India’s Drugmakers Fear Heat From The FDA
1 CommentBy Ed Silverman // November 17th, 2008 // 7:30 am
Anxiety and suspicion are on the rise. Indian drugmakers fear more stringent scrutiny of their plants and some even say recent FDA actions amount to a barrier for exporting Indian-made drugs into the US, following manufacturing issues at three major Indian drugmakers, The Economic Times writes.
An industry veteran, who didn’t wish to be identified, says the FDA will seize on even minor deficiencies: “Such developments will malign the Indian drug industry’s reputation and become a non-tariff hurdle for Indian companies despite the fact that there is no evidence to prove that any of their drugs lack either efficacy or safety.”
In October, FDA banned 30 Ranbaxy drugs made at two of its facilities in India and issued two warning letters. Earlier this month, the FDA decided not to give marketing approval for drugs made at Sun Pharma’s Detroit plant. On Wednesday, FDA pointed out 15 manufacturing deficiencies at Lupin’s Mandideep plant in Madhya Pradesh.
“The Obama government is looking at sourcing generic products and there may be an attempt by global innovator majors to question the standards of Indian drugs and stop their entry,” Daara Patel, secretary general of Indian Drug Manufacturer’s Association, tells the paper.
But pharma expert Sanjiv Kaul suggests India’s big drugmakers should prepare for FDA challenges. “The US government is trying to control healthcare cost. Only Indian generic companies have the marketing applications and the skill-set to supply large volumes of drugs at an economical price. The three companies who have come under (the FDA) scanner should be ready for any test conducted by any regulator, anytime,” he tells the Times.
Prabir Basu
Anyone who has looked into the details of the warning letters issued by the FDA to Ranbaxy will realize the gross violations of Good Manufacturing Practices. In fact, it is shocking to see the types of cGMP violations. I cannot but fully support what the FDA has done and I only hope that FDA has the resources to continue its vigilance of manufacturers who export medicinal products to this country. The safety of our patients is at stake and that should be our primary interest.
The increasing cost pressure in the pharma industry has led more and more of them to take advantage of the global low cost sources for the production of goods while reducing their own production capacities. In most cases, outsourcing decisions made by pharmaceutical companies are based on a simple comparison between the costs to make a product at one’s own location and the costs in the target country! Data from analysis made by University of St. Gallen, Switzerland of more than 100 production sites in high cost countries reveal that there is still a tremendous improvement potential at the existing sites and that labor costs account only about 20-25% of overall production costs. However, there is no incentive to improve manufacturing as long as they can avail themselves of the low cost production sources. We now know that several of the overseas plants are not being as thoroughly inspected as the plants in this country due to the lack of resources at the FDA and this is posing serious safety issues for our patients. The cost difference will probably reduce substantially if the plants overseas were to have equivalent quality standards as the plants in the U.S. This would create a more level playing field and will also provide an incentive for our pharma companies to invest in their manufacturing facilities here in the U.S.
The customers or patients in our country should have the right to know in which plant a medicinal product and its various components were manufactured in. Was that plant inspected by the FDA and if so, what was the quality rating of the plant? This information should be available on the label of the product. The manufacturing plants overseas should be quantitatively ranked and compared with their counterparts in the U.S. so that the patient is aware of the quality of the plants that the product was manufactured in. The patients in this country should have the choice to decide whether they would like buy a product that was made in a plant rated “4” for example or from a plant that was rated “9” in terms of quality and technology practices. I know what my decision would be if this information was available to me.
We can reduce cost of medicines by improving the technology and science of how these products are being made and by implementing QbD. We do not have to sacrifice the quality of our drugs and risk the health of our patients to reduce healthcare cost.