This is the first concerted attempt to develop a pan-India drug alert system for consumers, which some states like Gujarat have already started
New Delhi: The Drug Controller General of India (DCGI) has made it mandatory for all pharma companies and laboratories to report cases of substandard drugs. All details of such substandard/spurious/adulterated/ misbranded drugs will be uploaded on the website of the Central Drugs and Standards Control Organisation (CDSCO) every month.
In order to regulate the import, manufacture, distribution and sale of drugs, medical devices and cosmetics in India, it has been decided that the CDSCO is required to be informed about the quality defect in the medicinal products which require recall or restriction on supply.
Where a product is considered to be a risk to public health, the marketing authorisation holder will withdraw the affected product from use and the CDSCO as well as concerned state drug regulatory authority are required to be informed about such products so that suitable drug alert is issued for the information of the public, said DCGI Dr G N Singh in an order issued last week.
This is the first concerted attempt to develop a pan-India drug alert system for consumers, which some states like Gujarat have already started. The Gujarat drug controller regularly sends out SMS alerts on substandard drugs.
CDSCOs drug testing laboratories have also been instructed to send regular updates to the headquarters on drugs that fail the test. With the emphasis in the 12th five year plan on a gradual shift from voluntary disclosure for pharma companies to mandatory disclosure, this is one of the first steps in that direction.
The heft of CDSCO is such that even in the absence of laid down punitive provisions, a pharma firm that is found to have concealed information about substandard products may find the going tough in getting future clearances, said an official. – IE