Last Updated on December 30, 2023 by The Health Master
With a developing country like Brazil joining the Pharmaceutical Inspection Co-operation Scheme (PIC/S), it is high time India also be part of the league. This is all the more imperative since India’s neighbours like Pakistan, Bangladesh and China are already part of the same.
PIC/S is a non-binding, informal cooperative arrangement between regulatory authorities. It is open to any regulatory authority having a comparable GMP inspection system. Currently, PIC/S comprises 53 participating regulatory authorities including Europe, Africa, America, Asia and Australia. From January 1, 2021, Brazil will be 54th country. Other countries that are currently in the PIC/S application process include Armenia, Bulgaria, and Saudi Arabia.
Last year PIC/S came out with recommendations on how to demonstrate effectiveness of pharmaceutical quality system (PQS) in relation to risk based change management. It provided a practical guidance for GMP inspectors when seeking to evaluate the effectiveness of a company’s PQS in relation to risk-based change management.
Further it conveyed all steps related to management process, proposal, assessment, planning, implementation, review and effectiveness. In the wake of the C-19 pandemic, India’s tag as the pharmacy of the world will be strengthened joining the PIC/S.
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According to Kaushik Desai, pharma consultant, India is known to be the pharmacy of the world. If we have to further grow and compete globally, Indian regulatory authority needs to make a serious move to join PIC/S. This is also a long pending wish list of the pharmaceutical industry.
“The revised Schedule M of Drugs & Cosmetics Act is on the lines of WHO GMP guidelines. Hence, it should not be much of an issue to join PIC/S once implemented and contribute in surpassing export targets,” he added.
Speaking to Pharmabiz, Dinesh Dua, chairman, Pharmexcil, said “Brazil joining PIC/S is a huge development. India is deeply engaged in this exercise as well. Our country wants to become a member of PIC/S because there is a major advantage. Although having said that inspite of the mutual recognition of 50 odd countries, some of these nations still want their own inspections which defeats the very purpose of PIC/S. However, getting a PIC/S approval is a great heads-up and our country needs to definitely go for it.”
Now India will need a year to come up to the PIC/S benchmark. The regulatory department led by Dr VG Somani DCGI is working towards this and is pushing the entire CDSCO to gear up and be in line for the PIC/S assessment, said Dua.
Noting that it is good news for Indian exporters, Dr. Viranchi Shah, sr vice president IDMA, said “We have over 650 sites that are EU GMP certified and almost 600 plus US FDA approved. Both type of sites qualify as PIC/s approved sites. We also have large numbers of sites that are GMP certified from PIC/s nations. Brazil market will now become accessible to all these companies. Of course it also depends on MRA (mutual recognition agreement) between Brazil and other PIC/s nations.
According to Jatish N Sheth, director Srushti Pharma and member Steering Committee, Karnataka Drugs and Pharmaceutical Manufacturers Association, PIC/S enables mutual recognition. Now PIC/S mandate is to ensure total GMP compliance which Indian pharma is already adhering to. Now with the new Schedule M coming into the picture, its preparation too was to make India set for PIC/S compliance.
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