Asia-Pacific Roundup: India’s CDSCO shares guidance on seeking clearance to export new drugs
The Central Drugs Standard Control Organization (CDSCO) has shared guidance on obtaining a certificate to export new drugs from India.Companies need a no-objection certificate from CDSCO zonal offices to export new drugs. The certificates are required for exports of both approved and unapproved products but cannot be used to authorize the shipment of narcotics, psychotropic substances, and banned drugs.
CDSCO’s guidance describes a two-step process for obtaining a certificate. First, applicants need to apply to a zonal office with the required documents. Then, “the applicant needs to fill out the reconciliation details in the prescribed format, along with the requisite documents, and obtain clearance for the consignments from the concerned port office for its release,” CDSCO said.
The guidance lists the documents that companies need to provide in the first and second steps. CDSCO asks companies to submit evidence that the exported product is approved in the importing country; however, the guidance also provides options for when the paperwork is not available. Acceptable alternative evidence varies by product type, with CDSCO allowing different documents for active ingredients and finished products.
CDSCO has provided six key points at the end of the guidance. Specifically, the agency says that finished products must have 60% residual shelf life. Finished products with less than the required shelf life will be destroyed in the presence of the state licensing authority. Active pharmaceutical ingredients with less than three months of remaining shelf life also will be destroyed.
CDSCO Guidance
Pharmacists support reclassification of GSK’s RSV vaccine in New Zealand
Two bodies that represent pharmacists in New Zealand have backed plans to reclassify GSK’s respiratory syncytial virus (RSV) vaccine.
GSK has proposed reclassifying the product to enable pharmacists and other authorized vaccinators to administer the vaccine to adults aged 50-59 years who are at increased risk of RSV disease. The New Zealand Medicines and Medical Devices Safety Authority’s (Medsafe) Medicines Classification Committee is set to discuss the proposal at a meeting on 23 July.
A call for feedback to inform the discussion drew responses from the Pharmacy Guild of New Zealand and the Pharmaceutical Society of New Zealand. Both bodies voiced support for the proposal, with the Society providing a brief comment and the Guild submitting a more detailed assessment.
The Guild said the change “would support more timely and convenient access to vaccination, particularly in rural or underserved areas where general practices may be limited or overburdened.” Other benefits include the reduced need for patients to visit doctors, “easing pressure on the wider health system and empowering patients to receive vaccines where and when it suits them best,” the Guild said.
Both groups also backed plans to down-schedule tenofovir disoproxil and emtricitabine, which Gilead sells as Truvada, to allow pharmacists to offer the drugs for HIV prevention under certain circumstances. The Society said the new pharmacists' initiation pathway “promotes a more collaborative care model, and provides support to those who are unenrolled or unwilling to discuss PrEP with their GP.”
Comments
India delays mandatory use of GMP certificate portal after industry feedback
Industry feedback has persuaded CDSCO to give companies another month to start using a portal when applying for good manufacturing practice (GMP) certificates.
Last month, CDSCO said the process for applying for a World Health Organization (WHO) GMP Certificate of Pharmaceutical Product (COPP) was changing. Starting 15 July, CDSCO wanted companies to use the One Nation One Drug Licensing (ONDLS) portal to apply for the certificates. The agency planned to stop accepting physical files on 15 July, but the timeline prompted pushback from industry.
“It has come to the attention that several manufacturers are still in the process of registering and uploading documents onto the ONDLS portal,” CDSCO said. “We have also received representations from various industry associations highlighting challenges in onboarding on ONDLS portal and they need more time to complete the process.”
In response, CDSCO extended the deadline for switching to the portal to 15 August. The agency will keep accepting physical files for WHO GMP COPP applications until the revised deadline. CDSCO is planning to run sessions to give companies more clarity on the online process, if required.
CDSCO Notice
CDSCO establishes rules for reviews by Indian subject expert committees
CDSCO has released guidance on the subject expert committees (SECs) that advise it on proposals for the approval of new drugs, clinical trials and medical devices.
The guidance explains what SECs do, the composition of the committees and the criteria for selecting members. Subsequent sections include an overview of the SEC review process and details of categories of application that may not require a committee review. Some routine post-approval changes and minor protocol amendments are authorized without the input of a SEC.
CDSCO has included information about the roles and responsibilities of applicants. The briefing materials prepared for SECs should provide “a comprehensive overview of the product, including its mechanism of action or function with details of claims, indication, dosage and administration, adverse effects, contra indications, precaution and warning if any,” CDSCO said.
The document ends with guidelines for PowerPoint presentations prepared for SEC reviews. CDSCO has provided a suggested structure for presentations, as well as advice on the design and formatting of the materials.
CDSCO Guidance
National Medical Commission pushes to expand device safety reporting in India
The National Medical Commission has advised Indian medical institutions to set up committees to monitor medical device adverse events.
India set up a materiovigilance program to monitor medical device adverse events and risks in 2015. The program, which is coordinated by the Indian Pharmacopoeia Commission (IPC), is operated through a network of medical device adverse event monitoring centers in hospitals and medical colleges.
Last week, the Commission advised all medical institutions to set up device adverse event committees and register them with IPC. Officials provided institutions with a registration form and asked them to put the name of the coordinator of their committees, plus any additional members, on their websites. Institutions have until the end of July to update the committee member names on their websites.
The Commission presented involvement in the materiovigilance program as a way for institutions to achieve academic recognition, support the development of faculty and students, build infrastructure, influence policy and protect patient safety.
Public Notice
Other news
Australia’s Therapeutic Goods Administration (TGA) has extended the shortage notification for Concerta modified-release tablets until the end of 2026. Until then, TGA expects there to be periods when supply of the attention deficit hyperactivity disorder drugs is limited or when some strengths are unavailable. TGA expects shortages of other methylphenidate products to end in December. TGA Notice
Singapore’s Health Sciences Authority (HSA) shared an update to the label of Roche’s CellCept. The Swiss drugmaker is updating information about the product, which is used to prevent rejection of transplanted organs, in response to post-marketing data on the risk of anaphylactic reactions. HSA is advising healthcare professionals to be aware of signs and symptoms of anaphylactic reaction. HSA Notice
Chinese Vice-Premier Liu Guozhong has called for a push to strengthen collaborative research and policy implementation. During a visit to Peking University, Liu made the case for deepening international exchange and cooperation on pharmaceutical technology. Press Release
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