Indian Pharma Industry – An Overview:
Indian pharma industry is one of the most dynamic and vibrant industries as it ranks 3’rd in the world by volume and 10’th in terms of value and continues to evolve at a rapid pace. The industry specifically consists of a couple of sectors of medicines and medical devices. The medicines sector includes the segments of APIs or Bulk Drugs, Formulations, and Vaccines. Indian pharma’s mainstay for several decades has been generics.
As per WHO, generic medicines are “those produced without a license from the originator company when the patent on the originator product has expired.” Generic medicines would also include those medicines on which there is no patent in the countries of manufacture and sale.
These medicines are bioequivalent to the originator medicines and are approved by drug controllers on satisfaction of evidence of bioequivalence. They are therapeutically identical to the original medicine in that there is no significant polarity in rate and extent to which the active pharmaceutical ingredients or moiety becomes available at the site of medicine action when used in the same dose.
The therapeutic potency of generic medicines is what facilitated the Indian pharma industry to compete with well known large companies in the developed world and become the destination for affordable medicines all over the globe.
The pharma industry in India has gone through its fair share of structural and policy changes contributing to its growth and is now (2019-20) of the size of 43 USD Billion (Rs. 3,01,000 crore) with a growth rate of 7 to 8 % in drug sector and 15 to 16 % in medical devices sector.
It has dominating presence in India’s trade with exports to the tune of 20 USD Billion (Rs. 1,47,420 crore) of which 90 % is drugs and imports to the tune of 10.4 USD Billion (Rs. 72,800 crore) of which 48 % is drugs, the rest being medical devices. 90 % of the exports are of medicines (formulations, APIs and medical devices) and India is positioned as the largest provider of generic drugs at the global level accounting for 20 % of the entire global exports; it meets 50 % of the world’s vaccine needs too. WHO procures approximately 70 % of its vaccine needs from India.
India is designated as home to more than 60,000 generic brands across sixty different therapeutic categories. There are around 3,000 pharma firms in the country with a network of about 10,500 production units (TIFAC 2020).
They manufacture over 500 different APIs, making India the 2’nd largest contributor of global biotech and pharma workforce, creating approximately 2.7 Million jobs (either directly or indirectly- IBEF 2020).
The industry proudly contributes an estimated 1.72 % of India’s GDP. This is a kind of one sector, which saw growth during the COVID-19 (Coronavirus) induced lockdown in 2020, as per reports.
Indian pharma exports reach over 200 countries and the product spectrum includes bulk medicines, biologicals, intermediates, medicine formulations, Ayush & herbal products and surgicals. The Indian pharma industry is estimated to be among the top 5 contributors of India’s trade balance, generating a trade surplus of around 10 USD Billion. USA holds the position as the top importer of Indian pharma products while other regulated markets account for over half of India’s medicinal exports. The industry also shows an intense potential of penetrating other large markets such as Japan and China (IBEF 2020).
API Industry – Current Status (Manufacturing):
Indian API industry is estimated at 106 USD Million (Rs. 798 Billion) and is expected to reach USD 1748 USD Million (Rs. 1,307 Billion) by the year of 2026 at a CAGR of 8.57 %. It is now the biggest after China and the US. According to the IBEF report for August, 2020, domestic API consumption is expected to reach 18.8 USD Billion by financial year 2022.
There are approximately 1,500 plants manufacturing APIs. There are also more than 600 contract manufacturers in the Active Pharmaceutical Ingredients sector. These firms produce a wide range of medicinal products. The product range typically includes generic medicines and complex Active Pharmaceutical Ingredients. A few of these medicinal products typically require even isolated manufacturing areas. Certain large firms manufacture a whole range of medicinal products from significant starting materials, to intermediates to Active Pharmaceutical Ingredients to formulations in order to facilitate the complete vertical integration. Indian pharmaceutical companies produce anti-cancers, steroids, peptides, antidepressants anti-diabetic and so on.
Global Trade:
Bulk medicines and Intermediates form a sizable segment of India’s pharma exports. According to Pharmexil Annual Report 2020, the export figures of active pharmaceutical ingredients during the last 3 financial years (FY) are as below:
- 2017-18: 3525.65 USD Million (Rs. 24,679.55 cr.)
- 2018-19: 3895.38 USD Million (Rs. 27,267.66 cr.)
- 2019-20: 3867.11 USD Million (Rs. 27,069.77 cr.)
China, United States of America and Germany are the 3 countries to which the largest shares of Indian Active Pharmaceutical Ingredients are being exported, both in value and volume.
Opportunities and Challenges:
Pharmaceutical industry is the backbone of healthcare. Hopes from the industry, therefore, stem from that view. Meeting the needs of healthcare of the country and the world are the key tasks before the industry. Indian bulk medicine industry has the challenges to meet the domestic need and the global requirement for affordable medications. From an industry outlook, it opens a huge market for it.
India itself being the 2’nd most populous nation is one of the massive markets for drugs in the world. The disease burden in the nation is also very high. It is the nation with the largest number of TB patients. Country has inherited burden of perinatal, maternal and childhood diseases (17 %), communicable diseases (8.2 %), TB (2.8 %), HIV/AIDS (2.1 %), Malaria and certain other vector-borne diseases (1.6 %), and also the growing burden of non-communicable diseases (10 %), and cancers (3.4 %), mental illness (8.5 %), injuries (16.7 %). Diseases such as diabetes and hypertension which typically require lifelong medicine are growing. This enables a big domestic market for medicine manufacturers. Meeting the growing need of this wide patient group is the major challenge for the Indian pharma or/and Active Pharmaceutical Ingredients industry. Currently, by revenue, anti-infectives (13.6 %), cardiac (12.4 %) and gastrointestinal (11.5 %) have the major market share domestically.
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Reference:
https://ilearncana.com/details/Prospects-And-Challenges-Of-Pharmaceutical-Sector-In-India/2900
