Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
CDSCO Calls Top Pharma Firms to Meeting on Track-and-Trace Implementation
The Central Drugs Standard Control Organization (CDSCO) has called Novartis, Pfizer and other major drugmakers to a meeting about a planned trial of a track-and-trace system. CDSCO is holding the meeting to discuss implementation of the Drugs Technical Advisory Board’s (DTAB) recommendation that the top 300 pharmaceutical brands are covered by a track-and-trace mechanism.
DTAB discussed the track-and-trace proposal last month and agreed that manufacturers of the top 300 pharmaceutical brands should be invited to participate. The idea is to have these manufacturers participate on a voluntary basis to test a system for tracking and tracing medicines across the supply chain. DTAB stated the Drug Controller General of India (DCGI) could issue a notice to manufacturers affected by the proposal.
One month later, CDSCO has issued that notice. The letter is addressed to more than 50 companies that collectively make the top 300 pharma brands in India. CDSCO looked at sales data for the past year to draw up the list of 300 brands and their manufacturers. The list includes a who’s who of leading local and multinational drugmakers, some of whom make 10 or more of the top 300 brands.
DCGI Eswara Reddy wants to meet with these companies next week to discuss the track-and-trace proposal. While DTAB called the trial voluntary, CDSCO is asking the manufacturers to make the time to attend the meeting with Reddy.
The meeting marks a notable advance in efforts to establish a domestic track-and-trace system. India has a long-standing interest in supply chain technologies. In 2011, the Directorate General of Foreign Trade mandated the use of barcodes on secondary and tertiary packaging of drug exports. The following year, a task force formed by the government to look into track-and-trace systems filed its report.
Since then, track-and-trace systems have been discussed as a solution to the problem of counterfeit medicines in India without the idea progressing to the implementation stage.
Australia Commits to Phased Introduction of Revised GMP Fee Structure
The Therapeutic Goods Administration (TGA) of Australia has committed to the phased introduction of its revised good manufacturing practice (GMP) fees. TGA will hold off on fully implementing the new fee structure until July 2020 to give manufacturers enough time to prepare and adapt.
Australian officials originally planned to adopt the new fee structure next month, but changed course after the industry criticized the lack of forewarning. With budgets for the year already set using the old, lower fees, TGA accepted it would be inappropriate to hike its rates in July. Instead, TGA settled on a staggered transition, full details of which have now been published.
The first changes come into force on 1 July. After that, TGA will stop the accrual of “free” inspection hours, a practice that gives manufacturers a fixed allowance of inspection hours in return for paying an annual fee. TGA will continue to honor existing inspection hour allowances until July 2020.
Next month will also see TGA adopt a single annual license fee and increase its hourly rates for local inspections, but the agency has deferred the bigger changes until July 2019. That month, TGA will start charging the new, higher fees for compliance verification and the processing of GMP clearance applications.
The move to the new charging model will affect the service provided by TGA. The agency is temporarily disabling automated invoicing during the application process. Instead, TGA staff will raise an invoice once an application is submitted. The application will progress as usual once the invoice is paid.
CDSCO to Stop Accepting Hard Copy New Drug Applications This Week
CDSCO is set to stop accepting hard copy filings for new drug approvals on Friday. The move to a fully digital regulatory system comes two months after CDSCO began accepting new drug applications through its online Sugam portal.
CDSCO opened Sugam to applications related to new drugs and fixed-dose combinations in late April. Now, with a view to reducing regulatory timelines and costs, it is making use of Sugam mandatory for these regulatory filings. CDSCO will stop accepting physical applications on June 22.
The switch is a landmark moment in the multi-year rollout of the Sugam portal. CDSCO introduced Sugam late in 2015 and has moved regulatory services over to the portal in waves ever since. Some of the transitions identified problems with Sugam, delaying the rollout, but having worked through those CDSCO now has enough confidence in the portal to stop using paper for important processes.
Pakistan to Tweak Labeling Laws to Clarify Requirements for Exporters
Pakistan is planning to change the labeling laws that apply to exporters of medicines. The proposed change states that the labeling requirements of the importing country take precedence over those imposed by Pakistan.
As it stands, Pakistan’s Drugs (Labelling and Packing) Rules, 1986 exempts exported drugs from the requirements it places on products sold domestically. However, the section on exported medicines also states the labels of products destined for overseas markets should conspicuously display details including the name and batch number of the drug, and the name and address of the manufacturer.
Now, Pakistan is planning to add the following caveat to the law on exported drugs: “Provided further that if the labelling requirements and practices of an importing country are different from such requirements of this sub-rule, the labelling requirements of the importing country shall prevail.”
Pakistan is giving people 14 days to comment on the proposal.
SDA Makes Bristol-Myers’ Opdivo the First Checkpoint Inhibitor Approved in China
China’s State Drug Administration (SDA) has approved Bristol-Myers Squibb’s anti-PD-1 drug Opdivo. The regulatory nod makes Opdivo the first checkpoint inhibitor to win approval in China.
Antibodies targeting the PD-1/PD-L1 checkpoint blockade have reshaped the treatment of multiple types of cancer by facilitating immune system attacks on tumors. However, Opdivo and competing checkpoint inhibitors such as Merck’s Keytruda have been late arriving in China.
Bristol-Myers became the first company to enter the market this week when SDA approved Opdivo for use in the treatment of certain non-small cell lung cancer (NSCLC) patients. The filing was based on data from Chinese clinical trials that reported increases in overall survival over standard of care in the second-line treatment of NSCLC.
Opdivo is unlikely to be the last PD-1/PD-L1 checkpoint inhibitor approved in China. Merck and other multinational companies have such drugs in their portfolios, and a clutch of Chinese drug developers are working on rival therapies with similar mechanisms of action.
has asked Indian pharmacies to create shelves that exclusively stock generic medicines. Each retailer must have a shelf that only stocks off-patent drugs and is visible to consumers. Reddy told pharmacies to make the change after the topic was discussed by DTAB
and the Drugs Consultative Committee
. DCGI Notice
has developed a new website. The new site, which is available at www.cdsco.gov.in, features a page for each of the regulator’s divisions. DCGI Reddy
has asked the heads of divisions at CDSCO
’s headquarters and zonal offices to review pages relevant to them and propose changes. Divisions will manage their own pages under the new system. DCGI Notice