Drugmakers and importers are not complying with safety reporting requirements according to the Indian Drugs Controller General (DCG), which has given the offending firms three weeks to comply.
In India manufacturers and importers of all new drugs are required to submit periodic safety reports (PSURs) to the DCG office every six months for the first two years following approval and annually for the next two years.
However, according to comments in a letter published earlier this week not all pharmaceutical companies are complying with the regulations, which are mandatory under Schedule Y of India’s Drug and Cosmetics Rules.
The DCG goes on to order firms that have not updated their PSUR filings to do so in the next three weeks. Those failing to comply by the deadline run the risk of having their drug approvals suspended or cancelled.
The DCG’s move comes just a few weeks after the Central Drugs Standard Control Organization (CDSCO) was criticised for its oversight of mandatory safety reporting for new drugs in a report by India’s Parliamentary Standing Committee on Health and Family Welfare.
In the document – published in May – the committee reports that when asked for PSUR data on 42 drugs randomly selected from its database the CDSO was only able to provide information for eight products.
The authors said that: “This action reflected a poor follow-up of side effects on Indian patients. The Committee recommended that manufacturers of new drugs be warned about suspension of marketing approval unless they comply with mandatory rules on PSURs."