The drugs nimesulide suspension and Phenylpropanolamine (PPA) are still banned in many states and not available at the retail counters, in spite of a stay order by the Madras High Court on March 15. Even after a week since the order was passed, drug controllers are still clueless about their next step.
Under law, once the order was passed it was binding on all states, to lift the ban and allow sale of the two drugs for two weeks so that the companies could liquidate the stocks of the drugs in question. However, it is reported that the drugs are still banned in Gujarat, Goa, Rajasthan, Maharashtra in spite of the stay order from the court which amounts to contempt of court.
The officials from the respective state drug offices reasoned that the ban is still in force in the state as the Drug Controller General of India (DCGI) has yet to sent directives to the state drug controller's on the stay on the ban on two of the six banned drugs nimesulide suspension and PPA without which they could not take any action.
An official from the Goa Foods and Drugs Control Administration informed that they are still waiting for the DCGI to send in the directive so that they can take the requisite action.
T S Jaishankar, chairman, Confederation of Indian Pharmaceutical Industry (CIPI) informed that since it is a court order it is binding on all states from the time it was passed and does not require any directive to be send by the DCGI's office directly.
“The idea behind getting this order was to provide some relief to the small scale manufacturer's in the country from heavy losses due to its immediate ban. Those states that do not follow the court order will be liable for contempt of court. We have been sending letters to all the state drug offices on the same and its surprising that its still not being followed,”he said. He would be sending a letter to the DCGI's office as soon as possible to bring this matter to his notice and to take necessary action.
The Madras High Court, following a petition filed by CIPI and IDMA Chennai, had passed an interim order wherein it had stayed the ban on nimesulide suspension and PPA. The HC had given two weeks time to the companies to liquidate their stocks in the market so that the small scale manufacturer's would not suffer heavy loss due to sudden ban.
This year, the union health ministry had banned six of the most controversial drugs in the country Sibutramine and its formulations and R-sibutramine, the non-steroid anti-inflammatory drug nimesulide (for children below 12 years of age), gastroprokinetic agent cisapride, decongestant drug Phenylpropanolamine (PPA) and human placenta extracts with immediate effect. The ministry's decision in this regard was based on the recommendations of the Drugs Technical Advisory Board (DTAB) under the union health ministry and its recommendations are usually followed by the ministry.