Asia-Pacific Roundup: India decriminalizes compliance breaches, replacing imprisonment with fines
Indian lawmakers have voted to decriminalize some compliance breaches to reduce regulatory litigation burden, eliminating the potential for prison sentences while increasing monetary fines.
The country has a legal backlog that is driven in part by cases brought by the government. Amendments that recently passed both Indian Houses of Parliament could slow the flow of new cases by removing criminal penalties for minor procedural lapses and replacing them with civil penalties or administrative mechanisms.
India’s Drugs and Cosmetics Act, 1940 is among the laws affected by the amendments. Under the old law, individuals could face up to one year in prison and a fine of at least 20,000 rupees ($215) for failing to keep records or disclose information. The legal update eliminates the potential for imprisonment and increases the minimum fine to more than $3,000.
With the focus shifting from criminal to civil cases, lawmakers have created an adjudication mechanism to run alongside the existing prosecution route. For civil cases, India’s central and state governments can appoint an adjudicating officer to conduct inquiries and impose penalties. People have the right to be heard before receiving a penalty and can appeal to a higher-ranking authority within 30 days.
The civil adjudication mechanism gives authorities a potentially faster, more efficient way to enforce the regulations. Rather than pursue criminal prosecutions through India’s busy courts, authorities can set up their own mechanisms for issuing civil penalties for certain compliance breaches.
Lawmakers also voted to delete a provision that penalized people for using test reports from the central drugs laboratory or a government analyst in drug ads. Previously, using the reports in drug promotional materials was associated with a fine of about $50. The amendments also delete a section on punishing people who repeatedly use test reports in drug ads.
Philippine FDA seeks feedback on drug product and API registration documents
The Philippine Food and Drug Administration (FDA) has published draft amendments to the rules about registering pharmaceutical products and active pharmaceutical ingredients (APIs).
Under rules published in 2024, marketing authorizations, Department of Health-restricted approvals, and export-only certificates last six years when first issued by FDA. Upon renewal, the registration documents are valid for 6 or 12 years.
FDA has proposed changing the validity rules. Under the proposals, initial registrations will last 3 or 6 years and renewed certificates will be valid for 3, 6, 9, or 12 years. Applicants will decide how long they want their initial and renewal certificates to last. The validity of certificates authorizing foreign donations will remain unchanged, with FDA continuing to set a one-year expiry date.
The agency said giving applicants the power to choose the duration of other certificates will ensure “the framework remains responsive to evolving regulatory needs and operational realities.” FDA is seeking feedback on the proposals until 5 June.
One day after publishing the draft amendments, FDA issued a call for feedback on the recognition and adoption of official pharmacopeias for the registration of pharmaceutical products and APIs. FDA has proposed recognizing 11 pharmacopeias, including authorities in Europe, India, Japan, the Philippines, and the United States.
The agency said, “The most stringent acceptance criteria shall prevail if there are inconsistencies in the acceptance criteria specified in the monograph among the recognized and adopted pharmacopeias.” The policy is intended to ensure the quality, safety, and efficacy of the product or API.
FDA is seeking feedback on the proposal until 8 May.
Authorization Draft, Export Draft, Pharmacopeia Draft
Japan’s PMDA shares guidance on developing intravenous epilepsy medicines
The Pharmaceuticals and Medical Devices Agency (PMDA) has posted guidance on clinical development of certain intravenous epilepsy drugs for the Japanese market.
Epilepsy patients are sometimes unable to take oral medicines, for example because they have difficulty swallowing or are hospitalized and restricted from taking food or medication orally. Stopping treatment abruptly can cause health issues including the recurrence of seizures, creating a need for intravenous medicines that patients can receive while temporarily unable to take oral drugs.
PMDA has published an early consideration document to support clinical development of medicines that reformulate oral products for intravenous delivery. The document features considerations for companies that are developing intravenous versions of oral products with confirmed safety and efficacy.
Companies need to confirm that their oral and intravenous formulations have similar pharmacokinetic profiles. PMDA expects developers to examine the effect of switching from oral to intravenous products, and vice versa.
Developers who show that pharmacokinetic changes before and after switching are clinically judged to have “no impact” may be able to bring intravenous drugs to market without running randomized double-blind comparative studies, PMDA said. Alternative options include comparing the change in seizure frequency before and after switching from oral to intravenous formulations.
In principle, PMDA wants companies to study intravenous medicines in each indication covered by their oral equivalent. However, the agency acknowledged that it may not be feasible to run studies in every indication. In that situation, PMDA may accept alternative designs if companies confirm the rationale for the expected efficacy of the intravenous formulation.
WHO names Kazakhstan as first Central Asia country to reach regulatory milestone
The World Health Organization (WHO) has ruled that Kazakhstan has the technical expertise and systems to formally evaluate and approve health products.
WHO said Kazakhstan has reached Maturity Level 3 (ML3), making it the first country in Central Asia to achieve that milestone. ML3 shows a country has a well-functioning health authority capable of making independent, science-based decisions on the quality, safety, and efficacy of products. The maturity level also indicates the ability to perform post-market monitoring and address safety issues quickly.
Kazakhstan’s Committee for Medical and Pharmaceutical Control and the National Center for Expertise of Medicines and Medical Devices implement the country’s regulatory system. Working with the Ministry of Health, the bodies oversee medicines and vaccines across the lifecycle in Kazakhstan, a country with a population of 20 million that borders China and Russia.
As an ML3 country, Kazakhstan may be eligible for designation as a WHO Listed Authority. WHO will need to perform additional assessments before granting the designation, which enables countries to play a more prominent role in advancing global regulatory standards.
Indian Pharmacopoeia Commission seeks feedback on draft national formulary
The Indian Pharmacopoeia Commission (IPC) has published a draft update to the National Formulary of India (NFI) for consultation.
NFI provides information on approved drugs, including their indications, dosing, and adverse events. Indian trade publication Pharmabiz reported that NFI 2026 is intended to promote the rational use of medicines and tackle antimicrobial resistance (AMR).
IPC’s secretary and scientific director, V Kalaiselvan, said the draft document directly aligns with the Indian Prime Minister’s goal of reducing AMR burdens. The precautions listed in the draft include a note about the potential for extended or recurrent use of fusidic acid to raise the risk of antibiotic resistance. An appendix describes AMR, its causes, and strategies for preventing resistance in healthcare settings.
The draft is open for comments for 45 days. IPC is reportedly aiming to finalize the document in July.
Other News:
China’s National Radio and Television Administration (NRTA) has removed drug ads with false or exaggerated claims. NRTA said the removals were part of a nationwide clamp down on TV ads. NRTA Statement (Chinese)
