|
India’s bulk drug industry is well-positioned to reinforce its role as a global hub for high-quality, affordable, and sustainable Active Pharmaceutical Ingredients (APIs). With a robust manufacturing infrastructure, skilled workforce, and established regulatory frameworks, India has become a key player in the global pharmaceutical supply chain. The country’s ability to produce a wide range of APIs at competitive prices, while maintaining high standards of quality, allows it to meet the growing global demand for essential medicines, said A P Rameswara Rao, National President, BDMAI (Bulk Drug Manufacturers Association of India) in an email interaction to Nandita Vijayasimha. Excerpts:
What is the BDMAI’s stance on the current government policies affecting the bulk drug industry?
The government policies are largely aimed at strengthening the domestic bulk drug industry while enhancing the global positioning of Indian pharmaceuticals. While the policy framework itself is generally supportive, challenges often arise at the implementation stage.
BDMAI actively engages with both industry stakeholders and relevant government agencies to address such issues and facilitate timely, practical solutions, ensuring minimal disruption to operations. Moreover, the government regularly seeks industry feedback when introducing or revising policies. BDMAI plays a key role in providing these inputs, consolidating the perspectives of its members to help shape policies that are both effective and industry-friendly.
India is a major exporter of bulk drugs. What steps is BDMAI taking to ensure that Indian bulk drugs maintain their reputation for quality and safety on the global stage?
India is a significant exporter of bulk drugs, particularly to highly regulated international markets that mandate strict compliance with quality and safety standards. Our member companies are long-established exporters with robust systems that ensure adherence to the regulatory requirements of importing countries.
BDMAI plays a proactive role in strengthening these efforts by facilitating continuous capacity building, providing timely regulatory updates, and promoting knowledge sharing. We regularly organize seminars on global regulatory developments, quality systems, and advanced manufacturing technologies. Additionally, we disseminate information on emerging best practices and technological advancements to help our members consistently meet and exceed international expectations for quality and safety.
While much of the focus is on exports, what is the outlook for domestic demand for bulk drugs, particularly in the context of rising healthcare needs in India?
BDMAI’s member companies, many of which are MSMEs, have always regarded the domestic market as a key priority. However, due to the dynamic global landscape, India often has to rely on imports to meet certain bulk drug requirements. This should not be seen as a lack of interest from domestic manufacturers; rather, in some cases, it is simply not economically viable to produce specific bulk drugs locally because of the highly competitive pricing offered by exporting countries. To address this challenge and strengthen domestic self-reliance, the Government of India has introduced initiatives such as the PLI scheme. The products manufactured under this scheme are specifically intended to meet India’s internal demand, reducing import dependence and ensuring a stable domestic supply in line with the rising healthcare needs of the country.
What is the future of the bulk drug industry in India? Are there any specific trends or sectors you see growing in the next 5-10 years?
Given the highly conducive ecosystem for pharmaceuticals in India supported by strong scientific institutions, a skilled talent pool, and robust manufacturing capabilities, the bulk drug industry is well-positioned to reinforce its role as a global hub for high-quality, affordable, and sustainable APIs.
Over the next 5–10 years, the industry’s growth will be driven by several key trends. These include strengthening technical capabilities, accelerating the adoption of green chemistry and environmentally sustainable processes, and embracing digital and AI-enabled manufacturing to enhance efficiency and quality.
We also foresee significant growth in sectors such as complex APIs, high-potency APIs (HPAPIs), fermentation-based products, and specialty niche molecules. With continued policy support and industry innovation, Indian API manufacturers are poised to remain globally competitive and future-ready.
What is the role of BDMA in supporting small and medium-sized enterprises (SMEs) in the bulk drug manufacturing sector?
SMEs form a major part of BDMAI’s membership, and supporting their growth remains one of our core priorities. To strengthen their market visibility and competitiveness, BDMAI has developed a dedicated e-marketing portal that exclusively promotes Indian APIs, intermediates, pellets, CDMOs, analytical and consultancy services.
The platform also integrates vendors of equipment, chemicals, and instruments, enabling members to streamline their vendor management and access reliable suppliers. This initiative has been widely appreciated for improving market access and creating new business opportunities for MSMEs.
Additionally, BDMAI actively engages with state governments to advocate for the allocation of dedicated land parcels for MSMEs in upcoming bulk drug parks. Such measures are crucial to ensuring that smaller manufacturers have the infrastructure and support needed to scale their operations and remain competitive in a rapidly evolving industry
Sustainability is a growing concern. What steps are being taken by BDMA members to reduce the environmental footprint of bulk drug manufacturing?
Sustainability is a key priority for the bulk drug industry, and BDMAI actively supports its members in adopting environmentally responsible manufacturing practices. The Association promotes the adoption of green chemistry principles, efficient waste and water management systems, and cleaner, energy-efficient production technologies.
To build industry-wide capacity, BDMAI regularly organizes workshops and seminars focused on sustainability, environmental compliance, and emerging green technologies. Additionally, we share important regulatory updates, best practices, and case studies through our monthly e-bulletin, ensuring that members stay informed and continuously
improve their environmental performance.
What are the biggest challenges currently facing bulk drug manufacturers in India, and how is BDMA helping address them?
The bulk drug industry in India, like many other sectors, faces several structural and operational challenges. These include limited availability of land with essential infrastructure, the need to obtain multiple environmental clearances, and a declining interest among younger generations in choosing life sciences as a career. In addition, our penetration into high-value regulated markets remains constrained due to stringent compliance requirements and, in some cases, the lack of differentiated or innovative product offerings.
Issues such as margin pressure, duplication of efforts, price undercutting, and the absence of a unified global competitiveness strategy also affect overall industry growth. Addressing these challenges is an ongoing effort, and BDMAI actively works to support its members wherever possible. This includes engaging with government agencies on policy and regulatory matters, promoting skill development, facilitating knowledge sharing, and encouraging collaborative approaches that strengthen the sector’s long-term sustainability and global competitiveness.
With increasing global competition, particularly from markets like China, how can Indian manufacturers maintain their competitive edge in the bulk drug sector?
For over two decades, the Indian bulk drug industry has faced intense global competition, particularly from China. This competition is natural, given India’s strong formulations sector, which relies on competitively priced raw materials to remain globally competitive. However, unfair price-competition practices from China have, at times, led to the closure or consolidation of several smaller Indian manufacturers.
Despite these challenges, the Indian bulk drug industry continues to demonstrate resilient and positive growth. This has been made possible through sustained efforts to enhance cost efficiency—such as improving process yields, scaling up production volumes, and adopting modern, technology-driven manufacturing practices. By focusing on innovation, efficiency, and continuous capability-building, Indian manufacturers are well positioned to strengthen their competitive edge in the global market.
How are new technologies, such as AI and automation, being integrated into bulk drug manufacturing?
New technologies such as AI and automation are increasingly being recognized as powerful tools to enhance efficiency, improve process consistency, and reduce overall operational costs in bulk drug manufacturing. Like any advanced technology, their primary purpose is to optimize productivity and strengthen competitiveness.
While the industry is still in the early stages of adopting these tools—particularly among MSMEs—there is a clear understanding of their long-term benefits. To support this transition, BDMAI has been organizing awareness programs, workshops, and seminars focused on AI, digitalization, and automation. These initiatives aim to equip manufacturers, especially smaller units, with the knowledge and preparedness needed to gradually integrate these technologies and become future-ready.
|