API Dosage of Life

API Dosage of Life

Active Pharmaceuticals Ingredients (APIs) – Dosage of Life

A term that is often heard by all of us in the newspapers, magazines, blogs, internet, chemist shop, etc. But what does it mean? Why it is so pivotal and critical that everybody having some handful-knowledge is discussing this. So Basically API’s are the active part of the medicine, used in the finished Pharmaceutical product, intended to diagnosis, cure, mitigate, treat or prevent any disease or to have a direct effect in restoring, correcting, modifying physiological functions in the human beings. In simple language, API’s are the active part of the medicine that produces effects and are manufactured in the initial stage of drug production. API’s are also referred to as “Bulk pharmaceutical” that is produced in bulk and most of the API’s are powder or maybe gel etc.

If we go into some depth, every drug/medicine is made of two core components: – the API, central ingredient and the excipients, substances other than the drug that enables to deliver medication to our body. These excipients are chemically inactive substances as liquid or powder or mineral oil. For instance, if you have a common cold, stuffy nose, Phenylephrine medicine is used containing Phenethylamine class API and another liquid component in the capsule is excipient. From these API’s, formulations or medicines are produced.

API’s play a pivotal role in medication and great care is being observed right from its production to consumption. For instance, even the facilities, where these API’s are produced are being subject to periodic inspection and checks by domestic drug regulatory authorities or other like USFDA plus compliance of GMP. And if the wrong APIs are taken, this can lead to severe or life-threatening complications

Traditionally API’s were being produced in the home country by Pharmaceuticals companies themselves but now corporations have opted to transfer this process in the production chain to overseas. That has caused significant changes to how these drugs are to be regulated. Global Pharmaceutical markets are in the midst of major discontinuities. With the growth in developed markets is slowing down, emerging markets are taking a centre stage. So India, China, Brazil and Russia are spearheading growth within these markets.

To tap the potential in the API’s market in India, manufacturers are strengthening their production and distribution capacities, improving production yields, modifying and optimizing processes. The total production of API’s in India was valued $11 billion in FY2016 and is forecasted to grow at CAGR of around 9% during FY16-2022. Domestic APIs consumption is also growing at the CAGR of 10%1.

The following table shows the consumption of API in India.

On the other hand, there are various factors, driving growth of API in India such as rising health care expenditure both in urban and rural areas, increasing personal disposable income of the population at the CAGR of 12% during 2012-2016, growing geriatric population from 8.9% in 2015 to 12.5% in 2030, increasing incidence of chronic diseases like Cardiovascular disease, Cancer, Diabetes etc1.

Major API producer in India is DR Reddy’s lab, Aurobindo Pharma, Cipla, Ranbaxy, Sun Pharma etc. These companies are either manufacturing or giving a contract to other companies to manufacture generic APIs for them. Common APIs produced in the Indian market are Clopidogrel bisulfate, Acitretin, Atorvastatin, Amisulpride, Amoxycillin, Abiraterone, Albendazole, Mebendazole, Alosetron hydrochloride, Montelukast, Linagliptin, Nateglinide.

Indian Pharmaceutical sector contributes around 10% of the world drug volume and around 1.3% in terms of value. Indian Pharma sector largely consists of generic drugs producers, earns 70% of its revenue from the same. India also exports its Pharma products all over the world, illustrated with the help of pie-chart2.

The Indian government is also taking various initiatives to boost this sector growth with measures such as allocating lands in various states for the developments of Mega API parks, increased investment in R & D, declaring 2015 as “year of API” and constituting high-level committee to study global pharmaceutical practices, bringing out in bulk drug policy soon.

However, there are many challenges to be tackled by this sector like considerable dependence on China for lowest cost APIs around 57%-60%, complex license renewal procedure is a big barrier for the firms, due to they have to dedicate sizeable time to get regulatory approval from authorities, lack of infrastructure for small-medium enterprise with shortage of water-electricity & warehousing, lack of free trade zone are  continuously hammering their growth, less support from government, stringent regulatory requirement in the field of good manufacturing practices, inspection, fees, etc, price erosion in the USA market owing to customer consolidation, government efforts to make essential medicines affordable by including in National List of Essential Medicines(NLEM) are the rough patches, this sector is  facing right now.

In spite of being grappled with score of issues, there is still optimism for the Indian Pharma sector only, if following points are taken into consideration like developing next-generation noval APIs to further diversify their product portfolio, focus on higher import substitution by establishing mega API park, revival of Jan Aushadhi Scheme and Free Essential Drug Scheme provide good platform for small-medium producers, better e-governance, imparting robust practical knowledge to the Pharma graduates, exploring new market beyond USA-EU backed by export incentives and innovations, access to modern technology to efficiently optimize products and process, and at last bank should provide subsidize loan for capital requirement. These above measures are no doubt triggering a revolution in the APIs market will also prove to be hugely beneficial at a domestic and forex front. It will also in line with “Make in India” program of the government and build backward integration base of the country in the field of APIs and then see its multiplying effect.

1-http://publication.assocham.tv/data/product-file/48%20-%20Indian%20API%20Market%20Outlook%202022.pdf

http://www.careratings.com/upload/NewsFiles/SplAnalysis/Report%20on%20Pharma%20sector%20July%202017.pdf

Research Assistant
Pankaj Singh

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