Asia Regulatory Roundup: China to Begin Surprise Inspections, India to Monitor Medical Device Safety (14 July 2015)

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

China to Start Running Surprise Inspections of Drug and Device Plants

The China Food and Drug Administration (CFDA) is to start running surprise inspections of manufacturers of drugs and medical devices starting 1 September. The policy is intended to allow CFDA to act faster and eliminate the opportunity for manufacturers to destroy evidence before its inspectors visit.

Xinhua published a brief summary of the policy, in which it outlined the process for surprise visits and how CFDA will decide which facilities to target. CFDA will assess tip offs from whistleblowers, reports of adverse events and other factors before deciding to conduct a surprise inspection, at which point it will mobilize its team without informing the manufacturer of its plans. Inspectors will then visit the plant and only communicate their findings once they have gathered all the evidence.

The effectiveness of the strategy depends on CFDA’s ability to stop news of its inspection plans leaking to companies ahead of its visits. Recognizing the potential for unscrupulous officials to give companies advance notice, CFDA has implemented disciplinary measures for anyone found to have leaked confidential information deliberately. When officials are suspected of criminal activity, CFDA will pass the cases to law enforcement.

CFDA will begin enforcing the new policy on 1 September, two years after it started reworking its approach to fix shortcomings with its existing strategy. Officials became frustrated with the timeliness, standardization and inter-departmental coordination of inspections conducted under the old approach. The new strategy is intended to address these topics, while also stopping companies from destroying evidence and taking other actions to hinder inspectors.

Xinhua, CFDA Statement (Chinese), CFDA Explainer (Chinese)

Pakistani Politicians Pressure DRAP to Gain Recognition by WHO

Politicians in Pakistan have stepped up their calls for the country’s drug regulator to gain recognition by the World Health Organization (WHO). The Drug Regulatory Authority of Pakistan’s (DRAP) failure to achieve accreditation is tied to a long-running drug testing laboratory saga, DAWN reports.

Plans for a Federal Drug Surveillance Laboratory (FDSL) predate the creation of DRAP by six years, but the project has taken far longer than anticipated. When the proposal to set up FDSL was approved in 2006, the lab was supposed to be operational by the end of the following year. That deadline came and went but the building was completed, only for a decision to be made in 2011 to use it for the Federal Medical and Dental College (FMDC) instead of as a testing laboratory.

All the equipment bought for FDSL was then moved to the National Control Laboratory (NCL). This plan has been undermined by the fact that NCL lacks the space to house and run the equipment. As such, DRAP is still without a laboratory that meets WHO standards. The lack of WHO recognition limits the ability of plants in the country to export their products, an issue that contributed to the value of drugs shipped out of Pakistan falling by 16.5% last year.

With the government keen to establish a pharma export industry, politicians are now seeking a resolution to the situation. The current plan is to move FMDC to another site and install the testing laboratory in the building it was supposed to move into in 2007. Once the laboratory is operational and DRAP completes its hiring surge — it is currently recruiting for 192 posts — ministers hope the regulator will achieve recognition by WHO within a few months.

DAWN, Radio Pakistan

India Expands Quality Survey to Cover Imported APIs and Formulations

Having wrapped up the sampling component of its huge drug quality survey, India has shifted its attention to the standard of ingredients and formulations imported into the country. The new phase of the initiative will test the quality of pharmaceutical products that enter India through 12 ports.

Officials at the Central Drugs Standard Control Organisation (CDSCO) and the National Institute of Biologicals (NIB) are working together on the program, PharmaBiz reports. The initiative has the potential to generate some contentious findings, notably about the quality of active pharmaceutical ingredients (APIs) imported from China. Indian politicians are keen to re-energize the local API sector and lessen the industry’s reliance on China-made APIs. 

The start of the import-focused sampling program coincided with the transfer of CDSCO assistant drugs controllers from the regulator’s head office to its operations at ports. CDSCO moved five officials from its base in New Delhi to ports. Another two staffers were transferred from regional offices to airports, with the same number going in the opposite direction. The transfers amount to a significant reorganization of senior management within CDSCO. 

PharmaBiz, CDSCO Notice

Medical Device Safety Monitoring Program Gets Underway in India

The Materiovigilance Programme of India (MvPI) has formally started. Drug Controller General of India Dr. GN Singh made the announcement about the medical device safety monitoring program at the Indian Pharmacopoeia Commission (IPC), PharmaBiz reports.

Implementation of MvPI is central to the regulator’s attempts to gain a better overview of the safety of medical devices used in the country. IPC is coordinating the program. Sree Chitra Tirunal Institute of Medical Sciences & Technology is involved as a collaborating center, while the National Health Systems Resource Centre is providing technical support. DCGI is also seeking the support of other players in the medical device field.

“Considering the current healthcare needs of the country, MvPI is a necessity essential to safeguard the interest of the patients. Thus we would ask all the stakeholders to come forward and support us in this national cause,” Singh said. Aspects of the program are still being finalized. The technical committee was still deciding on the identities of the 10 adverse event monitoring centers and the design of the data management system at the time Singh formally started MvPI.

PharmaBiz

Other News:

DCGI has given zonal officers the power to approve the importation of small quantities of drugs for use in bioavailability/bioequivalence (BA/BE) tests. The new powers are limited to dosage forms that have been approved by CDSCO for at least four years. Also, zonal officers can only sign off on the importation of drugs destined for use in healthy volunteers, not patients. PharmaBiz

The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has published a letter AstraZeneca sent to healthcare providers. In the letter, AstraZeneca alerts physicians to the safety concerns regulators in the United States and Europe have raised about its Type 2 diabetes drug Forxiga and other SGLT2 inhibitors. Letter

DRAP has blocked increases to the prices of over-the-counter products. The Pakistani regulator ruled the amount charged for the products cannot rise above the maximum retail price fixed under the Drug Act of 1976. Pricing has been a contentious issue in the country, with plans to tie what companies can charge to changes in the Consumer Price Index (CPI) causing consternation. Business Recorder

The Indian Pharmaceutical Association (IPA) is pushing for changes to the terms and enforcement of drug labeling laws. IPA wants CDSCO to ensure drug labels are readable by enforcing standardization of the font size, ink colors and content of information included on packaging. As it stands, IPA thinks the situation is confusing for pharmacists and consumers alike. PharmaBiz

Apotex has worked with Australia’s Therapeutic Goods Administration (TGA) to recall one batch of ibuprofen children’s suspension. The recall was initiated after it was discovered that grooves on the lids of the bottles could break off during opening, potentially leading to the ingestion of small pieces of plastic. TGA Notice