The marketing approvals given to some commonly used medicines such as Nimesulide and Analgin will be reviewed by the Drug Technical Advisory Board (DTAB) of the Union health ministry in November.
The medicines, with a combined annual sale of about Rs 400 crore, have come under the regulatory scanner following reports of its adverse side effects from other parts of the world. Most of these medicines are not approved for use or have already been withdrawn from key markets in the US and Europe, senior officials said.
The country’s apex drug regulator, the Drugs Controller General of India (DCGI) said the agency will act on the basis of the DTAB recommendation.
“All drugs which are seen as irrational will be referred to DTAB. This includes the use of Letrozole for indications other than breast cancer and the use of Nimesulide in children below 12 years,” senior drug regulatory officials said.
DCGI’s decision to seek DTAB’s opinion isn’t necessary, say some. “There is no compulsion for the government to approach DTAB for approvals or a ban. If they feel the medicines should be banned or prescribed for restricted use, they can do it,” said C M Gulhati of Monthly Index of Medical Specialities.
According to Gulhati, some of the drugs being reviewed are marketed only in India. “Cisapride has been removed from key markets, including the US. Placenta extracts are also not permitted for use in most countries. Why should we delay a decision on banning such medicines?” he asks.
The authorities said they have decided, as a policy, to ask DTAB to review all medicines whose safety is under question in other parts of the world. DTAB will not be asked to take a decision on the basis of data generated within the country, but to see what the global practices are.
