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Sandeep Singh Dhillon
US Pharma Firms Concerned Over ‘HALAL’ Guidelines
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KUALA LUMPUR — US pharmaceutical companies have expressed concerns over the Health Ministry’s guideline on “halal” products, claiming preferential treatment.

The concern was among many issues highlighted by the Pharmaceutical Researchers and Manufacturers of America (PhRMA) in its annual submission to the US Trade Representative this month.

The report, which highlighted the challenges faced in key international markets for innovative pharmaceutical firms, was quoted by Fitch Group unit BMI Research in its follow-up publication released yesterday.

“According to (the ministry) 2017 guideline on halal pharmaceuticals, the government provides preferential treatment to medicines with halal ingredients in government procurement,” the report said.

“As such, PhRMA member companies are concerned that these guidelines could have unexpected negative implications on patients’ health.”

Last year, the Islamic Development Department of Malaysia (Jakim) became the first halal certifying body to certify controlled/prescriptive medicines (ethical products) based on the MS2424:2012 Halal Pharmaceuticals ― General Guidelines.

The current global halal pharmaceuticals prospect is valued at US$75 billion (RM331.9 billion), and estimated to reach US$132 billion by 2021.

PhRMA also complained that the ministry’s procurement process preferred locally-manufactured goods.

“The Malaysian government indirectly discourages an open and competitive marketplace for international pharmaceutical compounds through procurement preferences for locally manufactured products,” it said.

“For example, the government recently announced that it will grant three-year procurement contracts to companies that move production of imported products to Malaysia.”

This comes as PhRMA designated Malaysia a “priority foreign country”, together with South Korea in the region, complaining about what it saw as poor intellectual property (IP) protection and non-transparent compulsory licences (CLs).

“Malaysia’s designation as a ‘Priority Foreign Country’ in PhRMA’s 2018 submission highlights inadequate levels of intellectual property protection and mandatory medicine price disclosure as ongoing concerns for multinational drugmakers,” BMI said.

“Additionally, while the government has adopted a policy which prioritises the welfare of Malaysians, the use of a non-transparent process to issue compulsory licences as a method to coerce price reductions will continue to undermine investment by innovative drugmakers in the country.”

PhRMA highlighted so-called “onerous IP acts, policies and practices” and the use of CLs to promote the local production of medicines at the expense of manufacturers in the US.

“The non-transparent manner in which the announcement of the CL was made raised serious concerns as prior to the announcement, the Ministry of Health did not offer to meet with the relevant industry stakeholders to consider their concerns or evaluate their input,” BMI said.

The drugmakers stated that CLs issued by the Malaysian government “undermine a core tenant of IP protection and, if unaddressed, could inspire other countries to advance similar compulsory license schemes undermining vital IP”.

Sandeep Singh Dhillon
Biocon Malaysia unit gets FDA Form 483 notice – Times of India
Pharma Extra, Pharma News
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CHENNAI: Indian pharmaceutical giant Biocon on Wednesday told the BSE that the US-FDA (Food and Drugs Administration) has issued a Form 483 with six observations for its manufacturing facility in Malaysia.
Normally, the US-FDA issues the Form 483 when an inspection finds conditions in violations of food and drug safety. The company’s management is notified via Form 483 if the US-FDA team’s inspection has found “conditions or practices that any food, drug, device or cosmetic has been adulterated or is being prepared, packed, or held under conditions whereby it may become adulterated or rendered injurious to health.”
Biocon told the BSE that it would come up with a corrective action plan.
“The US-FDA has completed a pre-approval inspection of our manufacturing facility in Malaysia and has issued a Form 483 with six observations. As per the normal expectations of the agency, we intend to respond with a corrective and preventive action plan in a timely manner,” said Rajeev Balakrishnan, company secretary, Biocon.
On its website, Biocon lists its insulin manufacturing facility at Johor, Malaysia, as its first overseas biopharma manufacturing and research unit, started in 2015 with an investment of $275 million.
Biocon Malaysia, which has launched biosimilars such as Basalog and Insugen, started commercial operations in 2017 and has GMP certification from the European Medical Agency.
Biocon already supplies insulin from this plant in Malaysia and expects the insulin supplies to Europe upon product approval.
The company has received USFDA approval for Glargine and the same is likely to have triggered the inspection. The company had also indicated of the same in the recently quarterly earning conference call.
Biocon’s biosimilar version of Roche’s Trastuzumab — a drug to treat breast and stomach cancer — received US FDA approval last December.

