Asia Regulatory Roundup: India Hews Closely to WHO GMP Guidelines in Planned Changes to Schedule M

Regulatory NewsRegulatory News | 16 October 2018 |  By 

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
India Hews Closely to WHO GMP Guidelines in Planned Changes to Schedule M
India is planning to overhaul its legislation on good manufacturing practices (GMPs). The draft text draws heavily on the World Health Organization’s (WHO) GMP guidelines and thereby stands to bring India in line with global standards.
Today, the structure of India’s GMP legislation, Schedule M, and the language it uses are distinct from comparable documents used elsewhere in the world. Recognizing the downsides to divergence in a global industry, Indian officials have discussed moving closer to international standards for several years. Now, with India looking to boost exports, the government has proposed a new approach.
Aside from minor wording differences, large sections of the draft legislation are identical to the GMP document adopted by WHO. That means the draft covers key concepts absent from the current version of Schedule M, such as pharmaceutical quality systems and quality risk management. At 165 pages, the document is more than twice the length of Schedule M and goes into more detail about a wider range of topics.
Some manufacturers in India already follow WHO GMPs. However, most small and medium-sized enterprises base their quality oversight on India’s own rules. Once these companies adopt rules that are in line with WHO GMPs, the number of Indian manufacturers that can export drugs will increase significantly. 
That is a factor behind the move to the new system. The proposed revisions to Schedule M form part of India’s preparations to join the Pharmaceutical Inspection Co-operation Scheme (PIC/S), according to Pharmabiz. By adopting international standards and joining PIC/S, India hopes to give local companies more access to global markets.
India is accepting feedback on the draft legislation.
Gazette Notifications, WHO Guideline, Pharmabiz
Big Pharma-Backed OTC Trade Group Savages TGA’s Advertising Complaint Handling Plan
A non-prescription drug trade group has strongly criticized the Therapeutic Goods Administration’s (TGA) plan for handling complaints about advertising. The group, which lists Johnson & Johnson and Pfizer as members, thinks the Australian regulator’s proposed system will be “unnecessarily complex, unfair and biased.”
TGA released the draft for consultation in May as part of a push to implement the recommendations of the expert panel the government convened to review the regulations in Australia. The panel said Australia should disband its current mechanism for managing complaints about advertising of therapeutic products and create a new process “consistent with best practice principles.” The experts also argued Australia should put a single agency in charge of handling the new complaint process.
The Australian government accepted the recommendations and named TGA as the single agency to take control of advertising complaints. TGA responded with a document designed to create a system that is simpler, more consistent and delivers on the panel’s recommendations.
ASMI, the Australian Self Medication Industry, thinks TGA has fallen a long way short of that goal. In its response to the draft, ASMI accused TGA of producing a “rushed” document that is littered with errors and “questionable proposals.” To compound the situation, ASMI thinks TGA has also omitted “key considerations.” Undermined by these perceived failings, ASMI thinks TGA’s proposal fails to meet the expert panel’s brief and will yield a system “that is in many ways inferior” to today’s model.
The trade group listed faults with many aspects of TGA’s proposal in its 55-page submission. Some of the key criticisms relate to whether TGA has proposed a single-agency system consistent with best practices. While this was the stated goal of TGA’s proposals, ASMI thinks it has failed to hit the mark. As ASMI sees it, TGA’s focus on advertising that affects consumer safety undermines the single-agent idea. ASMI also accused TGA of failing to address best practices at all in the draft document.
Those criticisms are just a fraction of what ASMI thinks is wrong with the draft. To give an idea of the breadth of its criticisms, the feedback features 15 recommendations. Three of the recommendations relate to best practices or the single-agent approach.
Yet, while TGA’s proposal was strongly criticized by ASMI, the document was better received by other groups. Sanofi, for example, called the proposal “appropriate and an improvement compared to the current model.” Buoyed by that response and feedback from other organizations, TGA said the consultation had found “broad stakeholder support for the proposed complaints handling model.” 
TGA is revising the draft in light of the feedback, but there is no indication in its response that it plans to radically overhaul the proposal. Rather, TGA is changing the administrative process “to ensure complainants are advised of the priority level of their complaint” and factoring suggestions about reporting trends into its implementation of the new model.
ASMI Submission, TGA Response
Australian Government Accepts Calls to Revise Device Oversight Following Mesh Scandal
The Australian government has supported many recommendations made by a Senate committee that looked into the transvaginal mesh implant scandal. However, the government also pointed to several barriers to the regulatory changes proposed by the committee.
When the committee came out with its report earlier this year, it put the review of the adverse event reporting system at the top of its list of recommendations. Specifically, the committee called on the government to look into making medical practitioners report adverse events, providing guidance on what constitutes an adverse event and simplifying the reporting process.
In responding, the government said it supports the recommendations in principle before outlining the barriers to the changes. Notably, TGA has no power to make medical practitioners report adverse events.
In other areas, TGA is already working toward goals that overlap with the committee’s agenda. These efforts include the development of “an integrated electronic medical device adverse event reporting system to link reports across medical software platforms directly from hospitals to TGA's system.” TGA thinks the system will “increase the quality, efficiency and quantities of reports” while cutting the administrative burden on healthcare professionals.
The government also expressed tentative support for the creation of a registry of high-risk medical implants. Australia's expert regulatory panel proposed the establishment of such a registry in 2015, and the Senate committee added its support for the idea earlier this year. The government is open to the idea, but wants to assess its practicality and impact before making a firm commitment.
TGA Notice
India Proposes 50-Fold Increase to Import License fee in Major Review of Regulatory Rates
India is planning to significantly increase the fees it charges to perform a range of regulatory services. The proposed changes include a 50-fold jump in the fee CDSCO charges for licenses to import drugs for “examination, test or analysis.”
The planned import fee increase from Rs 100 ($1.35) to Rs 5,000 is the biggest change in percentage terms, but other revisions could have a bigger effect on companies operating in India. Officials plan to hike two payments linked to registration certificate applications from $1,500 to $10,000, and from $1,000 to $5,000. If an inspection is needed, the applicant will pay $25,000, up from $5,000 today.
India also plans to increase the fee for clearance to import drugs licensed for sale in India from Rs 1,000 to Rs 10,000. Other changes will affect fees associated with fixed-dose combinations.
The Indian government is accepting objections and suggestions related to the proposed changes.
Gazette Notifications


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