The third of a series of six virtual workshops on current Good Manufacturing Practices was inaugurated today by Dr Mandeep Bhandari, Joint Secretary, Ministry of Health & Family Welfare, Government of India.
This 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 the 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 VG 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 endeavours. 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 Sudarshan Jain, Secretary-General, Indian Pharmaceutical Alliance. “It is an essential and urgent need of the sector, especially at this crucial juncture,” he added.
Shirish Belapure, Senior Technical Advisor at Indian Pharmaceutical Alliance, said, “IPA Quality forum has one prime objective of upgrading the quality of Indian pharmaceuticals and these workshops meet the need. IPA fully supports this initiative”
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 pharma units in December 2020 on a unique and dedicated WHO-JSS AHER web portal.
Dr Surinder Singh, Vice-Chancellor, JSS AHER said, “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.