Planned: Bulk Drug Parks
Exports of Pharmaceutical products need incentives, while it is necessary for build manufacturing plants to cater to global markets, says Sudarshan Jain, Secretary-General of the Indian Pharmaceutical Alliance (IPA).
“We are on our way to having a turnover of US$120 billion in 10 years while being the largest supplier in terms of volume,” he said, commenting the recently announced policy to help create healthcare security along with diversified supply chains.
Jain spoke at CII’s organised a multi-stakeholder consultation on “the Indian API industry – Reaching the Full Potential” on 12 June 2020.
The Indian pharmaceutical industry is heavily import-dependent 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.
“India has the ideal ecosystem for AtmaNirbhar Bharat for the API industry,” added Dr V G Somani, Drug Controller General of India Ministry of Health & Family Welfare.
“We must use competitive advantages to reach our full potential. The Government has provided a push in infrastructure and financial incentives,” Dr Somani pointed out.
The government PLI schemes to boost API manufacturing was welcomed by G V Prasad, Chairman, CII National Committee on Pharmaceuticals & Co-Chairman and Managing Director Dr. Reddy’s Laboratories Ltd
The decision of setting up large bulk drug parks to make the Indian industry competitive on various fronts including cost was also appreciated.
Moderating the sessions, Prasad emphasised 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.
Business security and flexibility in environmental clearances while adhering to the high environmental standards is also pivotal for an ideal bulk drug policy, elaborated Mahesh H Doshi National President, India Drug Manufacturers’ Association (IDMA).
Key issues faced by the Bulk Drug Parks are land availability, high Infrastructure costs, limited Government Support, delayed timelines, delay in environmental clearances and others, according to Eshwara Reddy Executive Director of Bulk Drug Manufacturers’ Association of India.
Hyderabad Pharma City provides an ideal blueprint for the API industry in India, focusing on three areas: Competitiveness, Innovation and Eco-sensitiveness, added Shakthi M Nagappan, Director Life Sciences and Pharma CEO of Hyderabad Pharma City Ltd in 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 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,” he said.
“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,” added Anil Satwani, Managing Director, Symbiotech.
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, said Anish Swadi President – Strategy and Business Development, Hikal, in his call for more support for the industry. 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. fiinews.com
