In what can be the beginning of a prolonged battle between the drug authorities and the drug manufacturers of the country over the controversial issue of withdrawal of combination drugs from the market, a drug company (Ravenbhel Healthcare Pvt Ltd, Jammu) has got a stay order against the state drug controller's order to withdraw some of the combination drugs of the company from the market. Next hearing has been fixed for October 10, 2007.

According to information, more drug companies and some industry associations are also gearing up to move court on the issue in different parts of the country.

Source said the companies and the industry associations are waiting for the letter from the drug control department. Though the DCGI had directed the state drug controllers to withdraw combination drugs from the market in early June this year, the state drug controllers passed on the directive to the joint commissioners only some time back. The joint commissioners, who are the license issuing authorities, have started issuing letters to the drug companies to withdraw the combination drugs from the market immediately.

"We are waiting for the letter from the drug authorities. We are preparing to move court", said Aurangabad Drug Manufacturers Association president Vinay Jain. Though the industry associations have been asking the Drug Controller General of India (DCGI) to allow the companies to prove the rationality of their products, the DCGI is steadfast on his decision to immediately withdraw more than 1000 irrational combination drugs from the market. The industry associations are not against the action, but the way it is being implemented without giving an opportunity to the industry to prove the rationality of their products.

In fact, the IPA, an alliance of the country's top pharmaceutical companies including Ranbaxy, had proposed a mechanism for implementing the withdrawal of combination drugs from the market. "Companies are willing to adapt to new situations. But there should be a mechanism to implement it and the industry should be given some time to prove it", said Indian Pharmaceutical Alliance (IPA) secretary general DG Shah.

Besides, another industry association IDMA had also made a representation to the DCGI asking him to see reason while implementing the order. The IDMA letter was also a clear hint about the legal battle lying ahead as its argument was based on several provisions in the Drugs and Cosmetics Rules, 1945.