India API Industry - Market Size, Trends & Analysis - Forecasts to 2026

1. [Type text] The Indian pharmaceutical industry, as on April 2020, is the world’s third largest drug producer with respect to volume. Also, the Indian market manufactures about 60 per cent of vaccines globally. India is known for supplying affordable and low-cost generic drugs to millions of people across the globe and has operation for more than 250 US Food and Drug Administration (FDA) and UK Medicine and Healthcare products Regulatory Agency (MHRA) approved plants. Check the report description @: https://www.globalmarketestimates.com/healthcare/report- summary.php?report_id=2031&report_name=india-api-industry---market According to a recent report on the Indian pharmaceutical industry, the source of APIs is an important part of the pharmaceutical industry’s strategic plan to combat the COVID-19 pandemic. The majority of APIs for generic drug manufacturing globally are sourced from India, which also accounts for approximately 30 per cent of the generic APIs used in the United States. However, Indian pharma manufacturers rely heavily on the Chinese APIs for the production of their medicine formulations, procuring around 70 per cent from China, the top global producer and exporter of APIs by volume. With the outbreak of the SARS-CoV-2 coronavirus outbreak or COVID-19, the dependency of the Indian pharma sector on China for its API procurement has been exposed. Supply chain disruptions and product exportation restrictions from India was caused due to manpower shortages in China’s manufacturing plants. Supplies were additionally impacted by the disruption of logistic and transportation systems, restricting access and movement of products to and from ports. Before 1991, the Indian pharmaceutical industry only imported 0.3 per cent of its APIs from the Chinese manufacturers. However, with globalisation and the rise in large-scale formulation manufacturing prompted the increase in API procurement from China. This was due to the low cost of production. Since the pandemic highlighted the dependency of the Indian pharmaceutical companies on Chinese APIs, it prompted the Indian government to set up a taskforce to review the internal API sector. Some of the recommendations of the task force included fostering the approvals of pharmaceutical infrastructure developments, clearance from the environment ministry and providing tax exemptions and subsidies for the development and promotion of the pharmaceutical industry hubs which could benefit the market. The present situation pointed out that the Indian government should take important steps in order to remove the technical and financial barriers that will spur the pharmaceutical industry to ramp up its API production, reducing the dependency. The Indian government recently proposed an incentive package of 13.76 billion Indian Rupees (approximately USD180

2. [Type text] million) for the promotion of domestic manufacturing of critical key starting materials, drug intermediates, APIs and medical devices. Request sample copy of the report @: https://www.globalmarketestimates.com/healthcare/report- summary.php?report_id=2031&report_name=india-api-industry---market Let us also have a glance at the list of regulations existing in the Indian API market. The Drugs and Cosmetics Act of 1940, framed during the British India some 79-80 years ago, became the basis of import, distribution, manufacture and sales of drugs in India and continues to be so. The Drug and Cosmetics Rule of 1945 and the 1940 Act were later clubbed to list down detailed manufacturing requirements and to check the production of spurious and low-quality pharmaceutical ingredients. Other major regulations include the Pharmacy Act 1948, The Drugs & Magic Remedies (Objectionable Advertisements) Act, 1954, Indian Patent Act 1970, Trade Marks act 1999, Drugs Price Control Order, 1995 (DPCO), Uniform Code for Pharmaceutical Marketing Practices (UCPMP) and Research and Development Cess Act, 1986. These have, directly or indirectly, impacted this sector until 2019. Presently, in India, drug regulations are segmented into two bodies- the Central Drug Authorities and the State Drug Regulatory Authorities. The Central Drugs Standard Control Organization (CDSCO) is the apex national drug regulatory authority which carries out the responsibilities allotted to the Central Government in accordance with the Drugs and Cosmetics Act. Whereas, the State DRA controls the state level affairs. Besides CDSCO and State regulatory agencies, others are The Drug Controller General of India (DCGI) and National Pharmaceuticals Pricing Authority (NPPA – 1995). While many claim that the Active Pharmaceutical Ingredient (API) manufacturing industry is expanding and growing, there are some concerns. Till 2019, over 60 per cent of APIs are sourced from other countries. For some specific APIs, the dependence is over 80-90 per cent, according to the Department of Pharmaceuticals. There are serious raw material supply disruptions and pricing volatility in the Indian market which creates confusion in the market. Indian pharma market is one of the fastest growing markets after the Chinese market. In terms of demand in the market, India has a prominent place, but when it comes to manufacturing of API and generics, India continues to struggle in terms of getting approvals, maintaining international quality, GMP and more. Executing the policies have become an uphill task. Browse the report @: https://www.globalmarketestimates.com/healthcare/report- summary.php?report_id=2031&report_name=india-api-industry---market