Date:21/12/2004 URL: http://www.thehindubusinessline.com/2004/12/21/stories/2004122103070400.htm

Back Steps to strengthen drugs Act

Our Bureau

"Apart from regulating the clinical trials, the measure would also help the contract research organisations (CROs) gain creditability and confidence of foreign companies."

Hyderabad , Dec. 20

AIMED at regulating clinical trials, which is emerging as a major opportunity for the country, the Drugs Controller General of India (DCGI) is planning to strengthen the Indian Drugs and Cosmetics Act, the Deputy DCGI, Dr M. Venkateswarlu, said.

Talking to newspersons on the sidelines of a two-day summit on "Focus pharma" organised by the Confederation of Indian Industry (CII) here on Monday, he said, the Government was keen on ensuring good clinical trials practices.

Apart from regulating the clinical trials, the measure would also help the contract research organisations (CROs) gain creditability and confidence of foreign companies that were interested in outsourcing the clinical trials, Dr Venkateswarlu said.

On the delay in measures to regulate clinical trials, he said there was no point in simply formulating laws unless the operations of clinical trials reach a critical mass, he said.

The Government move to upgrade the Schedule Y of the Drugs and Cosmetics Act is in the final stages. Addressing the Summit, he stressed on the need to evolve accreditation system for the pharmaceutical exports pertaining to quality standards, he later told newspersons that it was his personal view and was not of the Government.

According to him, such accreditation system would lead to increased awareness among the buyers and would also enable exporters enjoy better incentives.

According to the Pharmexcil Executive Director, Dr T.V. Appaji, the country was emerging globally as a major source for acceptable drugs of high quality in various therapeutic segments.

A multi-billion-dollar opportunity beacons the Indian pharmaceutical sector, both in terms of volumes and value in the domestic as well as the global markets.

The CII Andhra Pradesh Chapter Chairman, Mr Ramesh Datla, said the Indian pharmaceutical industry is at a critical juncture with rapid changes taking place across the globe.