CDSCO certification has improved international repute of India, but domestic companies call for urgent Government support to invest in API facilities.
Amsterdam/The Netherlands – CPhI released the findings of the 2017 India Pharma Market Report, which identified a two-tier manufacturing market and also predicted the increased acquisitions by Indian companies, along with a notable improvement in the international reputation of Indian made pharmaceuticals. But a large majority of domestic companies have called for urgent support from the Government in order to invest in API sites.
The report, which consolidated opinions from 500 domestic and international companies, identified four main areas that Indian pharma companies are investing in – about 50% of funds have been raised this year for ‘commercial scale and scale-up facilities’; around one third for ‘continuous processing’; and just over 20% each for both ‘biologics’ and ‘aseptic/sterile’.
Over the next three years, however, the number of companies planning to invest in biomanufacturing facilities are expected to increase by one third. It is notable that expensive facilities and capabilities that are required for continuous processing and biomanufacturing are being added to India’s traditional base of commercial-scale finished-product facilities.
Over the next one to three years, 36% of Indian pharma companies are planning acquisitions; 20% are looking at facilities in the USA and Europe, with 7% exploring options in the rest of the world. Domestic acquisitions also point towards a scramble amongst many SMEs for greater size and scale, with some 25% also looking at facilities within India itself.
These findings have been announced ahead of CPhI India, an event which is expected to be held from November 27-30, 2017. About 40,000 attendees are expected to be present at the show. The report also highlighted that the international reputation of the country on ‘data integrity’ has also improved massively; 96% agree that the CDSCO certification programmes and initiatives are helping to increase compliance. Even more impressive is the fact that 52% of international respondents believed that the CDSCO is moving towards comparability with the regulatory standards of the EMA and FDA.
Securing Indian generics industry
A major concern highlighted amongst domestic companies (86%) was an over reliance on Chinese ingredients within the finished formulations sector. In fact, the majority of domestic companies (81%) believe that the Indian Government needs to ‘urgently invest in domestic API facilities and provide tax-breaks and incentives to secure the Indian generics industry’ and prevent losses in market share.
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