Asia-Pacific Roundup: India unveils pharmacovigilance awareness, reporting initiatives

The Indian Pharmacopoeia Commission (IPC) has disclosed new actions to improve pharmacovigilance awareness and reporting.

IPC, functioning as the National Coordination Centre for the Pharmacovigilance Programme of India (NCC-PvPI), kicked off the fifth National Pharmacovigilance Week last week. The week-long campaign, which concludes on 23 September, has the theme “Your Safety, Just a Click Away: Report to PvPI” and is intended to encourage reporting of adverse drug reactions.

As a part of the effort, IPC created a short film on PvPI, a pharmacovigilance comic published in multiple vernacular languages to enhance public awareness, and a new online reporting platform designed for easy access through a QR code.

The new initiatives aim to get healthcare professionals, regulators, researchers, and the public to actively report adverse drug reactions (ADRs) “through simplified digital platforms.” IPC and other Indian regulatory bodies are particularly keen to expand the variety of parties who make significant contributions to ADR reporting.

“Since the inception of the program, the majority of reports have come from healthcare professionals, whereas meaningful impact can only be achieved when patients themselves actively participate in reporting,” Rajeev Singh Raghuvanshi, the Drugs Controller General of India (DCGI), said.

Raghuvanshi said that India ranks “among the top contributors globally in reporting adverse events.” Yet, while the DCGI believes “pharmacovigilance has got a strong base and policies are being designed and regulated,” he identified a need for practices to change “as the context has changed in the country.”

Raghuvanshi added, “We need to develop a culture of curiosity within the organization, not the culture of apprehension, for better results.” Technology will play a role too, with the DCGI calling for the “smart integration” of tools and innovative approaches “to drive differential thinking.”

Press Release

CDSCO clarifies regulatory approval pathway for co-crystals in India

India’s Central Drugs Standard Control Organization (CDSCO) has clarified the pathway for approving pharmaceutical co-crystals.

CDSCO defines co-crystals as crystalline materials composed of two or more different molecules. The molecules are typically active pharmaceutical ingredients (API) and co-crystal formers. CDSCO said the molecules are in the same crystal lattice in a defined stoichiometric ratio associated by nonionic and noncovalent bonds.

When seeking approval for a co-crystal, applicants must show that the formulation performs better in vitro and in vivo than a physical mixture of its chemical components. Companies will need to test the physicochemical and pharmacokinetic properties of the co-crystal to gather the required evidence.

CDSCO outlined the use of diffraction methods such as single-crystal X-ray diffraction and spectroscopic analysis of the solid-state co-crystals using approaches including Raman spectroscopy. The agency said the technologies can determine whether a formulation is defined as a co-crystal or as a mixture of APIs or a fixed-dosed combination.

The conclusion has regulatory implications. CDSCO said co-crystals of active substances that are already approved are considered as new drugs and subject to the requirements set out in the New Drugs and Clinical Trials Rules, 2019.

Co-crystals that are classed as new drugs may need to undergo manufacturing process validation, stability tests, additional clinical and non-clinical studies, and bioavailability and bioequivalence assessments to demonstrate safety and efficacy.

CDSCO provided the information in response to requests for clarification. The agency said co-crystals can provide opportunities for engineering solid-state forms that enhance drug product bioavailability and stability. Other potential advantages include enhancing the processability of APIs in drug product manufacture.

CDSCO Notice

Regulators from China and Singapore discuss deepening cooperation

A delegation from the Health Sciences Authority (HSA) of Singapore has travelled to Beijing to talk to Chinese officials about strengthening cooperation.

Li Li, the commissioner of China’s National Medical Products Administration (NMPA), met with HSA CEO Raymond Chua Swee Boon at the talks. NMPA said the event included in-depth discussions on further strengthening cooperation in drug and medical device regulation between China and Singapore.

Specifically, the two sides exchanged views on promoting mutual reliance in drug and medical device regulation between China and Singapore. The regulation of traditional Chinese medicines was also on the agenda. NMPA said the two sides agreed to deepen practical cooperation in drug regulation and to jointly improve the quality and efficiency of drug regulation.

NMPA and HSA discussed opportunities for cooperation after setting out their approaches to drug and device regulation. Li explained how China has prioritized drug quality and safety while reforming the approval system and adding regulatory capacity. Chua discussed HSA’s participation in international drug regulatory harmonization and the establishment of reliance and cooperation mechanisms.

Press Release

CDSCO updates online portal for importers of devices and diagnostics

CDSCO has made a provision for “subsequent importers” of medical devices and diagnostics in its online portal.

The agency said applicants that intend to import devices and diagnostics “that are already approved by the Central Licensing Authority for marketing in the country may submit their application for import of such devices as subsequent importer as per checklist provided for the said purpose.”

CDSCO shared details of the new provision for subsequent importers alongside changes intended to simplify regulatory procedures. The changes include the publication of “tool tips” on CDSCO’s website to clarify technical requirements for people using its portal to seek regulatory approval.

The agency has also simplified the procedure for “brand approval.” CDSCO said it has created “minimum requirements and separated from the routine endorsement applications with the objective to reduce processing timelines and facilitate expedited approval.” The changes are part of a broader push to bring more transparency and accountability to the regulatory system.

CDSCO Notice

NPPA defers knee implant price ceiling decision with 2-month extension

India’s National Pharmaceutical Pricing Authority (NPPA) has extended the use of the current knee implant price ceiling by up to two months.

NPPA set the current price cap in September 2024. That notice extended the price ceiling for a range of primary and secondary knee replacement systems until 15 September 2025. NPPA capped the prices of knee implants in 2017 and has reevaluated the ceiling roughly every year since then.

On the day the current cap was set to expire, NPPA published a notice to extend the use of the existing ceiling until 15 November. The price watchdog said “representations received from manufacturers and industry associations by the Authority are under its consideration” in its notice to disclose the change.

Pharmabiz said industry groups have highlighted fluctuations in foreign exchange rates, increases in the cost of staff and freight, supply chain problems, and other factors when discussing the appropriate price cap for knee implants with NPPA.

NPPA Notice

Other news

CDSCO and the Indian Council of Medical Research have published a batch of 39 standard performance evaluation protocols for in vitro diagnostics. The organizations have run a series of consultations on protocols in recent months. The work has led to the publication of the first batch of finalized protocols, which officials see to support the Indian diagnostics industry. Evaluation Protocols

Australia’s Therapeutic Goods Administration (TGA) is seeking feedback on proposals to reclassify certain preparations of vitamin D, isotretinoin, mannitol, and efepoetin alfa. The consultation, which closes on 17 October, will inform advisory committee meetings that are scheduled for November. TGA Notice

Asia-Pacific Roundup: India unveils pharmacovigilance awareness, reporting initiatives

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