New Delhi, March 13: In a major move, the government has asked the Drug Controller General of India (DCGI) to revamp and upgrade the standard of Good Manufacturing Practices (GMP) being followed by pharmaceutical companies and bring it at par with the US Food and Drugs Administration standards (USFDA). This will help improve the quality of manufacturing practices followed by these companies. A detailed notification to this effect is soon expected to be issued by the ministry. The strategic management group (SMG) under the prime minister's office also intends to make the DCGI office more competent with the induction of experts. Also, an advisory board is being planned to be set-up to advise the DCGI regarding the knowledge base of the office and is being looked into by the Drugs Technical Advisory Board (DTAB). The ministry has already sent a proposal to the finance ministry to induct full-time experts at the level of Assistant Drug Controllers (ADCs) in core areas related to drug research and approval iebiopharmaceutics, toxicology, pharmacology, etc.A new time schedule for application processing for different stages of clinical trials is also being proposed and a strict programme scheduled for various phases of approval/clearance is likely to be made copulsory for pharma companies. The ministry of chemicals and fertilisers is also in the process of issuing notification for the fee to be charged at each stage of approval/clearance of new drugs.
There is also a proposal that the responsibilities of post-marketing surveillance should also be with the regulatory authorities and not with the research and development (R&D) institutions or pharmaceutical companies.
The strategic management group in a bid to expedite decision making of DCGI has called for providing national as well as international electronic networking of DCGI. DCGI is also in the process of improving the Adverse Drug Reaction (ADR) monitoring through the ADR monitoring centres already set up in Mumbai, Lucknow and New Delhi.
Copyright © 2001 Indian Express Newspapers (Bombay) Ltd.
