Jigmi Wangdi 

Bhutan Food and Drug Authority (BFDA) de-registered six products manufactured by Orbit Pharmaceuticals Limited (OPL), a company based in Gujarat, India this week.

The drugs are considered to be unfit for consumption after the BFDA found issues with the quality of these drugs.

Most of the drugs were prescription drugs for upper respiratory ailments such as asthma, and other medical conditions like diabetes.

An official from BFDA said that the authority conducts regular and routine sample testing on the drugs that are brought into the country.

“It is very difficult for us to conduct the testing when the drugs are being registered because the numbers are too high. However, we carry out routine testing after the drugs are in the country,” the official said.

The official said that BFDA regularly de-registers drugs after the tests prove the quality of a product. “We normally carry out parameter tests to study a drug’s dissolution or disintegration once it enters the body.”

“This time we tested some drugs from OPL at the registration level and found that the content of the drugs was of poor quality. We had suspicions and then tested OPL’s products that are already out in the market and found them poor in quality, which is why these drugs have been de-registered,” the official said.

The official said that these drugs do not have severe or life-threatening side effects.

“The public need not worry about every drug that is de-registered. Drugs with impurities are the ones that can cause serious side effects. However, the drugs from OPL are simply lacking the required contents. If there were drugs that caused severe harm, we would have carried out major interventions,” the official said.

BFDA conducts the parameter testing of drugs in an in-house mini-lab and also at the Royal Centre for Disease Control.

Orphylin

Exophylline 231mg and Theophylline 69mg prolonged release tablets IP

Metabit 500 

Metformin 500mg tablet

ORPAR

Paracetamol 500mg tablet

Glibit 5

Glipizide 5mg tablet

Orbiton 25 

Spironolactone 25mg

Orclot 3

Warfarin 3mg table