Goa Pharmaceutical Manufacturers’ Association (GPMA) recently conducted a one day workshop in collaboration with the Medicines and Healthcare products Regulatory Agency (MHRA) on GMP inspection and regulatory requirements in Goa. The workshop was conducted with an aim to benefit the technical personnels from pharma industry.
MHRA UK is the regulating agency which controls the products quality, efficacy and safety of drugs that are being manufactured and marketed and sold in UK. It also keeps a close watch on the overseas sites where products are manufactured and imported into UK. This is the first time in India that MHRA has held a workshop for the benefit of Indian pharmaceutical industry.
The workshop was inaugurated by Dr Prakash Mody, noted industrialist, chairman and managing director of Unichem Laboratories, Mumbai in the presence of Salim Veljee, director of Food and Drugs Administration (FDA) and senior inspectors Michael Woodhall, John Clarke from MHRA. Arun Naik, president GPMA welcomed the gathering while A K Burman proposed the vote of thanks during the event.
“We have deceide to have this workshop in Goa as the state is one of the major pharmaceutical hubs for exports and majority of units in Goa are certified by MHRA apart from other regulatory agencies across globe,” informed Naik, president GPMA.
The certification by MHRA enables overseas manufacturers to market their products in EU region through mutual recognition program. In addition to this, the certification also helps in registration and marketing of products in some more countries like Canada.
Michael Woodhall and John Clarke from MHRA introduced the agency and presented various topics of interest on quality assurance, regulatory affairs and changes in inspection scheme and expectations from overseas sites for supply of drugs to the UK.
Naik said, “This workshop was able to create a huge response from everyone present at the event and also came as a great benefit for the technical personnels from the pharma industry in Goa. We are happy to note that there were participants from other states as well who were able to utilise this opportunity to learn and understand more from on these technical sessions. Most importantly this workshop provided an change to clarify doubts and lead to fruitful discussions with resource persons from the regulatory body like MHRA and Goa FDA.”
Dr Praveen Khullar from Sanofi Synthelabo Development Centre, Goa, Vijay Kshirsagar from Unichem laboratories, Mumbai and Dr Himanshu Misra from CMC Limited Mumbai also shared some vital information on the current topics of interest.
The workshop was attended by over 140 delegates from industry, senior officers from drug control administration etc.