Express Pharma

Make in India

Amit Sehgal, Managing Director, Avantor India, explains how ‘Make in India’recognises ‘ease of doing business’ as one of the most critical factors to nurture entrepreneurs and startups in the life sciences industry, and its impact on the post-pandemic scenario

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Make in India (MII), launched in September 2014, is one of the major endeavours by the Government of India to transform the country into a global manufacturing hub. Its primary objective has been to create a conducive environment to attract foreign investments, make India digital, develop a strong and efficient manufacturing ecosystem, generate additional job opportunities, and empower secondary and tertiary sectors.

The initiative recognises ‘ease of doing business’ as one of the most critical factors to nurture entrepreneurs and startups that are considered to be major drivers for the success of Make in India. Therefore, various steps are being undertaken under the programme to support them, including eradicating the unnecessary laws and regulations, making bureaucratic processes faster and easier, and making the government more transparent, responsive and accountable.

At present, the programme focusses on the development of 25 priority sectors, including pharmaceuticals and biotechnology, that have high potential of attracting foreign capital.

Impact of ‘Make in India’ on lifesciences industry

The lifesciences industry constitutes sectors such as biomedicine, pharmaceuticals, biophysics, neuroscience, cell biology, biotechnology, nutraceuticals and environmental sciences, among others. Let us take a brief view on how the MII programme has impacted the various segments within these industries since its inception.

Pharmaceuticals: The Indian pharmaceutical sector enjoys its position as the largest generic drugs provider in the world. This sector caters to more than 50 per cent of the global demand for various vaccines. It also has a wide network of more than 3,000 drug companies as well as about 10,500 manufacturing units operating within it. Under the MII incentive, to build a self-reliant pharma sector, the government has taken various steps to enhance end-to-end manufacturing with the support of emerging technologies and processes, incentivising the production of raw materials, established bulk drug parks, and provided other stimulus measures to boost local production of Active Pharmaceutical Ingredients (APIs) and Key Starting Materials (KSMs).

Additionally, it is found that globally, every third new drug approved is a biotech drug, and with patent expiries of key biologics, biosimilars play a huge role in boosting the growth of pharmaceuticals. To effectively deal with roadblocks in biopharma production such as limited capital, inadequate infrastructure and complex regulatory framework, world-class bio-manufacturing hubs under MII are being set up to aid in the development and manufacturing of innovative products in various streams of biopharmaceuticals, including vaccines and biosimilars.

The growth in pharma sector is also propelling the laboratory chemicals market. The demand for high-purity chemical production, distribution and sales for usage in pharmaceuticals and biotechnology sectors accounts for almost 21 per cent of the chemicals industry.

MII’s 100 per cent FDI incentive and de-licensing of most chemical products’ manufacturing has provided the chemicals sector accelerated research and development efforts as well as modernisation and digitalisation of processes therein.

Medical devices: Identified as a sunrise sector of India under the MII campaign, this sector puts India amongst the top 20 global medical devices market and as the fourth largest in Asia. With a current market size of $11 billion, this industry is at the brink of massive growth in the next five years. With the help of MII and other government initiatives, the home-grown medical devices manufacturing, including In-Vitro Diagnostic (IVD) solutions, has enabled better accessibility of products to the general public as well as increased exports, globally. The provision of 100 per cent FDI allowance under the automatic route for both brownfield and greenfield setups has helped the domestic medtech companies to scale up their capabilities, furthering their growth and resilience.

Changing lifesciences landscape post-pandemic Meeting the global raw mamaterials shortages: During the course of the coronavirus pandemic, India stepped up to help navigate through the sudden shortage of APIs due to international trade coming to an abrupt halt and global pharma looking at alternatives for China, the biggest exporter for APIs in the world. The country ramped up its strategies to build a strong local capacity for specialised and novel APIs to cater for the sudden rise in domestic demand for bulk drugs. To aid this, under the MII scheme, the union government announced a Rs 30 billion project for setting up three bulk drug parks, as well as a 20 per cent financial incentive for the next six years to manufacturers for producing 53 critical bulk drugs, which would be further used to make medicines.

Significant growth in In-Vitro Diagnostic (IVD) solutions: With around 750-800 domestic medical device manufacturers in India, the contribution of medical devices and reagents during the ongoing COVID-19 pandemic has been significant. The IVD segment provided consistent supply of COVID-related medical devices and diagnostic kits, including ventilators, RTPCR kits, IR thermometers, PPE kits and N-95 masks.

Accelerated vaccine development: We saw governments, organisations, pharmaceutical and healthcare sectors, along with the scientific community, united together in fast-tracking the development of COVID-19 vaccines. Within merely a year and a half, India rolled out two vaccines, with more candidates in the pipeline, such as Sputnik V and ZyCoV-D. What has been truly exemplary is the fact that the typical 10-year-cycle of vaccine development was drastically reduced to a year and furthermore, a developing country like India came out with not only locally produced vaccines, but also an indigenously developed one. The Indian government provided resilient support with the launch of Mission COVID Suraksha in November 2020 to help accelerate the efforts made in research and development of Indian COVID-19 vaccines that are safe, efficacious, affordable and accessible to all Indians.

Developments in diagnostics and research: The lifesciences industry was seen ramping up and continuously evolving the diagnostics tools for virus detection, for detecting infections in symptomatic and asymptomatic patients, researching antibodies from the recovered patients, and for discovering a potential vaccine or therapy. Various existing therapies, including monoclonal antibody (mAbs), that are typically used to treat auto-immune conditions like rheumatoid arthritis, were seen being fast-tracked back through clinical trials to ascertain their effectiveness in treating symptoms of COVID-19 to save more lives immediately.

Development in biopharmaceuticals: Within the biopharma segment, the government announced an outlay Rs 1,660 crores ($227.94 million) for biotechnology research and development under the Union Budget 2021-22. Moreover, with the driving need to accelerate and promote local biopharma scale-up needs, the Telangana government partnered with a reputed global lifescience company to set up a 10,000 sq.ft. Fast Trak lab that would help the area’s biotechnology hub increase production efficiency, reduce cost and speed to market. Further, with the increased demand for monoclonal antibodies for testing on COVID-19 patients, pharma giants in the industry are exploring biological therapies for treating COVID-19.

Providing global assistance: Being one of the biggest vaccine developers in the world, India exported more than 60 million doses to 76 countries before the second wave of the pandemic resulted in acute short supply within the domestic market, putting an abrupt halt on exports. However, the sector is ramping up its production capacity to resume export of vaccines to the severely impacted countries by 2022. The pharma sector also increased exports of drugs that had the potential of treating COVID-19 infection with Remdesivir exports doubling in March 2021 to $14.8 million from $5.75 million in February 2021. The pandemic has been an example to reflect how all the stakeholders within the industry – the private enterprises, government, investors, academic and research institutions, and individuals- can transform challenges into opportunities by creating a collaborative ecosystem. To truly unlock the potential of the Make in India programme, stakeholders need to continue to work towards a common goal of creating a self-reliant and innovative ecosystem that is supported by integrating advanced digital technologies, a responsive and robust regulatory environment and strong global ties.

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