Asia Regulatory Roundup: India Begins Reviewing Drug Recall Guidelines (29 November 2016)

Regulatory NewsRegulatory News | 29 November 2016 |  By 

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

India Starts Review of Drug Recall Guidelines

The Drugs Consultative Committee (DCC) of India has committed to reviewing the guidelines on drug recalls to ensure substandard products are effectively removed from the market. Officials want to make manufacturers monitor the quality of drugs in the supply chain and hold them responsible for voluntarily recalling products that fall short of standards.

Members of the DCC discussed the proposal to set up an effective recall system for “not of standard quality” drugs at a meeting earlier this month. The discussion led to several policy suggestions and initiatives to advance the agenda.

Regulators want to see the Drugs & Cosmetics Rules changed to ensure drug manufacturers are held responsible for recalling products from the supply chain. The DCC also wants to make manufacturers oversee the supply chain by establishing “a system of regular market surveillance.” This would entail sampling products from the supply chain and assessing their quality. Drugs that fail quality tests would be subject to voluntary recalls. 

Under the proposals, manufacturers would also be expected to have systems in place for managing such voluntary recalls. Manufacturers would activate this system whenever they identified noncompliance at their manufacturing plants, discovered substandard drugs on the market or generated out-of-specification results in stability studies.

Officials plan to support the establishment of such processes by reviewing and updating guidelines on the topic. The DCC meeting tasked a three-person subcommittee with looking at the guidelines. At the meeting on 4 and 5 November, the DCC gave the subcommittee three weeks to file a report. The DCC then planned to give state regulators one week to comment on the draft rules.

The recall process was one of many quality-related regulatory topics discussed at the DCC meeting. Officials also used the event to clarify what Indian regulators should do when their foreign peers find fault with local manufacturing plants. The new process calls for the Central Drugs Standard Control Organization (CDSCO) to write to the affected State Licensing Authority (SLA). The SLA then has three days to investigate the matter and report back to CDSCO.

The timeline forms part of an attempt to make the regulatory system more responsive to the discovery of potential problems by other countries. When a country complains about the quality of drugs exported from India, Shri Sharma, the joint secretary, regulation, wants local regulators to prioritize their handling. Sharma said politicians and regulators from Mozambique recently raised concerns about the quality of drugs exported from India.

DCC Minutes

TGA Starts Consultation on Medicinal Cannabis Guidance

The Therapeutic Goods Administration (TGA) of Australia has released a standard and supporting guidance on the quality of medicinal cannabis products for consultation. TGA drafted the texts in response to the Australian government’s decision to facilitate access to medicinal cannabis products.

As of 1 November, cannabis can be administered medicinally in Australia when there is evidence to support its use. To ensure the quality of the cannabis plant, other ingredients and finished product are of an acceptable standard, TGA has released a standard for medicinal cannabis.

The text refers readers to a European Pharmacopoeia monograph on medicinal cannabis products and ingredients used in their manufacturing, but also features additional details. TGA has included sections on the use of macroscopic, microscopic and chromatographic techniques to identify plants used in the manufacture of medicinal cannabis products. The agency also warns against adulteration and the use of decontaminating treatments that are detrimental to product quality. TGA concludes the standard with a section on tests, including details of assay limits.

While the standard is a barebones, technically-focused look at ensuring the quality of medicinal cannabis products, the guidance is closer to a layperson’s guide to understanding and complying with TGA’s requirements. To achieve this goal, the guidance fleshes out each section of the standard. For example, while the standard just says companies must use three techniques to identify cannabis plants, the guidance explains the role of these tests by pharmacopoeias and how they apply to cannabis. TGA also points readers toward other documents. 

The comment period for the texts is open until 16 January. 

TGA Guidance, Therapeutic Goods Order

CFDA Clamps Down on Antidiabetic Pulled from US in 1970s

The China Food and Drug Administration (CFDA) is clamping down on the production, sale and use of phenformin. The antidiabetic drug was withdrawn from the US in the 1970s following reports of lactic acidosis, the potentially fatal buildup of lactate, but has remained on the market in China until now.

In a brief notice released this week, CFDA ordered the cessation of the production and sale of the drug. The notice was accompanied by instructions to regional regulators to step up their oversight of companies currently involved in the production and sale of phenformin. Batches still on the market at the end of the year are to be recalled and destroyed.

The action removes China from the short list of countries where phenformin is still used. According to a paper published in PLOS ONE, phenformin was still prescribed in Italy, Brazil, Uruguay, China, Poland, Greece and Portugal as of 2013.

Other countries followed the lead of the US Food and Drug Administration (FDA) and told doctors to use alternatives such as insulin. FDA took its action in 1977. The next year, phenformin was pulled from the market..

The ingredient has also been found in products purporting to be herbal medicines. FDA ordered the recall of such products in 2000.

Diabetics now typically take metformin rather than phenformin because of its superior safety profile. 

CFDA Notification

CFDA Posts Requirements for Drug Packaging Material Declarations

CFDA has established requirements for disclosing information about drug packaging materials. The document outlines the information companies need to share, such as details of the raw materials used and the companies that supplied them.

In the text, Chinese officials detail a lengthy list of information they want to know about drug packaging. Some of the information is basic, such as the intended route of administration and the address of the enterprise submitting the details. Other sections go into greater detail. CFDA wants detailed formulation information on all lubricants and other additives used in assembling packaging components. 

CFDA released the document alongside a similar text about excipients. The excipient document sets out the information and materials CFDA will demand of domestic and foreign manufacturers, as well as requirements that apply regardless of where a company is based. Details requested by CFDA include data on process development and validation, the physical and chemical properties of materials and the production equipment.

CFDA Notice, More (both in Chinese)

Other News:

TGA has released the results from a survey of users of Australian Public Assessment Reports (AusPARs). The survey found most users think AusPAR documents are useful and effectively provide greater transparency regarding TGA’s decision process. Suggested improvements include the addition of plain English summaries of TGA decisions. TGA Survey

CFDA has accused 26 manufacturers of producing substandard Chinese herbal supplements. The regulator has ordered the cessation of the manufacture and sale of the products. Recalls, investigations of the companies’ quality practices and corrective actions also are planned. CFDA Notice (Chinese)


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