TopNews + Font Resize -

Health ministry bans gatifloxacine and tegaserod due to adverse effects on human health

Ramesh Shankar, Mumbai | Saturday, March 19, 2011, 08:00 Hrs [IST]

After banning a set of controversial drugs like nimesulide (for use of below 12 years of age), cisapride, phenylpropanolamine and human placenta extracts, the union health ministry has banned two more controversial drugs--- antibiotic drug gatifloxacine and chronic constipation drug tegaserod due to adverse effects of these drugs on human health.

Earlier, the Drug Controller General of India (DCGI) decided to put these controversial drugs under the radar of the DTAB in the wake of serious concerns raised by the medical experts in the country over the adverse effects of these drugs on human health.

The Drugs Technical Advisory Board (DTAB), the highest decision-making body under the union health ministry on technical matters related to health issues, after taking its final call on nimesulide, phenylpropanolamine, cisapride and human placenta extracts, reviewed gatifloxacine and tegaserod. After review, it recommended to the ministry to ban these drugs as it is “satisfied that use of the following drugs is likely to involve certain risks to human beings and whereas safer alternatives to the said drugs are available”.

A communique from the union health ministry said, “And whereas the central Government is satisfied that it is necessary and expedient to prohibit the manufacture, sale and distribution of the said drugs in public interest; Now, therefore, in exercise of the powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture, sale and distribution of the following drugs with immediate effect, namely:-
(i)   Gatifloxacin formulation for the systemic use in human by any route including oral and inject able; and
(ii)   Tegaserod and its formulations for human use.”
(iii)   Nimesulide, cisapride, phenylpropanolamine, tegaserod, Drug Controller General of India, DCGI, Drugs Technical Advisory Board, DTAB

Comments

Dr Piyali Datta Chakraborty

Mar 19, 2011 8:54 PM

Human Placental aqueous Extract is a very safe drug. We the team of IICB, Kolkata ( A Unit of CSIR,India) are working with the drug ‘Placentrex’ project since 1999 with extension in every alternate year. A committee constituted by experts approved renewal of the project. Ours is a CSIR owned biomedical research institute of national importance. As per CSIR guidelines on human and animal ethics, it is not possible to undertake any research in the institute, which is hazardous or unsafe to human or animal health or the environment.

Two research scholars Dr. S. Nath and Ms. D. De, were awarded CSIR-senior research fellowship for continuation of their work on ‘Placentrex’ in 2004 and 2007 respectively. The expert committee of CSIR, New Delhi, awarded fellowships after extensive reviewing of research proposals. The committee members were fully aware of the manufacturing of the drug.

Three theses describing research on ‘Placentrex’ have been submitted to Jadavpur University for the

Meghal	Mar 19, 2011 12:58 PM
Gatifloxacin formulation for the systemic use in human by any route including oral and inject able whether this means the use of Gatifloxacin is band for Ophthalmic use also kindly let me know