India is called the ‘pharmacy of the world’, but since 2021 only 8 new medicines have been made here. America and China are hundreds of times ahead in this matter. According to experts, the country is lagging behind in innovation due to lack of rules like ‘clinical data exclusivity’.
New Delhi [भारत]June 30 (ANI): India has rightly earned its reputation as the “Pharmacy of the World”. We manufacture nearly one in five generic medicines consumed globally, supply vaccines to more than 150 countries and have become one of the world’s largest pharmaceutical manufacturing hubs.
But there is a question that needs much more attention – how many indigenous pharmaceutical innovations has India actually made since 2021? The answer is only eight. These innovations have come from Indian companies like Zydus Lifesciences, Wockhardt, Orchid Pharma, Biocon, Immunoact and Entod Pharmaceuticals to name just a few. These include new chemicals, biologics, immunotherapy, cell therapy and new formulations of medicines. These innovations prove beyond any doubt that Indian scientists and pharmaceutical companies have the ability to innovate at global standards.
India is far behind America and China in innovation
Still, the comparison with other innovative economies is striking. Since 2021, the United States has made nearly 500 significant pharmaceutical innovations, including approximately 160 new chemicals (NCEs). China has made about 150 pharmaceutical innovations, including about 95 indigenous NCEs. India’s count, despite its scientific talent and manufacturing prowess, has not even reached double digits.
The biggest obstacle in the way of innovation
The challenge is no longer scientific capability. It’s the ecosystem around innovation. Developing a new drug requires years of research, clinical trials, regulatory scrutiny, and huge financial investments, with no guarantee of success. Unfortunately, India has avoided discussing the issue that is perhaps the biggest problem – clinical data exclusivity.
Every major drug innovation ecosystem, including the United States, the European Union, and China, offers innovators a period of regulatory data exclusivity. During this period, competing companies cannot rely solely on the parent company’s clinical trial data to obtain marketing approval. This protection is separate from patents and exists because innovators often spend 8–12 years gathering the clinical evidence necessary for approval, by which time a significant portion of their patent life has already expired. However, there is no uniform framework for most indigenous drug innovations in India.
How will data exclusivity increase investment?
In my view, a carefully designed clinical data exclusivity framework will have little impact on drug pricing or patient access in the long term. Competition will also emerge over a period of time, as happens in other major pharmaceutical markets. This framework will incentivize companies to invest in addressing unmet medical needs, fill critical treatment gaps, accelerate indigenous drug discovery, improve health outcomes for our populations, and create a strong, high-value pharmaceutical industry.
It is therefore no coincidence that the strongest voices advocating such a framework are the same Indian companies that are investing in indigenous drug research. They understand that unless innovation is rewarded, it will remain the exception rather than the norm.
Now is the time for ‘forward engineering’
India has already mastered the art of ‘reverse engineering’, and that achievement turned our country into the ‘Pharmacy of the World’. The next chapter of India’s pharmaceutical journey must be about ‘forward engineering’ – discovering new molecules, developing breakthrough biologics and advanced therapies, and creating medicines that are made in Indian laboratories before they reach patients around the world.
India should not be recognized only as the world’s medicine manufacturing country. Now the time has come for India to become a country to make them. Disclaimer: The author is CEO, ENTOD Pharmaceuticals. The views shared here are personal. (ANI)
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