MUMBAI May 21 India will spend 30 billion
rupees ($511 million) and double the number of drug inspectors
in the next three years to meet global manufacturing standards,
the country's health regulator said on Wednesday.
A rash of import bans imposed by the U.S. Food and Drug
Administration on leading Indian generic drugmakers due to
lapses in production processes over the past year has triggered
concerns about the quality of drugs sold in other markets,
including in India.
The Indian government will increase the number of inspectors
at the Central Drugs Standard Control Organization (CDSCO) to
1,000 from 500 now, Drugs Controller General of India G.N. Singh
said in a statement on Wednesday.
The number of officials at state regulatory departments will
be raised to 3,000 from 800 now, he said.
"India's reference system (for drug testing and intellectual
property) will be at par with the top world standards in two to
three years and will even match the U.S. in three to five
years," Singh said.
In India, states regulate the manufacture and distribution
of drugs, while CDSCO, which is the federal authority, handles
approvals of new drugs and clinical trials, oversees drug
imports and coordinates the activities of state regulators.
A chronic shortage of inspectors has made it difficult for
regulators in India to monitor the more than 10,000 drug
manufacturing factories in India, which supply to more than 200
Multiple state drug regulators told Reuters in April that
skeletal staff and lack of enough drug testing laboratories had
rendered their departments unequipped to carry out their duties.
($1 = 58.7600 Indian Rupees)
(Reporting by Zeba Siddiqui in Mumbai; Editing by Prateek