Asia Regulatory Roundup: China Rolls out New Clinical Practice Rules (24 February 2015)

Regulatory NewsRegulatory News | 24 February 2015 |  By 

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

China Clarifies Sponsor-CRO Responsibilities in Draft Revision to GCPs

China Food and Drug Administration’s (CFDA) recently introduced draft good clinical practices (GCPs) will clarify the process for outsourcing to contract research organizations (CROs), Outsourcing-Pharma reports.

Katherine Wang, a partner at legal firm Ropes & Gray, told the publication the draft GCPs tell sponsors to state what responsibilities are being taken on by a CRO in their contracts with the vendor. The US Food and Drug Administration (FDA) takes a similar approach, with the regulator viewing sponsors as responsible for all tasks except those specifically named in writing as being transferred to the CRO.

CFDA has also followed FDA’s lead with regard to who is ultimately responsible for the quality and integrity of the work. The Chinese draft GCPs state regulatory responsibilities cannot be outsourced, meaning the onus is on sponsors to ensure their CROs are complying with CFDA standards. Overall, Wang expects the changes to have a positive effect.

“This clarification will aid a healthier development of the CRO industry ... [but] it may be more costly to run studies in China,” she said.


Blame Game Intensifies as India’s Swine Flu Death Toll Tops 700

The steady rise of the death toll from H1N1 past 700 has triggered a wave of comments from Indian manufacturers, pharmacists and the government about who is responsible for the lack of swine flu drugs. How such products are regulated is central to the issue.

Flu drugs such as Tamiflu — which is manufactured by multiple generic companies in India — are classified as Schedule X, meaning they can only be sold by pharmacists who have a certain license. Less than 1% of drug outlets in India have the license, and their distribution is uneven. The government has limited the distribution of Tamiflu — sold in India under its generic name oseltamivir — to these outlets to stop overuse of the drug and subsequent development of resistance.

Manufacturers think such caution is exacerbating the situation. “There are various licenses required to stock the medicines, which dissuades chemists to stock them,” a Cipla executive told The Economic Times. The lack of demand until recently also deterred pharmacists, resulting in the Serum Institute of India destroying thousands of batches before the outbreak started. Manufacturers want the government to buy products in between outbreaks so supplies are available when needed.

The government has contacted producers to check on the supply situation and threatened to remove the license of any Schedule X-approved pharmacy that fails to stock the drugs. Pharmacy trade groups are urging members to stock the products, but India’s supply chain could cause delays. Instead of going through the usual multi-layered supply chain, pharmacists are advised to source drugs directly from manufacturer-appointed distributors.

The Economic Times I The Indian Express I India Today I More

DRAP set to Receive Bigger Budget to Stamp Out Fake Drugs, Clear Backlog

A government committee has told the recently appointed CEO of the Drug Regulatory Authority of Pakistan (DRAP) where it expects him to direct his time and energy. Strong action against substandard drugs and the clearing of the backlog of pending applications topped the committee’s list of demands.

The Standing Committee on National Health, Services, Regulations and Coordination outlined its expectations of DRAP CEO Dr Muhammad Aslam and his colleagues during a meeting held at the regulator’s offices. Legislative changes to strengthen punishments for counterfeiting were considered, but for now DRAP will have to work within the existing legal framework.

Substandard drugs are one of many problems facing Aslam. The committee also wants DRAP to prioritize the clearing of the backlog of applications, which span from drug registration to the import and export of raw materials. To ensure leaders are in place to oversee the work, Aslam was told to fast track the promotions of senior officers who are eligible to make the step up.

DRAP is set to receive more money to cover the promotions and escalation of its activities. Officials have proposed an almost 70% year-on-year increase in the budget, although the gains are expected to be partly offset by a dip in money received through the grant-in-aid program.

Business Recorder I The News I More

Indian Budget Tipped to Level Medical Device Playing Field

The Indian government is considering changing the import duty on medical devices and the materials used in their manufacture. Domestic manufacturers are angry about the current situation, which is seen as favoring foreign businesses.

Importers of medical devices currently pay import duties of 5%, less than is charged when materials essential to their manufacture enter the country. Local medical device companies claim the difference between the two duties hamstrings their ability to compete on price with multinational businesses. In response, the government is considering doubling the import duty on medical devices.

The proposal is being considered alongside a plan to eliminate duties on raw materials used in the production of pacemakers. If both changes are included in the budget on 28 February, it will provide a boost to local medical device manufacturers, a group that has vocally criticized the allowance of 100% foreign direct investment and other changes since the new government came to power.

Press Trust of India

NPPA Orders Abbott, J&J to Attend Meeting for Failing to Submit Pricing Data

India’s National Pharmaceutical Pricing Authority (NPPA) has sent a letter to executives at Abbott, Johnson & Johnson and other leading cardiac stent manufacturers over the submission of pricing data. The letter orders the companies to attend a meeting at NPPA this week.

NPPA has written to the manufacturers twice this month to ask for data on the pricing of cardiac and drug-eluting stents, but is yet to receive the information it wants. To accelerate the process, NPPA has asked Abbott, J&J, Boston Scientific, Edward Lifesciences, Medtronic and any other concerned companies to meet to discuss the pricing and availability of stents.

The pricing body only formally gave the manufacturers two days notice about the meeting.

NPPA Letter

Other News:

The Medical Council of India (MCI) has suspended the registrations of 15 doctors for six months after finding fault with their relationships to a pharma company. The company allegedly sponsored trips to the United Kingdom for the doctors and in some cases their families. At least one of the doctors is alleged to have failed to disclose who paid for the tickets. Press Trust of India

CFDA has cleared Medistem to begin selling VeriQ C in China. The approval completes Medistem’s push to win approval for the technology in all of its major markets. VeriQ C is designed to make it easier for surgeons to plan and perform cardiac operations — particularly coronary artery bypass grafting — through the use of ultrasound imaging. Press Release

The Medical Journal of Australia has warned changes to patent practices proposed in the Trans-Pacific Partnership Agreement could drive up the cost of drugs. A report by the journal forecasts drugs will cost Australian taxpayers hundreds of millions of dollars a year more if the trade deal is enacted in its current form. The ability to “evergreen” patents is at the center of the concerns. The Guardian

Government officials are still waiting for answers from the All India Institute of Medical Sciences (AIIMS) to questions about the procurement of medical devices. The questions relate to a stockpile of unused medical devices that were found during checks by a committee last year. Officials have referred the case to the Central Bureau of Investigation. The Economic Times


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