Pharmaceutical companies in the country are upset over the pick and choose policy being followed by state drug control departments in various states in implementing the DCGI directive of withdrawing irrational combination drugs from the market.
Sources said that there is resentment among the industry over the way the entire issue is being handled by the drug control department. While implementing the DCGI directive to withdraw irrational combination drugs from the market, the authorities are issuing notices to some of the manufactures leaving others in the market. "Some companies have got notices to withdraw their products from the market as they have been branded as irrational, while other companies producing the same combination of drugs have been left out and are taking advantage", a pharma industrialist who is keenly watching the situation said.
Another anomaly is that under the Drugs and Cosmetics Act, the drug control department has to issue Form-15 to the manufacturers for withdrawing the product providing details about the reasons for withdrawal. Nothing of this sort is happening at present, he said.
As per Para 26 A of the Drugs and Cosmetics Act, the Drug Controller General of India (DCGI) is empowered to withdraw any product from the market on therapeutic justification. But, the drug department is simply issuing letters to the companies not to manufacture and sale the listed products without giving any therapeutic justifications, observers in the industry rued.
Para 26 A says that without prejudice to any other provision contained in this chapter, if the central government is satisfied, that the use of any drug is likely to involve any risk to human beings, then the government may by notification in the official gazette prohibit the manufacture, sale or distribution of such drug. For example manufacture, sale and distribution of Astemizole and Terfinadine was prohibited from 1.8.2003 vide govt. notifiation No GSR 732(E) dated 29.10.2002 and GSR No 191(E) dated 5.3.2003. Similarly many other products like Rofecoxib, etc were also banned by the government with proper notification.
As per law, the drug department has to send a show cause notice to the companies before finally withdrawing the product from the market. The companies should be given proper time to justify their product combinations. But, the drug control department is simply asking the companies to withdraw the products from the market, industry sources said.
Another vital factor, which DCGI office has not kept in view, is the loss of packaging and printing material, raw material, solvents, excipients and material in the pipe line. An estimated Rs 2500 to 3000 crore is at stake, sources said.