Drug regulatory infra gets Rs 1,750 cr

With rising instances of quality scrutiny faced by Indian pharmaceutical companies in foreign markets, the government on Wednesday okayed Rs 1,750 crore to strengthen the drug regulatory system.

The money will be spent to set up testing laboratories and a training academy for regulatory and testing officials, among other things.

The decision by the Cabinet Committee on Economic Affairs says Rs 900 crore will be used to strengthen the central structures and Rs 850 crore made available to state governments. Much of state-level drug regulatory infrastructure lacks upgradation due to lack of funds.  

Provision has been made for additional equipment and personnel in existing testing laboratories, setting up of new labs for testing drugs, medical devices and cosmetics, making mobile drug testing laboratories available, hiring of additional personnel for regulatory structures, including for new and emerging areas such as stem cells, regenerative medicine, biologicals and medical devices, in addition to drugs.

The upgrading will also introduce e-governance and information technology-enabled services, and setting up a training academy for regulatory and drug testing officials, of central and state governments.

India is one of the largest makers of drugs and exports pharmaceutical products to about 200 countries. Facilities of top companies like Sun and Lupin have been facing regulatory scrutiny by the Food and Drug Administration in the US, the largest export market. Recently, the European Union banned sale of pharma products tested at the GVK Biosciences facility in Hyderabad.