Page 187 - CW E-Magazine (16-1-2024)

Special Report Special Report

and hydrocarbons, thereby opening up EU’s list of critical medicines: Its impact for API
applications in areas where ammonia
or hydrocarbons as single-stage refrige- manufacturers
rant would not be applicable.
he European Commission, the including being critical in more than
Algae biofuel Heads of Medicines Agencies, one third of EU/EEA countries.” PATRICIA VAN ARNUM
Algae crop contain 20-25% oil, Tand the European Medicines Editorial Director
depending on species. Algae biofuel Agency have published the fi rst version The list contains active substances Drug, Chemical & Associated
is produced from algae crop, which is of the EU’s list of critical medicines for of innovator and generic drugs cover- Technologies Association,Inc. (DCAT)
used as eco-friendly biofuel. The large which the EU is prioritizing continuity ing a wide range of therapeutic areas, duction within the EU, or adhering
production of algae biofuel would of supply. What active pharmaceutical and includes vaccines and medicines to additional regulatory requirements
reduce use of petroleum fuel and reduce ingredients made the list, and what is for rare diseases. It refl ects the outcome or obligations. Other measures could
India’s import of crude oil. During the the impact on API manufacturers?. of the review of 600 active substances include investment incentives and
production of algae biofuel from algae taken from six national lists of critical procurement approaches with more
crop, methane (natural gas ) is pro- aging, etc. Other areas of application polymerization of p-phenylenediamine On December 12, 2023, the medicines. The list will be expanded substantial contractual obligations for
duced, which can be used for power include biomedical fi eld, textile/sani- (PPDA) and terephthaloyl chloride. European Commission (EC), the in 2024 and will then be updated every allocation and delivery.
generation. By fermentation of bio- tary products/fabrics. PLA is seen as Meta-aramid fi bre is produced from Heads of Medicines Agencies (HMA) year, according to the EMA.
mass, ethanol is produced. Commercial an alternative for polyethylene tereph- the reaction of m-phenylenediamine and the European Medicines Agency The publication of the list will not
algae biofuel plants are in operation thalate (PET) due to its mechanical (MPDA) and isophthaloyl chloride. published the fi rst version of the The review was carried out with all impact existing or to-be-established
abroad. properties such as low impact strength, European Union’s (EU) list of criti- EU member states, and criticality was national lists of critical medicines,
hardness, stiffness, and elasticity. Aramid fi bers have extremely high cal medicines. It contains more than assigned based on an agreed methodo- according to the EMA. However, it will
Polylactic acid tensile strength, which is why they are 200 active substances of medicines for logy developed in consultation with key support the network’s efforts in draw-
Polylactic acid or polylactide (PLA) Indian import is around 2,360 commonly used in armour and ballistic human use considered critical for stakeholder groups, including patients’ ing up national lists where these do not
is a biodegradable thermoplastic. PLA tonnes per annum. Global demand is protection application. Application healthcare systems across the EU/ and healthcare professionals’ organisa- yet exist. In addition, it will support
is produced by fermentation of starch. around 0.5-mt. sector include optical fi bres, tyre rein- European Economic Area, for which tions and industry associations. Medici- and expedite the European Commis-
Being biodegradable, PLA can be forcement, electrical insulation, rubber continuity of supply is a priority and nal product criticality was based on the sion’s analysis of the supply chain of
employed in the preparation of loose fi ll Aramid fi bres reinforcement, and ropes & cables.. shortages should be avoided. In its following two criteria: the therapeutic critical medicines to determine poten-
packaging, drinking cups, salad cups, Aramid fi bre is a kind of polyamide Global demand for aramid fi bres is release of December 12, 2023, the indication of the medicine; and the tial vulnerabilities, as announced by
overwrap, compost bags, food pack- fi bre. It is produced by condensation about 150,000 tonne per annum. EMA said that the European medicines availability of appropriate alternatives. the European Commission’s com-
regulatory network will prioritize criti- Medicines on the list can continue munication of October 24, 2023. The
cal medicines for EU-wide actions to to be prescribed and used as usual by European Commission’s and the EMA’s
Chemical Weekly Buyers’ Guide
strengthen their supply chain. patients and healthcare professionals. Medicines Shortages Steering Group
www.cwbg.in Additional reporting requirements for (MSSG) may propose measures to
www.cwbg.in “The list is an important tool to marketing authorization holders and address vulnerabilities in the supply of
Pocket-Friendly Pay-as-you-use Subscription Plans support the EU’s efforts in ensuring national competent authorities will be those medicines, to ultimately prevent
supply security and preventing shortages established and become effective once and mitigate shortages.
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Plan Hours of usage INR* USD* sion in the list does not mean that the (as proposed in the European Com-
Plan 25 25 1,500 25 medicine is likely to experience a short- Critical medicines and the supply mission’s Communication) include
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Plan 100 100 4,500 75 Directory prevention of shortages is particularly Although the supply of all medi- to diversify and attract manufacturing
Plan 150 150 6,000 100 on Indian
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signifi cant harm to patients and pose vant actions can be taken to guarantee strategies to better support security of
For more information or for a FREE trial contact: and Trade
important challenges to health systems. their availability, medicines identifi ed supply. There may also be requests for
Mr. Kiran Iyer Mr. Abhishek Vora A medicine is considered critical if it as critical for public health will receive input into the assessment of the vulner-
kiran@chemicalweekly.com abhi@chemicalweekly.com is used in serious diseases and cannot particular attention. They will be prio- ability of the supply chain, which is car-
Chemicals & Search & download
Chemical Weekly Database Pvt. Ltd. related products / data on 8,500+ be easily replaced by other medicines, ritized for EU-wide policy measures ried out by the European Commission.
602-B, Godrej Coliseum, K.J. Somaiya Hospital Road, Equipment & Manufacturers / for example in case of a shortage. It is to improve their security of supply,
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Phone: +91-22-24044471 72 Consultants Merchant Exporters
medicines if it meets certain criteria, sifi cation of suppliers, stimulating pro- medicines across the EU and avoid

186 Chemical Weekly January 16, 2024 Chemical Weekly January 16, 2024 187

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