Asia-Pacific Roundup: Indonesia revokes licenses of suppliers linked to contaminated cough medicines

The Indonesian Food and Drug Authority (BPOM) has revoked the licenses of two ingredient suppliers as part of its investigation into contaminated cough syrups linked to the deaths of 195 children.
 
Responding to the deaths and cases of acute kidney injury, BPOM has carried out inspections and tried to trace the sources of raw materials that contain levels of ethylene glycol and diethylene glycol above the acceptable threshold. The work led the regulatory agency to revoke the licenses of two suppliers of chemicals that distributed the solvent propylene glycol in Indonesia.
 
BPOM revoked the licenses of PT Mega Setia Agung Kimia and PT Tirta Buana Kemindo after finding they distributed raw materials containing the contaminants to the pharmaceutical industry. The investigation also found the companies procured raw materials from general chemical distributors without performing the necessary checks.
 
The regulatory agency has also investigated other players in the supply chain, including the chemical distributor CV Samudra Chemical. Ten propylene glycol samples taken from the firm contained ethylene glycol, while the contaminant was not found in two samples. BPOM has taken evidence including drums of chemicals and documents and will share its materials with the police.
 
In parallel, the regulatory agency has been testing finished products manufactured by pharmaceutical companies. Last week, BPOM revealed the tests have identified more products that contain levels of ethylene glycol or diethylene glycol above the acceptable limit. The discovery led the agency to order PT Samco Farma and PT Ciubros Farma to recall the medicines and to ban them from producing syrups.
 
BPOM has stopped the companies from manufacturing products that use propylene glycol, polyethylene glycol, sorbitol or glycerol/glycerin as solvents until there is further development regarding the results of a good manufacturing practice test and inspection.
 
BPOM Notice (Indonesian), AFP Article
 
India’s NPPA shares fixes for problems with implementation of pharmaceutical database
 
India’s National Pharmaceutical Pricing Authority (NPPA) has updated the Integrated Public Database Management System 2.0 (IPDMS) in response to feedback from stakeholders about operational issues.
 
Last month, NPPA met with stakeholders to discuss the implementation of IPDMS 2.0, the system used to collect information from pharmaceutical manufacturers online, and to solicit feedback on operational issues faced by the industry. The meeting resulted in 40 issues that NPPA described and responded to in a new summary of the discussion.
 
NPPA has already implemented changes in response to some of the feedback. The cost watchdog extended the idle session time to up to one hour after hearing that manufacturers were needing to login multiple times. NPPA also granted manufacturers the power to edit information about the locations of their production facilities after stakeholders said they were unable to correct erroneous facts migrated from version 1.0 of the IPDMS.
 
In other cases, NPPA is still working on fixes to the issues. Stakeholders told the administration that the plant verification step is taking too long, with companies having to wait up to three weeks and complaining that the lag is preventing the smooth implementation of IPDMS 2.0. In response, NPPA said it will remove the plant verification process but, at the time it published the summary, the change was still “under process.”
 
NPPA needs more information to process some of the requested changes. The administration heard from companies that want to use a drop-down menu to enter the strength of their active pharmaceutical ingredients, rather than having to input text. NPPA is performing an “impact analysis” of the request but noted it will need manufacturers to share possible strengths so it can populate the drop-down menu.
 
NPPA Notice
 
China’s NMPA to switch to electronic certificates for European API exports next month
 
China’s National Medical Products Administration (NMPA) will start using electronic certificates for the “Documentation for Export of APIs to [the] EU” and “Certificate of a Pharmaceutical Product” from 1 December.
 
NMPA framed the change as part of a push to “provide drug export enterprises with more efficient and convenient administrative services.” The electronic certificate and paper version are “equally authentic,” the administration said.
 
NMPA has created a new template for the Certificate of a Pharmaceutical Product that it will put into use in line with China’s pharmaceutical export practices and World Health Organization guidelines. Starting on 1 December, provincial-level drug regulatory authorities will issue the Certificate of a Pharmaceutical Product in accordance with the new template. Provincial drug regulatory departments should clarify the relevant guidelines to companies when their application systems are used to issue electronic certificates.
 
Applicants will need to register and be authenticated by NMPA online. Once set up, companies will be able to view and download certificates from the administration’s “online office hall” and app. NMPA has created a frequently asked question section related to electronic certificates on its online platform.
 
NMPA Notice
 
India moves to update drug pricing law
The Indian government has updated the Drugs (Prices Control) Order, 2013 to reflect the release of the National List of Essential Medicines (NLEM) 2022.
 
In September, Indian officials published the updated NLEM, dropping 26 medicines and adding a further 34 to create a list of 384 approved products deemed essential by the government. The list includes more cancer therapies, newer diabetes treatments and four products with patent protection and informs the scope of Indian price controls.
 
The updated legislation lists the medicines in the NLEM along with the level of healthcare at which they are used — primary, secondary or tertiary — and the dosage form and strengths covered by the price control order. Companies that reformulate ingredients on the NLEM to improve on the standard product will be subject to different policies.
 
“Innovation in medicine must be encouraged,” the legislation states. “The formulations developed through incremental innovation or novel drug delivery systems like lipid/liposomal formulations etc. should be considered as included only if specified in the list against any medicine. Such different formulations should be considered differently for purposes such as procurement policy, pricing, etc.”
 
Updated Legislation
 
Pakistan’s DRAP signs agreement to use integrated electronic platform for regulatory forms
 
The Drug Regulatory Authority of Pakistan (DRAP) has signed a memorandum of understanding as part of its plans to provide the industry with an integrated electronic platform for the import and export of raw materials and finished products.
 
DRAP signed the agreement with the Pakistan Single Window (PSW), an initiative led by the country’s customs body. PSW aims to reduce the time and cost of doing business by digitizing Pakistan’s cross-border trade and providing a single entry point to fulfill all import, export and transit-related regulatory requirements.
 
Signing the agreement is intended to improve cooperation between the two parties and support the integration of PSW’s IT system with DRAP’s regulatory processes. DRAP expects both its staff and the companies it regulates to benefit from having a single electronic working environment.
 
DRAP Notice
 
Other News:
 
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