Cancer Risk; DRAP Advises Halt in Ranitidine Production

Food and Drug Regulatory Authority of the US made an announcement on September 13th, which alerted the pharmaceutical industry and public alike. FDA had determined that N-nitrosodimethylamine (NDMA) could be produced during the manufacturing of ranitidine drugs. Ranitidine (commonly marketed under 'Zantac') is a common heartburn medicine/antacid, which is easily available over the counter.

NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.

The industry was roiled last year when it learned that NDMA and two other suspected carcinogens could form during the manufacturing of the commonly used “sartan” blood pressure meds valsartan, losartan and irbesartan.

But the industry only just learned that the same kind of production phenomenon also applied to ranitidine-containing drugs. Regulators and the industry were tipped off to the problem by online pharmacy Valisure, which discovered it during its own testing. The company then filed a Citizen Petition calling on the FDA to seek a market recall of all of the drugs and establish standards for testing and manufacturing.

Several pharma manufacturers have begun to voluntarily recall all Ranitidine drugs. Concerned countries are now placing ban on the import and distribution of these drugs as well.

Drug Regulatory Authority of Pakistan (DRAP) has issued notice to pharmaceutical companies across the countries to halt Ranitidine drugs production and to recall all such products already on the market.

The DRAP letter stated: FDA and Euro­pean Medicines Agency (EMA) are evaluating the risk associated with low levels of NDMA in Rani­tidine. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables. Drap is closely working with international regulatory agencies to monitor the outcome of the investigations. However, in the greater public interest and in order to protect patients from probable risk associated with the detection of low levels of NDMA in Ranitidine, it is advised to suspend production for all dosage forms of Ranitidine-containing drugs till further orders; the stoppage of the release/distribution of all dosage forms of Ranitidine-containing drugs till further orders; and the stoppage of the sale/supply/utilisation of all dosage-forms of Ranitidine-containing drugs till further orders. Furthermore, it is requested to initiate the recall of the medicine available in sale outlets/distributors/hospitals/healthcare facilities.

Following are the brand names by which ranitidine is being marketed in Pakistan:

Brand Name	Manufacturer/Mnf. Representative
ACEDONIL	GLOBAL PHARMACEUTICALS
ACIDRAN	VALOR PHARMACEUTICALS
ALTAL	ALSON PHARMACEUTICALS
ANZOL	INDUS PHARMA (PVT) LTD.
BIODINE TABS	ALKEMY PHARMACEUTICAL LABORATORIES (PRIVATE) LTD.
CHASE	SHROOQ PHARMACEUTICALS
DANITN	MIRACLE PHARMACEUTICALS(PVT) LTD
DART	MEDICAIDS PAKISTAN (PVT) LTD.
DEGUST	HYGEIA PHARMACEUTICALS
DINETAC	UNEXO LABS (PVT) LTD.
DINOLIVE	OLIVE PHARMACEUTICALS
DUOTEC	ASKARI PHARMACEUTICALS.
FESNIDINE	ALFALAH PHARMA (PVT) LTD.
FOZAB	PEARL & PEARL
GERTOCALM	NOBLE PHARMA
GLAMET	SPENCER PHARMA
H2 REC	ZAFA PHARMACEUTICAL LABORATORIES (PVT) LTD.
HEALALSER	LISKO PAKISTAN (PVT) LTD
KANTAC	DRUG PHARM (PVT) LTD.
LOMADRYL	MEEZAB INTERNATIONAL
MARIQUINE	LISKO PAKISTAN (PVT) LTD
MONOCID	WEBROS PHARMACEUTICALS
NAZDAC	FYNK PHARMACEUTICALS
NIPODUR	A.J. & COMPANY.
NITID	DANAS PHARMACEUTICALS (PVT) LTD
NITISAF	SAAAF PHARMACEUTICALS
NOULCE	LOWITT PHARMACEUTICALS (PVT) LTD
NULCER	BOSCH PHARMACEUTICALS (PVT) LTD.
OBATIDINE	OBSONS PHARMACEUTICALS
PEPTAC	MASS PHARMA (PRIVATE) LIMITED
PEPTICURE	NABIQASIM INDUSTRIES (PVT) LTD.
PEPTINIL	WILSONS PHARMACEUTICALS
PUROD	CAYLEX PHARMACEUTICALS (PVT) LTD.
PYRAD	GENOME PHARMACEUTICALS (PVT) LTD
RADICON	MEDISURE LABORATORIES PAKISTAN (PVT.) LTD.
RAMAT	BLOOM PHARMACEUTICALS (PVT) LTD.
RAMED-AC	RAAZEE THERAPUTICS (PVT) LTD.
RANAX	STANDPHARM PAKISTAN (PVT) LTD.
RANEXIN	AKSON PHARMACEUTICALS (PVT) LTD.
RANI	Siam Pharmaceuticals
RANIDIN	FEROZSONS LABORATOIES LTD.
RANIGARD	VEGA PHARMACEUTICALS LTD.
RANILOC	ORTA LABS. (PVT) LTD.
RANIPEP	DAVIS PHARMACEUTICAL LABORATORIES
RANISCOT	SCOTMANN PHARMACEUTICALS
RANISON	LIFE LINE PHARMACEUTICALS (PVT.) LTD.
RANIZAN	MEDIZAN LABS (PVT) LTD
RANTAB	JAWA PHARMACEUTICALS(PVT) LTD.
RANTAC	SAPIENT PHARMA
RANTID	CIBEX (PRIVATE) LIMITED
RANTIN	MACTER INTERNATIONAL (PVT) LTD.
RANULCID	MERCK PRIVATE LTD.
RATAC	PARAMOUNT PHARMACEUTICALS
RATIDINE TABLET	GRAY`S PHARMACEUTICALS
RELIANCE	MEGA PHARMACEUTICALS (PVT) LTD
RENACID	DRUGS INN PAKISTAN
RENATA	PLATINUM PHARMACEUTICALS (PVT.) LTD.
RENATIL	GOODMAN LABORATORIES
RENERA	MEDERA PHARMACEUTICALS (PVT) LTD.
RENILOC	ORTA LABS. (PVT) LTD.
RENOXID	AXIS PHARMACEUTICALS
RESOTAC	RASCO PHARMA
REXOTIDE	REX PHARMACEUTICALS PAKISTAN
RINAI	Z-JANS PHARMACEUTICAL (PVT) LTD.
RIO	MACQUINS INTERNATIONAL
RITADINE	CHAS. A. MENDOZA
STOMACID	WERRICK PHARMACEUTICALS
TAGNA	PANACEA PHARMACEUTICALS
TATIDINE	DOSACO LABORATORIES
TIOBINE	GRAY`S PHARMACEUTICALS
ULCEMED	MEDICEENA PHARMA (PVT) LTD.
ULCENOR	FLOW PHARMACEUTICALS (PVT) LTD.
ULCER OFF	UNIPHARMA (PVT) LTD.
ULCERID	MEDICRAFT PHARMACEUTICALS (PVT) LTD.
ULSFREE	ZESION PHARMACEUTICAL (PVT) LTD
XETAC	XENON PHARMACEUTICALS (PVT) LTD.
XETRON	HIGH - Q INTERNATIONAL
ZANIATE	MEDIATE PHARMACEUTICALS (PVT) LTD
ZANTAC	GLAXOSMITHKLINE
ZENIT	DR. RAZA PHARMA (PRIVATE) LIMITED
ZOMTIC	ALLIANCE PHARMACEUTICALS (PVT) LTD.