Medicine Control Agency, Pharmaceutical Association Explain Testing of Drugs from SRA Nations

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By Nelson Manneh

The Medicine Control Agency of the Gambia and the Pharmaceutical Association of The Gambia have informed Foroyaa that drugs that are imported from SRA nations do not require shipment to India for testing.

Stringent Regulatory Authority (SRA) is a national regulatory authority or institution which is considered by the Medicines Control Agency to be competent and trusted with the application of stringent standards for quality, safety, and efficacy in its process of regulatory review of medicines and related products for marketing authorization (registration).

The spokesperson of the Pharmaceutical Association of The Gambia, Ma HawaNjie, said samples of pharmaceutical products that are imported from Stringent Regulatory Authority (SRA) nations are no longer referred to India for testing.

The spokesperson of the Pharmaceutical Association said importers of medical products were initially asked to send all their products that were coming from other nations to India for testing before putting them in to the market. In India, the Gambia Government has signed a memorandum of understanding with a company to do testing for the drugs that are imported into the country.

“This process was very tedious, but the Medical Control Agency has reconsidered that decision and allowed us to import Pharmaceutical products from Stringent Regulatory Authority (SRA) in to the Gambia without going through that process,” he said.

The regulation mandates medicine Importers and related products manufactured from any of the gazetted list of SRA Countries as per the current Gazette to take full responsibility and liability of any quality, safety and/or efficacy issue that may emanate from the products.

MrNjie said importers who import pharmaceutical products from Stringent Regulatory Authority (SRA) only list the products and when they arrive in the country, they clear them and start selling them in the market.

“It is now cheaper and the process is faster than it used to be. For us to register pharmaceutical products from a Stringent Regulatory Authority (SRA) nation will not be an easy thing because the quantity you need in order to register Pharmaceutical products from Stringent Regulatory Authority (SRA) is high,” he said.

He said pharmaceutical products that they import from India are still tested in India based on the arrangement of the Control Agency and an Indian company that it has agreement with.

“We pay for the listing of the products but it is cheaper than registering them. This new process has also helped a lot when it comes to the availability of the pharmaceutical products,” he said.

EssaMarenah, the Acting Director at the Medical Control Agency (MCA), said the MAC Act has been amended and it has now catered for pharmaceutical products imported from Stringent Regulatory Authority (SRA) nations to be listed and not registered.

 “We are just following the MCA Act. The burden is now on the importers because any importer who imports medicines and related products manufactured from any of the gazetted list of SRA Countries as per the current Gazette shall take full responsibility and liability of any quality, safety and/or efficacy issue that may emanate from the products,” he said.

He said that the process is now cheaper and faster because it does not require quarantining pharmaceutical products awaiting test results.

“For medical drugs that come from India still follow the process like before,” Marenah said.