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Halal pharmaceutical industry: opportunities and challenges

Nor Norazmi M, Lim LS

Trends Pharmacol. Sci., 2015 Aug;36(8):496-7.
PMID: 26187623 DOI: 10.1016/j.tips.2015.06.006

The expanding global Muslim population has increased the demand for halal pharmaceuticals. However, there are several challenges for this emerging niche industry, foremost of which is the need to establish a proper, well-regulated, and harmonized accreditation and halal management system.

Matched MeSH terms: Drug Industry/standards; Drug Industry/ethics*
Comment on Fincham editorial: drug promotion: the need to teach future healthcare practitioners

Jamshed SQ

Int J Pharm Pract, 2014 Jun;22(3):234-5.
PMID: 24825117 DOI: 10.1111/ijpp.12072
Matched MeSH terms: Drug Industry/ethics*
Health professional associations and industry funding-reply from Savage

Savage F

Lancet, 2017 04 29;389(10080):1696.
PMID: 28463138 DOI: 10.1016/S0140-6736(17)31061-9
Matched MeSH terms: Drug Industry*
Ethical boundaries between the medical profession and the health care industry (2)

Choe TS

Med J Malaysia, 2000 Aug;55 Suppl B:51.
PMID: 11125523
Matched MeSH terms: Drug Industry*
Drug policies in Malaysia

James PF

Lancet, 1984 Feb 25;1(8374):453.
PMID: 6142178
Matched MeSH terms: Drug Industry/standards*
Fulltext Regulatory guidelines for biosimilars in Malaysia

Abas A

Biologicals, 2011 Sep;39(5):339-42.
PMID: 21784655 DOI: 10.1016/j.biologicals.2011.06.009

The biosimilars sector continues to attract huge interest and controversy. Biosimilars are new biopharmaceuticals that are "similar" but not identical to the innovator product. Characteristics of biopharmaceuticals are closely related to the manufacturing process, which implies that the products cannot be exactly duplicated. Minuscule differences in the product's structure and manufacturing process can result in different clinical outcome. This raises concerns over the safety, efficacy and even pharmacovigilance of biosimilars. Thus, biosimilars are unique - they are not a true chemical generic and are regulated via a distinct regulatory framework. This report discusses the features of Malaysian regulatory oversight of biosimilars and experience acquired in the evaluation of some products from various countries. Ensuring regulatory position adequately reflects scientific advancement, expertise/resources is key. The regulatory situation is an evolving process. Various guidance documents are being prepared with the aim of developing a uniform global framework towards assuring the dual goal of lower costs and patient safety while expediting the availability of important biosimilar products.

Matched MeSH terms: Drug Industry/legislation & jurisprudence*; Drug Industry/standards*
How might the Trans-Pacific Partnership impact on the pharmaceutical sector in Vietnam?

Binh NH, Anh PN, Phuong NM

Pharm Pat Anal, 2016 Jul;5(4):261-70.
PMID: 27346326 DOI: 10.4155/ppa-2016-0008

Ratification of the Trans-Pacific Partnership (TPP) will attract a large number of foreign drug companies in the coming years to Vietnam. It is anticipated to bring investment to Vietnam's pharmaceutical industries, lead to increased infrastructure and enable the use of more sophisticated technologies for the discovery, development and manufacture of drugs. However, with respect to pharmaceutical companies, which are producing generic drugs primarily, the availability of biologic will be reduced. Thus, the consequence is, an increase in drug cost resulting in difficulties for patients wishing to procure these drugs. This will be particularly detrimental for developing countries, such as Vietnam and Malaysia.

Matched MeSH terms: Drug Industry*
Fulltext Nature and Trends in Personal Payments Made to the Respiratory Physicians by Pharmaceutical Companies in Japan between 2016 and 2019

Murayama A, Hoshi M, Saito H, Kamamoto S, Tanaka M, Kawashima M, et al.

