Regulatory uncertainty hits drug trials in India

An avalanche of reforms to rules governing the conduct of clinical trials in India has led to an exodus of drug companies and research organizations. Given the uncertain regime, drug companies and CROs are cutting back on clinical trials in India. The Indian Pharmaceutical Alliance (IPA), which represents leading domestic pharmaceutical companies, says that the increasing reluctance of India’s drugs and devices regulator to grant approvals for new drugs, even if they are approved in developed countries, and to allow clinical trials or bio-studies for export purposes, has severely hampered the industry. The effects of the regulatory uncertainty are already being felt. Max India, for example, has announced that it will sell its clinical research business for US$1.5m to JSS Medical Research, a Canadian CRO. The company says the regulatory challenges have made it difficult to scale up the business.
Other Indian pharmaceutical companies, such as Biocon, Alembic, Zydus Cadila, Torrent and Lupin, have already moved trials out of the country. At Biocon, the research and development (R&D) spend is 134% higher in the second quarter of 2015 compared with the same period in 2014. The company’s chairman, Kiran Mazumdar-Shaw, said at an analyst briefing that the high R&D spend is a result of ongoing global clinical trials that require large investment. For example, Biocon’s global phase III trial for biosimilar trastuzumab is being conducted in Europe.
Indian CROs, such as Veeda Clinical Research and Lambda Therapeutics, have also moved out to other Asian countries, including Malaysia and Thailand. An official at Veeda says the high degree of uncertainty in India has discouraged clinical trials.