Asia Regulatory Roundup: India Looks to Join Pharma Inspection Scheme (15 September 2015)

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

Abbott Contests Indian Allegations of Substandard Cough Syrups

A dispute between Abbott and regulators in India has raised doubts about the effectiveness of the quality testing regimens implemented by local authorities. The case centers on a sample of a product branded as Abbott’s cough syrup Phensedyl that was found to contain twice as much codeine as was listed on the label, Reuters reports.

Officials in West Bengal ran the tests after seizing bottles of the syrup near to the border with Bangladesh. After discovering the sample contained 21.37mg of codeine per 5ml, not the 10mg that the labeling claimed, officials included the batch in their monthly roundup of substandard products. Under an effective regulatory system, such a discovery would trigger a recall. Yet in this case, the 80,000 bottles in the batch are still on the market and it is unclear if a recall is even necessary.

West Bengal drug controller CM Ghosh said the region lacks the funds to follow up the case. Abbott is trying to run its own investigation but has encountered an administrative roadblock. Tests run by the company and a third party on a sample of the suspect batch it retained from production found it met with quality standards. Abbott wants a sample of the batch tested by West Bengal to check if it is genuine or counterfeit, but obtaining one has proved to be difficult.

Officials in West Bengal think it is up to Himachal Pradesh, where the syrup is manufactured, to provide information to Abbott. Regulators in Himachal Pradesh think the task is the responsibility of their peers in West Bengal. West Bengal’s Ghosh said Abbott must look elsewhere if it wants to challenge the test results. The drug controller said that if Abbott wants to mount such a challenge, it must gain clearance from a court to analyze a sample at a lab run by the central government.

While the case is dragging on, the batch is still officially classed as being “not of standard quality,” a stigma that has been applied to Abbott since February. “We are awaiting response from the authorities,” an Abbott representative said. While Abbott waits, substandard products, whether they are genuine or counterfeit, are likely still on the market.

Reuters

DCGI Readies Slate of Initiatives to Lessen Regulatory Burdens

A slate of long-discussed improvements to the regulatory process in India is now on the cusp of coming to fruition, PharmaBiz reports. The adoption and enhancement of IT infrastructure forms the backbone of the overarching strategy to lessen the regulatory burden on biopharma companies.

Once the new processes are established, something the Drugs Controller General of India (DCGI) expects to start happening in the coming weeks, it should become quicker and easier for companies to obtain licenses and approvals for imports, exports and other tasks. DCGI GN Singh, who in March said “everything should be online,” is looking to a new, more transparent IT system to deliver the promised improvements.

While government-led IT initiatives have a patchy record of living up to expectations, data from the Indian states that have pushed ahead with adoption of online licensing systems are encouraging. In April, Maharashtra Food and Drug Administration said a geographically limited introduction of an online licensing system had cut the time it took to process applications from two months to 15 days. The time savings enabled the regulator to clear 15,000 applications in six months.

Part of the task facing the Central Drugs Standard Control Organization (CDSCO) is to create standard operating practices that connect it to state systems. The objective is to create a network on which regulators and applicants can keep tabs on the progress of filings. It is hoped the lower burdens will boost investment. “We would look to encourage small-medium pharma entrepreneurs together encourage the start-ups in this sector to increase the upfront investments in sector,” Singh said.

PharmaBiz

South Korea Approves First Biosimilar from Merck-Samsung Collaboration

The Korean Ministry of Food and Drug Safety (MFDS) has approved a biosimilar developed by a joint venture between Merck and Samsung. Approval of the biosimilar version of Amgen’s Enbrel continues a busy period for MFDS, which has cleared a clutch of biological copies since 2014.

South Korea passed legislation covering biosimilars in 2009, since when it has co-developed guidance with the World Health Organization. As in the European Union, a region with which South Korea has harmonized its policies, MFDS has also written guidelines covering specific classes of biologics. The establishment of the regulatory framework took place before the recent uptick in the rate of biosimilar approvals. MFDS first approved a biosimilar in 2012 but the sector only started to take off in 2014.

In January 2014, MFDS approved two biosimilars, a copy of Herceptin from Celltrion and Sandoz’s human growth hormone, Omnitrope. An approval of a biosimilar version of Enbrel developed by Hanhwa Chemical followed in November. Brenzys, Merck and Samsung’s copy of the immunology drug Enbrel has now joined this short but expanding list of biosimilars to win approval from MFDS.

Press Release

India Embarks on Campaign to Convince Skeptics of Merits of PIC/S Membership

The Indian commerce ministry is ramping up its attempts to convince the industry of the merits of joining the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme (PIC/S), The Economic Times reports. Businesses are concerned about the cost of joining.

Signing up to PIC/S is predicted to necessitate investments to raise standards at manufacturing sites. For small companies focused on the domestic market, the value of making the investment, which some people estimate will amount to Rs 5 crore ($753,000), is questionable. As it stands, the owners of 8,600 of the nearly 10,000 drug units in India are forecast to have to make investments in their operations if India joins PIC/S.

The process of showing such skeptics the benefits of joining PIC/S is set to get underway later this month when officials from the commerce ministry meet with the industry at a forum in Hyderabad. Pharmaceuticals Export Promotion Council Director-General PV Appaji said India will only join PIC/S if all stakeholders are behind the plan. With around 85% of drug units needing to invest if India joins, achieving such a broad consensus could be challenging.

The Economic Times

Other News:

The Australian Therapeutic Goods Administration (TGA) has provided guidance on how clinical trial sponsors can manage the transition from its offline to online systems. Sponsors that notified TGA of their clinical trials before the changeover date of 1 July that want to amend their information must use a transition form created by the regulator. TGA Notice

The China Food and Drug Administration (CFDA) has changed the Drug Manufacturing Certificate and Pharmaceutical Preparation Certificate for Medical Institution. CFDA will start using the new versions from January 1. The revised certificates were introduced alongside new enforcement guidance for regional regulators in China.  CFDA Notice, More (Chinese)

TGA has released guidelines covering the storage of poisons by retailers. The guidelines cover two classes of poisons, namely those that must be kept away from children and more dangerous items that only authorized users can handle. While child-resistant packaging is sufficient for the first class of products, the latter must be locked away. TGA Notice