Indian Active Pharmaceutical Ingredient (API) Industry- An overview on Challenges, Opportunities & Regulatory prerequisites
Abstract
Active pharmaceutical ingredient is a chemical compound which is most important raw material to formulate a finished pharmaceutical medicine and has a pharmacological effect. India has a long history of being heavily dependent for these raw materials on China due to one major reason i.e. Low manufacturing cost. But overdependence of APIs imports from China brought various liabilities to India including supply chain disruption and price hikes during pandemic, leading to shortage of various important APIs/KSMs. This COVID 19 widespread has solidly put the center of our country on being “Atma Nirbhar”. And this activity had brought out the strengths, market patterns and opportunities in five divisions counting Healthcare, which are basic from country’s point of view. In view of changing geo-political situation and recalibrated trade arrangement, it is crucial that India become self-reliant within the generation of APIs and KSMs, which is why decreasing the Import reliance for Active pharmaceutical ingredients (APIs) & Key starting materials (KSMs) particularly from china has been focused upon with the assistance of productive linked incentive scheme (PLIS) passed by Department of pharmaceuticals, Government of India to thrive Indian API industry.
Hence, this review highlights the current state of Indian API industry, evaluates challenges, opportunities give suggestions for moving forward for self-sufficiency of APIs as well as centers on current regulatory prerequisites for Active pharmaceutical Ingredients.
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References
2. Good manufacturing practice Ukraine (UA). Active Pharmaceutical Ingredients [Internet]. Ukraine:gmpua; 2018 [cited 2020 Oct 22]. Available from: https://gmpua.com/API/index_en.html
3. Global Market Estimates, Indian API Industry - Market Insights [Internet]. India:global market estimatescom; 2020 May 20 [cited 2020 Nov 11]. Available from: https://www.globalmarketestimates.com/market-report/india-api-industry---market
4. Technology information, Forecasting and assessment Council (TIFAC). Active pharmaceuticals ingredients: Status, Issues, Technology Readiness and challenges [Internet]. India:tifac; 2020 Jul 10 [cited 2020 Nov 14]. Available from: https://tifac.org.in/images/pdf/2020papers/API_Report_-Released_on_July_10_2020.pdf
5. Confederation of Indian Industry [CII] in paid partnership with KPMG. Indian API Industry - Reaching The Full Potential [Internet]. India: cii; 2020 Apr 22 [cited 2020 Nov 21]. Available from: https://www.cii.in/PublicationDetail.aspx?enc=swL3yNIPL0AFuvDG0sBN7B3wn5Ja6Tk6tm/uEMPcN0k=
6. Federation of Indian Chambers of Commerce and Industry(FICCI).A white paper on Trends & Opportunities for Indian Pharma [Internet]. India: ficci; 2018 [cited 2020 Nov 21]. Available from: http://ficci.in/spdocument/22944/india-pharma-2018-ficci.pdf
7. Market insight, a subdivision of Orion market research (OMR). India Active Pharmaceutical Ingredient (API) Market [Internet]. India: marketinsight; 2020 Aug 12 [cited 2020 Dec 14].Available from: https://marketinsight.in/industry-reports/pharmaceutical-industry-in-india
8. Sandhu G. Express pharma. Making India self-sufficient [Internet]. India:expresspharma; 2020 Aug 28 [cited 2020 Dec 20]. Available from: https://www.expresspharma.in/making-india-self-sufficient/
9. Munde K. India Ratings& Research: A fitch Group company. Market Wire- US API supplies to Improve: China Dependence for Raw material to remain High [Internet]. India: indiaratings; 2020 Jul 27 [cited 2020 Dec 21]. Available from: https://www.indiaratings.co.in/PressRelease?pressReleaseID=51921&title=market-wire%3A-us-api-supplies-to-improve%3B-china-dependence-for-raw-materials-to-remain-high#recent-p-tab
10. World Health Organization. China policies to promote local production of pharmaceutical products and protect public health [Internet] Geneva: WHO; 2017 [cited 2020 Dec 31]. Available from: https://www.who.int/phi/publications/china_policies_promote_local_production_pharm/en/
11. World Health Organization. Indian policies to promote local production of pharmaceutical products and protect public health [Internet] Geneva: WHO; 2017 [cited 2020 Dec 31]. Available from: https://www.who.int/phi/publications/indian_policies_promote_local_production_pharm/en/
12. Dhadich A. European pharmaceutical review. The covid-19 pandemic and the Indian pharmaceutical industry [Internet]. European Pharmaceutical Review; 2020 Apr 22 [cited 2021 Jan 04]. Available from: https://www.europeanpharmaceuticalreview.com/article/117413/the-covid-19-pandemic-and-the-indian-pharmaceutical-industry/
13. Joseph K. Express pharma. Reducing India’s Import Dependence on APIs: A possible way out [Internet]. India: expresspharma; 2020 Apr 27 [cited 2021 Jan 10]. Available from: https://www.expresspharma.in/guest-blogs/reducing-indias-import-dependence-on-apis-a-possible-way-out/
14. Cadila pharmaceuticals limited. Opportunities for Active Pharmaceutical Ingredients (API) manufacturing in the Indian manufacturing Industry [Internet]. India:cadilapharma; 2020 Sep 22 [cited 2021 Jan 15] Available from: https://www.cadilapharma.com/blog/innovation/future-of-active-pharmaceutical-ingredients-api-in-india/
15. Department of pharmaceutical, Government of India. Guidelines for the production linked incentive scheme for promotion of domestic manufacturing of critical key starting material(KSMs)/Drug intermediates(DIs)/Active pharmaceutical ingredients(APIs) in India [Internet]. India:pharmaceuticals; 2020 Oct 29 [cited 2021 Jan 15]. Available from: https://pharmaceuticals.gov.in/sites/default/files/REVISED%20GUIDELINES%20FOR%20BULK%20DRUGS-29-10-2020.pdf
16. Department of pharmaceutical, Government of India. Guidelines of the Scheme "Promotion of Bulk Drug Parks” [Internet]. India:pharmaceuticals; 2020 Oct 29 [cited 2021 Feb 13]. Available from: https://pharmaceuticals.gov.in/sites/default/files/Guidelines%20of%20the%20Scheme%20Promotion%20of%20Bulk%20Drug%20Parks_1.pdf
17. PricewaterhouseCoopers(PwC) in association with Nat health(Healthcare federation of India).Funding Indian healthcare-Catalysing the next wave of growth [Internet]. India: pwc; 2017 [cited 2021 Feb 20]. Available from: https://www.pwc.in/assets/pdfs/publications/2017/funding-indian-healthcare-catalysing-the-next-wave-of-growth.pdf
18. Sarwal R, Prasad U, Madangopal K, Kalal S, Kaur D, Kumar A et al. Investment Opportunities in India’s Healthcare Sector [Internet]. India: NITI Aayog; 2021 Mar [cited 2021 Mar 31]. Available from: https://niti.gov.in/sites/default/files/2021-03/InvestmentOpportunities_HealthcareSector_0.pdf
19. Bhatt M. Republic world. Amid Coronavirus, Government to fast-track Green Nod process for bulk drug projects [Internet]. India: republicworld; 2020 Mar 12[cited 2021 Apr 02].Available from: https://www.republicworld.com/india-news/general-news/amid-corona-fear-government-to-fast-track-green-nod-process-for-firms.html
20. Srilakshmi C. Regulatory Requirements for Registration of API in US and EU. International Journal of Pharma and Clinical Research [Internet]. 2017 Jun [cited 2021 Apr 02]; 3(2):312-328.Available from: http://www.ijpacr.com/files/07-04-2017/30.pdf
21. ICH-International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use. The common technical document for the registration of pharmaceuticals for human use: quality – M4Q(R1) [Internet]. US:ICH; 2002 Sep 12 [cited 2021 Apr 11]. Available from: https://database.ich.org/sites/default/files/M4Q_R1_Guideline.pdf
22. Ministry of health and family welfare (Department of health),India. Schedule M-Good manufacturing practices and requirements of premises, plant and equipment for pharmaceutical products [Internet]. India: rajswasthya; 2001 Dec 11 [cited 2021 Apr 11]. Available from: http://www.rajswasthya.nic.in/Drug%20Website%2021.01.11/Revised%20Schedule%20%20M%204.pdf
23. PricewaterhouseCoopers(PwC). Reviving India’s API Industry: from the viewpoint of covid-19 outbreak [Internet]. India:pwc; 2020 [cited 2021 Apr 21]. Available from: https://www.pwc.in/assets/pdfs/industries/pharmaceuticals-and-life-sciences/reviving-indias-api-industry.pdf
24. Patel K and Chotai N. GMP requirements for “buildings and facilities” for API – comparison of schedule M, India and ICH guideline and approach for compliance to different regulatory expectations. An International Journal of Pharmaceutical Sciences [Internet]. 2013 Jan [cited 2021 Apr 21]; 4(1):3584-3616. Available from: https://docplayer.net/18626288-Vol-4-issue-1-jan-2013-issn-0976-7908-chotai-et-al-pharma-science-monitor.html
25. ICH-International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use .ICH-Q7 GMP guide for active pharmaceutical ingredients, Quality guidelines [Internet]. US:ICH; 2000 Nov 10 [cited 2021 May 02]. Available from: https://database.ich.org/sites/default/files/Q7%20Guideline.pdf
26. Saha A, Mallik S. Impact of active pharmaceutical ingredient (API) scarcity in pharmaceutical sectors amidst covid-19 pandemic. International Journal of Pharmacy and Pharmaceutical Sciences [Internet]. 2020 Oct [cited 2021 May 10]; 12(12):22-25.Available from: https://innovareacademics.in/journals/index.php/ijpps/article/view/39396/24003
27. Chatterjee P. Indian pharma threatened by Covid-19 shutdowns in China. The Lancet [Internet]. 2020 Feb 29 [cited 2021 May 10]; 395(10225):675. Available from: https://dx.doi.org/10.1016%2FS0140-6736(20)30459-1
28. Jain P, Srinath S, Khaleeli S. Pharmabiz. API for global & Indian markets: Regulatory perspective [Internet]. India: Pharmabiz; 2015 Oct 08 [cited 2021 May 11]. Available from: http://www.pharmabiz.com/PrintArticle.aspx?aid=92390&sid=21
29. Confederation of Indian Industry [CII] in paid partnership with KPMG. Indian bulk drugs industry-Regaining the lost glory [Internet]. India: cii; 2017 [cited 2021 May 11]. Available from: http://ciipharma.in/pdf/API-Report-2017.pdf
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