Posted 15 August 2017
By Nick Paul Taylor
Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
Nine Months After Deadline Passed, No Manufacturers Have Complied With DCGI GMP Request
The Drug Controller General of India (DCGI) has repeated his demand for manufacturers to assess the quality of their facilities and submit the resulting reports. DCGI Dr. GN Singh made the original request one year ago, but is yet to receive good manufacturing or laboratory practice (GMP/GLP) self-assessment reports from any companies.
Singh has given companies until the end of August to comply with the repeat request, although with firms having missed the earlier deadline by nine months without being punished, it is unclear what his office can or will do to ensure the demand is met. The wording of the new notice suggests the original demand was ignored by the whole industry.
"All drug manufacturers and pharmaceutical associations were requested ... to make self assessment of their manufacturing units as part of their self audit and mandatorily share their reports. However, CDSCO is yet to receive self inspection reports," Singh wrote. "In view of the above, all drug manufacturers are requested to submit the report of self assessment of their units along with self certification stating that they are complying with GMP/GLP requirements."
The new request, like the old one, calls for companies to use the GMP and GLP checklist prepared by the Central Drugs Standard Control Organization (CDSCO) to assess their own facilities. CDSCO created the 40-page checklist to increase the consistency of inspections carried out by its staff and their collaborators from state agencies. That original focus expanded this time last year when Singh asked companies to use the checklist in self-assessments.
Singh wants manufacturers to assign themselves a quality rating based on the benchmarks set by the checklist. The regulatory chief also wants companies to submit their reports to the licensing authority.
The notice states the demand for self-certification follows deliberations at the "highest level." Yet, recent history suggests at least some manufacturers will continue to ignore the request. The failure of any companies to comply with the GMP/GLP request follows similarly lackluster responses to demands related to fixed-dose combinations, track and trace and a marketing code.
In a bid to achieve a better response to the second request, Singh sent a separate notice to state drug controllers. The notice ordered the regulatory leaders to pressure manufacturers in their jurisdictions to comply with the demand.
Manufacturer Notice, Regulator Notice, Original Notice
Pfizer Recalls Heparin and Lignocaine From Australia After Discovering Product Mix-up
Pfizer is recalling batches of heparin and lignocaine from Australia after learning of a mix-up. The recall began after one patient collected a pack of heparin from a community pharmacy only to discover the packaging contained lignocaine.
A photograph of the affected pack shared by the Therapeutic Goods Administration (TGA) shows multiple sheets of lignocaine ampoules inside a box marked "heparin injection." In response to the discovery, Pfizer is working with TGA to recall one batch of heparin and another of lignocaine. TGA wants pharmacies and distributors to inspect their stock and quarantine defective packs.
News of the recalls comes months after Roche, Apotex, Arrow Pharmaceuticals and Novartis’ Sandoz pulled products from Australia after learning some packs contained the wrong drugs. However, while TGA immediately highlighted evidence of medicine tampering in those cases, there is no indication the Pfizer recall was triggered by foul play.
Rather, the recall appears to be the result of the sort of manufacturing mix-up that affect firms from time to time, Pfizer included. In recent years, Pizer has recalled lots of its antidepressant Effexor XR because some packs contained Tikosyn, and pulled 1 million birth control packs after putting in the wrong number of active tablets.
TGA Statement, Heparin Notice, Lignocaine Notice
DCGI Tells Regulators to Grant Licenses for Device Coating, Sterilization After Spotting Bottleneck
DCGI Singh has told regional offices of CDSCO to grant licenses to sites that want to coat, assemble and sterilize medical devices. Singh sent the circular after learning medical device manufacturers are struggling to set up facilities that carry out these functions.
The circular does not directly state why manufacturers are facing difficulties. However, by asking state regulators to grant licenses to companies that want to perform the listed tasks, the letter implies the bottleneck stems from difficulties obtaining regulatory clearances.
This impression is reinforced by a section of the circular that sets out why regulatory resistance to the granting of licenses runs counter to the Drugs and Cosmetics Act, 1940. The legislation defines "manufacture" as any work that involves making, altering, ornamenting, finishing, packing, labeling, breaking up or otherwise treating or adopting any drug or device.
Singh thinks the coating, assembly and sterilization of medical devices are covered by this definition of "manufacture." Companies therefore need a manufacturing license to perform these tasks and, by extension, state agencies must grant them to organizations that meet the requirements needed to do the work.
Saudi Arabia Applies for PIC/S Pre-Accession Membership
The Saudi Food and Drug Authority (SFDA) has applied for Pharmaceutical Inspection Co-operation Scheme (PIC/S) pre-accession membership. PIC/S will appoint rapporteurs to oversee assessment of the application at a meeting in Taipei next month.
Application for pre-accession membership marks the culmination of Saudi Arabia’s efforts to get its regulatory infrastructure up to the standard needed to join PIC/S. These efforts have seen Saudi Arabia bring in consultants to compare its systems and procedures to the requirements regulators have to meet to join PIC/S.
Full membership in PIC/S is still some way off. The pre-accession procedure is a voluntary step agencies can take to bridge the gap to PIC/S membership. At the end of the process, PIC/S will know whether SFDA meets its standards and recommend a path forward. The process can lead to immediate invites to apply for membership or create lists of improvements that must be made before an application is considered.
SFDA will have a clearer picture of where it stands in two years, the maximum timeframe for the pre-accession procedure. If SFDA applies for full membership, it will then start the six-year process PIC/S uses to assesses if regulators meet its entry requirements.
NPPA Publishes More Data on Cost, Profit Margins of Knee Implants
The National Pharmaceutical Pricing Authority (NPPA) has published more data on the prices and profit margins of medical devices. NPPA’s latest release covers the use of orthopedic knee implants in revision surgery cases.
The data presented by NPPA show the the average margins for importers on knee systems and individual components, such as tibial plates, ranges from 33% to 65%. Distributors and hospitals mark up the price of devices further still. NPPA reports the average margins at this step range from 89% to 200%. The upshot is the total trade margin is well into three figures.
NPPA defended the data on Twitter the day after releasing it to the public. The agency said the margins are based on official customs data and information provided by companies, before adding its analysis is accurate.
The accuracy of the analysis will become significant if NPPA decides to cap the price of knee implants. Hip and knee implants were among the devices a parliamentary committee discussed with the chairman of NPPA at a meeting earlier this year.
NPPA NoticeNPPA Post