Asia Regulatory Roundup: China's Regulatory Red Tape (27 January 2014)

Regulatory NewsRegulatory News | 27 January 2015 |  By 

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

Drugmakers Bemoan China and India’s Regulatory Red Tape

The length of time it takes to bring new products to market in China and India has faced renewed criticism from Western drugmakers.

“It takes much longer now to get products approved [in China],” Paul Stoffels, chief scientific officer at Johnson & Johnson, told Bloomberg. The process of bringing a new drug to market in China can now take up to seven years, Stoffels said, and requires “much more investment.” An extra step in the process has reportedly delayed at least 34 applications.

India has a different set of problems, but the outcome is still that it takes longer for patients to get new medicines. The Wall Street Journal looked at the effect these delays have on the treatment of tuberculosis (TB), which infects 2.1 million people a year in India. J&J and Otsuka Pharmaceutical have won approval for new TB drugs in the West in recent years, but availability in India is limited.

In 2013, Indian regulators asked J&J to run a local trial if it wanted to sell its drug in the country. Otsuka is yet to approach regulators in India. The Japanese drugmaker’s last interaction with the Indian regulatory system was discouraging and it decided to make Eastern Europe the near-term focus for its TB drug.

BloombergI WSJ

India Mulls Linking Pricing Negotiations to Marketing Approval

The Indian government is considering making manufacturers negotiate prices before they are allowed to access the marketin a bid to drive down the cost of patented drugs. If the government pushes ahead with the plan, it also intends to work with manufacturers to bring down the cost of drugs that are already on the market.

A committee has begun the process by asking the National Pharmaceutical Pricing Authority (NPPA) to provide details of the prices and market share of patented drugs already sold in the country, The Economic Times reports. The data will inform a discussion about whether the government can — and should — change the approval process to negotiate lower prices for drugs.

Currently, India caps the prices of 348 essential medicines through its National Pharmaceutical Pricing Policy. The model being considered would be far more wide-reaching, but probably less restrictive in terms of the prices it imposed.

The Economic Times

TGA Adopts Drug Release Guidance to Cover Differences to EU

Australia’s Therapeutic Goods Administration (TGA) has released guidance on the verification of production and quality control records that must occur before a drug is shipped for sale. TGA was encouraged to write the document by manufacturers that were concerned by the lack of guidance on the differences between the Australian and European systems. 

Australian regulations often take their lead from Europe, but their approaches to release for supply differ. The guidance document explains TGA’s requirements for release for supply by an Authorised Person (AP) — which are different than the European process of batch release by a Qualified Person — and how they apply to multi-site manufacturing operations in Australia and overseas.

As well as detailing the AP’s responsibilities with regard to product quality review and ongoing stability testing, the document includes a currently blank section on considerations for specific areas of manufacture. TGA plans to update the section as and when it agrees with industry associations on what extra information is needed.

TGA Guidance

Indian FDA Official Accused of Taking Bribe

India’s Anti-Corruption Bureau (ACB) has accused a senior Indian regulatory official of accepting a bribe. ACB made the accusation after running a sting operation that allegedly caught assistant commissioner Gulab Gore accepting a Rs 1,000 ($16) bribe.

The investigation into Gore began after the owner of a grocery shop filed a complaint. Gore allegedly demanded Rs 10,000 from the grocery shop owner to renew a license, which expired in May 2014. The store owner reportedly negotiated Gore down to Rs 3,000, two thirds of which he paid on the spot, the Press Trust of India reports.

ACB claims Gore said the complainant could pay the rest when he received the license. Before going to pay the outstanding Rs 1,000, the complainant alerted ACB. Anti-corruption officials allegedly caught Gore accepting the Rs 1,000 in his office.

Press Trust of India

CFDA to Clamp Down on Substandard Alcohol as Chinese New Year Nears

The China Food and Drug Administration (CFDA) has called for local regulators to intensify oversight of alcohol production operations. CFDA made the request in response to the deaths of two people earlier this month.

With Chinese New Year happening next month, CFDA is concerned poor sanitation and other quality control failings at some facilities could put people at risk. The regulator has asked local officials to step up sampling and law enforcement activities during the festival. Officials are to report anyone found selling counterfeit alcohol to the legal system for punishment.

The fragmented network of small operations that produce alcohol in China is hard to police. As such, CFDA wants officials to run censuses in their regions and establish records of who is producing what. These records can then facilitate more effective regulatory oversight.

CFDA Notice (Chinese)

Multinationals Fire Back in Scrap over Indian Investment Law

The Organisation of Pharma Producers of India (OPPI) is lobbying the Indian government to relax the laws covering foreign investments in drug and device companies. After several years of restrictive legislation, the current government has indicated a willingness to reconsider the law. 

A proposal to allow 100% direct foreign investment in medical device companies sparked a mixed reaction among Indian businesses. Any changes to the rules covering drug companies are likely to trigger even more vehement reactions, but multinational trade group OPPI thinks they are needed.

“We believe that India must have a predictable, stable and transparent FDI policy. And so we have sought revision allowing 100% FDI under the automatic route for both greenfield and brownfield investments,” Ranjana Smetacek, director general of OPPI, told The Economic Times

The Economic Times

Other News:

The Indian Pharmacopoeia Commission (IPC) has taken steps to implement the Pharmacovigilance Programme of India (PvPI). IPC plans to identify 30 new adverse drug reaction monitoring centers (AMCs) by March. The new centers will bring the total number of AMCs in India up to 180 and boost coverage outside the big cities. A physician education program is also underway. PharmaBizI More

Myanmar Food and Drug Administration (FDA) has reported an increase in seizures of counterfeit drugs. Authorities have captured fakes on Myanmar’s borders with India and China. Myanmar FDA plans to respond by adopting a licensing process in line with practices in the Association of Southeast Asian Nations (ASEAN). The country recently relaxed its rules on foreign investment. Eleven Myanmar

The Indian Drug Manufacturers Association (IDMA) is lobbying the government to overturn a ban on the production of diluted nitroglycerine solution. Authorities outlawed the substance because of its explosive properties, but it is also used in heart disease medication. IDMA wants to delay the ban by two years to give manufacturers time to switch to alternative formulations. PharmaBiz

An Indian committee tasked with suggesting changes to drug regulations has split itself into seven subgroups. The subcommittees will look at drugs, medical devices, clinical trials, biologicals, blood banks and cosmetics. Press Trust of India

Delhi High Court has told Biological E to give it 25% of the amount it is reportedly overcharging for its tetanus vaccine while the dispute is being settled. Press Trust of India


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