Singapore, July 29, 2010: India’s pharmaceutical regulator, the Drugs Controller General of India (DCGI), has tightened the approval mechanism for clinical trials and marketing licenses for biotechnology drugs, medical devices and vaccines in the country.

Earlier this month, four marketing approval applications for vaccines were cleared, while four others, from drug majors such as Johnson & Johnson and GlaxoSmithKline, as well as Panacea Pharma, were returned with attached deficiency letters.

Medical devices, biotechnology and vaccine manufacturing and marketing firms - both domestic as well as multinationals - are facing intense regulatory heat these days in India after the country's drug regulator decided to act tough.

Lengthy delays are the result and a fuming industry is complaining about the sudden bureaucratic hurdles they are facing. "The department is aware of the complaints," said the DCGI Mr Surinder Singh, adding that the delays are caused because of the incomplete applications that are submitted by the companies.

The most serious of all complaints, said Mr Singh, is the practice of post approval changes where companies tweak the biotechnology products which were not part of the early disclosure. "We cannot allow such changes," he stated.

"If an application is incomplete, or there are post-approval changes, the marketing approval for the specific product gets rejected in most developed countries. Here we are only issuing deficiency letters and allowing companies to rectify their mistakes and approach us again. This is why there is a delay. The industry should appreciate this," the DCGI said.

The regulatory tightening over biotech products has come at a time when the biopharmaceutical market is expected to turn major revenue driver for most global drug firms.

According to the Association of Biotechnology Led Enterprises (ABLE) and PricewaterhouseCoopers, the domestic biologics market was worth $1.9 billion in 2009-10. With over 20 companies that are already producing biosimilars or low-cost versions of patented biotechnology products sold globally, India is already in a growth mode.