“We have been doing business in Ghana for 13 years and there have been no quality issues,” says Gagan Harsh, who heads Bliss GVS Pharma’s international business.
BLACK-LISTED
The Mumbai-based drug maker is now in a regulatory spot in Ghana, over an anti-malarial product that it sold in the African country, which the regulator said had not been checked for safety or efficacy. This was followed by Ghana’s Food and Drugs Authority black-listing Bliss GVS from selling other products in the market. Denying wrong doing, Harsh said the company’s products in Ghana were in the process of re-registration. There were administrative delays at various levels in Ghana, he said, adding that Bliss had re-submitted its documents and were hopeful of having the problem sorted out soon.
SELLS 45 PRODUCTS
The company sells 45 products in Ghana and 28 were up for re-registration, he said. The company had submitted its applications and paid $ 57,000 as fees, he said. But the administrative delays resulted in the companies re-registration taking time and “technically the products became unregistered overnight,” he said.
More than half of Bliss’ Rs 350 crore revenues come from the African markets, including Kenya, Nigeria, Zambia, Malawi, Sudan and Ghana, Harsh said, without giving specifics.
ANTI-MALARIAL DRUG
The Ghana FDA had initially trained its guns on Bliss GVS over its ant-imalarial medicine GSUNATE plus suppositories. The efficacy and safety of the product had not been checked since there had not been a clinical trial study to justify the use of this product for malaria, the regulator said.
It had further pointed out that Bliss was not selling the anti-malaria product to children in India.
Explaining why, Harsh clarified that the Indian market was not open to suppository products, given through the rectal route. Besides, there are situations where companies export products if approvals are given by the importing country.
Meanwhile, Pharmaceuticals Export Promotion Council of India’s Director-General P.V. Appaji said that he would urge the Indian Government to convey to regulators in other countries that they first verify details with authorities in the importing country, before going ahead and making statements that impact the reputation of the company and the country.
BLACK-LISTED
The Mumbai-based drug maker is now in a regulatory spot in Ghana, over an anti-malarial product that it sold in the African country, which the regulator said had not been checked for safety or efficacy. This was followed by Ghana’s Food and Drugs Authority black-listing Bliss GVS from selling other products in the market. Denying wrong doing, Harsh said the company’s products in Ghana were in the process of re-registration. There were administrative delays at various levels in Ghana, he said, adding that Bliss had re-submitted its documents and were hopeful of having the problem sorted out soon.
SELLS 45 PRODUCTS
The company sells 45 products in Ghana and 28 were up for re-registration, he said. The company had submitted its applications and paid $ 57,000 as fees, he said. But the administrative delays resulted in the companies re-registration taking time and “technically the products became unregistered overnight,” he said.
More than half of Bliss’ Rs 350 crore revenues come from the African markets, including Kenya, Nigeria, Zambia, Malawi, Sudan and Ghana, Harsh said, without giving specifics.
ANTI-MALARIAL DRUG
The Ghana FDA had initially trained its guns on Bliss GVS over its ant-imalarial medicine GSUNATE plus suppositories. The efficacy and safety of the product had not been checked since there had not been a clinical trial study to justify the use of this product for malaria, the regulator said.
It had further pointed out that Bliss was not selling the anti-malaria product to children in India.
Explaining why, Harsh clarified that the Indian market was not open to suppository products, given through the rectal route. Besides, there are situations where companies export products if approvals are given by the importing country.
Meanwhile, Pharmaceuticals Export Promotion Council of India’s Director-General P.V. Appaji said that he would urge the Indian Government to convey to regulators in other countries that they first verify details with authorities in the importing country, before going ahead and making statements that impact the reputation of the company and the country.
Credits: thehindubusinessline
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