The Genetic Engineering Approval Committee (GEAC) under Ministry of Environment and Forests is likely to bring in more stringent systems for post-marketing adverse drug reaction (ADR) monitoring of recombinant drugs in the country. The regional offices of the environment ministry, on whose recommendations the revalidation of genetically modified drugs and therapeutics are considered, would soon be empowered to seek expert help from outside the ministry for monitoring any possible ADRs of such drugs that are in the market.
Informed sources hinted that the GEAC is to propose such a change in view of the growing use of recombinant drugs against many life-threatening diseases in the country.
Currently, all GEAC clearances are immediately intimated to the Ministry's six regional offices in the country. These offices, located at Lucknow, Bhopal, Bangalore, Chandigarh, Bhuvaneshwar and Shillong would take note of the approvals and keep watch on the products for any reported ADRs. The reports from these regional committees are vital when these drugs reach GEAC for renewed marketing clearances after four years.
As per the plans, the regional offices would be supplied with certain set protocols and instructions to be followed while tracking the drugs for ADRs. If need be the offices would be allowed to seek external help from scientific bodies to ensure proper surveillance of the rDNA drugs that are in the market.
The recently held GEAC meeting had renewed the marketing approvals for two products of Pune based Serum Institute of India. The committee considered giving revalidation permission for import and marketing of Gonal-F r-Human follicle stimulating Hormone (follitropin alpha) and Saizen (r. DNA Human Growth Hormone) of Serum Institute after receiving the feedbacks from the regional centers. The meeting had also given fresh import / marketing clearances for 12 products.
GEAC is the supreme authority when it comes to the sanctions for import, export, manufacture, process, sell, use of any genetically engineered substances or cells including food stuffs and additives that contains rDNA products.