Asia Regulatory Roundup: CFDA Seeks to Exempt More Devices From Clinical Trials (23 May 2017)

Posted 23 May 2017 By Nick Paul Taylor

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

Abbott, Novartis and Sanofi Targeted in NPPA Clampdown on Drugs Sold Without Price Approval

The National Pharmaceutical Pricing Authority (NPPA) of India is taking action against drugmakers including Abbott, GlaxoSmithKline, Novartis and Sanofi. NPPA included the top pharmaceutical firms on a list of companies that allegedly introduced drugs without seeking price approval and may have to pay back what they overcharged.

In a letter to the companies targeted by the action, Roshni Sohni, director of enforcement at NPPA, accused the businesses of altering scheduled formulations, either by changing the dose or combining the drug with a non-scheduled medicine. To NPPA, such changes represent the introduction of new drugs. As such, the companies should have obtained approval from NPPA for the prices of their new products before introducing them to the market.

Companies used to reformulate drugs to evade price controls but officials have sought to correct such activities. The NPPA letter suggest there is still a problem, though. According to NPPA, many companies have failed to comply with its price approval requirement. The list of drugs affected by its regulatory action features 201 products.

Abbott accounts for nine of the products, almost all of which NPPA thinks were introduced in 2015. Most of the products are combinations of active ingredients, such as a mix of paracetamol and the opioid pain medication tramadol. The list also features products from GSK, Novartis and Sanofi alongside brands manufactured by local players such as Lupin and Ranbaxy. Officials targeted the companies collectively, rather than issuing individual show cause notices “because of paucity of manpower in NPPA,” the cost watchdog said.

NPPA wants manufacturers on the list to submit batch wise production and sales records, plus the corresponding maximum retail price “duly certified by a chartered/cost accountant.” The regulator also wants companies to submit an explanation for why they failed to comply with the pricing rules. NPPA has given companies until 15 June to send the information.

The regulator is threatening to use powers enshrined in the Drug Price Control Order (DPCO), 2013 and Essential Commodities Act, 1955 on firms that fail to submit information by the deadline. All companies are potentially liable to pay the amount they overcharged plus interest and a penalty, although NPPA has a poor track record of clawing back such monies from noncompliant firms.

NPPA sent its letter the day after the Drug Controller General of India (DCGI) also issued a notice to flag up ongoing problems in the oversight of fixed-dose combinations (FDCs). Despite efforts to stop companies bypassing the Central Drugs Standard Control Organization (CDSCO) to introduce irrational FDCs, regulatory staffers have told DCGI Dr GN Singh state licensing authorities are still signing off on products without prior approval of the national body. This is the same loophole that led to the banning of hundreds of irrational FDCs.

Singh said the practice is illegal and “would have disastrous consequences” in a letter asking state drug controllers to comply with the regulatory process. In its letter, NPPA questioned whether the FDCs that had come to market without its approval are rational and have the blessing of CDSCO. NPPA thinks some of the drugs affected by its action came to market as recently as October 2016, seven months after the government’s tried to ban 344 FDCs that previously used the loophole.

NPPA Memo, NPPA List, DCGI Note

TGA Creates GMP Guide for Manufacturers of Compounded Medicinal Products

The Therapeutic Goods Administration (TGA) of Australia has released a good manufacturing practice (GMP) guide for producers of compounded medicinal products. TGA has designed the text to help manufacturers interpret the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme’s (PIC/S) GMP requirements.

Compounding describes the combination, mixing or alteration of drug ingredients by a pharmacist, physician or certain outsourcing facilities to create a medicine that meets the specific needs of an individual patient. The practice has a long history of quality control failings. Officials at the US Food and Drug Administration (FDA) released guidance on the practice in 2002 to counter the growing number of reports of accidents. A decade later, compounded drugs made at New England Compounding Center and other facilities were linked to tens of deaths.

To ensure compounding pharmacies in Australia have access to the resources to avoid such serious GMP failings, TGA has released a document that translates the PIC/S Guide to GMP for Medicinal Products to their operations.

The TGA document picks out clauses in the PIC/S document and explains how they apply to makers of compounded medicines. For example, as there is no marketing authorization for compounded medicines, the TGA document explains how product formulation must follow the order supplied. If the order is unclear, the compounding manufacturer must clarify it with the customer. The onus is on the manufacturer to keep a list of “approved formulas” for each type of product and ensure their formulations are not the same as those available commercially.

TGA has written similar clarifications for each clause of the PIC/S text that needs interpreting to make it relevant to the operation of compounding pharmacies. The result is a guide that walks makers of compounded medicines through how they should approach personnel, equipment, documentation, quality control and other aspects of their operation if they are to comply with GMP requirements.

The TGA guide provides the most detail on how manufacturers should interpret the production, sterile medicine and quality control chapters of the PIC/S guide. These chapters cover starting material traceability, the design of aseptic processes, microbiology and other aspects of the production process that, if mishandled, could affect patient safety.   

TGA Guide

CFDA Proposes Exempting More Classes of Medical Devices from Clinical Trials

China Food and Drug Administration (CFDA) has proposed exempting more medical devices from clinical trials. The proposal covers 28 types of Class II and III medical devices that, if the draft plan comes into force, will join hundreds of other products already exempt from clinical trials.

CFDA is proposing to exempt 22 types of Class II medical devices. The list of Class II medical devices covered by the draft includes endoscopic spinal surgical instruments, insulin pens and ultrasound bone densitometers. CFDA has provided a description of each type of device. The regulator has provided similar details for the six Class III medical devices it wants to exempt from clinical trials.

Publication of the proposal comes one year after CFDA last shared a draft list of medical devices to be exempted. That proposal, which came into force in September after minor changes, affected the status of 276 Class II and 92 Class III medical devices. CFDA first proposed exempting certain medical devices from clinical trials in 2014. That original list covered 488 categories of Class II devices and 79 types of Class III products.

The latest list of devices eligible for exemption is open for comment until June 20. 

CFDA Notice (Chinese)

Other News:

TGA has updated its code of practice for tamper-evident packaging. The update does not place additional requirements on manufacturers. Rather, the changes are intended to bring the text in line with contemporary practices. TGA published the first and, until this week, only version of the document in 2003 in response to extortion attempts against drugmakers. TGA Document

 

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Categories: Biologics and biotechnology, Drugs, Medical Devices, Government affairs, Manufacturing, News, Asia, Oceania, CFDA, CDSCO, TGA

Tags: Asia Regulatory Roundup, NPPA, medical device exemptions, PIC/S

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