Dependency on Imports & Complex Regulatory Process Major Challenges for Indian API Market

?A complex license renewal process, overdependence on China for API imports, and inadequate infrastructure facilities hindering the growth of Indian API industry?, says RNCOS.

According to our report, ?Indian API Market Outlook 2022?, there are numerous challenges which are being faced by the Indian API industry. Currently, overdependence on China for the import of APIs is a factor negatively impacting the Indian API industry. Active pharmaceutical ingredients for some of the major drugs are imported from this particular country. India imports approximately 57-60% of API from China. India is dependent on China for its APIs because importing raw material from China saves 15-20% of the overall costs for the Indian drug makers.

Another problem faced by the Indian API industry is that the API manufacturers have to approach multiple authorities for application of license renewal. The licenses are given after consent is obtained from multiple regulatory bodies such as the DCG of India or State FDA. These are given for a period of one, two or three years. After that, the manufacturers of API have to apply for the renewal of their licenses. This increases load on the department as well as the industry. Therefore, major players prefer to opt out of the API industry.

Furthermore, infrastructure is the main area where India lacks in comparison with other countries. The small & medium enterprises engaged in API manufacturing face a lot of problems in terms of infrastructure as they do not have enough supply of water or electricity, also they do not have warehouses where they can keep their excess stock or raw materials. In other countries such as China, there are 15 free trade zones, 53 high tech parks and 56 export processing zones. In India, the recommendations for the development of API parks are still under consideration and will take time to get implemented. Therefore, all these challenges are greatly hampering the growth of the Indian API industry.

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RNCOS is a leading industry research and consultancy firm incorporated in 2002. As a pioneer in syndicate market research, our vision is to be a global leader in the industry research space by providing research reports and actionable insights to companies across a range of industries such as Healthcare, IT and Telecom and Retail etc. We offer comprehensive industry research studies, bespoke research and consultancy services to Fortune 1000, Trade associations, and Government agencies worldwide.

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