Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at email@example.com if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Regulatory News | 14 January 2015 | By Nick Paul Taylor
Welcome to our Asia Regulatory Roundup, a new weekly overview of the top regulatory news in Asia.
China’s Food and Drug Administration (CFDA) has admitted the current food and drug safety situation in the country is “grim” and outlined how it intends to improve matters. CFDA plans to hire more staff and standardize training, although industry observers fear incomplete laws and resourcing shortfalls could undermine the initiatives.
The regulator has faced a string of safety scares over the past decade, from the contaminated heparin scandal to the alleged sale of out-of-date meat to fast food chains. CFDA says it knows it has a problem. “We must soberly recognize the current foundations of China's food and drug safety are still weak, with new and old risks together creating a grim situation,” CFDA said in a statement seen by Reuters.
In response, CFDA plans to take a more proactive approach to safety. More unannounced inspections and random tests are planned. At the same time, CFDA will work to bring the quality of its workforce, legal structures and management methods up to the standards befitting a country that is set to become the world’s second largest healthcare market.
Observers have doubts about CFDA’s ability to improve. The fragmentation of supply chains poses problems for inspectors, while it also lacks an adequate legal framework to support some of its activities.
The Indian government has requested permission for its officials to accompany their peers at the US Food and Drug Administration (FDA) on inspections of local pharmaceutical companies, according to the Press Trust of India. Indian officials hope the presence of local regulators will prevent “cultural differences and body language” from affecting the outcome of FDA inspections.
FDA has found fault with practices at Ranbaxy, IPCA Labs, Wockhardt and other Indian manufacturers in recent years. The resulting regulatory enforcement actions have dented Indian exports and caused concern at the highest levels of the Indian government, PV Appaji, director general of Pharmexcil, told Press Trust of India.
Appaji said, “FDA's increased inspections and observations [under 483] also are troubling us. The Ministry of Commerce has taken up the issue seriously. Earlier practice was that whenever they are visiting any Indian site they used to inform us. Now they started coming without any notice.” Reports FDA was switching to unannounced inspections of Indian facilities first emerged in October 2013, though FDA has rejected those claims.
The request to FDA comes three months after the Central Drugs Standard Control Organization(CDSCO) said its officials were already accompanying their international peers on inspections. CDSCO framed the joint visits as a way to better understand the demands of overseas regulators.
Press Trust of India
India is considering introducing five-year prison sentences for anyone twice found guilty of running unapproved drug or medical device clinical trials. The draft legislation proposes capping sentences for first-time offenders at three years for drug studies and two years for medical device trials.
Legislators included the sentencing terms in the draft Drug and Cosmetics (Amendment) Bill, 2015, The Economic Times reports. Parliament is expected to consider the bill in the upcoming budget session. If the bill is approved, regulators and the legal system will gain new powers to detect and punish unapproved clinical trials.
The law will clear regulators to conduct unannounced inspections of the facilities, records, data, documents, books and drugs involved with a clinical trial. Anyone found guilty of running an unapproved trial will face a fine and prison sentence.
The Economic Times I Draft Bill
China is nearing the date on which it will allow the online sale of prescription drugs. Last year’s reports of an October publication date for CFDA guidance proved premature, but the regulator is now said to be “days or weeks” from releasing a list of drugs that may be sold online.
An anonymous senior healthcare policy advisor and executive at China Jo-Jo Drugstores both told Reuters the release of CFDA guidance is imminent. “The policy will be released in January or February and the CFDA is actively working on it,” the policy advisor said. CFDA is currently finalizing a list of the prescription drugs that pharmacies will be allowed to sell online.
Online markets are tipped to shave 10% off the cost of drugs, although it may take time for prices to come down. Initially, business-to-business sales are expected to account for the bulk of online activity, but retailers will join in over time. Alibaba and Walmart are among the firms cleared to sell over-the-counter drugs online, although the market is yet to take off.
The policy board of the Drug Regulatory Authority of Pakistan (DRAP) has sent its two picks for CEO of the agency to the prime minister. When Prime Minister Nawaz Sharif makes his selection, a two-year period in which DRAP has been without a leader will come to an end.
DRAP’s policy board picked Aslam Afghani and Ahsan Siddiqui from the six candidates it was considering. Afghani and Siddiqui both come from the private sector, while the four unsuccessful candidates are all public servants. Afghani is a technical director at Otsuka and Siddiqui currently works at Novartis.
The appointment of either as full-time CEO should bring some stability to DRAP. Since being founded in 2012, DRAP has had two acting CEOs, despite the law stating temporary leaders can only hold the post for 90 days. DRAP has advertised the post three times but is only now nearing an appointment. The law covering CEO appointments gives priority to public sector workers, but none qualified.
The Express TribuneI The NationI DAWNI More
India is considering allowing certain cancer drugs to go on sale without local trial data. The law would apply to select drugs that are already approved in other markets. Manufacturers of such drugs would receive conditional approval and be asked to track the responses of the first 500 Indian patients to receive the treatment. The criteria for receiving a waiver are currently unclear. The Economic Times
Pakistani politicians have called for regulators to take a tougher line on manufacturers of spurious drugs. Senator Abdul Haseeb Khan warned the country is “killing our new generation” with substandard medicines. The creation of local regulatory authorities was proposed as a way to improve oversight. DAWN
A CDSCO official has said the agency is still waiting on the funds and clearances to increase its headcount. The government agreed to the addition of 1,200 permanent and 1,200 contract staff, but CDSCO is yet to make the hires. The Economic Times
Consumer advocates have criticized an Australian proposal to accept overseas approvals of drugs and medical devices. Critics of the plan fear it sacrifices patient safety to make life easier for businesses. The Sydney Morning Herald
A clutch of large Indian states are failing to keep up with reporting of adverse events and drug utilization. Resource shortages and a lack of awareness are reportedly behind the problem. PharmaBiz
The Indian high court has stopped Cipla from selling a generic version of Novartis’ Onbrez. Cipla must apply for a compulsory license if it wishes to resume selling the product. The Economic Times
Tags: Asia Regulatory Roundup, Regulatory Roundup