India Plans to Bring All Medical Devices Under CDSCO Oversight in December
The Indian government is planning to give the Central Drugs Standard Control Organization (CDSCO) oversight of the import, manufacture and sale of all medical devices in December. If finalized, the change would require many more medical device companies to seek certification and authorization.
India has been slowly bringing more medical devices under the drugs rules in recent years, starting with high-end products such as imaging equipment. In April, the Drugs Technical Advisory Board (DTAB) signed off on a major expansion of the move to treating devices as drugs, drafting legislation that would require companies that import, make and sell products including contraceptives and certain disinfectants to seek certification and authorization from the national regulator.
The Indian government recently published the draft legislation created by DTAB. The draft is open for comment for 30 days, but the government expects to take little time to review the feedback. Under the current plan, the changes will take effect on 1 December.
DTAB proposed starting to treat the devices as drugs 18 months after the release of the legislation. The advisory board also set out a staggered, risk-based timeline for complying with requirements related to the change and discussed the potential for companies to obtain exemptions. The notice issued by the government, and shared by CDSCO, lacks these details.
Adoption of the timeline proposed by DTAB would have given industry and CDSCO time to adapt to the changes. At the April meeting, DTAB presented the regulatory change as a major undertaking for CDSCO. DTAB proposed creating a new drugs controller position to oversee a team of 449 medical device regulatory officials, most of whom would hold the rank of drugs inspector (medical device) or assistant drugs inspector (medical device).
DTAB also listed 305 laboratory positions and 31 experts and specialists it advised hiring on a contract basis. The result is an almost 800-strong team. Finally, DTAB advised adding staff and infrastructure at the state level to support the increased oversight of medical devices.
CDSCO Notice, DTAB MInutes
Trade Group Argues TGA Device Plan Would Impose ‘Unreasonable Burden’
The Medical Technology Association of Australia (MTAA) has pushed back against proposed changes to the classification of active implantable medical devices (AIMD). MTAA argued the up-classification of some devices would “impose unreasonable burden on manufacturers and sponsors, disproportionate with their intrinsic risk.”
Australia’s Therapeutic Goods Administration (TGA) proposed the changes in March as part of its efforts to strengthen oversight of medical devices in light of the regulatory framework that is set to come into force in the European Union.
The TGA proposal has two overarching goals. First, TGA wanted to simplify is classification rules by moving active implantable devices from Class AIMD to Class III. Second, TGA wanted to expand the rules on accessories to AIMDs to capture all accessories. Under the current rules, AIMD accessories can fall into Class I, IIa or III. TGA argued all accessories, both implantable and non-implantable, are Class III devices, as their role in the safe functioning of AIMDs creates significant risks.
MTAA pushed back against that idea.
“The implication for Australian sponsors is that non-implantable accessories to active implantable medical devices currently classified below Class III or AIMD would be up-classified to Class III, including low risk non-implantable accessories that are not essential for the ability of the AIMD to be used in accordance with its intended purpose,” MTAA wrote in its feedback.
TGA responded to the feedback by holding discussions with stakeholders concerned about its plans. Specifically, TGA sought information about the accessories the industry wants to see put into a lower risk category. The consultation persuaded TGA to change course.
Analysis and comparison of the risks associated with the information and examples provided, supports the suggestion that in regards to accessories to AIMD, only long-term surgically invasive and implantable accessories to AIMD should be classified as Class III, rather than all accessories to AIMD,” TGA wrote in its response to the feedback.
That change is the only amendment discussed by TGA in its brief analysis of the feedback it received. Having resolved the main point of conflict with the industry, TGA is now working on guidance to clarify which devices will be reclassified and lay out the transitional arrangements.
TGA presented transitional arrangements in the March consultation. With TGA concluding “no major concerns” were expressed about the proposed arrangements, the final plan is likely to hew closely to that set out in the consultation. The proposed transitional arrangements would give companies that file to sell an AIMD in Australia before the changes come into force in August 2020 until August 2024 to comply with the new rules
MTAA Response, More
TGA Tests Find NDMA Levels in Most Ranitidine Medicines Exceed Limit
TGA has found excessive levels of N-nitrosodimethylamine (NDMA) in 80% of batches of ranitidine medicines. The tests suggest many ranitidine medicines available in Australia before recent recalls contained quantities of the carcinogenic contaminant above the internationally agreed limit.
TGA received samples of 34 products from 10 sponsors, giving it 135 batches of ranitidine medicines to test. The vast majority of the batches contained NDMA at above 0.3 parts per million (ppm), the internationally agreed limit. One batch sold by Alphapharm contained an estimated 14 ppm of NDMA, although TGA notes that the test becomes less accurate above 3 ppm.
The near-term consequence of the result is the restriction of the availability of ranitidine medicines in Australia to the 26 batches that contained less than 0.3 ppm of NDMA. All the batches that passed the test came from Arrow Pharma and Sandoz, both of which also provided other samples that exceeded the 0.3 ppm limit.
After seeing the test results, TGA reiterated its view that the additional risk of cancer posed by the levels of NDMA found in ranitidine medicines is very low. Even so, TGA is considering further action.
TGA is set to place new requirements on ranitidine medicines to ensure they only contain acceptable levels of NDMA. In addition, TGA is considering suspending products that fall short of its quality and safety standards.
TGA Starts Sports Supplements Consultation Amid Illegal Advertising Concerns
TGA has started a consultation about the regulatory status of sports supplements. The agency wants to clarify that sports supplements are therapeutic goods “when used, advertised or presented for supply in a particular way.”
Sports supplements sit at the regulatory intersection between foods and medicines. TGA notes that certain supplements carry explicit or implied claims and are marketed for therapeutic use, yet some products may be classed as foods for regulatory purposes.
To clarify the situation, TGA is proposing to use a decision tree to determine if a sports supplement is a therapeutic good. The proposal would lead to all pills, tablets and capsules that meet TGA’s criteria for sports supplements being treated as therapeutic goods.
The consultation follows a period in which TGA has repeatedly used its recently gained powers over the advertising of therapeutic goods to target suppliers of sports supplements. In its annual report on advertising compliance, TGA identified 80 complaints about the advertising of unregistered Schedule 4 therapeutics, some of which related to the “promotion of unregistered prescription medicines for athletic and body enhancement.” – Raps