We have enough evidence about two pharmaceutical companies PT Samco Farma and PT Subros Farma
Jakarta (ANTARA) – The National Agency for Drug and Food Control (BPOM) divulged the names of two other private drug firms in Indonesia that had violated the regulation on syrup drug raw material usage by exceeding the safe threshold.
“We have enough evidence about two pharmaceutical companies PT Samco Farma and PT Subros Farma,” Head of BPOM Penny K. Lukito noted at a press conference in Depok, West Java, Wednesday.
The syrup drugs produced by the two companies are proven to contain Ethylon Glycol (EG) and Diethylene Glycol (DEG) from Propylene Glycol (PG), Polyethylene Glycol, Sorbitol or Glycerin solvents that exceed the safe threshold.
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The safe threshold for the EG/DEG raw material is a maximum of 0.1 percent.
Due to this violation, the agency has stopped, withdrawn, and destroyed syrup drugs that exceed the safe threshold.
“This withdrawal encompasses all stores, starting from Pharmaceutical Wholesalers (PBF), government installations, hospitals, puskesmas (public health centers), clinics, pharmacies, drug stores, and health workers’ independent practices,” she remarked.
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Syrup drugs withdrawn from the market include Citomol produced by PT Ciubrus Farma, Citoprim manufactured by PT Ciubrus Farma, Samcodril produced by PT Samco Farma, and Samconal produced by PT Samco Farma.
Other syrup drugs produced by PT Ciubrus Farma and PT Samco Farma that contain propylene glycol, polyethylene glycol, sorbitol, or glycerin solvents will be withdrawn until there are further examination results, she noted.
Earlier, the BPOM had revoked the Good Manufacturing Practice (CPOB) Certificate and the distribution license of three private pharmaceutical companies in Indonesia — PT Yarindo Farmatama, PT Universal Pharmaceutical Industries and PT Afi Farma — that had proven to have used chemical compound materials that exceed the safe threshold.
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