The SME Pharma Industries Confederation (SPIC), a confederation of thousands of small pharma units across the country, has asked the union health minister Ghulam Nabi Azad to keep in abeyance the ministry's recent notification banning some of the controversial drugs, including nimesulide, till the expiry of stocks of these medicines in the market.

Taking strong exception to the ministry's decision to ban these drugs with immediate effect without consulting the industry, SPIC said that pharma industry is indeed surprised at the sudden ban imposed by government prohibiting the manufacture and sale of several drugs including Nimesulide (kid), Cisapride, Phenylpropanolamine, Human Placenta Ext formulations, Sibutramine etc. with immediate effect. The stakeholders were neither taken into confidence nor granted a hearing before the ban was imposed, which is contrary to the assured policy.

Such a sudden ban was justified if the government had discovered adverse reactions causing devastating effects on human health by a certain drug. In the present case several drugs have been banned and withdrawal of these drugs has been mandated from market for destroying the stocks, SPIC said.

SPIC secretary general Jagdeep Singh said, “Even if there is no doubt that these formulations need to be banned, there is no justification in imposing the sudden ban with immediate effect because there are huge stocks of these items lying with the manufacturers as well as traders. Withdrawal of stocks is not only cumbersome but also impossible. Manufacturers and traders certainly deserve some notice since these products were sold for years. Government action can close down many units apart from the fact that it is a huge national loss.”

Based on the recommendations of the Drugs Technical Advisory Board (DTAB), the union health ministry had on February 10 banned four of the most controversial drugs in the country --- the non-steroid anti-inflammatory drug nimesulide suspension, gastroprokinetic agent Cisapride, decongestant drug Phenylpropanolamine (PPA) and human placenta extracts--- with immediate effect.  Some time ago, the ministry had banned Sibutramine and its formulations and R-Sibutramine and its formulations in the country.

The health ministry's rather belated decision in this regard came after it was found by the DTAB that these drugs will have adverse effects on human health. The DTAB is the highest decision-making body under the union health ministry on technical matters and its recommendations are normally followed by the ministry.