CII organised a Multi-stakeholder Consultation on “Indian API industry – Reaching the Full Potential” on 12 June 2020 – bringing together experts from the Government and Industry leaders. It focused on the new API policy that has been launched, its strength and weakness, and deliberated on enabling large scale API/intermediates and KSM manufacturing in India.
The Indian pharmaceutical industry is heavily import dependant for its key starting material, intermediates and active pharmaceutical ingredients (APIs). Over the past two decades, India’s reliance has grown for imports of low-cost intermediates and APIs. Over-dependence on imports has increased the threat to the nation’s health security. COVID-19 has brought forth the need for India to have its own strengths and supplies of API for its robust pharma sector and the Government’s recently approved package of INR 9,940 crore shall boost the domestic production of bulk drugs and exports.
Dr V G Somani Drug Controller General of India Ministry of Health & Family Welfare, Govt of India emphasized that India has the ideal ecosystem for AtmaNirbhar Bharat for the API industry, and we must use the competitive advantages to reach our full potential. The Government has provided a push in infrastructure and financial incentives.
Moderating the sessions, Mr G V Prasad Chairman, CII National Committee on Pharmaceuticals & Co-Chairman and Managing Director Dr. Reddy’s Laboratories Ltd welcomed government PLI schemes to boost API manufacturing and decision of setting up large bulk drug parks to make the Indian industry competitive on various fronts including cost. He laid emphasis on developing bulk drug parks with many common services as the next generation industry parks, and how it will play a fundamental role for India in regaining its position as a global leader.
We are on our way to have a turnover of USD 120 billion in 10 years while being the largest supplier in terms of volume stated Mr Sudarshan Jain, Secretary General IPA. The recently announced policy will help create healthcare security along with diversified supply chains. However, moving forward, exports also need to be provided with incentives, while it is necessary for us to build plants to cater to a global scale. Business security and flexibility in environmental clearances while adhering to the high environmental standards is also pivotal for an ideal bulk drug policy stated Mr Mahesh H Doshi National President, IDMA. Mr V V Krishna Reddy President BDMA spoke on how the new policy will allow us to regain our past glory, while allowing us to become a global leaders in exports.
Mr Eshwara Reddy Executive Director, BDMA speaking on the Future of Bulk Drug parks in India highlighting the key issues – land availability, high Infrastructure costs, limited Government Support, delayed time-lines, delay in environmental clearances and others. Hyderabad Pharma City provides an ideal blueprint for the API industry in India, focusing on three areas: Competitiveness, Innovation and Eco-sensitiveness stated Mr Shakthi M Nagappan Director Life Sciences and Pharma CEO Hyderabad Pharma City Ltd, Govt. of Telangana
For the revival of the fermentation industry, the new policy needs to be applicable for mature products providing incentives for old plants and the expansion of them stated Mr Sudhir Vaid Chairman & Managing Director, Concord Biotech. Our policies should cover domestic production and exports, while laying emphasis that the fermentation industry should be considered a national asset. Mr Anil Satwani, Managing Director, Symbiotech opined that our policy shouldn’t focus on specific APIs because industry many not have appetite to put large investments required for fermentation APIs for only few of the selected products.
The timelines to get approvals in India is lengthy and complicated, with up to 34 clearances required for environmental approvals. There needs to be a single window clearance with the central and state government working in sync stated Mr Anish Swadi President – Strategy and Business Development, Hikal. This along with deemed export benefits need to be reinstated. Dr Azadar Khan Senior Vice President - India Regulatory Affairs & Corporate Relations, Sun Pharmaceutical Industries Ltd highlighted the minor inconveniences that are having a drastic impact on costs while emphasizing on the importance for the scope of product linked incentive scheme to be expanded to brownfield projects as well.
12 June 2020