Asia-Pacific Roundup India to study regulatory bottlenecks in drug, device supply chains

India’s Department of Pharmaceuticals (DoP) is planning to study the country’s pharmaceutical and medical device supply chains to identify regulatory bottlenecks and find ways to enhance the reliability and efficiency of logistics.

DoP said the rapid expansion of the pharma and medtech industries and their significant role in domestic and international markets makes a comprehensive study of logistics “increasingly critical.” The scope of the planned study extends beyond regulations, with infrastructure deficiencies and inefficiencies within the remit of the project, but policy and regulatory matters are central to the proposal.

“The primary objective of the study is to propose strategic interventions that can optimize the efficiency and effectiveness of pharmaceutical and medical device logistics in the country,” DoP said. “These interventions include policy and regulatory provisions, infrastructure advancements, and logistics service improvements at critical production and consumption hubs, including at ports.”

DoP is seeking expressions of interest from organizations that want to run the study. The department wants the successful applicant to perform consultations and surveys with stakeholders such as regulators and manufacturers.

The primary and secondary research will inform assessments of topics including the regulatory and enabling environment. DoP wants the study to include a review of “existing processes, approvals, policies and regulations, and regulations impacting logistics in the pharmaceutical and medical device sectors.”

Another section of the study will address the ease of doing business in India. That section will evaluate trade facilitation measures, customs processes and cross-border logistics to identify pain points. DoP is seeking to understand the flow of goods at international, regional and national levels, with a focus on the trade of pharmaceuticals and medical devices through seaports and airports.

The research will inform the development of a sectoral plan for efficient logistics. The plan will cover recommendations for addressing gaps identified in collaboration with Indian bodies including the Central Drugs Standard Control Organization (CDSCO).

DoP wants one section of the plan to focus on digital transformation, including digital interventions for track and trace. The interventions will “enable real-time tracking for temperature-sensitive items especially, to maintain compliance with quality standards and regulatory requirements, data sharing and collaboration across the supply chain to ensure timely delivery and reduce wastage,” DoP said.

Interested parties can apply to run the study until 2 May. DoP expects the successful applicant to deliver the first report on regulatory requirements and other factors affecting logistics four months after starting the project. The sectoral plan for efficient logistics is due within six months of the start date.

Study Outline

TGA accepts compounding pharmacy’s court-enforceable advertising commitments

Australia’s Therapeutic Goods Administration (TGA) has accepted a court-enforceable undertaking from a compounding pharmacy. The agreement follows a TGA investigation into potential online advertising of GLP-1 medicines.

From November 2023 to June 2024, Your Solution Compounding Pharmacy (YSCP) provided order forms for semaglutide and tirzepatide on its website. The GLP-1 receptor agonists are, respectively, the active ingredients in Novo Nordisk’s Ozempic and Wegovy and Eli Lilly’s Mounjaro and Zepbound. Semaglutide and tirzepatide are prescription-only medicines and, as such, cannot lawfully be advertised directly to the Australian public. The ban applies to compounded drugs.

TGA became concerned that the order forms unlawfully advertised prescription-only medicines. The agency named pricing schedules for semaglutide that could be ordered throughout the website, buttons that redirected readers to pages for semaglutide orders and pages with portals to upload prescriptions for the GLP-1 drugs as potential problems.

After TGA raised its concerns, YSCP acknowledged that its website likely unlawfully promoted the use or supply of prescription-only medicines. YSCP has voluntarily agreed to take certain steps for three years. The compounding pharmacy will engage an external qualified compliance professional to write a report on whether its website complies with Australian legislation.

YSCP will implement all recommendations the consultant makes in their report unless TGA specifically waives the requirement in writing. The compounding pharmacy will pay the costs of its compliance with the undertaking. TGA’s investigation of YSCP was part of a broader evaluation of the compounding of obesity drugs that led Australia to stop pharmacies supplying compounded GLP-1 medicines to patients.

TGA Notice, More

CDSCO starts auto-generating medtech codes and certificates to simplify procedures

India’s CDSCO has updated its medical device portal to support the auto-generation of certain codes and certificates. CDSCO said it made the changes to “promote ease of doing business and to simplify the regulatory procedure.”

Under the old system, the central licensing authority provided neutral codes. The codes, alphanumeric identifiers for Indian medical device manufacturers, can stand in for a company’s name and address on some device labels and packaging.

The new system allows manufacturers to generate neutral codes themselves on CDSCO’s medical device portal when they want to export a product. The portal now features an option for downloading codes for an approved manufacturing license from the dashboard.

CDSCO added the capabilities alongside an option for auto-generating medical device market standing certificates (MSCs) and non-conviction certificates (NCCs). MSCs show a medtech company has a valid license. NCCs confirm a company has not breached Indian regulatory requirements.

CDSCO Notice, More

Philippine FDA allows companies to group multiple post-approval changes in 1 filing

The Philippine Food and Drug Administration (FDA) has started allowing companies to include multiple post-approval change requests in a single regulatory submission.

Seeking to streamline the processing of applications, FDA has updated the approach to post-approval changes that it established in 2014. The revised process, which applies to major variation and minor variation-prior approval applications, allows companies to group multiple changes for a single product in a single application. The process for minor variation-notification submissions is unchanged.

The integrated application form FDA established in 2014 only has room for three post-approval changes. FDA is asking applicants that are making more than three changes to write “Please see attached list of post-approval changes” on the form. The agency has created a template applicants can use to provide the complete list of post-approval changes.

FDA Notice

CDSCO creates procedure for transferring drugs, APIs out of special economic zones

CDSCO has created a procedure for companies to move medicines and active pharmaceutical ingredients (APIs) from special economic zones (SEZs) to domestic tariff areas (DTAs).

Materials imported into and manufactured in India’s SEZs are exempt from aspects of the Drugs and Cosmetics Act and Rules. The exemption applies because the materials cannot be diverted for sale in India. However, the law does permit the sale and distribution of the materials in the domestic area, provided they meet the standard requirements for import and registration.

CDSCO has created a process to streamline the transfer of drugs from a SEZ to a DTA. The process prohibits companies from transferring banned drugs made for export to a DTA. API, semi-finished and finished dosage forms in bulk packs that lack registration certificates or import licenses cannot be sent to a DTA. Transfers of other unapproved and approved drugs are possible, provided conditions are met.

CDSCO Notice

Other News:

The Philippine FDA has given companies more time to comment on its implementing guidelines on the registration of chemical and biological pharmaceutical products. Companies now have until 18 April to submit feedback on the drafts. FDA Notice

Asia-Pacific Roundup India to study regulatory bottlenecks in drug, device supply chains

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