The Indian government is providing $29 million between 2018 and 2020 to the country’s drug industry to encourage competitiveness, provide easy access to testing and facilities, decrease the cost of bulk drugs by up to 25%, and assist small- and medium-sized pharmaceutical companies in upgrading their technology. By bolstering infrastructure facilities and lowering the cost of bulk drug production, the government hopes to transform India into a global leader for bulk drug exports.

The initiative will be implemented as one-off grants meant to provide financial support for developing facilities that are backed by state governments or state corporations. The maximum grant will be $14.64 million per “bulk-drug park,” which are clusters of bulk-drug facilities. Pharmaceutical companies can also apply to develop Common Facility Centers for bulk-drug production, at a maximum limit of $2.93 million per cluster of Centers. These projects will be part of the Pharmaceutical Technology Upgradation Assistance Scheme (PTUAS), which will be allocated $21 million.

For small- and medium sized enterprises (SMEs), PTUAS will provide interest subvention if they have GMP-compliant production facilities for bulk-drug and pharmaceutical formulations. Usually, SMEs that look to upgrade their production infrastructures and technologies in order to meet WHO-GMP standards must obtain loans from financial institutions, but under PTUAS, eligible SMEs can apply for grants to upgrade their facilities. Currently, approximately 75% of pharmaceutical SMEs are strictly production companies with proprietary facilities, while 13% are active in both manufacturing and trading. Of that 13%, about 11% of companies are conducting R&D, including clinical tests and contract research, and 50% of these SMEs export to countries worldwide.

New markets for more affordable pharmaceuticals that the Indian government is focusing on include Africa and Latin America. In 2017–2018, the US represented 31% of India’s pharmaceutical exports, which totaled $17.27 billion. India also has the highest number of US FDA-approved pharmaceutical plants outside the US. Along with expanding into new regions, India is additionally looking to reduce its dependence on China for API sourcing, and is in the process of developing a roadmap to increase API production in India.

SourceThe Pharma Letter


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