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India’s manufacturing strength will spur R&D push

pharmafile | August 21, 2013 | News story | Manufacturing and Production, Sales and Marketing India, MHRA, manufacturing 

The world’s pharma manufacturing base is moving to India, claims a new report, which notes the country now has 546 manufacturing certified facilities, a number only topped by the US.

The India Brand Equity Foundation (IBEF) also says that the country’s exports have grown at 21.5% a year over the last three years to reach $13 billion in sales, mainly from generics, and suggests this growth will now lead to increased investment in innovative medicines.

The country’s manufacturing base now features 23 companies holding around 1,100 authorisations from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), as well as 166 companies with which hold Certificates of Suitability (CEPs) for ingredients from the European Directorate on the Quality of Medicines and Healthcare (EDQM).

“The huge growth in generics production has seen the country become a hotbed of manufacturing innovation,” says the IBEF, pointing out that India was responsible for 40% of the entire drug master files (DMFs) filed in the US last year.

“The Indian pharma market is now at the precipice of the next stage in its development”, says the IBEF, adding: “India is now ready to challenge traditional big pharma and start producing more patented products”.

Rising export revenues from generic drugs will be re-invested in research, helped by a multibillion dollar public-private initiative set up by the Indian government, along with tax breaks on R&D expenses.

India’s Dr. Reddy’s, Lupin Labs, Sun Pharma, Ranbaxy and Cipla have invested over $500 million in R&D this year, and this is allowing increased innovation in manufacturing processes  and will help to lower the cost of medicines production, says the IBEF.

Protecting its assets

Meanwhile, India is also taking steps to protect its pharmaceutical sector with an overhaul of its rules on foreign direct investment (FDI) amid fears that its domestic drugmakers are at risk of being swallowed up by foreign multinationals, according to local press reports.

The Business Standard says the Department of Industrial Policy and Promotion (DIPP) has prepared draft proposals that contain a number of measures including making it mandatory for multinationals to invest a certain proportion of sales on R&D.

The newspaper says overseas groups that acquire domestic drugmakers are currently spending only around 1% of turnover on R&D, and the government is concerned that the current free run at FDI could lead to reduced supply of essential medicines such as antibiotics, vaccines and cancer drugs as acquirers concentrate on making drugs for export markets.

Phil Taylor

 

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