Asia Regulatory Roundup: India Chided for Oversight of Fixed-Dose Combinations (19 May 2015)

Regulatory NewsRegulatory News | 19 May 2015 |  By 

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

India Lambasted Again for Allowing the Sale of Illegal FDCs

For the second time in three months, academic researchers have criticized India for allowing the sale of unapproved fixed-dose combinations. The latest analysis found unapproved formulations accounted more than two-thirds of antidepressant FDC sales by volume from 2007 to 2012. 

A team of United Kingdom- and India-based academics — including an author of the earlier report into metformin FDCs — published the antidepressant finding in a paper in PLOS Medicine. The analysis found unapproved FDCs also held smaller but still significant shares of 43% and 28%, respectively, in the markets for anti-psychotics and non-steroidal anti-inflammatory drugs. In all three sectors, the number of illegal FDCs on the market dwarfed the figure for approved products.

The data predate the 2012 Indian parliamentary committee report into the issuing of production licenses for FDCs without the approval of the Central Drugs Standard Control Organization (CDSCO). However, the authors think the problems that allowed unapproved FDCs to win market share are still in place. To improve the situation, the authors propose an immediate ban on the sale of unapproved FDCs, followed by a staged withdrawal starting with high-risk products.

Reuters, PLOS Medicine

India Supreme Court Backs Merck in Patent Fight Against Glenmark

The Indian Supreme Court has barred Glenmark Pharmaceuticals from producing more of the diabetes drugs Zita and Zita-Met. Merck & Co had objected to the sale of the products, alleging they infringe on its patents for Januvia and Janumet.

Glenmark has suffered a series of setbacks in recent months, starting with a ruling by the Delhi High Court that restrained the company from producing and selling Zita and Zita-Met. The Supreme Court has maintained some of the constraints, although it cleared Glenmark to sell all of its existing stock of the products over the coming months, the Press Trust of India reports. Stocks of the products are thought to be sufficient to meet market demand for the next six months.

The court has blocked Glenmark from processing unfinished formulations, at least for now. A local commissioner is now to record cross-examination testimonies and other evidence, a process that is expected to take until the end of June. While the Supreme Court is yet to start a detailed analysis of the merits of the patents and the decision of the lower court, the decision to stop Glenmark from producing more Zita and Zita-Met while the case is ongoing is a boost for Merck.

A suit against Glenmark was filed by Merck in 2013, and since then several decisions have shown the Indian courts’ willingness to reject Big Pharma patent appeals. The Supreme Court dismissed Novartis’ plea for patent protection for its blood cancer drug Glivec in March, while the patent office started 2015 by knocking back an application from Gilead Sciences covering the blockbuster hepatitis C drug Sovaldi.

Press Trust of India

Japan Proposes Opening up Patent Process to Foreign Companies

Japan is set to make it easier for foreign companies to apply for patent protection in the country. The proposal would end the need for foreign companies to work with a Japanese representative to file a patent application, making it easier for businesses to protect their innovations.

Nikkei reports the model being considered would allow foreign companies to mail their patent applications. The opening up of the patent application process is part of Japan’s planned signing of the Patent Law Treaty and Singapore Treaty on the Law of Trademarks, a pair of international intellectual property treaties. Signatories of the treaties accept patent applications in the language of any other members.

Japanese politicians are working on draft legislation related to the treaties, setting the country up for a reworking of multiple aspects of its approach to patent applications from domestic and foreign companies. The proposal is designed to make the patent office more helpful, notably by having officials alert applicants to problems with their submissions and guiding smaller businesses through the process.

If Japan signs the treaties as expected, it will become one of the first Asian countries to do so. Some observers hope the example set by Japan will prompt more Asian countries to join, increasing the value of being a signatory. “If this encourages other Asian countries to join, getting patents in emerging economies would become easier,” an anonymous telecommunications source said.

Nikkei, FiercePharmaAsia

TGA Deep Dive into Gardasil Data Fails to Find Safety Concerns

Australia’s Therapeutic Goods Administration (TGA) has published the findings of a school-based surveillance program to assess the safety of Merck’s Gardasil. The data show no safety concerns in either males or females who received the vaccine against human papillomavirus (HPV).

The report is the first to be based on data from an enhanced surveillance program, which TGA implemented after five years of passive oversight. TGA focused its enhanced surveillance on four adverse events: anaphylaxis, general allergic reaction, loss of consciousness and hospitalization. The rate of adverse events varied by age and gender, from 122 per 100,000 doses in 12-year old girls to 44 per 100,000 doses in 14-year old boys.

TGA gathered the data from schools, which reported events regardless of whether the vaccination team thought there was a causal link to the jab. Loss of consciousness was the most common adverse event across all demographics and its incidence far exceeded the rate seen in the United States. TGA attributed the difference to the enhanced surveillance program focusing on loss of consciousness and thinks the events have more to do with the vaccination process than Gardasil.

TGA Notice,Surveillance Report

Other News:

The Indian health ministry is aiming to start a Materiovigilance Programme of India (MvPI) in three months to monitor adverse events linked to medical devices. Officials will start by setting up MvPI operations at 10 medical colleges, which will be tasked with collecting and sharing reports of medical device adverse events. The model is similar to the pharmacovigilance program. PharmaBiz

India’s commissioner for departmental inquiries is yet to complete an investigation into alleged unethical drug trials that started three years ago. The cases relates to whether informed consent and other trial processes were handled properly in studies in Bhopal. A whistleblower claims the case has been delayed deliberately to protect doctors accused of misconduct. The Times of India

The Indian health ministry has recommended that clinical trial sponsors continue to provide drugs to participants after a study stops if they appear effective. An amendment to the law to make sponsors continue supplying drugs, without any liability, is proposed. The decision to continue the treatment would rest with the investigator, ethics committee and individual patient. PharmaBiz

TGA has posted safety warnings about three medical devices. Astral 100 and Astral 150 ventilators and ResMed devices that use Adaptive Servo-Ventilation (ASV) therapy are being recalled, while the regulator also flagged potential problems with the HeartWare Ventricular Assist System. Astral, ResMed, HeartWare

The Indian Department of Pharmaceuticals (DoP) is set to start the pilot phase of its revised Jan Aushadhi scheme on June 21. DoP will initially set up stores in six states to supply low-cost generic antibiotics, anti-cardiacs, anti-diabetics, anti-infectives and gastrointestinal drugs. The plan is to expand the geographic and therapeutic scope of the program over the next few years. PharmaBiz


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