The clinical trial industry in the country, especially the bioavailability and bioequivalance (BA/BE) studies, is crippled by the inordinate delay in clearing their proposals by the office of the Drug Controller General of India (DCGI).
According to industry sources, due to the indifferent attitude of the officials, there is a huge backlog of files pending in the DCGI office. Sources said that there are 1820 files regarding clinical trial, most of them BA/BE studies, pending in the DCGI office till January 31 this year. With the DCGI office head-less for most part of the February after the exit of Dr VG Somani, the number of pending files has only increased.
At a time when there is intense competition in the clinical trial field, the non-clearance of these proposals by the Indian regulators will adversely affect the Indian companies. Due to its several factors including cheap labour and skilled workforce, India has over the last some years become a hotspot for clinical research activities in the world, including BA/BE studies. But the Indian regulators' apathetic attitude will go definitely against the overall interest of the clinical trial industry in the country, sources said.
Industry sources said that the immediate fallout of the inordinate delay in getting approval from the DCGI office is that the business is gradually shifting to other countries where decision making is fast and prompt. Most of the business is going to Malaysia and East European countries like Poland, sources said.
An industrialist who has been in the clinical trial sector in the country for some time said that he is also planning to establish a clinical trial facility in Malaysia where decision making is fast and there is high proof system under which approvals are guaranteed in 15 to 30 days.
The regulators started tightening the regulations on the clinical trial sector in the country after the controversy in June last year surrounding the Hyderabad-based CRO, Axis Clinicals, in which the company is alleged to have conducted clinical trials of a breast cancer drug on nearly 30 illiterate agriculture labourers after luring them with Rs.10,000 each.