In response to deaths and cases of acute kidney failure, BPOM has conducted inspections and attempted to trace sources of raw materials containing levels of ethylene glycol and diethylene glycol above the acceptable threshold. The work led the regulatory agency to revoke the licenses of two chemical suppliers who distributed the solvent propylene glycol in Indonesia.
BPOM revoked the licenses of PT Mega Setia Agung Kimia and PT Tirta Buana Kemindo after it was discovered that they were distributing raw materials containing contaminants to the pharmaceutical industry. The investigation also revealed that the companies were sourcing raw materials from general chemical distributors without carrying out the necessary checks.
The regulatory agency also investigated other players in the supply chain, including chemical distributor CV Samudra Chemical. Ten propylene glycol samples taken from the company contained ethylene glycol, while the contaminant was not found in two samples. BPOM has collected evidence, including chemical canisters and documents, and will share its documents with the police.
In parallel, the regulatory agency tests finished products manufactured by pharmaceutical companies. Last week, BPOM revealed that testing identified more products with ethylene glycol or diethylene glycol levels above the acceptable limit. The discovery led the agency to order PT Samco Farma and PT Ciubros Farma to recall the drugs and ban them from producing syrups.
BPOM has stopped companies from making products that use propylene glycol, polyethylene glycol, sorbitol or glycerol/glycerin as solvents until there are further developments regarding the results of a test and an inspection of good manufacturing practices.
BPOM Notice (Indonesian), AFP Article
Indian NPPA shares fixes for pharma database implementation issues
The National Pharmaceutical Pricing Authority (NPPA) of India has updated the Integrated Public Database Management System 2.0 (IPDMS) in response to stakeholder feedback on operational issues.
Last month, the 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 encountered. by industry. The meeting resulted in 40 issues which the NPPA outlined and responded to in a new summary of the discussion.
The NPPA has already implemented changes in response to some comments. The cost watchdog has extended session idle time to up to an hour after learning that manufacturers need to log in multiple times. The NPPA also granted manufacturers the authority to change information about their production facility locations after stakeholders said they were unable to correct erroneous facts migrated from version 1.0 of the NPPA. IPDMS.
In other cases, the NPPA is still working on fixes to the problems. Stakeholders told the administration that the factory verification stage was taking too long, with companies having to wait up to three weeks and complaining that the delay was preventing the smooth implementation of IPDMS 2.0 . In response, the NPPA said it would scrap the factory verification process but, at the time it released the summary, the change was still “in progress”.
The NPPA needs more information to process some of the requested changes. The administration has heard from companies that want to use a drop-down menu to enter the strength of their active pharmaceutical ingredients, rather than having to enter text. The NPPA is doing an “impact analysis” of the request, but noted that it would need manufacturers to share possible strengths in order to fill out the drop-down menu.
NPPA Notice
China’s NMPA to Switch to Electronic Certificates for European API Exports Next Month
The China National Medical Products Administration (NMPA) will start using electronic certificates for “Documentation for Exporting APIs to [the] EU” and “Certificate of Pharmaceutical Product” from December 1st.
The NMPA introduced the change as part of an effort to “provide drug export enterprises with more efficient and convenient administrative services.” The electronic certificate and the paper version are “equally authentic”, the administration said.
The NMPA has created a new pharmaceutical product certificate template that it will use in accordance with China’s pharmaceutical export practices and World Health Organization guidelines. As of December 1, provincial drug regulatory authorities will issue the Certificate of Pharmaceutical Product in accordance with the new model. Provincial drug regulatory authorities should clarify relevant guidelines for companies when their application systems are used to issue electronic certificates.
Candidates will need to register and be authenticated by the NMPA online. Once configured, companies will be able to view and download certificates from the “online office room” and administration application. The NMPA has created a Frequently Asked Questions section regarding electronic certificates on its online platform.
NMPA Notice
India set to update drug pricing law
The Government of India has updated the Medicines (Price Control) Order 2013 to reflect the release of the National List of Essential Medicines (NLEM) 2022.
In September, Indian authorities released the updated NLEM, removing 26 drugs and adding 34 others to create a list of 384 approved products deemed essential by the government. The list includes more cancer therapies, new diabetes treatments and four patent-protected products and informs about the scope of Indian price controls.
The updated legislation lists NLEM drugs along with the level of health care 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 the standard product will be subject to different policies.
“Innovation in medicine should be encouraged,” states the legislation. “Formulations developed through incremental innovation or new drug delivery systems such as lipid/liposomal formulations, etc. should only be considered included if specified in the list against any drug. These formulations different should be considered differently for purposes such as sourcing policy, pricing, etc.
Updated legislation
Pakistan DRAP signs agreement to use integrated electronic platform for regulatory forms
The Drugs Regulatory Authority of Pakistan (DRAP) has signed a Memorandum of Understanding as part of its project to provide industry with an integrated electronic platform for the import and export of raw materials and products finished.
DRAP has signed the agreement with Pakistan Single Window (PSW), an initiative led by the country’s Customs Authority. PSW aims to reduce the time and cost of doing business by digitizing Pakistan’s cross-border trade and providing a single point of entry to meet all regulatory requirements related to import, export and transit.
The signing of the agreement aims to improve cooperation between the two parties and to support the integration of PSW’s IT system with DRAP’s regulatory processes. DRAP expects its staff and the businesses it regulates to benefit from a single electronic work environment.
PARD Notice
Other news:
Australia’s Therapeutic Goods Administration (TGA) has issued a Product Defect Alert regarding new issues with certain Trilogy 100 ventilators that Philips has corrected as part of its recall. After Philips replaced the recalled PE-PUR foam, some users found that the new silicone noise canceling foam could become dislodged from its position and block airflow. TGA Reviews
