|Year : 2021 | Volume
| Issue : 2 | Page : 93-94
Research in novel active pharmaceutical ingredients: A necessity to strengthen India’s position as a pharma capital of the world
Sushil Kumar1, Ipseeta Ray-Mohanty2
1 Department of Obstetrics and Gynecology, MGM Medical College & Hospital, MGM Institute of Health Sciences, (Deemed to be University), Navi Mumbai, Maharashtra, India
2 Department of Pharmacology, MGM Medical College & Hospital, MGM Institute of Health Sciences, (Deemed to be University), Navi Mumbai, Maharashtra, India
|Date of Submission||26-Apr-2021|
|Date of Acceptance||26-Apr-2021|
|Date of Web Publication||02-Jun-2021|
Dr. Sushil Kumar
Department of Obstetrics and Gynecology, MGM Medical College and Hospital, MGM Institute of Health Sciences, (Deemed to be University), Navi Mumbai-410209, Maharashtra.
Source of Support: None, Conflict of Interest: None
|How to cite this article:|
Kumar S, Ray-Mohanty I. Research in novel active pharmaceutical ingredients: A necessity to strengthen India’s position as a pharma capital of the world. MGM J Med Sci 2021;8:93-4
|How to cite this URL:|
Kumar S, Ray-Mohanty I. Research in novel active pharmaceutical ingredients: A necessity to strengthen India’s position as a pharma capital of the world. MGM J Med Sci [serial online] 2021 [cited 2021 Oct 21];8:93-4. Available from: http://www.mgmjms.com/text.asp?2021/8/2/93/317447
India, in spite of being a third-world country, has made its mark in the export of drugs around the world. So much so, it is often referred to as the “Pharma Capital” of the world. Export of the anti-COVID-19 vaccine across the globe has also focused the world’s attention on India as a global giant for the supply of bulk pharmaceuticals and vaccines at a very competitive price.
| Active pharmaceutical ingredients|| |
An active pharmaceutical ingredient (API) is defined as “any substance or substances that are intended to be used in the manufacture of a drug product and that, when used in the production of a drug, becomes an active ingredient in the drug product.” Every medicine is made up of two main components: One is the pharmacologically active substance/s, responsible for the treatment, mitigation, prevention, cure or diagnosis of diseases, and known as APIs; the other is made up of inert ingredients, which generally have no pharmacological effects.
The API market alone is already a multi-billion-dollar market. The bulk of the manufactured APIs are the patent-expired generic drugs whereas a small portion comprises novel APIs that are protected by the inventors/ assignees through patents. India manufactures a large number of generic APIs for its consumption and exports. Currently, India manufactures only two patented novel APIs but more than 1000 generic APIs.
The APIs are mainly produced in large production plants involving a complex chemical process of several steps. The starting material for API can be a raw or intermediate material often sold in large quantities to drug manufacturers. During the early 1980s, Indian pharma companies manufactured and formulated most of this in-house. However, the API market was soon dominated by China, which resorted to mass production at a cheaper rate than the Indian products. Gradually and over the years, the Indian pharma companies shrunk the manufacturing of APIs because of low-profit margins or loss, and they started outsourcing their requirements to reduce costs.
Currently, most of the raw materials and bulk drugs are being imported by countries from China, Singapore, Italy, and the United States. The United States leads the API market with a 28% approval rating, followed by Europe at 26%, India at 18%, and China at 13%, respectively. Therefore, perhaps, it is the apt time for India to focus its resources on expanding the API manufacturing and export capabilities. To boost domestic drug manufacturing, the Government of India has introduced a Rs. 6,940-crore Production Linked Incentive (PLI) scheme. This policy is aimed at reducing the dependence on imports through the promotion of domestic manufacturing of critical Key Starting Materials (KSMs) / Drug Intermediates and generic APIs in India.
Therefore, the article published in the current issue titled “Novel Active Pharmaceutical Ingredients from India: The Issues-Part-II” focused on the status, issues, technology readiness, and challenges for prioritized and scaled-up indigenous production of novel and generic API from India, which is the need of the hour. Dr. PK Ghosh, the author of the article, is a highly learned authority on biotechnology. He has also published Part I of the article in the previous issue of the MGM Journal of Medical Sciences.
Financial Support and sponsorship
Conflicts of interest
There are no conflicts of interest
| References|| |
Ghosh PK Novel active pharmaceutical ingredients from India: The actors-Part-I. MGM J Med Sciences 2021;8:73-82.