Asia Regulatory Roundup: India's CDSCO May Soon Regulate Devices (18 February 2015)

Regulatory NewsRegulatory News | 18 February 2015 |  By 

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

CDSCO Readies to Take Control of Medical Devices as Pricing Row Escalates

The Central Drugs Standard Control Organization (CDSCO) will gain oversight of medical devices if a proposed legislative amendment is introduced and passed. CDSCO is preparing for the new powers by hosting a workshop to discuss how medical devices are regulated in India and overseas, The Times of India reports.

An article in the same newspaper highlights one of the problems facing the sector. The paper reports that the general public is paying $1,600 for drug-eluting stents that can cost government employees as little as $320, adding to the chorus of criticism of stent prices in the country on the week a panel set up to review the medical device sector is due to report its findings.

While the prices are somewhat cheaper than in Western Europe and the United States, critics note the cost in India is very high when considered against gross domestic product (GDP). At the upper end of the price range, a stent in India costs 130% of GDP per capita, compared to 6% in the US. The cost in India is driven up at each step in the supply chain, with distributors and hospitals taking big cuts.

Pricing is one of many contentious topics facing the medical device sector in India. A task force set up to suggest solutions to some of the problems — which span pricing, import tariffs and regulations — is scheduled to release a detailed report this week. Aspects of the move toward recognizing medical devices as distinct from pharmaceuticals are already underway, notably the creation of testing labs.

The Times of India I More I PharmaBiz I The Economic Times

Indian State Could Pass Orphan Drug Bill this Year

A committee led by the managing director of Biocon has proposed draft rare disease and orphan drug legislation. The group is aiming to get the act passed in the Indian state of Karnataka by the end of the year, a fast-track timeline it thinks can be achieved by skipping the industry consultation phase.

Kiran Mazumdar-Shaw, managing director of Biocon and head of the Karnataka Vision Group on Biotechnology, told PharmaBiz a comment period is unnecessary because the panel that drafted the act is made up of experts who understand the importance of the topic. If the legislation passes as planned, it would mark an early advance for the Indian rare disease and orphan drug sector.

The legislation is intended to increase the availability of orphan drugs and enable the earlier detection of rare diseases. For now, the legislation is only being considered by lawmakers in Karnataka, but the panel that drafted the act would like to see an orphan drug model adopted across India.


Alibaba and Jo-Jo Partner Ahead of China’s Relaxation of Online Drug Sales

The powerhouses of China’s pharmacy and e-commerce sectors have started to prepare for the imminent relaxing of online prescription drug sales. China Jo-Jo Drugstores has signaled its intention to claim a slice of the nascent market by striking a deal with Alibaba Health Information Technology.

Leading drug distributor and pharmacy chain Jo-Jo has partnered with Alibaba Health — a unit of China’s online retail behemoth — to access Alijk, a mobile app. Alijk allows users to send photos of their prescriptions to nearby pharmacies, check the availability and pricing, pay for the product they pick and arrange for home delivery or in-store collection.

Jo-Jo entered into the deal in preparation for new laws covering online drug sales, which the firm expects to be released later this year. Faced with the task of complying with emerging regulations in a technological, consumer-facing sector, the company has decided it is best served by working with a third party.

Press Release   

Pakistan set to Clear Sovaldi for Distribution After Lengthy Delays

The bottleneck that has stopped significant numbers of patients in Pakistan from receiving Gilead’s Sovaldi is reportedly on the verge of clearing, three months after the Drug Regulatory Authority of Pakistan (DRAP) set a price for the hepatitis C blockbuster.

DAWN reports the process came to a stop at the Federal Ministry of Health Services Regulations — which needs to formally sign off on Sovaldi before it can be cleared for distribution — but is set to get underway again this week. If the ministry acts as expected, it will end the Pakistani hepatitis C community’s long wait for Sovaldi. 

The registration and pricing process took one year, a timeline that was criticized by local media. Hepatitis C is a major problem in Pakistan, where more than 10 million people are infected.


DCGI Bars Kivi for 5 Years After Data Fabrication Investigation

The Drug Controller General of India (DCGI) has barred Kivi Labs from filing applications with CDSCO for any purpose for five years. DCGI took the action after concluding Kivi had submitted forged and fabricated data.

Several applications for fixed-dose combinations (FDC) were investigated by DCGI, which concluded Kivi had worked with a consultant to submit dodgy data. The consultant allegedly fabricated documents and forged the signature of the director of Kivi. DCGI based its decision to clear Kivi to manufacture several FDCs on the documents.

The investigation and punishment suggest DCGI is trying to get on top of data falsification and FDCs, a field that was criticized heavily in a recent paper in The Lancet.

DCGI Letter

Other News:

Australia’s Therapeutic Goods Association (TGA) has warned the public about Biomet components in metal-on-metal total hip replacements. TGA issued the warning after its analysis of an Australian joint replacement registry revealed that Biomet M2a components have a higher than expected revision rate. Biomet has stopped supplying the parts, which were last used in Australia in 2011. TGA Notice

DCGI is to meet to discuss how prepared the country is to cope with the recent uptick in cases of swine flu and has told manufacturers to stockpile drugs. DCGI wants to establish the availability of Tamiflu, which is reportedly in short supply in some regions. The supply situation became a pressing concern after H1N1 infected 239 people in Maharashtra. PTI I PharmaBiz

A high court in Pakistan has ordered officials at the health department to comment on a case against a multinational pharma company. The suit alleges the company colluded with DRAP to unlawfully register a hepatitis vaccine, accusations that the firm denies. The court will discuss the matter later this month, by which time the health ministry must have commented. The News

The government of Kashmir has suspended the licenses of five production plants after authorities found they were manufacturing substandard drugs. Regulators seized products from the sites. The governor is trying to clamp down on substandard drugs and has ordered the local regulator to report on its activities over the past year. Rising Kashmir I Greater Kashmir

MoneyLife has discovered 31% of posts at Maharashtra FDA are vacant. The staffing shortage means the state regulator has one officer per 135,000 people. More than 20% of the drug inspector posts sanctioned by the government are unfilled, as are half of the senior technical officer roles. MoneyLife


© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy