The Andhra Pradesh Drugs Control Administration (APDCA) has initiated the process of recalling drugs that involve gatifloxacin and tegaserod formulations, following a gazette notification issued by the Ministry of Health and Family Welfare, dated March 16, 20011, banning these two drugs due to certain health risks.

The notification prohibited manufacturing, sale and distribution of these two drugs with immediate effect. The Drugs Controller General of India (DCGI) sent letters to all the state drugs controllers on March 28, 2011, asking them to ensure that the manufacturing licenses granted in the respective states for the manufacture of these drugs formulations are cancelled with immediate effect and the formulations recalled from the market on top priority. It has asked the state drugs controllers to direct the chemists and druggists in the respective states to stop the sale of these formulations with immediate effect and to return the unsold stocks to the manufacturers. The DCGI letter also states that safer alternatives of these formulations are available in the market.

It is learnt that state drugs control administration has directed all the drugs inspectors to start recalling these drugs from the market. It has also asked all the manufacturers and distributors to stop manufacturing and distribution of these drugs.

According to an APDCA official, gatifloxacin, an antibiotic, is marketed under various brand names such as Gatiflo, Gatri, Gatispan, Gatiquin, Gatigo, Biogat, Q-gat and Gatri-OZ by different companies. Gatifloxacin is also used in several eye drops available in the market. Gatifloxacin is also available as tablets and in various aqueous solutions for intravenous therapy. It is understood that the decision to ban gatifloxacin was because it posed higher health risks.

Tegaserod formulations are used for the management of irritable bowel syndrome and constipation and marketed under the brand name of Tegibs.