cGMP workshop: Making India’s Pharma Industry future ready

It is for the first time anywhere in the world that we have attempted a program like this

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Last Updated on June 16, 2021 by The Health Master

Mysuru, 14 June 2021: The third of a series of six virtual workshops on current Good Manufacturing Practices to support the Indian pharmaceutical industry’s vision of providing world class quality medical products was inaugurated today by Dr Mandeep Bhandari, Joint Secretary, Ministry of Health & Family Welfare, Government of India.

Health Ministry, WHO, JSS AHER, Indian Pharmaceutical Alliance and partners provide a unique learning platform

The C-19 pandemic has brought into sharp focus and reinforced the need to enhance quality production for sustainable supply chains to meet national and global needs. These workshops address the vital importance of strengthening the capacities of pharma manufacturing facilities meet current Good Manufacturing Practices and sharing global practices to promote availability and access to quality medical products.

This unique initiative is the result of an active collaboration between the Union Ministry of Health & Family Welfare (MoHFW), the World Health Organization (WHO), JSS Academy of Higher Education & Research at Mysuru (JSS AHER), and the Indian Pharmaceutical Alliance (IPA).

In his inaugural address, Dr Bhandari, MoHFW said, “This initiative of establishing a robust learning and training platform meets the critical need of enabling further upgradation of pharmaceutical sector for global standards of quality. This will have a far-reaching positive impact. It reiterates our commitment to quality medical products and reinforces our position of being the vaccine hub and pharmacy of the world.”

“I congratulate WHO and partners for this timely and much needed initiative,” he added.

Welcoming the capacity-strengthening workshops, Dr V.G. Somani, Drug Controller General of India, said, “We are committed to the highest regulatory standards to ensure quality, safety and efficacy of medical products. It is our constant endeavour that our standards are at par with the best in the world.”

“The objectives of the workshop are aligned with the broader goals of the national regulatory authority and in this context I am particularly pleased to see the enthusiastic participation of the pharma industry in these workshops. It augurs well for this vitally important sector,” he said.

Speaking on the occasion, the WHO representatives from HQ, WHO Regional Office for South-East Asia, and WHO Country Office for India said, “It is for the first time anywhere in the world that we have attempted a program like this. At the heart of these workshops is the underlying philosophy behind the current Good Manufacturing Practice (cGMP) – ensuring that products are consistently produced and controlled according to quality

standards.” “WHO is fully committed to supporting such endeavors. Given the encouraging response to the earlier workshops, we hope to expand the outreach and have participation from other countries in the Region through the WHO South East Asia Regulatory Network ,” they added.

The genesis of these workshops is a survey of the pharmaceutical sector in India by WHO in 2014, which had recommended further strengthening of the cGMP with the support of WHO.

“The virtual workshops on cGMP is a key step in that direction, and we are delighted to partner in this path-breaking program,” said Mr Sudarshan Jain, Secretary General, Indian Pharmaceutical Alliance. “It is an essential and urgent need of the sector, especially at this crucial juncture,” he added.

National and international experts, including from WHO (HQ, Regional Office for South- East Asia, Country Office for India) and leading industry voices came together to design a need-based workshop program. This was followed by a successful pilot workshop on cGMP for pharmaceutical units in December 2020 on a unique and dedicated WHO-JSS AHER web portal.

“It is a privilege for us to have anchored this initiative. We are grateful to the Health Ministry, WHO and partners for the faith reposed in us,” said Dr Surinder Singh, Vice Chancellor, JSS AHER. “An important component of these workshops is Mentorship,” he shared. To ensure long-term impact, a mentor will be guiding the participants for an informed understanding and implementation of WHO cGMP, prequalification guidelines and other world-class quality standards.

Importantly, the workshops are also contributing to the larger developmental agenda of health for all. As Dr B. Suresh, Pro Chancellor, JSS AHER said, “The workshops are an important step for enabling the enhancement of pharma standards and contributing to global agendas, including the 2030 Agenda for Sustainable Development. We are delighted to be part of this process.”

Under this initiative, a total of six workshops are being conducted – two for formulation manufacturing pharma units, three for active pharmaceutical ingredients (APIs) manufacturing units, and one for medical devices and IVD manufacturers. Cumulatively, over 650 plus participants from over 185 units will take part in this capacity- strengthening program. The third workshop is well attended; it has 125 participants from 40 pharma units.

For more information about the virtual workshops, please contact Dr Vishal Kumar Gupta, Deputy Director (Academics), JSS Academy of Higher Education & Research at email: [email protected], and Mobile: 9242157508.

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