- http://www.tribuneindia.com/2011/20110218/himachal.htm#2 Nimesulide banned for kids Five other drugs also on the list Ambika Sharma Solan, February 17 With theMessage 1 of 1 , Feb 18, 2011View Source
Nimesulide banned for kids
Five other drugs also on the list
Solan, February 17
With the drug controller notifying a ban on the paediatric use of the analgesic, nimesulide suspension, following imposition of a ban by the Ministry of Health and Family Welfare, its manufacturing, sale and distribution has been put on hold in the state since last evening.
Drug controller Navneet Marwaha said an intimation had been sent to the director, health services, all drug inspectors, and presidents of Chemist and Druggist Associations and the Himachal Drug Manufacturers Association to ensure its compliance at their end as licence to manufacture the product had been withdrawn.
He added that the doses of 100 mg and above would be required to bear a warning, “not for children below 12 years of age” on their label.
Interestingly, the drug is banned in most of the countries but MNCs like Panacea Biotech and Dr Reddy’s Lab were among its key manufacturers in the state. The directions followed the recommendations of a sub-committee of the government’s chief advisory body, the Drug Technical Advisory Board.
The Central Drugs Standard Control Organisations of India have also banned its use. A ban on its production would severely impact these MNCs which manufactured these on a large scale in the Baddi-Barotiwala-Nalagarh industrial area.
The drug has been under the government scanner for long as several reports of adverse reactions, including liver toxicity, were coming forth. While the drug has only been banned for paediatric use, physicians recommend its ban even for adults. Barring a few nations, the drug is banned in most of the countries. Several European countries, the Irish Medicines Board and the Singapore Health Science Authority were among those who had banned its use. Interestingly, the drug was never used in Switzerland, where it was invented.
The drug controller has also notified a ban on other drugs, including the use of human placenta extract and its formulations, cisapride, a drug which increases motility in the upper gastrointestinal tract, phenylepropsalamine which is used as a stimulant decongestant.
The use of sibutramine and R-sibutramine, which are used for losing weight, has also been banned as studies have confirmed that these drugs increase the risk of cardiovascular diseases like heart attack and stroke.
Marwaha added that the manufacturers had been directed to withdraw their stock from the market with immediate effect failing which an action under Section 18 of the Drug and Cosmetics Act, 1940, would be taken against them.Thank you very much.With warm personal regards,NikhilDr. Surender N. Gupta,MBBS; PGDHHM;PGDMCH;PGDCHFWM;FAIMS;;MA (Phil);FIMS;MAE (Epidemiology); OCCRTI
Faculty, Regional Health and Family Welfare Training Centre,
CHHEB, Kangra-Himachal Pradesh, India.
Pin-176001.01892-265472 (Fax); 01892-263472 (Office)
Mobile: 094181-28634.E-mail IDs: drsurendernikhil@...