Pharma API Leaders Conclave discusses regulatory compliance, technology adoption and automation

Mumbai, March 4, 2023 :

While discussing the growth prospects of the global active pharmaceutical ingredients (API) market, Pharma API Leaders Conclave held between March 2 and 3 in Mumbai discussed ways to address regulatory hurdles, intellectual property issues, need and adoption of advanced technologies, automation and pricing pressures in the global API market. The theme of the conclave was ‘Cost Effective API Scale-Up from Lab to Plant’.

Ashish Chauhan, Director, BlueTech Media conducted the proceedings during the event with title partner of the event as Rockwell Automation.

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

Addressing these issues, Dr Roshan Palewar, CEO, Pharma Global Leader, Mumbai said, “The increasing prevalence of chronic diseases, rising demand for biologics and biosimilars and the growth of the generic drug market are some of the key trends driving the growth of the global API market. Additionally, the outsourcing of API manufacturing to low-cost countries and the expansion of the pharmaceutical industry in emerging markets are also contributing to market growth.”

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.
 
Sharing her views on the sidelines of the Conclave, Dr Pradnya Deshmukh, president, global head, quality and compliance, Wockhardt Group said, “India is outsourcing APIs from other countries and China because of factors like logistics cost, labour and utility cost. SEZ infrastructure is not sufficient to support expansion and there is no research and development ecosystem in the country with industrialists fearing loss of business for want of quick pay back at the cost of doing dedicated and timely research. She also cautioned that delay in API production means lost market opportunities.”

On the positive side, Dr Pradnya Deshmukh further added that the industry has a predicted growth of 6.4% annually till 2028. It has a dynamic focal point for mergers and acquisitions, facility expansion, investment in innovation and development of new chemistry platforms.

Further discussing the positive aspects, Dr Palewar further 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.

While sharing his views, Dr Ashok Kumar Bhattacharya, MLE, Harvard Square, Fellow, Institute of Directors, Mumbai said 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.

Rajan Sundavadra, product architect, JEKSON VISION, Ahmedabad said that in order to implement the Central government Gazette Notification mandating QR Codes on active pharmaceutical ingredients (APIs) effective January 1, 2023, our company has recommended approaches and solutions which conforms to GS1 standards and provides a complete solution as per legislations on serialization, aggregation and e-pedigree with a flexible software suite. This helps manufacturers to print QR Code towards compliance with the Gazette Notification and also ensures security, verification and recall of the APIs when needed in a seamless manner.

JEKSON VISION is a global provider of vision inspection and track & trace solutions for the pharmaceutical industry. Its key focus is on research, design, software development and engineering, providing high quality and affordable solutions.

Taking pride in being India’s first woman-led Parma-Tech in supply chain software, Anubha Dixit, Founder CEO, TONGADIVE said, “Our product Evidnt provides an innovative and unique algorithm combining GS1 serialisation, blockchain and artificial intelligence for track and trace requirements. There is no fuss plug and play deployment with no changes required to existing IT systems. It has intuitive and differentiated end user experience with 'Compliance on a Click' reporting.”

TONGADIVE is a leading player in next-generation track and trace and labeling software systems for pharmaceutical APIs and formulations. It has an end-to-end track and trace solution for supply chain visibility and 300 drugs QR code requirement.

Companies which participated in the two day Conclave included TONGADIVE, JEKSON VISION, Rockwell Automation India Pvt Ltd, Blue Ocean Compliance, ThermoFisher Scientific India Pvt Ltd, Mettler Toledo and Ascent Total Solutions Ltd. Pharmabiz