In this week’s news, India aims to boost API business, MHRA tweaks GMP and more…
India commits to boost API capacity to cut reliance on China
The Indian government has rolled out a $1.3-billion plan to up domestic starting materials and API production capacity.
India announced the plan last week, explaining that the idea is to try and encourage local production to reduce the country’s reliance on chemicals and drug ingredients made in China.
Prime Minister Nadrendra Modi said the government is committed to helping the industry in maintaining supply of Active Pharmaceutical Ingredients (API), underlining the importance of manufacture of such APIs within the country.
He said in order to ensure production of critical drugs and medical equipment within the country, the government has approved schemes worth Rs 10,000 crore and Rs 4,000 crore respectively.
Some NR 3,000 crore of the money allocated will be used to build three bulk drug parks in India over the next five years. The parks will have common utilities such as solvent recovery plants, distillation plants, power and steam units, and common effluent treatment plants.
According to a DCAT article, at present India imports 70% of the APIs used by CDMOs and drug companies from China.
UK MHRA relaxes GMP rules for drugs from third countries
The UK MHRA – the agency that regulates medicines in the UK – has relaxed some of the manufacturing rules for products made in so-called “third countries,” states outside the EU.
The London-based agency announced the relaxation last week, explaining it had removed some import testing requirements to facilitate easier importation processes.
It wrote “We consider that adhering to the principles for third party reliance set out in Annex 16 – in the current exceptional circumstances – could give QPs some flexibility by not having to repeat all quality control tests on importation from a third country manufacturer.”
Berry to prioritize healthcare sector during Covid-19
Plastics firm Berry Global has prioritized the production of healthcare materials at its facilities in China.
The firm said it “has shifted capacity to supply maximum output in response to increased demand for healthcare materials; these include materials for hard surface disinfectant wipes and face masks.
“In Europe, the Company’s melt blown lines are running around the clock to produce materials for face masks and other healthcare applications, such as materials used in blood filtration.”
James Cropper rejigs to maintain supply to pharma sector
Paper supply firm James Cropper has adapted operations to keep supplying products used by the pharmaceutical and healthcare packaging sector.
The firm announced the reorganisation last week, explaining “In the light of the Coronavirus pandemic the business has adapted its operation processes in order to fulfil customer orders and field incoming enquiries, while also moving swiftly to protect its 600 employees and the wider community.”
Also in the news
India has relaxed temporary export restrictions imposed on certain drug ingredients earlier this month.
According to an Economic Times report the Government will allow 24 of the 26 ingredients two ship. Restrictions will remain on paracetamol and its formulations.
In related news, the spread of Covi-19 in India is likely to result in shortages of generic drugs globally according to the Timmerman Report.
CDMOs and sponsors need to make supply chains more efficient according to a report by Trirx. The article predicts that competition will force contractors to adopt novel, more efficient systems.
J&J says it will establish vaccine manufacturing capacity in the US and elsewhere to prepare to supply its developmental Covid-19 vaccine. See press release.
Some development of note in the contracting space.
The US Government has asked Emergent BioSolutions to help speed up development of a Plasma-Derived Therapy for COVID-19. The drug in question – COVID-HIG – is made from antibodies extracted from the plasma of recovered patients.
Akron Biotechnology has bought a manufacturing site in Sarasota, Florida. The firm said the plant will increase capacity for the production of ancillary materials for cell and gene therapy development.
Frontage Laboratories has bought Biotranex, a New Jersey-based provider of drug metabolism and pharmacokinetic analysis services.