Asia-Pacific Roundup: India opens new CDSCO office, drug testing lab to improve medicine monitoring

The Indian health minister has inaugurated a sub-zonal office of the Central Drugs Standard Control Organization (CDSCO) and a Central Drug Testing Laboratory (CDTL) site in Indore, Madhya Pradesh, to equip another city to monitor medicine quality and provide regulatory services.

Mansukh Mandaviya, the Union Minister of Health and Family Welfare, said the CDSCO and CDTL sites will support monitoring of the quality of medicines, ensure access to high-quality therapeutics, and “provide ease of doing business” for the pharmaceutical industry in the state of Madhya Pradesh. The sites will handle multiple regulatory functions that used to occur outside of the city.

“CDTL and Sub-Zonal Office at CDSCO Bhawan, Indore, will be entrusted with various responsibilities of regulation of drugs, cosmetics, and medical devices,” Mandaviya said. “This will ensure proper implementation of the provisions of the Drugs and Cosmetics Acts and Rules made to ensure the safety and welfare of patients and for better coordination with State Drug Controller Organizations.”

The Indian government has installed 12 high-performance liquid chromatography devices, one gas-liquid chromatography machine, one ultraviolet-visible spectrophotometer and other instruments at the CDTL site. The equipment will enable the facility to analyze medicine samples to confirm their quality standards.

Press Release

Pakistan’s DRAP finds contaminated raw material, orders recall of finished products

The Drug Regulatory Authority of Pakistan (DRAP) has warned the pharmaceutical industry about a batch of the excipient propylene glycol that is contaminated with toxic and potentially deadly ethylene glycol.

Propylene glycol is used as a solvent in the production of oral liquid formulations such as cough syrups; ethylene and diethylene glycol are similar, cheaper substances that have been found in raw materials and finished products. Ethylene glycol and diethylene glycol are not intended for use in pharmaceutical preparations and can cause health problems such as kidney damage. Some recipients, particularly children, have died.

DRAP’s Central Drug Laboratory in Karachi detected unacceptable levels of ethylene glycol in a batch of propylene glycol that lists Dow Chemical, Thailand, as the manufacturer. The regulatory field force has “taken possession of a contaminated batch of propylene glycol and is investigating the entire supply chain of this batch.” DRAP told its field force to seize all oral products made using the batch and submit the report within 24 hours.

Officials are taking other actions to stop finished products that contain the contaminated excipient from being used by patients. DRAP has asked the therapeutic goods manufacturer to recall any finished products made using the lot of the excipient. The agency wants other manufacturers to hold finished products made from other lots of the solvent and test them for contaminants before release.

DRAP also wants manufacturers to screen raw materials for ethylene and diethylene glycol before using them in oral liquid preparations. The Central Drug Laboratory is running further tests of raw materials and finished products.

Press Release, Rapid Alert

CDSCO sets out pathway for fixed-dose combinations based on committee reports

India’s CDSCO has told manufacturers of certain fixed-dose combinations (FDCs) what data they need to generate to support their products' continued production and sale.

CDSCO has spent more than a decade trying to ensure FDCs sold in India contain rational combinations of ingredients and are supported by evidence. As part of that process, an expert committee has examined certain FDCs that came to market without central licensing authority approval. The committee shared recommendations on five FDCs in two notices published last week.

One letter covers three FDCs that contain paracetamol, caffeine and other active ingredients. The committee recommends that manufacturers of two FDCs run Phase 4 clinical trials to generate safety and efficacy data “within time frame of one year.” One of the trials will compare the FDC to the individual ingredients it contains.

The expert committee recommended the third paracetamol-based FDC for continued manufacturing and marketing with certain conditions. That FDC must undergo “active postmarketing surveillance” again within one year.

Manufacturers of the two other FDCs can continue making and selling their products without generating more data, although the committee recommends some restrictions on their use. The experts want to limit how long people take an FDC for comorbid anxiety conditions and to see label changes intended to prevent overdoses of a combination that contains an antihistamine.

CDSCO Notice

Philippine FDA updates device procedure, limiting opportunities to fix deficiencies

The Philippine Food and Drug Administration (FDA) has updated the application process for certificates of medical device registration and notifications. The changes affect initial and renewal applications that lack all the required information when first submitted to the agency.

Under the revised procedure, FDA will provide applicants with “a one-time compliance” for correcting any deficiencies found during the review of the first submission. If the company fails to address the issues by the deadline, “the application shall be considered disapproved,” FDA wrote.

“For a disapproved application, a re-application and full compliance can be made. It shall be complied with within 60 calendar days for the Initial application and 30 calendar days for the Renewal application from the date of disapproval,” FDA wrote. FDA will assign a new tracking number for re-applications and charge the fee again.

The agency is asking companies to include a copy of the notice of deficiencies and the documents needed to address them in re-application submissions.

FDA Notice

Other news:

Singapore’s Health Sciences Authority (HSA) plans to increase regulatory fees by an average of 5% on 1 July. The agency is capping the maximum fee increase at Singapore $200. According to HSA, the fee revision is necessary “to recover part of the costs for the services rendered to businesses.” The changes apply to filings for medical devices, therapeutic products, cell and gene therapies, and more. HSA Notice

The Philippine FDA is seeking feedback on guidelines for classifying vitamins and minerals. FDA is creating guidelines to limit the amounts of vitamins and minerals a product can contain and still be classified as a food/dietary supplement. The upper limits will determine whether a product is a drug or a food. FDA is accepting feedback on the proposal until 26 January. FDA Notice

Australia’s Therapeutic Goods Administration (TGA) has seized 478 sports supplements that contain potentially dangerous substances from a retail store in Sydney. Some products claim to contain substances banned in Australia because of the risk they pose to human health. TGA seized the supplements as part of ongoing investigations into unapproved therapeutic goods. TGA Notice

Asia-Pacific Roundup: India opens new CDSCO office, drug testing lab to improve medicine monitoring

Related topics

Recommended content

Welcome to the new RAPS Digital Experience