A Remarkable Journey, Health News, ET HealthWorld
By Ranjit Barshikar
The Indian pharmaceutical industry holds a significant place in the global economy. It ranks third in volume and fourteenth in value worldwide. During the COVID-19 pandemic, it showcased exceptional performance, making a mark on the global stage. Despite a nationwide lockdown, the industry ensured a steady supply of medicines and vaccines. It played a vital role in vaccinating 2.2 billion Indians and providing over 290 million vaccine doses to more than 100 countries through the ‘Vaccine Maitri’ initiative. The industry also worked tirelessly to develop medicines, testing kits, and treatments for COVID-19. This showed its dedication, flexibility, and enormous potential. Therefore, our Pharmaceutical Industry is known as “Pharmacy of The World”.
This success story extends beyond the pandemic. The industry has contributed to longer life spans, better disease treatments, and affordable medications. Even before the pandemic, India was the world’s leading exporter of generic medicines, meeting 20 per cent of global demand. More than half of the world’s vaccines are made in India. The country is also a major supplier of vaccines for diseases like DPT, BCG, and Measles. Indian-made drugs make up around 40 per cent of generics used in the United States and a quarter of medicines sold in the United Kingdom. India plays a crucial role in providing antiretroviral drugs to combat AIDS globally. Its affordable generic medicines have significantly increased AIDS patient treatment. Back home, the industry has helped reduce the burden of disease by 36 per cent between 1990 and 2016, while drug availability increased by 50 per cent. It played a key role in India becoming polio-free in 2014. India currently has 2nd largest, US-FDA approved Manufacturing sites, Globally.A Notable Journey
The Indian pharmaceutical industry’s journey began with significant steps towards global recognition. The introduction of the Indian Patents Act in 1970 and the Drug Policy of 1978 set the stage for Indian companies to establish themselves in international markets. By the 1980s, India had transformed from a major medicine importer to a leading exporter. The 1984 Hatch-Waxman Act in the U.S. boosted the production of generic medicines, benefiting Indian drug makers. The economic reforms of 1991 further propelled the Indian pharmaceutical industry onto the global platform by removing licensing restrictions.
An Economic PillarThe pharmaceutical industry is a cornerstone of India’s economy, contributing significantly to foreign exchange earnings and providing jobs to nearly three million people. With a market size of $50 billion in 2020-21, it boasts an annual trade surplus of $17 billion. In 2022, pharmaceutical exports exceeded $25 billion. While generics have been its stronghold, the industry is now focusing on areas like biosimilars, complex generics, and precision medicine. With the right resources, it aims to reach a market size of $130 billion by 2030, expanding its scope beyond generics to biologics, new drug development, and innovation.
Current landscape and Future Prospects
It is important to highlight that over the past few months, the Government has implemented a series of significant measures aimed at regulating industry practices, ensuring strict adherence to mandated guidelines by companies, and imposing penalties on those lacking in compliance. The Central Drugs Standard Control Organisation (CDSCO) and state licensing authorities have recently completed risk-based inspections of 162 pharmaceutical manufacturing sites in India, resulting in substantial regulatory interventions.
Our Health Minister, Shri Mansukh Mandavia has presented a comprehensive overview of the outcomes arising from these inspections, reflecting the collaborative achievements of both CDSCO and state licensing authorities. A noteworthy outcome is the issuance of show cause notices to a total of 143 pharmaceutical companies and in 40 companies, the enforcement of a “stop production” order has been initiated, resulting in a temporary cessation of manufacturing processes due to identified non-compliance issues. Further, now manufacturers of cough syrups need to obtain a government-approved laboratory’s certificate of analysis before proceeding with the export of their products. Greater degree of collaboration between Indian government and the Pharma industry, both playing a pivotal role to further strengthen its position in the global market.
The future looks promising for the pharmaceutical industry. Government policies, such as production-linked incentives and collaborations with research labs, are set to enhance the industry’s growth. In under two years, India has managed to produce 38 APIs that were once imported. This reduces dependence and strengthens the supply chain. The industry aims to become a volume leader and a top-10 contributor in terms of value by 2030, with aspirations to reach the top 5 by 2047. A large volume of imported medical devices and supplies will be made in India, decreasing India’s reliance on imports, ensuring smooth business activities. The pharmaceutical industry in India is expected to reach $65 Bn. by 2024 and to $130 Bn. by 2030.
While innovation, quality, and global reach remain crucial, collaboration among stakeholders – Indian pharma companies, government bodies, and regulators – will be key to unlocking the industry’s potential and ensuring its continued progress. More pharmaceutical companies are moving towards Digitalisation, using Artificial Intelligence applications for various obvious advantages and ensuring Patient centric manufacturing compliance & safe drugs.
Ranjit Barshikar, CEO, QbD International, QbD / CGMP Consulting and United Nations Adviser
(DISCLAIMER: The views expressed are solely of the author and ETHealthworld does not necessarily subscribe to it. ETHealthwold.com shall not be responsible for any damage caused to any person / organisation directly or indirectly.)
- Published On Sep 2, 2023 at 12:15 PM IST
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