Leading Indian drug makers may soon be asked to furnish fresh clinical trial data for 11 medicines in therapeutic categories like orthopaedics, anti-diabetes and the central nervous system that are currently being marketed in the country.
The Drugs Controller General of India, the medicine regulator, has come round to the view that around 90 brands of these 11 drugs would require fresh safety and efficacy proof through fresh clinical trials if they are to be approved for use in the country.
These brands belong to 60 pharmaceutical firms including Sun Pharma, Torrent, Ipca, Elder Pharma, Alkem, Mankind and Shreya Life Sciences.
This initiative of the DCGI could put at stake business worth over Rs 1,000 crore. These firms may now have to carry out fresh clinical trials on drugs they have been selling for years.
"The department has already sought a report on the current marketing licence status of these drugs," DCGI M Venketeshwarlu said, adding: "If the states still allow the production of these drugs, they will be asked to cancel their licences immediately. The companies will be allowed to continue their sales only after they submit clinical trial reports."
The move comes after the DCGI conducted an analysis of the medicines that were being sold in the country with marketing licences from the state drug authorities, but not the central regulator.
Venketeshwarlu said the fresh clinical trials were part of a larger plan to monitor fixed- dose combination medicines that were approved by state drug authorities during the last one decade.
The DCGI had sought cancellation of the marketing approvals given by states to nearly 300 categories of drugs. The regulator had also found that over 100 of these medicines were either rejected or banned by his office.
The DCGI was also of the view that another 150 medicines will need further examination before their marketing status could be reviewed. The ones that require clinical trials are part of the remaining 50 medicines.
