The Indian pharma industry and its regulators needed to gather momentum in its efforts to get itself compliant for Pharmaceutical Inspection Cooperation Scheme (PICS), stated Mala Mohan, Director, Site Quality, Cipla Bengaluru.
This will enhance its GMP (good manufacturing practice) inspection system and garner a quality system of global acceptance certification for its production facilities, she added.
PICS is a global benchmark. Indian pharma needs it to boost exports and strengthen its credentials among the global manufacturers. It enables enhanced market access, facilitates networking and confidence-building. It also facilitates reduction in duplication of inspections, she stated.
“However, we see that government support can promote companies to adopt to PICS which is a compliance to reduce bridging the gap between the industry and regulators to maintain and sustain the good manufacturing practice momentum,” said Mohan in her presentation at an event organised by the Karnataka Drugs and Pharmaceutical Manufacturers Association (KDPMA) on ‘The Essential Journey From Schedule M to PICS'.
Speaking on the topic ‘Regulatory expectations of PICS’, Mohan said that the objective of PICS leads to global development, implementation and maintenance of harmonized GMP standards and quality systems of inspectorates for medicinal products.
The intent of the over two-decade-old compliance was removal of non-tariff barrier in the trade of pharmaceuticals in Europe through mutual recognition of inspection report and certification. Therefore, PICS is designed for a harmonized inspection systems, training of inspectors and information exchange. Further, it is a platform of mutual confidence, facilitates a forum for GMP inspectors. This has also led to the formation of a Think Tank, to encourage global harmonization of GMP.
A company manufacturing and supplying pharmaceuticals to multiple countries would be subjected to audits from the different regulatory bodies of each country. For those countries who are members of PICS, an audit by another PICS member country will be accepted without the need for a further assessment, she explained.
Globalization of the supply chain leads to increase of finished products and APIs imports. There are new opportunities for manufacturers but also considerable challenges for both industry and the regulators. “It is here we see that being PICS compliant will also significantly reduce the compliance burden and costs of inspection if companies are supplying product to multiple countries,” said Mohan.
PICS is driven by participation and is a platform for interaction with regulatory authorities. For the inspectors it is a forum to brainstorm, discuss new ideas and share information. Such networking spurs information exchange on preview of GMP procedures. Therefore Indian pharma should go in for PICS going by the existing accreditation. The industry accounts for 1120 CEPs (certificate of suitability), 1200 TGA approvals and around 500 sites approved by the US FDA. All these have made the Indian pharma globally visible but now it needs to step up its pace towards PICS compliance, said Mohan.