Respiration, 2022;101(12):1088-1098.
PMID: 36353778 DOI: 10.1159/000526576

BACKGROUND: Financial relationships between healthcare professionals and pharmaceutical companies have historically caused conflicts of interest and unduly influenced patient care. However, little was known about such relationship and its effect in clinical practice among specialists in respiratory medicine.
METHODS: Based on the retrospective analysis of payment data made available by all 92 pharmaceutical companies in Japan, this study evaluated the magnitude and trend of financial relationships between all board-certified Japanese respiratory specialists and pharmaceutical companies between 2016 and 2019. Magnitude and prevalence of payments for specialists were analyzed descriptively. The payment trends were assessed using the generalized estimating equations for the payment per specialist and the number of specialists with payments.
RESULTS: Among all 7,114 respiratory specialists certified as of August 2021, 4,413 (62.0%) received a total of USD 53,547,391 and 74,195 counts from 72 (78.3%) pharmaceutical companies between 2016 and 2019. The median (interquartile range) 4-year combined payment values per specialist were USD 2,210 (USD 715-8,178). At maximum, one specialist received USD 495,332 personal payments over the 4 years. Both payments per specialist and number of specialists with payments significantly increased during the 4-year period, with 7.8% (95% CI: 5.5-9.8; p < 0.001) in payments and 1.5% (95% CI: 0.61-2.4; p = 0.001) in number of specialists with payments, respectively.
CONCLUSION: The majority of respiratory specialists had increasingly received more personal payments from pharmaceutical companies for the reimbursement of lecturing, consulting, and writing between 2016 and 2019. These increasing financial relationships with pharmaceutical companies might cause conflicts of interest among respiratory physicians.

Matched MeSH terms: Drug Industry*
Artificial intelligence in drug development: present status and future prospects

Mak KK, Pichika MR

Drug Discov Today, 2019 03;24(3):773-780.
PMID: 30472429 DOI: 10.1016/j.drudis.2018.11.014

Artificial intelligence (AI) uses personified knowledge and learns from the solutions it produces to address not only specific but also complex problems. Remarkable improvements in computational power coupled with advancements in AI technology could be utilised to revolutionise the drug development process. At present, the pharmaceutical industry is facing challenges in sustaining their drug development programmes because of increased R&D costs and reduced efficiency. In this review, we discuss the major causes of attrition rates in new drug approvals, the possible ways that AI can improve the efficiency of the drug development process and collaboration of pharmaceutical industry giants with AI-powered drug discovery firms.

Matched MeSH terms: Drug Industry
Fulltext Using VigiBase to Identify Substandard Medicines: Detection Capacity and Key Prerequisites

Juhlin K, Karimi G, Andér M, Camilli S, Dheda M, Har TS, et al.

Drug Saf, 2015 Apr;38(4):373-82.
PMID: 25687792 DOI: 10.1007/s40264-015-0271-2

Substandard medicines, whether the result of intentional manipulation or lack of compliance with good manufacturing practice (GMP) or good distribution practice (GDP), pose a significant potential threat to patient safety. Spontaneous adverse drug reaction reporting systems can contribute to identification of quality problems that cause unwanted and/or harmful effects, and to identification of clusters of lack of efficacy. In 2011, the Uppsala Monitoring Centre (UMC) constructed a novel algorithm to identify reporting patterns suggestive of substandard medicines in spontaneous reporting, and applied it to VigiBase(®), the World Health Organization's global individual case safety report database. The algorithm identified some historical clusters related to substandard products, which were later able to be confirmed in the literature or by contact with national centres (NCs). As relevant and detailed information is often lacking in the VigiBase reports but might be available at the reporting NC, further evaluation of the algorithm was undertaken with involvement from NCs.

Matched MeSH terms: Drug Industry/standards*
Malaysia seeks biotech partners

Aldridge S

Nat Biotechnol, 2009 Apr;27(4):305.
PMID: 19352354 DOI: 10.1038/nbt0409-305c
Matched MeSH terms: Drug Industry/organization & administration*
Fulltext Making pharmaceutical research and regulation work for women

Ravindran TS, Teerawattananon Y, Tannenbaum C, Vijayasingham L

BMJ, 2020 10 27;371:m3808.
PMID: 33109511 DOI: 10.1136/bmj.m3808
Matched MeSH terms: Drug Industry/legislation & jurisprudence*
Ethical boundaries between the medical profession and the health care industry (1)

Ravindran J

Med J Malaysia, 2000 Aug;55 Suppl B:43-50.
PMID: 11125521
Matched MeSH terms: Drug Industry*
Identification, control strategies, and analytical approaches for the determination of potential genotoxic impurities in pharmaceuticals: a comprehensive review

Reddy AV, Jaafar J, Umar K, Majid ZA, Aris AB, Talib J, et al.

J Sep Sci, 2015 Mar;38(5):764-79.
PMID: 25556762 DOI: 10.1002/jssc.201401143

Potential genotoxic impurities in pharmaceuticals at trace levels are of increasing concern to both pharmaceutical industries and regulatory agencies due to their possibility for human carcinogenesis. Molecular functional groups that render starting materials and synthetic intermediates as reactive building blocks for small molecules may also be responsible for their genotoxicity. Determination of these genotoxic impurities at trace levels requires highly sensitive and selective analytical methodologies, which poses tremendous challenges on analytical communities in pharmaceutical research and development. Experimental guidance for the analytical determination of some important classes of genotoxic impurities is still unavailable in the literature. Therefore, the present review explores the structural alerts of commonly encountered potential genotoxic impurities, draft guidance of various regulatory authorities in order to control the level of impurities in drug substances and to assess their toxicity. This review also describes the analytical considerations for the determination of potential genotoxic impurities at trace levels and finally few case studies are also discussed for the determination of some important classes of potential genotoxic impurities. It is the authors' intention to provide a complete strategy that helps analytical scientists for the analysis of such potential genotoxic impurities in pharmaceuticals.

Matched MeSH terms: Drug Industry
Trade, TRIPS, and pharmaceuticals

Smith RD, Correa C, Oh C

Lancet, 2009 Feb 21;373(9664):684-91.
PMID: 19167054 DOI: 10.1016/S0140-6736(08)61779-1

The World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) set global minimum standards for the protection of intellectual property, substantially increasing and expanding intellectual-property rights, and generated clear gains for the pharmaceutical industry and the developed world. The question of whether TRIPS generates gains for developing countries, in the form of increased exports, is addressed in this paper through consideration of the importance of pharmaceuticals in health-care trade, outlining the essential requirements, implications, and issues related to TRIPS, and TRIPS-plus, in which increased restrictions are imposed as part of bilateral free-trade agreements. TRIPS has not generated substantial gains for developing countries, but has further increased pharmaceutical trade in developed countries. The unequal trade between developed and developing countries (ie, exporting and importing high-value patented drugs, respectively) raises the issue of access to medicines, which is exacerbated by TRIPS-plus provisions, although many countries have not even enacted provision for TRIPS flexibilities. Therefore this paper focuses on options that are available to the health community for negotiation to their advantage under TRIPS, and within the presence of TRIPS-plus.

Matched MeSH terms: Drug Industry/economics*; Drug Industry/trends; Drug Industry/statistics & numerical data
Three-Dimensional (3-D) Printing Technology Exploited for the Fabrication of Drug Delivery Systems

Zeeshan F, Madheswaran T, Pandey M, Gorain B

Curr Pharm Des, 2018;24(42):5019-5028.
PMID: 30621558 DOI: 10.2174/1381612825666190101111525

BACKGROUND: The conventional dosage forms cannot be administered to all patients because of interindividual variability found among people of different race coupled with different metabolism and cultural necessities. Therefore, to address this global issue there is a growing focus on the fabrication of new drug delivery systems customised to individual needs. Medicinal products printed using 3-D technology are transforming the current medicine business to a plausible alternative of conventional medicines.
METHODS: The PubMed database and Google scholar were browsed by keywords of 3-D printing, drug delivery, and personalised medicine. The data about techniques employed in the manufacturing of 3-D printed medicines and the application of 3-D printing technology in the fabrication of individualised medicine were collected, analysed and discussed.
RESULTS: Numerous techniques can fabricate 3-D printed medicines however, printing-based inkjet, nozzle-based deposition and laser-based writing systems are the most popular 3-D printing methods which have been employed successfully in the development of tablets, polypills, implants, solutions, nanoparticles, targeted and topical dug delivery. In addition, the approval of Spritam® containing levetiracetam by FDA as the primary 3-D printed drug product has boosted its importance. However, some drawbacks such as suitability of manufacturing techniques and the available excipients for 3-D printing need to be addressed to ensure simple, feasible, reliable and reproducible 3-D printed fabrication.
CONCLUSION: 3-D printing is a revolutionary in pharmaceutical technology to cater the present and future needs of individualised medicines. Nonetheless, more investigations are required on its manufacturing aspects in terms cost effectiveness, reproducibility and bio-equivalence.

