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Boosting domestic APIs crucial for India to sustain its global stronghold as generic supplier: Experts

A Raju, Hyderabad
Saturday, October 24, 2020, 08:00 Hrs  [IST]

With India receiving the double whammy of widely spreading COVID-19 pandemic and the sudden cutting down of API imports from China due to the border disputes and other currently prevailing issues, it has been clearly understood that the Indian pharmaceutical industry which is boasting of its global stronghold as a lead generic supplier to the world is highly vulnerable and cannot sustain for long, unless and until the Indian government and its policy makers do not take urgent corrective steps to save the industry, according to industry experts.

According to Dr P V Appaji, former Director General of Pharmexcil, although India is known as the “Pharmacy of the World”, as it contributes 20 per cent of the world generics and 60 per cent of the total vaccines in the global market, it is a matter of great concern that even today India is depending on a single country like China for sourcing its APIs, Key Starting Materials (KSMs) and other intermediates.

“Even though Indian pharma industry has made long strides and succeeded to rule the roosts of global markets in supplying high quality low cost generics, the recent COVID-19 pandemic and the border disputes with China have really opened up our eyes and made us understand that whatever we have achieved is not going to stay sustained for longer, unless and until we take concrete steps to boost our domestic API sector,” opined Dr. Appaji.

Despite the fact that India is among the few countries in the world which has 665 US FDA approved plants outside US and has 44 per cent global ANDAs, the country’s dependence on China to source its pharmaceutical raw materials will make all these achievements demean if the Indian pharma sector is not self reliant in producing its own APIs.

If one looks at how the recent prevailing COVID-19 has impacted the policy decisions of central government with regard to changes in import-export policies, the DGFT (Directorate General of Foreign Trade) during the month of March this year has made changes in their export policy and they banned several formulations. Later, on 25th March 2020 again, this export policy was changed and the “wonder drug” hydroxychloroquine, considered for treatment of COVID-19, too was included in the list.

All this was done because the API which is used in the manufacturing of these formulations is imported from the global market especially from China and due to COVID-19 the import of these APIs was badly affected, as these APIs were in short supply. In view of this, it can be clearly observed how COVID-19 pandemic has gravely impacted India’s policy decision making machinery. Taking lessons from this, it is high time the Indian government and its policy makers take urgent initiatives to boost India’s API capabilities, or else Indian pharma sector will become vulnerable not just due to global pandemics like COVID-19, but also will be compelled to dance to the tunes of countries like China and may even lose India’s stronghold as a global generic supplier to the world market,” warned S V Krishna Prasad, CEO and managing director of Cito Healthcare.  

However, despite COVID-19 pandemic created havoc in India, the one thing that is hailed all over is Indian bulk drug industry’s growth rate. While during the period 2016-20 the industry has witnessed its growth between 8-9 per cent, even during the COVID-19 pandemic ruining all kinds of businesses and giving a shocker to the economy, the Indian pharmaceutical sector is still hovering  around 8-9 growth rate which is a positive sign even during the period of healthcare uncertainty in India, observed industry experts.


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