The Madras High Court has allowed an interim stay on the notification of the union health ministry (GSR 82 E) dated February 10, 2011 in which the ministry had banned four of the most controversial drugs--- the non-steroid anti-inflammatory drug nimesulide (below 12 years age), gastroprokinetic agent cisapride, decongestant drug, Phenylpropanolamine (PPA) and human placenta extracts---in the country with immediate effect.
Hearing a petition moved by pharma major Cipla Ltd on March 23, the court has stayed the health ministry's notification.
It is a big blow to the union health ministry's efforts to ban these drugs in the country. Earlier on March 15, the Madras High Court had allowed the drug companies to liquidate the stocks of nimesulide suspension and Phenylpropanolamine (PPA). In the interim order, the court has given 15 days time to the companies to liquidate their stocks in the market. The Madras High Court was hearing a petition in this regard filed by Confederation of Indian Pharmaceutical Industries (CIPI), an association of thousands of small pharma companies in the country.
In a gazette notification dated February 10, the ministry had banned these controversial drugs due to its adverse effects on human health.
Earlier, the DCGI had brought these controversial drugs under the radar of the DTAB in the wake of serious concern raised by the medical experts in the country over the side-effects of these drugs.
Among these drugs, nimesulide was the most controversial drug as even though it was banned in US, Britain, Canada, Sweden, Denmark, Australia, New Zealand, Japan and other 168 countries, the drug was freely available in India, being aggressively marketed by prominent drug companies. Though the drug was banned in most of the countries following information suggesting an increased risk of liver toxicity compared to other drugs in the same class, the then drug authorities in India claimed that no adverse drug reaction report had been received on the use of nimesulide in the country so far to necessitate a ban.
Cisapride, a drug which increases motility in the upper gastrointestinal tract, has been either withdrawn from the market or had its indications limited in many countries due to its side effects. Serious cardiac arrhythmias including ventricular tachycardia, ventricular fibrillation, torsades de pointes and QT prolongation have been reported in patients taking cisapride.
Similar is the case with use of placenta extraction. According to reports, all products containing extract of human placenta have been banned by the US FDA since they can transit diseases and pose serious health hazards to consumers. Placenta extract was never permitted for use as medicine in the western countries such as US, UK, Australia, Canada and European Union states due to lack of efficacy and safety data. However, some companies in US were importing products containing human placenta as dietary supplements. However, on April 14, 2008, all products containing human placenta extracts even for use as cosmetics have been banned by the US government.
But in India, human placenta extract sold as Placentrex lotion, gel, and injection is being actively promoted as a remedy for a variety of unrelated disorders such as vitiligo, wound dressing, prevention of adverse effects due to radiotherapy, fallopian tube blockage, female infertility, scarring, post-phlebitic ulcers, scars due to acne, etc.
Due to its potential to cause stroke, Phenylpropanolamine (PPA) used in cold and cough remedies was banned in all North American countries including US and western Europe. But in India, PPA -containing cough and cold remedies are available in the market.