The Drugs Control Administration of Kerala has issued an order prohibiting the sale of fifteen irrational formulations, marketed in the state without clearance from Drugs Controller General of India. A circular issued to the drug inspectors, listing the irrational formulations prohibited from market, instructed to freeze stock of the drugs pending submission of approvals issued by the DCGI.
The irrational formulations identified by the state DCA are, alprazolam+paracetamol, nimezulide+dicyclomine+simethicone, nimesulide+paracetamol+serratiopeptidase, nimezulide+cetrizine+pseudoephedrine, aceclophenac+paracetamol+ serratiopeptidase, aceclophenac+paracetamol+ serratiopeptidase+tizanidine, norfloxacin+tinidazole+ dicyclomine, nimesulide+tizanidine +paracetamol, amoxicillin+cloxacillin+lacto bacillus+ serratiopeptidase, roxithromycin+ serratiopeptidase, diazepam+dried aluminium hydroxide gel, atenolol+alprazolam, propranolol+diazepam, propranolol+alprazolam and atrovastatin+folic acid+methyl cobalamin+pyridoxine.
The state DCA has found that many of the irrational formulations, which do not have the clearance from DCGI are being approved by the states like Tamil Nadu and Pondicherry.
"We found out that even a major company from Gujarat has acquired such approval from Pondicherry, and was marketing the product in Kerala. When we asked them to retrieve the product from market until submission of clearance certificate from DCGI, the company withdrew the product without any delay," A.Abdul Shukkoor, Drugs Controller, Kerala told Pharmabiz.
According to Shukkoor, Kerala is one of the major markets for such irrational formulations, acquiring approval from neighbouring states. But the authority also noticed that the companies are withdrawing such products from the market as soon as they receive warning from the administration.
The state DCA has added provisions, in the revised inspectional report of April 2005, for entering the details of irrational formulations found at the time of inspection. The DCA also received a complaint on movement of 150 irrational formulations in the state, from some NGOs, submitted to the government through the opposition leader of state legislative assembly. Though the whole list may not be accurate, the department will check every irrational formulation in the market, added Shukkoor.