Asia-Pacific Roundup: India proposes banning over-the-counter syrup sales after contamination crisis

India’s Central Drugs Standard Control Organization (CDSCO) has proposed removing cough syrups from the list of medicines that can be sold without a prescription.

The draft change, which was published on 29 December and is open for comment for 30 days, will affect Schedule K of the Drugs Rules, 1945. Under the legislation, products listed in Schedule K are exempt from the requirement that patients have a prescription to buy the medicine from a retail store. There are already limits on the exemption, but it still supports ready access to cough syrups in parts of India.

Currently, Schedule K lists “syrups, lozenges, pills, and tablets for cough” among 15 classes of household remedies that benefit from the exemption. CDSCO has proposed removing syrups from the list of exempt cough remedies.

The legislative proposal lacks a justification for the proposal, but the reasoning was explained at a Drugs Consultative Committee (DCC) meeting in November. At the meeting, committee members were told about incidents linked to contaminated cough syrup and asked to consider the change to Schedule K in that context. DCC approved the proposal to remove syrups from the list of exempt cough remedies.

In September, the World Health Organization (WHO) identified localized clusters of acute illness and child fatalities in India. The following week, CDSCO told WHO it had found diethylene glycol (DEG) in at least three oral liquid medicines that were reportedly consumed by the affected children. At least 20 children died after taking cough syrups contaminated with DEG, a toxic substance used in industrial solvents.

Indian officials have taken multiple steps to prevent further illnesses and deaths. The Indian Health Ministry told physicians and pharmacists not to prescribe or dispense cough and cold medications to children below two years. Such medicines are generally not recommended to children below five years, officials said.

Other Indian departments have moved to stop DEG and ethylene glycol, another toxic contaminant, from entering the medicine supply chain. DCC has considered whether manufacturers should stop using solvents such as propylene glycol that are at risk of contamination. The committee asked CDSCO to consult stakeholders before taking any action.

CDSCO Notice

WHO designates Australian and Indonesian regulatory agencies as listed authorities

WHO has designated Australia’s Therapeutic Goods Administration (TGA) and the Indonesian Food and Drug Authority (BPOM) as listed authorities.

Anthony Lawler, head of TGA, said WHO listed authorities (WLAs) “play a critical role in improving global health by enabling others to rely on and have trust in the decisions we make.” The status means other national regulators, global health partners, medicines procurement agencies such as the Global Fund and UNICEF, and other countries can rely on the decisions of WLAs to support access to medicines.

The designation of TGA and BPOM means the global WLA network now comprises 41 authorities from 39 countries. All the agencies have been through a voluntary technical evaluation to demonstrate advanced and reliable oversight across specific areas of medical product regulation.

BPOM is the first regulatory authority from a middle-income country to achieve WLA status as a standalone agency. WHO said the achievement reflects “sustained political commitment and long-term investment in regulatory system strengthening, particularly for vaccine oversight in one of the world’s largest and most complex health markets.”

Indonesia’s success shows advanced regulatory capacity is attainable across diverse resource settings, WHO said. The global organization expects Indonesia’s example to encourage other regulatory agencies, especially in low- or middle-income countries, to pursue similar pathways.

TGA was previously classified as a stringent regulatory authority (SRA), the designation that preceded the WLA network. All agencies recognized under the old designation have now formally transitioned into the WLA framework. WHO said TGA’s designation as a WLA “completes a carefully planned shift toward a single, transparent and predictable global system.”

Other national regulators have submitted expressions of interest to enter the WLA process, WHO said. Regulatory agencies in 18 countries, including China and India, are transitional WLAs because of their status under the old SRA system.

WHO Statement, TGA Notice

CDSCO posts guidelines on handling breaches of Indian medicine legislation

CDSCO has published draft guidelines on a legal framework for addressing regulatory noncompliance without prosecuting companies or individuals.

Traditionally, noncompliance with India’s Drugs and Cosmetics Act, 1940 could result in prosecution. The government introduced an alternative pathway for sanctions to address minor and technical breaches without overburdening the judicial system. The recently introduced Section 32B allows for central and state governments to “compound” certain offenses to eliminate the need for prosecution.

CDSCO shared more information in guidelines on the compounding of offenses. The guidelines describe how the compounding authority will consider requests from regulators. If the authority agrees that an offense can be compounded, it will set the amount the offender needs to pay and grant them immunity from prosecution.

The compounding authority will grant immunity if it is satisfied that the offender has cooperated and made “a full and true disclosure of facts relating to the case.” Immunity will be withdrawn automatically if the offender fails to pay the requested amount or breaches certain conditions. The authority may also withdraw immunity if it finds the offender concealed any facts or gave false evidence.

CDSCO published the guidelines alongside answers to frequently asked questions about compounding and a standard operating procedure for processing applications under Section 32B.

CDSCO Guidelines

Hong Kong starts offering one-on-one meetings before ‘1+’ new drug applications

Hong Kong’s Department of Health (DH) has started accepting applications for one-on-one pre-new drug application meetings with companies seeking approval via the “1+” mechanism.

The mechanism, which was implemented in 2023 and expanded last year, allows companies to use an approval from one reference authority to support filings for authorization in Hong Kong. Companies used to need approvals from two reference authorities. The policy has supported 16 new drug approvals. More than 180 pharma companies have contacted DH about the mechanism.

DH said the creation of a pre-submission meeting service will optimize the approval process. Companies that are using the 1+ mechanism for the first time can meet with DH to receive tailored advice and guidance on applicable drug registration categories and application pathways. The service is also open to companies that want advice about the evidence they will need to support filings for specific products.

Initially, DH will not charge fees to encourage uptake of the service. Officials have created guidance for companies that plan to request a meeting.

Press Release

IPC updates Indian Pharmacopoeia amid push for international recognition

The Indian Pharmacopoeia Commission (IPC) has published the tenth edition of its drug standards guide.

With 121 new monographs, Indian Pharmacopoeia 2026 has 3,340 monographs. Indian health minister J. P. Nadda said the additions strengthen coverage of key therapeutic categories including antitubercular, antidiabetic, and anticancer medicines.

The Indian Pharmacopoeia is now recognized in 19 countries. The recognition follows a push by India to establish the credibility of its pharmacopeial standards globally and enhance its international standing.

Nadda also noted the progress of IPC’s Pharmacovigilance Programme of India (PvPI). India was the eighth most active contributor to WHO’s pharmacovigilance database in 2025, Nadda said. The country ranked 123rd from 2009 to 2014. India’s rise up the rankings follows a push to strengthen reporting of adverse events through PvPI.

Press Release, More

Other news:

The Jordan Food and Drug Administration (JFDA) joined the Pharmaceutical Inspection Co-operation Scheme (PIC/S) as a participating authority on 1 January 2026. Statement

Asia-Pacific Roundup: India proposes banning over-the-counter syrup sales after contamination crisis

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