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Malta becoming preferred destination for EU testing & batch release of medicinal products post Brexit: SM Mudda

Shardul Nautiyal, Mumbai
Monday, February 6, 2023, 08:00 Hrs  [IST]

Malta is becoming a preferred destination for European Union (EU) testing and batch release of medicinal products post Brexit, says SM Mudda, founder managing director of Malta based Misom Labs Ltd.

Indian Pharmaceutical industry used to rely on the UK for testing and batch release for the EU markets. Post Brexit many Indian generic companies shifted their testing and release base to Europe.

This is a big gain for the Indian pharmaceutical industry which used to rely on the UK for testing and batch release. Post Brexit many Indian generic companies shifted their testing and release base to Europe.

“Malta being an English-speaking country with a proven track record in pharmaceuticals has evolved as a testing hub for India and other regulated markets,” SM Mudda added.

SM Mudda has held senior management positions in technical and business functions including executive director-technical & operations, director-global strategy (technical). He is actively engaged with the government, regulatory agencies, industry and professional associations in India and abroad on matters related to quality management and drug regulations.

The country of Malta became independent from Britain and joined the Commonwealth in 1964 and was declared a republic on December 13, 1974. It was admitted to the European Union (EU) in 2004.

Registered in Malta and located at Malta Life Science Park in November 2017, Misom Labs Limited is a modern state-of-the-art laboratory designed in accordance with EU GMP regulations. It is an international class facility for Life sciences development. It received GMP License in May 2019 and is commercially operational since June 2019.

The park facilitates informal interaction with several global health sciences companies thus providing learning and collaborative business opportunities.

Malta is connected by air to over 35 major cities in Europe, North America and the Middle East through partner airlines. Malta Free port is the third largest port in the Mediterranean and is connected to over 165 ports on all continents.

The total area of the laboratory is 400 square meters. The layout of the lab is logical to the workflow. The lab is divided in two major parts – chemistry and microbiology and further divided into different sections such as wet lab, instrumentation lab, HPLC room etc.

"We could complete our project with all approvals including the EU GMP Certification by the Medicines Authority of Malta within a record time of 8 months in May 2019. We found Malta to be a conducive place for establishment of business in the pharmaceutical sector. Misom has thus earned a reputation as a quality service provider in a short time." said SM Mudda.

SM Mudda explains, “Misom started its operations at a very right time that coincided with Brexit. With the UK leaving the EU, the global pharmaceutical companies had to shift their testing and batch release activities from the UK to EU. The company could provide the necessary strategic support to the companies with the expected speed to meet the targeted deadlines of Brexit. The speed and quality of our service coupled with a well-established robust and flexible quality management system helped us to open doors for business better than we expected.”

The main activities of Misom include Testing of imported Medicinal Products and Batch Release (QP Release). In the last 3 years, despite a temporary disruption due to Covid pandemic, we could build and grow our testing capacity from a small number of 30 batches per month to 150 batches per month and are still growing. In a short span of time, we received the MIA approval and now have a capacity to perform EU Batch Release of 100 batches in addition to testing.

India being one of the key suppliers of generic medicines to the EU a number of Indian companies have a strong presence in the EU. Based on our proven track record in India, the company understands the expectations of customers and are therefore able to attract large Indian multinational companies to shift their base from the other EU countries to Malta. Some of the companies have made Malta as their headquarters for the EU.

“There are other Indian companies aspiring to enter the EU market are now seeking our guidance in getting their facilities and quality system designed to meet the EU GMP requirements. Our QPs have been able to guide such companies successfully and soon we expect them to get certified by the authorities to be able to start their business in Malta,” SM Mudda informs.

“The company is looking for further opportunities of collaboration between the Indian pharma industry and Malta in the areas of research and development and primary packaging. Shipping of bulk product from India and getting the final product packed in Malta will help save the freight costs, apart from other benefits,” SM Mudda concludes.


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