With the U.S. Food and Drug Administration (FDA) adhering to tougher import norms, a group of U.S.-based Indian-American scientists is now helping Indian pharmaceutical companies sharpen their knowledge and maintain competitiveness. These scientists include Dr. Vinod Shah, a veteran of three decades at the U.S. FDA; Dr. Umesh Banakar, President, Banakar Consulting Services; Dr Kailas Thakker, Co-founder and President, Tergus Pharma, and Dr. Vatsala Naageshwaran, Associate Director, Scientific Operations, Absorption Systems. This group, along with other top scientists, was here last week to share their knowledge on the latest in dissolution science with over 200 Indian pharma scientists. Dissolution science is about establishing whether a medicine gets dissolved in the body and works after being taken by a patient. Dissolution testing is a crucial part in meeting the stringent guidelines on export of generic and branded drugs to the U.S. and Europe. “Indian pharma companies are well advanced (in dissolution science), but we (India) need to be careful. We are leading in product development but China is coming right behind us. It may overtake India. Until now we had the language advantage but that is no more, ” said Dr. Shah, who has become a pharmaceutical consultant after retirement.
“We need to be cautious. Some Indian companies are known for cutting corners, after the product gets approved, to make it cheaper. That is a problem and the product gets recalled. Through such lectures I am educating Indian companies,” Dr. Shah said.
In 1976 only six tablets were mandated by the FDA to pass the dissolution test, but today all pharma products including tablets, capsules, stents, cream and patches need to qualify. “Dissolution testing along with permeability and solubility testing provides a way to obtain biowaivers for generic drugs and bypass expensive and time consuming human bio studies.
“Absorption Systems is the world leader in biopharmaceuticals classification system (BCS) and our focus is to work with companies in India and other emerging markets to apply the BCS and BCS-based biowaivers to avoid clinical bioequivalence testing through a more ethical and definitive in vitro test system whenever possible,” said Dr. Vatsala Naageshwaran.
She said that while there is tremendous institutional knowledge and expertise available in India , an improved awareness and understanding of the in vitro approach can help to bring better quality low cost generic medicines. Seventy per cent of medicine produced globally undergoes the dissolution test before being released. Eighty per cent of pharma exports to the U.S. are classified as generic drugs. “Dissolution methods and its applications are kept so confidential by companies that they are not easily available for others. We at the Society for Pharmaceutical Dissolution Science (SPDS) are channelising our efforts towards updating pharma scientists and analytical chemists to improve the quality of pharma products. Currently, every fourth tablet consumed in the U.S. and Europe is from India, our target is make it third in some time,” said Dr. Lakshmanan Ramaswami, Managing Director, Sotax India, and General Secretary, SPDS.
In the past, some Indian companies were banned by U.S. FDA for exporting drugs which had failed dissolution tests. In 2008, the FDA had banned 30 generic drugs produced by Ranbaxy for gross violation of approved manufacturing norms.