the pharma industrys quality and regulatory challenges in india lessons learned way forward

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The Indian pharmaceutical industry has shown promising growth over the last few decades. The rise of dependable third-party pharmaceutical manufacturing allowed India from being an import dependent nation in the pharmaceutical industry to one of the key global players in pharmaceutical exports. Today, the Indian pharmaceutical industry ranks third globally in terms of volume, and is estimated to be worth $42 billion. With more than 206 export destinations across the globe and supplies of more than 60% of the global vaccines demand, all of these indicate the prospects of tremendous growth in the coming years. The growth not only boasts significant economic gains for India but also exhibits a prospect of increased innovation in the pharma industry. However, as with any industry seeking rapid growth and capture of international share, there are some recognized challenges and bottlenecks needing to be overcome to realize the growth potential. For India’s pharmaceutical industry, quality and regulatory challenges require attention.


Growth Potential for Indian Pharmaceutical Industry


Benefiting from the massive human resource, third party manufacturers for pharma can leverage this to realize considerable growth in the coming years, studies have shown that the current $42 billion Indian pharmaceutical market is likely to reach $65 billion by year 2024, and the industry is overall ambitioned to grow threefold to $120-130 billion by year 2030. Enabled by a large network of best third-party manufacturing, India proved its mettle in the pharma industry especially during the pandemic, where Indian pharmaceutical products and vaccines were imported by more than 80 countries across the globe. With a strong industrial base, massive human resource and capacity of pharmaceutical third party manufacturing like Akums, India’s largest contract manufacturing pharmaceutical company, the country exhibits the ability and potential to offer high-quality and considerably low priced pharmaceutical products to the world, considerably lower than that of the USA, which presents itself as a massive opportunity for growth of Indian pharma in domestic, as well as global industry.


Quality and Regulatory Challenges to Indian Pharma:


The bottlenecks faced by the Indian pharmaceutical industry currently include quality and regulatory challenges that can potentially restrict the projected growth of the industry over the coming years. With lack of a stable policy environment and a defined pricing regime for pharmaceutical products, the market shows considerable fluctuations in the drug pricing which is something that discourages critical growth investment in third party drug manufacturing.


Also, with a wide range of third-party manufacturers for pharma in India, there’s a need for effective implementation of quality standards to ensure delivery of reliable products to the consumer base. Studies have shown that due to the lack of comprehensive quality control and insurance regime in the Indian pharmaceutical industry, India has undergone the highest number of FDA (Food and Drug Administration) inspections since 2009.


Lessons Learned and Way Forward


With a strong base of pharmaceutical third party manufacturing in India, the resilience shown especially during the pandemic, it is clear at a global level that India’s pharmaceutical industry carries considerable strength and growth potential. However, it is pertinent that issues relating to regulations and quality are overcome in an effective and lasting manner. To begin with, channels and dedicated platforms of communication between regulators and major stakeholders are established to ensure best pharma third-party manufacturing practices are adhered to. For the sake of this, dedicated ministries or independent governing bodies could be created. To further streamline the processes, dedicated manufacturing regions and pharma parks are viable options, allowing for more convenient oversight and quality assurance. Also, to encourage innovation and indigenous pharmaceutical research, it is important that regulators and drug approval processes are streamlined and aligned with global regulatory authorities, that way, the research sector for pharma drug development would attract more investments and allow for industry to grow towards innovation and research. In a nutshell, with the help of thoughtful policy development, quality assurance and effective regulations regime, India can truly leverage its talented human resource to expand at a global scale.