Sandeep Singh Dhillon
Malaysia’s healthcare budget below WHO recommendation – The Malaysian Insight
Pharma News, Pharma Notables
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By Noel Achariam

MALAYSIA’S budget for healthcare is 3% lower than the World Health Organisation (WHO) recommendation and needs to be raised, said a consultant.

InfoMed chief executive officer Mohan Manthiry said the nation’s current budget for healthcare was 4% of the gross domestic product, and the government must spend more to provide quality care especially in public hospitals.

“The general population, where a majority are hard-pressed by inflation, are now flocking to government hospitals.

“Malaysians can’t afford proper healthcare because of stagnant salaries, poor revenues and negative growth.

“The government needs to provide more services, improve facilities and reduce congestion.

“To do this effectively, the government needs to allocate more funds for healthcare,” he said after speaking at the Malaysian Insurance Institute on Medical Health and Insurance Seminar today.

It was reported that the Health Ministry would seek a bigger allocation under Budget 2018 due to increasing medical costs.

Its minister, Dr S. Subramaniam, said the RM23 billion allocated for this year was insufficient, which prompted the ministry’s request for an increased allocation.

He said the ministry was committed to providing the people with quality healthcare.

Budget 2018 will be unveiled in Parliament on October 27. In past budgets, the ministry had received between 10% and 15% more in the annual allocation.

Mohan said according to WHO, the recommended budget for healthcare in Malaysia should be 7%.

“Malaysia’s current budget (for healthcare) is 4% of GDP. Singapore, whose healthcare is among the best in the world, is only spending 5% of its GDP, and is still able to provide quality healthcare.

“This is because the funds have to be efficiently utilised. Otherwise, quality healthcare is not going to be felt by the public.”

Mohan said the healthcare sector should be geared towards prevention and enhancing the education system to reduce incidences of chronic diseases.

“There is a worrying trend in non-communicable diseases, such as diabetes and obesity. This is something we should focus on, which is consuming most of the resources in healthcare. ”

WHO had stated that almost 70% of the global mortality rate was due to such diseases, he said, adding that in Malaysia, the number of patients was on the rise, with the country being No. 1 in diabetes and obesity in the region.

“To manage this, we need to get individuals to take charge. We cannot leave it to the government, doctors and hospitals.

“This has got to do with lifestyle, and one of the major causes is the food we eat.

“We need to have a long-term plan, and I have been advocating the need for education in healthcare.”

Mohan said it was crucial for healthcare to be taught as a subject at the primary school level.

“It should be in the curriculum, where children are taught everything in healthcare and matters related to health, from food and the environment to exercising.

“Such education should start at home, but it’s not happening. So, it has to become part of formal education.

“It is good if this can be implemented in primary schools. Then, the government would not have to spend so much money (in its healthcare budget) because it’s part of the curriculum.”

The original article can be viewed at

Sandeep Singh Dhillon
Supply Chain Manager – Novartis
Pharma Job Portal
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Job Description

Job ID 214902BR
Position Title : Supply Chain Manager
Division Novartis Technical Operations
Country : Malaysia
Work Location : Petaling Jaya
Company/Legal Entity : NOV MALAYSIA
Functional Area : Technical Operations
Job Type : Full Time
Employment Type : Regular

•Responsible for implementation of global SCM processes and initiatives
•Facilitation and implementation of local S&OP process and forecasting with the Sales & marketing team
•Responsible for proper Net Requirement Planning and Order Management
•Review/evaluate demand data of active assortment items coming from the business units/product management vs. rules and assumptions
•Provide demand data to global demand and supply planning
•Planning and managing physical levels of stockholding.
•Controlling movement of each individual item closely to meet unexpected short term variations and deviations
•Up-to-date and accurate submission of demand files to SCM.
•SKUs reductions & pruning program
•Demand planning & tracking analysis on stock forecast requirement and accurate data and ensure timely submission
•Timely transmission of monthly sales & inventory reporting
•Establish & integrate local processes in alignment to GISC processes.
•Fine-tune and enhance if necessary the control parameters within the inventory system and all decision-related processes in the total logistic operation.
•Identifying areas of best cost trade-off for all inter-related activities within both our distributors’ networks which will optimize the efficiency of the total distribution process.
•Maintaining high level of inventory record accuracy
•Ensure all relevant data and documentation for both sales & inventory transactions are up-to-date and in-line for a smooth, accurate and fast month end closing
•Build and maintain supplier relationships to secure continuity of supply and support business goals
•Participate as part of a cross-divisional team to identify reliable, cost-effective, good quality suppliers for both new and existing products
•Product Lifecycle Management Launches: support new launches and make sure that all milestones are met.