Matched MeSH terms: Drug Industry
Fulltext Conflicts of interest in orthopaedic surgery: The intertwining of orthopaedic surgery, peer review publications and corporate sponsorship

Dhillon KS

Malays Orthop J, 2015;9(1):47-59.
MyJurnal

Conflicts of interest in medicine has created deep concerns about the integrity of medicine and raised doubts about the trustworthiness of the medical professional. New stories of conflict of interest in medicine have become a commonplace. The interactions between the medical professional and the biomedical device as well as the pharmaceutical industry has become so pervasive that the primary interest of the medical professional in protecting and promoting the welfare of the patient has been compromised. The professional judgement and actions have been influenced by secondary interests, the major fungible and quantifiable being financial interest. The industry influence not only affects the way we practice orthopaedics but also affects medical education and peer review publications. Peer review publications have been shown to exaggerate benefits of the industry products while at the same time downplaying the risks. These conflicts of interest in orthopaedic surgery are particularly common in spinal and joint replacement surgery where joint replacement has been described as a ‘fashion trade’. The introduction of new products appears to be an uncontrolled experiment which has been hijacked by large corporations. This article explores the unhealthy pervasive interaction between the orthopaedic surgeon and the medical devices as well as the pharmaceutical industry. It highlights how the biomedical and the pharmaceutical industry dominate all aspects of the healthcare system. With its wealth and political clout, its influence is present everywhere, from the use of devices and drugs, research, publications, trials, education and even formulation of CGPs.

Matched MeSH terms: Drug Industry
Production of acetoin from hydrothermally pretreated oil mesocarp fiber using metabolically engineered Escherichia coli in a bioreactor system

Mohd Yusoff MZ, Akita H, Hassan MA, Fujimoto S, Yoshida M, Nakashima N, et al.

Bioresour Technol, 2017 Dec;245(Pt A):1040-1048.
PMID: 28946206 DOI: 10.1016/j.biortech.2017.08.131

Acetoin is used in the biochemical, chemical and pharmaceutical industries. Several effective methods for acetoin production from petroleum-based substrates have been developed, but they all have an environmental impact and do not meet sustainability criteria. Here we describe a simple and efficient method for acetoin production from oil palm mesocarp fiber hydrolysate using engineered Escherichia coli. An optimization of culture conditions for acetoin production was carried out using reagent-grade chemicals. The final concentration reached 29.9gL(-1) with a theoretical yield of 79%. The optimal pretreatment conditions for preparing hydrolysate with higher sugar yields were then determined. When acetoin was produced using hydrolysate fortified with yeast extract, the theoretical yield reached 97% with an acetoin concentration of 15.5gL(-1). The acetoin productivity was 10-fold higher than that obtained using reagent-grade sugars. This approach makes use of a compromise strategy for effective utilization of oil palm biomass towards industrial application.

Matched MeSH terms: Drug Industry
Fulltext Placebo Controlled Trials: Interests of Subjects versus Interests of Drug Regulators

Sasongko TH, Othman NH, Hussain NHN, Lee YY, Abdullah S, Husin A, et al.

Malays J Med Sci, 2017 Aug;24(4):1-4.
PMID: 28951684 DOI: 10.21315/mjms2017.24.4.1

The use of placebo-controlled trials in situations where established therapies are available is considered ethically problematic since the patients randomised to the placebo group are deprived of the beneficial treatment. The pharmaceutical industry and drug regulators seem to argue that placebo-controlled trials with extensive precautions and control measures in place should still be allowed since they provide necessary scientific evidence for the efficacy and safety of new drugs. On the other hand, the scientific value and usefulness for clinical decision-making may be much higher if the new drug is compared directly to existing therapies. As such, it may still be unethical to impose the burden and risk of placebo-controlled trials on patients even if extensive precautions are taken. A few exceptions do exist. The use of placebo-controlled trials in situations where an established, effective and safe therapy exists remains largely controversial.

Matched MeSH terms: Drug Industry
[Lauritz Toft and DUMEX--the man, the idea and the way to its realization]

Overø K

Theriaca, 2009.
PMID: 20027790

Lauritz Toft (1920-1991), also known as Lau, graduated with a MSc degree in pharmacy at the Royal Danish School of Pharmacy in 1944. During the education and parallel activities Lau had shown gifts for intuition and improvisation, together with special talents for leadership and large-scale working. In 1945 he got the idea during the organization of the East Asiatic Company Ltd. to sell the best of the products from the Danish pharmaceutical companies in India under a common trade mark: DUMEX (Danish United Medical Export). The article describes Lau's difficulties and problems in realizing this idea. The adventure peaks in the mid-1950's with about 40 pharmacists in DUMEX-departments in India as well as Thailand, Malaysia, Indonesia, China etc.

Matched MeSH terms: Drug Industry/history*; Drug Industry/organization & administration

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