A mechanism for the mutual recognition of regulatory approval for pharmaceutical products between countries will be beneficial for industry, according to experts.
“Mutual regulatory recognition can help drugs cross boundaries without complex processes,” said R. K. Agarwal, President, Bulk Drug Manufacturers’ Association (BDMA), in a discussion on industry expectations from regulators at the iPHEX and Global Regulators Conclave here.
Manufacturers were always busy with different regulatory approval processes with an average of 75 audits a year, he said.
“The need of the industry in the regulation space is mutual recognition, which saves time and brings down the cost of production to an extent,” Agarwal said.
According to Viranchi Shah, President, Indian Drug Manufacturers’ Association (IDMA), it would be prudent for regulators of other countries to accept approvals issued by the Indian regulator.
Stating that Europe was following mutual recognition of regulation to an extent, he said the pharma industry would be benefitted by coordination between regulators.
Sudarshan Jain, Secretary General, Indian Pharma Alliance (IPA), said the Covid-19 pandemic had changed many perceptions about regulation.
“Emergency Use Authorisation practice offers significant opportunities. We should explore this further,” he added.