Asia-Pacific Roundup: CDSCO seeks feedback how to ensure a level playing field for drug approvals

The Central Drugs Standard Control Organization (CDSCO) has started a consultation into how to ensure a level playing field for the approval of new drugs in India.

Under the New Drugs and Clinical Trials Rules, 2019, developers of new drugs that are approved in other countries typically need to conduct a trial in the Indian population. The local trial requirement may be waived in certain circumstances.

CDSCO said it often receives and authorizes filings from multiple applicants to run clinical trials and bioequivalence studies for a new drug. Yet while multiple applicants may receive clearance to test a new drug, CDSCO said that in many cases only one company runs the trial and bioequivalence study and submits the data for approval.

Once CDSCO approves the product based on the data, the other applicants simultaneously submit the bioequivalence study report and obtain approval for the same new drug as a subsequent application, the agency said.

Waiting until the first company has won approval for a new drug frees subsequent applicants from the need to run a clinical trial. CDSCO will approve filings for additional approvals of new drugs based on chemical, pharmaceutical and bioequivalence data.

“Therefore, there is lack of level playing field between the first applicant who obtains approval of a new drug first time in the country based on clinical trial and bioequivalence study data and the subsequent applicants who obtain approval of the same new drug based on bioequivalence study data for whom the cost of regulatory compliance is much lesser as they are not required to conduct the clinical trial,” CDSCO said.

CDSCO wants to “remove the discrepancy” to encourage the development of new drugs. The agency is yet to make proposals. Rather, officials have asked affected organizations to share feedback to inform the development of a “balanced policy.”

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CDSCO Notice

India’s CDSCO calls for strict quality compliance after deaths linked to contaminated syrups

CDSCO has told regional regulators to take steps to ensure drug batches are tested before being released to the market.

The Indian regulator framed the request in light of the deaths of at least 17 children in the central state of Madhya Pradesh. The children died after consuming cough medicine that contained diethylene glycol, a toxic chemical that has repeatedly been found in oral liquid formulations. Police recently arrested the owner of a cough syrup company in relation to the case.

CDSCO said inspectors found “manufacturers are not carrying out testing of each batch of the excipients/inactive and active pharmaceutical ingredients for verification of compliance with the prescribed standards before using them in the manufacture of formulations and also in the finished products.”

The findings led the agency to highlight the regulations on the testing of each batch or lot of a raw material and of each batch of the final product, as well as the rules on maintaining records. CDSCO asked regional regulators to ensure the rules are followed and make sure that manufacturers have robust vendor qualification systems and only use excipients from reliable, approved suppliers.

CDSCO issued the notice days after the Ministry of Health and Family Welfare met to discuss the production of cough syrups. Attendees discussed the initiation of risk-based inspections of 19 manufacturing units in six states.

CDSCO Notice, More

Japan’s PMDA creates action plan for using AI to enhance operational capabilities

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has set out plans to use artificial intelligence to enhance its operational capabilities.

PMDA said it will proactively use AI in line with the policy described in its action plan. The agency wants to make administrative operations more efficient by using AI technologies that are already available.

In its 2025 financial year, PMDA will establish the daily use of AI in tasks such as document retrieval and summarization, meeting minutes preparation and translation. The plan for 2026 includes an evaluation of the impact of AI to determine whether to expand the use of the technologies.

The work will take place in parallel to the introduction of specialized AI technology for technical verification and information gathering. In 2025, PMDA plans to start building AI models for internal testing. The agency is aiming to be ready to assess the issues, costs and technical limitations linked to the specialized AI systems by the midpoint of its 2027 financial year.

PMDA has appointed a chief AI technology officer to facilitate the integration of AI into its operations. The agency has also established a working group for the introduction of AI to centrally review and coordinate the implementation of the technology.

Action Plan

TGA starts consultation to inform regulation of digital mental health tools in Australia

Australia’s Therapeutic Goods Administration (TGA) is seeking feedback on digital mental health tools (DMHTs) to inform a review of its regulations.

TGA is reviewing its approach to software-based medical devices, including DMHTs that are used to screen, diagnose, monitor or treat patients with mental health conditions. To inform the review, the agency is seeking input from people who develop, supply and deploy the technologies.

The survey features a series of questions about respondents’ DMHTs, covering topics such as whether products have been accredited under a national scheme, are in the Australian Register of Therapeutic Goods as a medical device and are based on established clinical practice guidelines.

TGA is interested in DMHTs that are available as web apps, mobile apps and computer programs. The consultation covers software used in the management of a wide range of mental health conditions.

None of the questions relate specifically to the regulation of DMHTs. Instead, the consultation is focused on helping TGA to better understand the types of products that are in use in Australia.

TGA Consultation

Philippine FDA adopts temporary system for generic drug filings after pilot problems

The Philippine Food and Drug Administration (FDA) has implemented a temporary semi-electronic system for the registration of generic drugs.

FDA previously developed a platform for the end-to-end processing of applications for initial registration of generic medicines. The agency piloted the Electronic Certificate of Product Registration (e-CPR) Information System in 2024. During the three-month pilot, FDA received 1,791 applications, 68 of which were pre-assessed. Six applications were paid for.

“However, due to system issues raised, the processing of those applications (including the pre-assessment of the remaining 1,723 applications) through the e-CPR Information System was temporarily suspended until 23 January 2025,” FDA said.

While evaluating feedback on how to improve e-CPR, the agency is using a new temporary semi-electronic system. The system uses the existing manual pre-assessment, evaluation and release of final output documents and the existing FDA eService Portal System.

Using the system, FDA completed pre-assessment of the remaining 1,723 applications earlier this year, finding 642 of the submissions to be acceptable. The agency has extended the validity of all pre-assessment result forms until the end of October to facilitate processing of the applications.

FDA Notice

Other News:

The Drug Regulatory Authority of Pakistan (DRAP) has published guidelines on referring cases for prosecution. DRAP said that, while drug laws support penal consequences for various violations, a lack of guidance on when to refer a matter to a court has led to inconsistent implementation. DRAP Guidelines

Asia-Pacific Roundup: CDSCO seeks feedback how to ensure a level playing field for drug approvals

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