Most pharmaceutical companies, having irrational combinations in their products lists, are getting ready to file fresh applications in place of their products which will be withdrawn as part of DCGI's drive to weed out irrational combinations from the market. The state drug authorities are all set to implement the DCGI order.
After more than two months of his decision to withdraw irrational combination drugs from the market, the DCGI last week wrote to state drug controllers to withdraw licenses issued to irrational combination drugs. The decision is based on the studies of NPPA, Indian Drug Review, MIMS and CIIMS.
The DCGI letter directs the state drug controllers to withdraw licences to such products which were licensed by state drug controllers and not approved by the DCGI, products which were licensed by state drug controllers and approved by DCGI since 1971, applications which were approved by state drug controllers but rejected by DCGI for insufficient information and the products which were banned by drug controllers but are reportedly available in the market.
Sources said that the affected companies are weighing different options to face the situation. Though legal options are always open, the companies are also collecting data to move an application with the DCGI for fresh license. They are collecting information such as stability data, dissolution data, manufacturing process, sources of raw material, certificate of analysis, draft label, etc for moving the fresh application with the DCGI for license.
According to industry sources, an estimated Rs 3,000 crore of pharma business will be immediately affected due to the DCGI order. Apart from the end product, the decision to withdraw irrational drugs will have a chain affect on the raw material, packaging industry, promotional materials, etc.