City Hospital defeats Gov’t in case to import drugs from India

A private city hospital has won the case against the Government’s Food and Drug Department which was blocking the health institution from importing pharmaceuticals from India.

The Dr Balwant Singh’s Hospital had filed an application to quash the Food and Drug Director Marlan Cole’s refusal to issue an import licence for 18 lifesaving drugs, the hospital’s lawyer, Devindra Kissoon said in a statement.

Kissoon said Chief Justice (ag) Roxane George-Wiltshire on January 30, 2018, ruled that Cole’s refusal to grant the registration of various life-saving drugs to the hospital was arbitrary, capricious and unlawful.

News Room understands that Cole refused to register these drugs because the Food and Drug Administration entered into a Memorandum of Understanding with Caribbean Public Health Agency (CARPHA) which implemented a New Caribbean Regulatory System in Guyana, and since those drugs for which applications were submitted were not registered with CARPHA, licences could not be issued.

Dr Balwant Singh’s Hospital, in its application, argued that it had routinely been issued licences for drugs manufactured in India pursuant to Section 78(2)(k)(v) of the Food and Drug Regulations.

In August 2017, the Government introduced a new pharmaceutical importation system where a regional hub will be tasked with recommending approval for drugs to be imported in member States including Guyana.

CARPHA was tasked with hosting the Caribbean Registration System (CRS) – a body established to assess drugs for importation into various Caribbean Community (CARICOM) countries.

Previously, suppliers would have submitted dossiers to local regulatory bodies for review and approval of the drugs they wanted to sell on the market.

Under the new system in place, suppliers will now have to make electronic submissions to the CRS, for it to peruse and do an assessment of the drug.

Following the assessment, the CRS would make recommendations for that drug to be registered in the respective territory.

At the time of introduction of the new system, a number of stakeholders were up in arms, contending that the new measure would mean that majority of generic medicines, from India, China, Brazil will now be banned from entering Guyana.

Cole had told reporters then that there are a lot of health and safety concerns about importing drugs from India.

“The issue with India – this is listed anecdotally and this is not proven or tested – [there is] in excess of 3500 clandestine operating facilities in India, or sometimes they say it is more than that. So, in order to safeguard your society against those facilities, you depend on them being either certified by one of the ABC countries, WHO or in some cases, Argentina, Mexico and Cuba,” he had explained.