The Government of India launched two schemes in July this year for the promotion of indigenous manufacturing of active pharmaceutical ingredients (APIs), drug intermediaries (DIs), and key starting materials (KSM). The production linked incentive (PLI) scheme exclusively focuses on those APIs, which the Drug Security Committee constituted by the Department of Pharmaceuticals (DoP) has identified as heavily import-dependent on China. The API Parks scheme, on the other hand, has the objective of enhancing the competitiveness of the Indian API industry by providing easy access to common utilities such as steam, waste management, etc. in three selected API Parks. The industry response to these schemes, however, has been lukewarm especially the PLI scheme. A closer examination shows that the design of these two schemes has some major flaws which may result in much less than the expected outcome in terms of elimination of import-dependence on China.
The history of Indian pharma industry shows that the focus of the private sector has always been on the formulations and not APIs. The Hathi Committee (1975), the recommendations of which laid the foundation of the vibrant generic pharma industry in India, had looked into this issue and found that the capital invested to turnover ratio was much higher in APIs as compared to formulations. It was coercion in the form of marketing approval of formulations tied to the indigenous production of APIs that made the Indian private sector invest in the production of APIs. Withdrawal of this coercion and removal of restrictions on imports through economic reforms in the 1990s again made the private sector to shun indigenous production of APIs.
Another interesting aspect of the dynamics of the Indian pharma industry is that small and medium enterprises (SME) have an important role, especially in the production of APIs. It is reported that they account for 70-80 per cent of the APIs produced in India in terms of quantity. This may sound defying logic, small fellows producing more capital-intensive segments of the pharma industry. But, as APIs are sold in their chemical name, without branding, large firms have no interest in the production of APIs and their focus is on branded formulations. Their production of APIs, if at all, is largely for captive consumption. The SMEs, which are not in a position to establish brands, focus on APIs.
Continue reading your story on the app
Continue reading your story in the magazine
We might need to redefine our approach to drug discovery and approval to be prepared for the future
Hitesh Windlass, MD,Windlas Biotech gives an overview of the changes bought by COVID-19 pandemic in the pharma industry, his organisation’s plans for future growth and more, in an interview with Lakshmpriya Nair
We help our customers create future-ready pharma manufacturing and biotech facilities
Sanjay Sudhakaran, VP, Digital Energy, Schneider Electric India expands on the value proposition of digital energy systems for the pharma sector, giving some examples of how companies achieved RoI on this investment, in an interaction with Viveka Roychowdhury
Virtual clinical trials would have a tremendous advantage in expanding the reach of clinical trials
Suneela Thatte, VP and Head - R&D Solutions India, IQVIA speaks on the challenges faced by CROs due to the pandemic, the subsequent learnings in clinical research/trials, emerging trends in this arena and more, in an interaction with Viveka Roychowdhury
Waters Corporation appoints Pearl S Huang to Board of Directors
She has significant scientific expertise in the discovery of biologics, small molecule and nucleic acid-based therapies, as well as in drug discovery and the development of clinical trials
Fighting counterfeiting requires a long-term battle and we need to start somewhere
Globally, incidents of fake, counterfeit pharma products are on the rise and recent cyber attacks on some pharma companies involved in the development of COVID-19 vaccines are raising further alarm. Nakul Pasricha, President, Authentication Solution Providers’ Association (ASPA) talks about the need for a phygital approach to secure supply chain integrity and facilitate easy identification of genuine COVID-19 vaccines, with Usha Sharma
FDI in brownfield pharma projects - Critical analysis
Arvind Sharma, Partner, Shardul Amarchand Mangaldas & Co informs that the extant regulatory regime for FDI in brownfield projects follows a balanced approach as it safeguards supplies for domestic consumption and ensures foreign investments as well as technological advancement for the pharma sector
Effective effluent management: Key to tackle AMR
Dr Jyoti Joshi, Head-South Asia,The Center for Disease Dynamics, Economics & Policy (CDDEP); Adjunct Professor,Amity Institute of Public Health emphasises that the government and the pharma industry need to establish strategic partnerships to address the issue of growing AMR due to pharma plant effluents
CIMS Medica organises Business Excellence Awards 2020
The award ceremony was held at the The Leela Palace Hotel, New Delhi to honour companies who contributed to the growth and development of the healthcare and pharma industry
BLUEPRINT FOR PROGRESS
Experts and veterans examine and explore strategies for India Pharma Inc to implement the lessons learnt from the COVID-19 pandemic as we enter a new year and a new decade
Reverse Brain Drain: Accelerated By Covid-19
Ankit Goyal, Healthcare and Lifesciences Leader India, Heidrick & Struggles finds that leadership hiring is attracting ‘returnee Indians’ in healthcare companies due to growing opportunities in India, and more recently, the impact of the pandemic
CHINA'S GEELY, BAIDU ANNOUNCE ELECTRIC CAR VENTURES
Chinese automaker Geely says it will form an electric car venture with tech giant Baidu, adding to a flurry of corporate tie-ups in the industry to share soaring technology development costs.
YOGA & PEACE
DEEPAK CHOPRA speaks with DAAJI about the role Yoga has to play in bringing about world peace. This is an excerpt from their conversation broadcast on International Day of Peace, September 21, 2020. That documentary is available at https://heartfulness.org/en/international-day-of-peace/.
Create the habit of meditation
CHIRAG KULKARNI, Co-Founder and CMO of Medly Pharmacies in the USA, speaks with RISHIKA SHARMA about creating a regular meditation practice, so as to make it a habit. He also shares how meditation has benefited both his personal and professional life.
Where Is Jack Ma, China's E-commerce Pioneer?
China’s best-known entrepreneur, e-commerce billionaire Jack Ma, made his fortune by taking big risks.
SHIA'S PRIVATE TEMPLE OF DOOM!
Indiana Jones gig derailed by abuse scandal
Gain Of Function
How much risk of an accidental pandemic is too much?
Yin Lu CHINESE HERITAGE AND SYMBOLISM
Yin Lu CHINESE HERITAGE AND SYMBOLISM
HUAWEI: A GENUINE COMPETITOR TO APPLE AND GOOGLE
Now considered the poster child of China’s technology sector, Huawei has defied the odds in recent years amidst growing pressure from political leaders in the US and Europe. But just how did the company climb to the top, and overtake Samsung to become the world’s biggest smartphone brand? Let’s pull back the curtain and reveal the secrets behind its success.
"Food Raconteur” Ashok Nageshwaran wants to tell you a story.
THE MAKING OF A MODEL MINORITY
Indian Americans rarely stop to ask why our entrance into American society has been so rapid—or to consider what we have in common with other nonwhite Americans.