The domestic pharma market was valued at US$ 15.4 Billion in 2014, and is expected to expand at a CAGR of 13.3% to US$ 32.7 Billion by 2020, according to a study jointly conducted by The Associated Chambers of Commerce and Industry of India (ASSOCHAM) and RNCOS. Driven by favourable demographics including growing aging population, increasing lifestyle diseases, steep growth in disposable incomes and increasing penetration of Indian drug players in the global market, India is likely to be among the top three pharmaceutical markets by incremental growth and sixth largest market globally in absolute size, noted study.
India ranks 4th in pharmaceutical production in the world with a production output of about US$ 31 Billion in 2014. The country has a 1.4% share by value and 10% by volume in the global pharma industry. India is one of the leaders in pharmaceutical exports.
India has a meager number of 1,500 well equipped inspectors for more than 10,000 factories engaged in pharmaceutical products leading to the country’s products facing regulatory hurdles in the overseas markets like the US which follow stringent protocols for the manufacturing processes, a sectoral study done by ASSOCHAM and research firm RNCOS has pointed out.
It said the Indian pharmaceutical sector which made rapid strides in the global markets, is now faced with several regulatory hurdles, especially in the US and EU, according to a study on ‘Focus on Quality Management in Pharmaceutical Manufacturing,’ jointly conducted by The Associated Chambers of Commerce and Industry of India (ASSOCHAM) and RNCOS.
"While at times, the US Food and Drug Administration (FDA) gets into minute details which have more to do with the cumbersome procedure rather than quality, we need to get our own house in order by way of continuous skilling of the regulators at the national and state levels in sync with the best global practices. However much we may wish otherwise, the pharma sector is and will always remain one of the most regulated sectors all across the world for the sake of public health," ASSOCHAM Secretary General Mr D S Rawat said while releasing the study.
The mismatch between the domestic regulatory mechanism and the international regime is resulting in recall and rejection of drugs made by even some of the well known companies, leading to unrest and frustration. In the long run, the pharmaceutical exports during the fiscal year 2013-14 reported US$ 14.8 billion of drug exports would take a setback.