Industry

Pharma API Leaders discusses regulatory compliance

She noted that India is outsourcing APIs from other countries and China because of factors like logistics cost, labor, and utility cost.

The Health Master

March 4, 2023

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Last Updated on March 6, 2023 by The Health Master

Pharma API Leaders discussion

The Pharma active pharmaceuticals ingredients (API) Leaders Conclave, held in Mumbai from March 2 to 3, brought together industry experts to discuss the growth prospects of the global API market.

The theme of the event was “Cost Effective API Scale-Up from Lab to Plant”. Participants discussed the following topics:

Regulatory hurdles
Intellectual property issues
The need and adoption of advanced technologies
Automation
Pricing pressures in the global API market

The Covid-19 pandemic has disrupted supply chains and caused shortages of certain APIs, highlighting the need for more resilient supply chains in the future.

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According to Dr Roshan Palewar, CEO of Pharma Global Leader in Mumbai, the growth of the global API market is driven by several key trends, including:

The increasing prevalence of chronic diseases
Rising demand for biologics and biosimilars
Growth in the generic drug market
Outsourcing of API manufacturing to low-cost countries
Expansion of the pharmaceutical industry in emerging markets

The Indian API industry faces challenges but predicts annual growth of 6.4% until 2028

The Indian API industry is the most expensive and complex manufacturing sector. Its size, complexity and diversity of products are hard to comprehend.

It has an annual turnover of over 2 trillion US Dollars, has over 58,000 manufacturers and generates employment for close to 2 million people.

In FY 22, it registered a growth of 7% to 9% mainly driven by market access to developing nations and emerging economies like India.

Dr Pradnya Deshmukh, President of Wockhardt Group’s global head of quality and compliance, shared her views on the sidelines of the Conclave.

She noted that India is outsourcing APIs from other countries and China because of factors like logistics cost, labor, and utility cost.

Dr. Deshmukh also cautioned that delay in API production means lost market opportunities, while also highlighting that the industry has a predicted growth of 6.4% annually till 2028.

Opportunities for growth in the global API market

Dr. Palewar also added that the growing demand for personalized medicine, the increasing use of biologics and biosimilars, and the development of complex APIs are some of the key opportunities for growth in the global API market.

Additionally, the use of AI and machine learning in drug discovery and development is expected to drive demand for APIs in the future.

Government planning to encourage startups in the API industry

Dr. Ashok Kumar Bhattacharya, MLE, Harvard Square, Fellow, Institute of Directors, Mumbai, stated that the government is also planning to encourage startups in the API industry by providing them with financial assistance and other incentives.

This will encourage innovation and entrepreneurship in the API industry and create new job opportunities.

JEKSON VISION provides solutions for compliance

JEKSON VISION, a global provider of vision inspection and track & trace solutions for the pharmaceutical industry, recommended approaches and solutions which conform to GS1 standards and provide a complete solution as per legislations on serialization, aggregation, and e-pedigree with a flexible software suite.

Other notable participants in the two-day Conclave included: