Asia-Pacific Roundup: India cuts prices of more than 30 drugs and biologics
India’s National Pharmaceutical Pricing Authority (NPPA) has announced price reductions for more than 30 drugs and biological products as part of a recent revision to the country’s drug pricing legislation.
The Indian government said the drug price changes would come into effect on 30 June, and impacts companies based on the “the stock handled by each retailer, distributor, or stockist found selling the formulation above the ceiling price (plus local taxes as applicable) pertaining to that batch.”
The government has lowered prices on 39 commonly used drugs, including medications that manage high blood pressure and coronary artery disease, high cholesterol, cardiovascular disease, blood clots, type 2 diabetes, and chronic kidney disease.
NPPA has also targeted price reductions for vitamin D as well as antibiotics such as amoxicillin and medications that serve as pain relievers, reduce swelling and inflammation, eye drops for inflammation and intraocular pressure, HIV drug combinations, and the cancer therapy imatinib.
Separately, the government announced price ceilings for calcium and vitamin D tablets, a triple combination maintenance therapy for chronic obstructive pulmonary disease, intravenous fluid packs, an anti-rabies biologic, and a pneumococcal polysaccharide conjugate vaccine.
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NMPA completes QMS review for vaccine and drug GMP compliance
The National Medical Products Administration (NMPA) announced it has completed its management review of the quality management system for drug and vaccine good manufacturing practice compliance on 30 June.
NMPA said it identified problems and corrective actions taken from 2025 in the review and examined suggestions for improvement in the system. NMPA Commissioner Huang Guo said in the announcement the QMS has aided in improving regulatory work, allocation of resources, and personnel training. He noted that the QMS has been implemented across several organizational divisions with NMPA, and relevant departments have instituted requirements for risk management, risk identification, and whole-process management.
The agency also said provincial-level drug regulatory authorities in China have completed a 3-year observational period of an internal NMPA review. There is a need for “further efforts to promote the comprehensive and multi-level coordination, alignment and improvement of the system based on the current progress,” according to Guo.
Pharmacopoeial Discussion Group announces harmonized standards for osimertinib mesylate, osimertinib tablets
The Pharmacopoeial Discussion Group has announced its first trilateral harmonization project that would standardize the document standards for osimertinib mesylate and osimertinib tablets.
The group, which comprises the European Pharmacopoeia, Japanese Pharmacopoeia, and United States Pharmacopeia, has traditionally looked to retrospectively harmonize general chapters and excipient monographs, this is the first prospective harmonization project for the discussion group.
The project would expand harmonization to small molecule drug substances and finished dosage forms, the group said. The goal of the initiative is to have monographs for active ingredients and drug products across the three regions.
Philippine FDA issues public health warnings, voluntary product recall for drug products
The Food and Drug Administration of the Philippines (FDA) is warning the public not to purchase and use two unregistered drugs, noting both products have not undergone the required review process and may be harmful if used or consumed.
The Philippine FDA said that after post-marketing surveillance, they found that 10-mg uncoated medroxyprogesterone acetate tablets USP (Provera) and Southstar’s 70% isopropyl alcohol 330 mL spray bottle had not followed the proper registration process in the country and have not received a certificate of product registration. The agency told the public not to purchase these products until they have been authorized by the Philippine FDA.
A voluntary recall of specific batches of iodixanol 652 mg/mL, an x-ray contrast medium, was also announced by the agency. The voluntary recall is being conducted after metal particulates were detected in certain batches of iodixanol filled at an Ireland manufacturing site. The Philippine FDA is issuing a class I recall of the affected batches.
Other News:
PDMA has also released an English-language translation of its conditional approval for raguneprocel (AMCHEPRY), an induced pluripotent stem (iPS) cell-based therapy for Parkinson's disease. The report states the product has been approved for 7 years and must undergo post-marketing assessment until it receives a standard marketing approval.
