In an order which will be music to the ears of hundreds of drug manufacturers in the country, the Madras High Court has allowed the drug companies to liquidate the stocks of nimesulide suspension and Phenylpropanolamine (PPA), which were recently banned by the union health ministry along with some other drugs that were found to make adverse effects on human health, it is learnt.
Sources said that in the interim order the court has given four weeks 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. Former Attorney General Masila Mani represented the CIPI and IDMA, which also joined the case, in the court.
On February 10 this year, the union health ministry had banned four of the most controversial drugs in the country --- 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. Some time ago, the ministry had banned Sibutramine and its formulations and R-Sibutramine and its formulations in the country. The ministry's decision in this regard was based on the recommendations of the Drugs Technical Advisory Board (DTAB), which is the highest decision-making body under the union health ministry on technical matters and its recommendations are normally followed by the ministry.
But, the ministry's decision to ban these drugs with immediate effect caught the industry on wrong foot as there was a large volume of these banned products still in the market. After the sudden ban, apart from discontinuing the manufacturing, the industry had to recall the products from the market, which might have resulted in huge financial losses to several companies.
When contacted, CIPI chairman T Jaishankar said that the court order will be a big relief to the companies as there is an estimated Rs.50 crores of nimesulide alone in the market.
Ever since the ban came into force on February 10, the industry has been pleading with the government to allow the sale and distribution of these formulations which are already in the market till their expiry date. 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 pleaded. The industry had apprised the government that in several cases, the ban may force some manufacturers to shut down their units.