Minimum requirements

•University degree in supply chain management, business administration or Commercial degree.
•Fluent in English
•3-5 years experience in supply chain management, and works independently
•Ability to lead and drive initiatives and projects with minimum supervision
•Excellent organizational, planning skills, and effectiveness in a complex environment, as well as ability to communicate throughout different cultures, functions and hierarchies.
•Good understanding of the (generic) pharmaceutical industry is preferred (awareness of regulatory procedures, Quality assurance, and patent issues)
•Sound knowledge of ERP

Apply here at

Sandeep Singh Dhillon
WHO commends Malaysia’s medical research work – MIMS Malaysia
Drug Discovery, Pharma News, Pharma Notables
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Newly-elected WHO director-general, Dr Tedros Adhanom Ghebreyesus has expressed interest in harnessing Malaysia’s medical expertise. The Health Ministry said the World Health Organisation (WHO) is truly impressed with the country’s medical research work and the accessible and affordable healthcare available here.

“WHO is looking into harnessing our expertise based on this unique model of the research ecosystem in Malaysia to bring down the cost of medicine. We highlighted crucial issues close to the heart of many in developing countries such as cost and access to diagnostics and medicine, where we are convinced that this new partnership model can close the gap of equitable access to medicine,” said Datuk Dr Noor Hisham Abdullah, the Health director-general.

He also took to social media to relay Ghebreyesus’s fascination with this country’s work on Hepatitis C treatment. This programme is in partnership with the global non-profit organisation, Drugs for Neglected Diseases Initiative.

Medical research a valuable field

Despite progression in research, the country still faces some barriers to producing high quality data. A healthcare professional weighed in on this issue recently and described that a basic skill set to conduct good research is required and should be identified in potential researchers.

The medical expert also explained that a large chunk of studies published comes from high-income countries with a Caucasian population. Thus, data from these places might not suit our population entirely and local research would prove beneficial. Another barrier faced here would be low number of cases per hospital and thus, effective research sample sizes are reduced and the study’s significance might be questionable.

Health minister advocates for zero hunger and good health

Health Minister Datuk Seri Dr S. Subramaniam said courageous steps are required as advocators to address the co-benefit of innovative public policy for health. Speaking at the 70th World Health Assembly (WHA) last week, he stated that a better, sustainable health system can be built when our view of the system goes beyond healthcare.

Subramaniam also said at the WHA in Geneva, Switzerland that pollution and climate change are not merely environmental issues once it changes the pattern of communicable disease. This is because Arbovirus infections such as dengue can spread beyond its usual temporal and geographical boundaries.

“A hungry world, a polluted world or a world where women do not stand equally cannot be defined or considered as a healthy world. Achieving zero hunger and good health goes hand in hand. In our passionate search for new vaccine and medical technology, we must remember that no vaccine can prevent the detrimental effect of famine and no medicine can replace the damaging effects of stunted growth,” he added. MIMS

Biocon wins Rs.460 crore contract for insulin from MoH, Malaysia
Pharma News
Sandeep Singh Dhillon
Moving medical research forward: Malaysia aims for 1,000 clinical trials by 2020 – MIMS Malaysia
Pharma News, Pharma Notables

When 37-year-old Diana was told that her current treatment was not working in her favour, her heart sank. But thanks to a clinical trial, her hope was rekindled. The trial drug offered her fresh hopes and possibilities.

Every treatment is hope for the patient; it is the fruit of clinical research, which advance patients’ health and push medical boundaries.

The Clinical Research Malaysia (CRM), wholly owned by the Ministry of Health (MOH) in Malaysia, was set up in June 2012 to facilitate and enable clinical research by garnering support from the industry, public and medical fraternity. This non-profit organisation is tasked with creating awareness among the public, media and policy makers, exploring ways to improve facilities and resources for industry sponsored research (ISR), and developing sites and investigators.

Dr Akhmal Yusof, the chief executive officer of CRM, said Malaysia would be the preferred destination for ISR, and CRM would develop clinical research as an economic growth engine.

The health ministry has approved 80 ISR sites which are a synergy of public and private hospitals. To align with vision 2020, CRM is targeting 1000 ongoing trials.

