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China’s dominance in CRAMS fades as India grabs global opportunities with talent & infrastructure
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Nandita Vijay, Bengaluru
September 27 , 2021
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With China no longer dominating the CRAMs (contract manufacturing and research services) space, India has taken full advantage of the situation. Indian pharma has maximized this opportunity to prove its capabilities in CRAMS. Its 562 US FDA approved units have provided a headway in the stringent regulated regions of US and Europe for CRAMS’ orders. There is revenue generation, recognition of competence and cost advantage with high standards of quality and adherence to delivery timelines, said GG Gurudatta, CEO, Estima Pharma
Indian pharma has made strategic moves with acquisitions to propel expertise. It invested in infrastructure for advanced equipment and technology to cater to the requirements for research and manufacturing of APIs and specialty chemicals for global companies. There is no looking back but only going forward in CRAMS as the regulated regions of US and European Union look to Indian pharma as a reliable supplier, he added.
Capabilities of Indian pharma are justified with qualified English speaking workforce armed with technical skills in organic chemistry per se. This along with advanced infrastructure and instrumentation for analysis and accuracy of chemicals gives companies an edge in CRAMS, he added.
Though Indian pharma cannot be compared to China for its production volume, huge orders for API manufacture are coming through after China's slump following the pandemic. Our industry's strengths in reverse engineering have given adequate scope to gain in-depth knowledge about APIs in formulation development. This worked in favourably as global pharma opted for India as their best choice for CRAMS, Gurudatta told Pharmabiz.
In the last few years, Gurudatta noted that the large and medium sized pharma companies have gone in for backward integration to set up full-fledged R&D centres and upgrade manufacturing plants so that they need not outsource any service. Installing the latest analytical systems like gas chromatography-mass spectrometry (GC-MS), liquid chromatography-mass spectrometry (LC-MS), gas chromatography-infrared spectroscopy (GC-IR), and liquid chromatography-nuclear magnetic resonance spectroscopy (LC-NMR) have given them the recognition globally to be dependable for CRAMS.
In addition, Union government moves to encourage domestic manufacturing and reduce imports of key starting materials (KSMs), drug intermediates (DIs) and APIs brought in schemes like the production linked incentive (PLI) and promotion of bulk drug parks. This has considerably brought down dependence on China and in the next five years, India will be self-sufficient, he noted.
States including Gujarat, Andhra Pradesh, Telangana, Karnataka and Maharashtra are looking at Bulk Drugs Parks to augment capacity in 2 years. There is no doubt India is the place for CRAMS. Particularly in Andhra Pradesh and Telangana CRAMs is happening on a big scale. From a global perspective there is no competition whatsoever. With China’s dominance in CRAMS fading, India has taken full advantage of the situation, said Gurudatta.
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