Pharmaceutical regulatory body to inspect drug manufacturing units countrywide
The development comes more than two months after the World Health Organization issued a global alert for four India-made cough syrups.
The Central Drugs Standard Control Organisation, along with state authorities, has started carrying out joint inspections of drug manufacturing units across the country, the Union health ministry said on Tuesday.
A committee comprising two joint drug controllers has been set up to monitor the process of inspection, reporting and subsequent action. The committee has been tasked with ensuring compliance of the manufacturing units with the Drugs and Cosmetics Act, 1940.
“An action plan for nationwide inspection of manufacturing units which are identified to be at the risk of manufacturing Not of Standard Quality (NSQ)/adulterated/spurious drugs was made prior to carrying out of inspections,” the ministry said in a press release.
The development comes months after the World Health Organization issued a global alert for four cough syrups made by Haryana-based Maiden pharmaceuticals.
This was after authorities in The Gambia linked 66 deaths, most of them due to acute kidney failure, to the cough syrups – Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup.
However, the Drugs Controller General of India on December 13 wrote to the global health body, saying that it drew a premature link between the deaths of the children and the cough syrups. The authority said that samples of the syrups were tested in a government laboratory and found to be complying with specifications.
Last week, Nepal’s Department of Drug Administration barred imports of medicines manufactured by 16 Indian companies. The authority said that the firms did not adhere to the World Health Organization’s good manufacturing practices.
The World Health Organization’s good manufacturing practice system is aimed at ensuring that products are “consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorisation”.