Asia Regulatory Roundup: China FDA Seeks Comment on Generic Drug Quality Guidance (24 November 2015)

Posted 24 November 2015 | By Nick Paul Taylor 

Asia Regulatory Roundup: China FDA Seeks Comment on Generic Drug Quality Guidance (24 November 2015)

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

FIA Remands 4 Senior Pakistani Officials in Fraudulent Drug Approval Case

The Federal Investigation Agency (FIA) has remanded four senior officials at the Drug Regulatory Authority of Pakistan (DRAP). FIA took the action after investigating the alleged issuance of a fake drug registration letter for a treatment for premature ejaculation.

DRAP’s deputy director general of registration and deputy drug controller are among those affected by FIA’s action. The case relates to the issuance of a registration letter to Everest Pharmaceuticals for Everlong 60mg tablets. DRAP believes the letter was issued without an application first going through the proper process. Having made the accusation, DRAP passed the case along to FIA, which has arrested four of the individuals who were allegedly involved with the fake registration. 

Mohammad Aslam, CEO of DRAP, is confident that wrongdoing has taken place. “The fact is that a fake registration letter was issued with the involvement of different officers. So we held an inquiry and it was recommendation of the inquiry committee that the case should be handed over to the FIA,” Aslam told DAWN. The accusations, which follow a long-running investigation into Everest Pharmaceuticals, could lead to the officials being dismissed from DRAP.

Officials at DRAP seized products from Everest Pharmaceuticals’ facility earlier this year and followed this action up with an investigation into the registration letter. At a meeting in May, DRAP said Everlong tablets were “neither considered nor approved by registration board in any meeting.” The investigation went on to discover that records relating to the false registration are missing. Yet while the case presented by DRAP sounds compelling, some people inside the regulator are unconvinced.

“We know that our colleagues are innocent but because of the decision of the DRAP management and ministry, they would be facing humiliation,” an anonymous DRAP employee said. The rift with some staff is one of several issues DRAP must resolve in the wake of the case. Government officials want DRAP to implement standard operating practices for the registration process that minimize the opportunities for malpractice. DRAP is also being encouraged to audit five years of its records.

Government Statement, DAWN

NPPA Resets Database Registration Deadline Again

The National Pharmaceutical Pricing Authority (NPPA) of India has reset the deadline by which firms must register on its database. It is now more than one year since the original deadline passed, but “many” companies are yet to register on the pricing authority’s online platform.

NPPA has spent the past 12 months finding companies and attempting to allay their concerns about the platform, which it sees as an important tool for keeping track of the production, pricing and importation of medicines. The pricing authority is now giving companies until 15 December to sign up for its Integrated Pharmaceutical Database Management System (IPDMS) and submit the necessary forms. NPPA originally asked companies to register by 31 October 2014.

Officials at NPPA view companies’ failure to register as “tantamount to harming public interest” and want to punish them accordingly for taking this course of inaction. The letter to extend the deadline includes a threat to take penal action against companies that miss the latest target. NPPA thinks the Drugs Prices Control Order, 2013 gives it the power to follow through on such a threat. Whether the risk of legal action is enough to prompt the industry to act remains to be seen.

Multiple deadlines have come and gone over the past year. In between these missed milestones, NPPA has held meetings to listen to and address the concerns of pharmaceutical firms, resulting in software that it thinks is “fine-tuned” to the needs of the industry. Yet while NPPA has succeeded in shortening the list of unregistered companies over the past year, it is still a long way short of hitting a level of completeness that befits the mandatory status of the online submission of data.

NPPA Letter, PharmaBiz, Press Trust of India

CFDA Calls for Feedback on Generic Drug Quality Guidance

China Food and Drug Administration (CFDA) has opened a document on the quality and efficacy of generic medicines for comment. The document is the latest component of CFDA’s ongoing attempt to raise the standard of drugs on the market in China and the rigor of the approval process.

Drugs that have already won approval and those that are still in development are both affected by the latest document. CFDA wants to make manufacturers of generics that have already come to market carry out the same conformity assessment it plans to put development-stage drugs through. Manufacturers who fail to perform the assessment by a certain deadline will lose their marketing approval. The requirement is intended to weed out drugs that fall short of the new standards.

CFDA is seeking feedback on this requirement and its draft advice on generic research processes, from the selection of the reference product through to tests for in vivo bioequivalence and in vitro dissolution. The regulator views actions to improve these processes as a way to make the Chinese generics industry more competitive globally, while also raising the quality of products that are sold locally.

Officials at CFDA plan to change their own activities to facilitate these improvements. The draft document includes sections on the need for CFDA to retool its operation to oversee the consistent evaluation of generic filings and a call for a government-wide shift in approach to the sector. Part of the goal is to strengthen coordination and cooperation between different government departments to promote the agenda of generic quality.

CFDA Notice

India Releases 2016 Formulary, Advances Work on Pharmacopeia Research Facility

The Indian Pharmacopoeia Commission (IPC) has released the fifth edition of its national formulary, a text intended to encourage the rational use of medicines. IPC published the formulary at an event that also marked the advance of a project to create a pharmacopoeia research facility.

Publication of the National Formulary of India, 2016 comes four years after IPC last released such a document. The latest edition includes up-to-date details of the National List of Essential Medicines, a resource that has undergone changes since IPC last published the formulary in 2011. IPC hopes that the formulary will encourage the rational use of medicines on the list.

The pharmacopoeia released the formulary as part of a larger event, at which government officials laid a foundation stone at an IPC research facility. IPC is building the facility to give it the space and capabilities it needs to carry out a range of activities that are growing in step with the Indian pharmaceutical industry.

IPC Notice, More

Other News:

The Indian Ministry of Health is planning to revise the regulations covering biosimilars. Officials want to complete the revision by the end of the year. The process is seen as a way to fix failings in the original text from 2012. “Some key issues were not specified in the first guidelines, which had created scope for interpretations,” an industry executive said. The Economic Times

DRAP is re-inspecting the capacity of 12 companies it cleared to produce copies of Gilead Sciences’ blockbuster hepatitis C drug Sovaldi. As it stands, only one manufacturer supplies Sovaldi in Pakistan, resulting in the price of the drug being three times what one of the other 12 firms claims it will sell it for. Some view the new inspection process as a way to extend the monopoly. The Express Tribune

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