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. |
