Drugmakers fight to attain approval
Drugmakers fight to attain approval
Switzerland’s drug maker Novartis Pharma Services AG has announced a GMP qualification for Lek Pharmaceuticals d.d. within the scope of certification for medicines in Vietnam, but doubts have been raised about recognition in regards to the valuable and much-sought-after PIC/S-GMP and EU-GMP standards.
Confusion reigns over the status of certification for Novartis’ Lek arm, Photo: Le Toan
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The Drug Administration of Vietnam (DAV) under the Ministry of Health (MoH) has announced the list of foreign-invested manufacturing factories failing to attain PIC/S-GMP and EU-GMP recognition, with some being required to make further clarifications. They include Novartis Pharma Services AG.
Specifically, in Annex 2 of the DAV’s Dispatch No.3518, Novartis Pharma Services AG site with the registered name Lek Pharmaceuticals d.d. is required to give further clarification regarding the company submitting a general file of the manufacturing establishment showing the manufacture of dosage forms without special requirements.
Novartis was also asked to provide an inspection report, or CPP certificate of a Good Manufacturing Practice (GMP) certification agency, clearly showing the dosage forms without special requirements within the scope of certification.
A representative of Novartis Vietnam Co., Ltd, told VIR, “Novartis appreciates the MoH’s transparency with regards to the announcement, which shows the prudent-monitored operations of the industry, and makes it convenient for companies and the community to have fast access to sufficient information and guidance from the MoH during the implementation of the process.”
The representative also elaborated, “As one of the leading global pharmaceutical companies with operations in Vietnam, we comply with all regulations and guidance from the MoH. As of now, the DAV and MoH have approved and announced the GMP qualification for Lek Pharmaceuticals within the appropriate scope of certification for our medicines in Vietnam.”
Despite Novartis’ announcement of the GMP qualification, it remains unclear whether the manufacturing site gets the high-in-demand PIC/S-GMP and EU-GMP certifications.
GMP is a basic standard, in a system for ensuring products are consistently made and controlled according to quality standards. It is designed to minimise the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. In Vietnam in 2004, the MoH issued Decision No.3886/2004/QD-BYT implementing the principles and standards of good manufacturing practices.
For western medicines, by the end of 2010, all enterprises producing external medicines and medicinal drug had to achieve GMP-WHO standards at least.
Meanwhile, PIC/S-GMP and EU-GMP are higher-standard certifications than GMP. EU-GMP certification is the highest recognition available by companies in the pharmaceutical space, while the PIC/S-GMP is a non-binding, informal co-operative arrangement between regulatory authorities in the field of GMP of medicinal products for human or veterinary use.
It is open to any authority with a comparable GMP inspection system. PIC/S presently comprises 53 participating authorities from all over the world.
On receiving the EU-GMP and PIC/S-GMP certifications, drugs channels can gain advantages and high profit in tenders in Group 1 of brand-name drugs which go to the hospital system, or the ethical drugs channel, which is the most profitable segment.
At present, there is no difference in tax incentive treatments in domestically-owned and foreign-invested facilities conducting outsourcing in Vietnam, all being subject to VAT exemption. Together with that exemption, currently the cost of brand-name drugs is 10-20 times higher than generic products, thus bringing in high profit for multinational corporations.
In the wake of the advantages, multinationals are rushing to seek PIC/S-GMP and EU-GMP recognition for their manufacturing sites. Besides Novartis, other famous multinational corporations in the race include GlaxoSmithKline, Sanofi, F.Hoffmann-La Roche Ltd., and more.
However, the path is not rosy for all of them. In the 72nd list of application for the announcement of manufacturers with PIC/S-GMP and EU-GMP qualifications which meet or did not meet requirements announced by the DAV-MoH in April, 64 applications require additional dossiers/clarifications.
French pharmaceutical giant Sanofi Vietnam Shareholding Company, proposed by Sanofi Vietnam, and Pharmatis, proposed by Abbott Laboratories Singapore Plc. and Dr. Reddy’s Laboratories Ltd.-FTO-3, are also on the list of those failing to receive the standards recognition.
