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Ramesh Shankar
Wednesday, May 29, 2024, 08:00 Hrs  [IST]

For quite some time, the Indian government has been taking several initiatives to become a member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) which is a non-binding, informal co-operative arrangement between regulatory authorities in the field of Good Manufacturing Practice (GMP) of medicinal products for human or veterinary use. It is open to any authority having a comparable GMP inspection system. This elite group presently has 56 participating authorities across Europe, Africa, America, Asia and Australasia. Drug regulatory bodies from across the globe including the US, the UK, China, Canada, Japan, France, Germany, Australia, New Zealand, Italy, Mexico, South Africa, Spain, etc are all part of this group. PIC/S aims at harmonising inspection procedures worldwide by developing common standards in the field of GMP and by providing training opportunities to the drug inspectors. It also aims at facilitating co-operation and networking between competent authorities, regional and international organisations, thus increasing mutual confidence. This is reflected in PIC/S’ mission which is to lead the international development, implementation and maintenance of harmonised GMP standards and quality systems of inspectorates in the field of medicinal products. Although PIC/S is not a trade agreement, membership in PIC/S may facilitate the export of pharmaceuticals. Some non-PIC/S authorities accept GMP certificates from PIC/S participating authorities. This means that non-PIC/S authorities and organisations have a greater confidence in medicines manufactured in countries where the regulatory authority is a PIC/S participating authority. Consequently, the pharmaceutical industry located in these countries indirectly benefits from PIC/S membership. A PIC/S membership reduces duplication of inspections, facilitates the industry in export, and provides huge market access among other benefits.

India is the largest provider of generic drugs globally and adorns, and aptly so, the epithet of ‘the pharmacy of the world’.  The Indian pharmaceutical sector supplies over 50 per cent of global demand for various vaccines, 40 per cent of generic demand in the US and 25 per cent of all medicines in the UK. Unfortunately, the country is not a member of PIC/S so far, which would have helped India maintain global standards and enhance global confidence in drugs coming from India. Several industry bodies, including the Indian Pharmaceutical Alliance, have long been urging the government of India to join the PIC/S to enhance recognition of the country as provider of quality drugs and boost drug exports. To become a PIC/S member, Indian drug regulators, both at the central and state levels, need to undergo intense training programs and the country’s research laboratories need to be upgraded. Similarly, at the industry level, pharmaceutical companies in the country need to set up their facilities that comply with international regulatory requirements like the WHO-GMP, US FDA and train their workforce to make them compliant with good manufacturing, good laboratory and good documentation practices. Under this background, the Union Health Ministry has taken a right step as the ministry has recently notified the Revised Schedule M norms for the Indian pharmaceutical industry to bring the pharmaceutical quality standards in the country on par with the international standards. The PIC/S membership will help exporters significantly save cost and time. The Union Health Ministry should implement the Revised Schedule M in letter and spirit as it has the potential to take India closer to get entry into the elite PIC/S group.

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