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Quality drugs lead local cos to gain access to global regulated mkt

Shamsul Huda | March 18, 2015 00:00:00


Local pharmaceutical companies' reputation for manufacturing excellence and products' quality help them get approval for export of drugs to the world's highly regulated market.

Half a dozen leading pharmaceutical companies have already got approval from United Kingdom Medicines and Healthcare Products Regulatory Agency (UKMHRA) and Australian Therapeutic Goods Administration (TGA).

Approval sought by two local firms from the United States Food and Drug Administration (US FDA) is also underway. The two companies can export medicines to the US market after getting permission.

According to sources, Square, Beximco, Eskayef, Incepta and Renata are enjoying UKMHA and these companies have gained access of at least 15 products to the UK market.

Square and Beximco have already obtained approval from the Australian TGA and a USFDA team inspected their factories several months back with positive signals that the two companies are qualifying for their standards.

Apart from the Western regulatory market, pharmaceuticals are being exported to the Middle East countries as per the approval from the Gulf Cooperation Council (GCC).

A senior administrative officer of Square Pharmaceuticals Company Ltd said initially it was difficult to get permission for export of medicines to the European market as they are highly sensitive about drugs.

"At the initial stage of getting permission from the UK, there were many problems and one of them was to take money as expenditure outside the country due to the central bank's strict rules on money transfer under capital account."

Due to the growing needs and demands, he said, the central bank as well as the government took the problems into account. "It was possible for us to make necessary arrangements for relaxed policy."

The regulatory market's approval for Bangladeshi pharmaceuticals has inspired confidence in other Asian, African, Middle East, South American and European countries. "As a result, export market expands to more than 90 countries," he said.

The white-collar-based drugs industry is flourishing in the country and currently meeting more than 95 per cent of local demands.

At least 1,400 generics are being manufactured in more than 22,000 brand names in different doses forms of suspensions, intravenous, inhalations and others.

Dr Momenul Haq, senior vice president of the Bangladesh Association of Pharmaceuticals Industries, said ten to twelve other companies are also waiting to obtain the regulatory market's approval.

It is a matter of vast amount of money, he said, adding that to get such approvals, the companies need to maintain international standards production facilities, quality control and different compliances.

Mr Haq said as the local products are being branded in the international market, exports growth will increase in the coming days.

Another association member said industrial biotechnology-based drugs are being manufactured locally and currently insulin, vaccines, hormones, anti-depressed and anti-cancer drugs are manufactured by local companies for domestic and export market.

Due to concerted efforts made by local pharmacists, chemists, microbiologists, lab technicians, researchers and academic staff, the companies are getting international approval, he added.

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