical sector is $20 billion and is likely to touch $55 billion by 2020.

As in most other countries, India's medical regulatory structure is divided between national and state authorities. The Drug Controller General of India (DCGI) is the national authority responsible for regulating pharmaceuticals. The DCGI registers all imported drugs, new drugs, and biologicals in selected categories and is responsible for approving clinical trials and maintaining quality standards. Recent events indicate that tighter scrutiny by the US FDA (Food and Drug Administration) for drugs shipped to the US is emerging as a key challenge for this sector, one that is causing delays in product approvals and launches. For the short term at least, this is likely to slow growth in India and other countries.

Since India is home to one-fifth of the world's population, global pharmaceutical companies know that the country's market is a potential goldmine. Domestic pharmaceutical companies are collaborating and joining hands with global companies to expand their geographic footprint. In a connected world, what impacts one industry or country has global ramifications.

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Keywords: Pharmaceutical, Mergers & Acquisitions, Government Initiatives, US FDA, R&D, Data Accuracy, Quality, Safety, India, ARC Advisory Group.