INDIAN PHARMA FIRMS BEAR FDA'S SLOW APPROVAL PROCESS
The slow approval process by the country's Food and Drug Administration (FDA) hamper the entry of Indian pharmaceutical companies in the Philippines according to the Federation of Indian Chambers and Commerce (Phil.) Inc. (FICCI) and the Indian Business Forum Philippine Association Inc. (IBF).
IBF director Aseem Roy said the FDA's stringent rules are one of the key issues that prevent the entry of Indian pharmaceutical firms according to findings in a joint webinar of the two business groups.
“What we hear most frequently is the delay of pharmaceutical products, even some products can take more than three years for approval,” he said.
Among the recommendations of the IBF is implementing a premium charge to expedite the process of registration, which will help in clearing the backlogs for FDA approvals.
Roy added that those products that are approved and registered in markets such as the United States and the European Union should be able to get their FDA approval in the Philippines within six months.
“Some of the products that are already registered in the US or European Union, that means that product has gone through a very stringent regulating approval, so these kinds of products should be approved in a fast rate basis,” he said.
He also said that for the Philippines to have access to cheaper medicines, Indian pharmaceutical firms urged the government to allow them to participate in biddings of the Department of Health.
“Indian companies cannot participate in Department of Health biddings. It’s because the local laws do not allow Indian pharma companies to do it. Because of this, we are paying for almost huge commissions to local partners as they represent Indian pharma companies. Hence, our products become more expensive, but on the contrary, they should be extremely affordable,” said Roy.
He added that this recommendation should be a high priority in the trade discussions between the Philippines and India.