Malaysia as the preferred site for ISR
Malaysia is an ideal trial site because it has an adequate and efficient healthcare system with a strong pool of highly qualified medical professionals, state-of-the-art medical technology and an excellent information system. Besides, its consistent start-up timelines, prevalence of non-communicable diseases, competitive trial cost and strong commitment from the government make it an attractive hub that will enable faster, safer and cheaper trials while upholding quality and integrity.

The efforts of CRM have been encouraging. It has improved the number of feasibilities by 300% and recorded a 50% growth in new sponsors. Through participation in international conferences and exhibitions, CRM has generated a 200% growth in inquiries about ISR opportunities in the country.

What the country lacks is quality resources that are comparable with international standards. So far, CRM has provided refresher courses for MOH investigators and also partners with George Clinical Malaysia to enhance skills in conducting trials.

Breakthroughs in research are likely
Several innovative research have kicked off and breakthroughs are likely.

A multidisciplinary team of scientists and research scholars from the MARA University in Malaysia are using the saliva of patients to develop a diagnostic technology for the early detection of life-threatening diseases such as dengue fever and encephalitis. The research is currently in its early stages.

Another research involves finding antibiotic alternatives to fight superbugs. Shu Lam, a Malaysian doctoral candidate, has developed a chain of star-shaped polymer molecules that could kill superbugs by tearing the bacterial walls apart.

“What I’ve discovered is a class of new antimicrobial agents. We hope that these will be replacements for antibiotics,” Lam said.

She is also working with her team on the use of polymers to treat cancer.

A new dawn is approaching as Malaysia intensifies its push for greater collaboration with the industry, medical fraternity, public and patients to initiate more clinical trials. MIMS

Sandeep Singh Dhillon
Big Data to revolutionize healthcare in Malaysia – MIMS Malaysia
Pharma Notables
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For a long time, returning visitors to government clinics in Malaysia would identify themselves at the reception counter, and wait for the officer on duty to retrieve the odd stack of cards and papers that made up their health record.

When did you last–? The doctor might ask, rifling through the stack and settling for an estimate as both parties are unable to provide the exact information. Go to a different medical institution and you would be started on a new stack altogether, with no thought or reference of the old stack.

This situation is about to change however, as the Malaysia Health Data Warehouse project (MyHDW) begins its implementation this August, bringing big data to the Malaysian healthcare scene.

Introduced only within the last few decades, big data is defined as extremely large sets of data or amounts of information that can only be analysed by computers to reveal patterns, trends and associations. In this case it refers to a consolidation of patient information from the entire public healthcare system.

The first dataset to go in the Malaysia Health Data Warehouse is the Sistem Maklumat Rawatan Perubatan (SMRP), which will collect information from patients’ every visit to healthcare centres.

MyHDW is meant to be a trusted, comprehensive source of healthcare data, which must come from every healthcare visit, including those from allied health professionals, traditional and complementary medicine practitioners, and maternal health, said Dr Md Khadzir, MOH Planning Division deputy director and Health Informatics Centre head.

“In the data warehouse, we should be able to link them all up,” he said, giving the example of being able to track how many patients diagnosed with stroke go on to visit physiotherapists, occupational therapists and traditional medicine practitioners.

“So, this is the intention: to have a snapshot of every visit to the healthcare system and to provide value-added data to the people in the Ministry of Health to make policy.”

The implementation of this system brings the significant benefit of unifying patient data. As Clinical Research Centre director Dr Goh Pik Pin from Taylor’s University notes, there is a lot of data from the nation’s public healthcare system, but it is inaccessible and cannot be used because it is stored in various places, in different formats.

With a single system for medical records including patient history, current and previous medications, clinical tests and imaging results, doctors will be able to quickly obtain more accurate information about their patients. This would the process of diagnosis and treatment more efficient, saving both time and costs for patients and healthcare providers alike.

Big data can also be utilised for its high analytical potential. Information from the general population can and should be used as a basis for making and assessing public health policy. The large amounts of available data would also be a boon for medical research efforts. MIMS

Not ready to benefit from biologics and biosimilars
Pharma News
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THE market for biological drugs is stirring as the patents for many products are about to expire, but local pharmaceutical players are generally not ready to take advantage of the opportunities opening up. Read more …

MOPI – Good (Quality Control) Laboratory Practices (G(QC)LPs)
Regulatory Affairs, Upcoming Events & Interviews
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