Extremely dismayed over the Union health ministry's decision to ban some of the drugs including the nimesulide suspension without consulting the industry as stakeholders, the pharma industry has asked the union health minister Ghulam Nabi Azad to allow the sale and distribution of these formulations which are already in the market till their expiry date.
Expressing anguish over the manner in which the decision to ban these drugs was taken by the ministry, the industry said that despite assurance from the minister that industry as stakeholders would be consulted before any action is taken in this regard, the ministry announced the ban of these drugs without consulting the industry.
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.
The industry pleaded with the minister that banning of these drugs with immediate effect will have tremendous impact on the manufacturers of these products as they will be forced to discontinue their products immediately, leaving a lot of stocks in the market which will result in heavy financial losses to these companies. The industry apprised the minister that in several cases, the ban may force some manufacturers to shut down their units.
Besides all these, the immediate recalling of the formulations that are already in the market will be a very difficult task for the manufacturers and also time consuming, the industry said.