The drug traders in Kerala may approach the High Court challenging the drug controller's new directive on provisions regarding drug storage, following a recent High Court directive to immediately enforce strict provisions to maintain the quality of drugs.
The executive committee of the All Kerala Chemists and Druggists Association (AKCDA), the only association of drug traders in Kerala, will meet in Kochi during the first week of August to decide on future course of action, including legal proceedings to stall the order. "We held discussions with the Drug Controller on the directive. We don't want the matter to be taken to the court. The DC has agreed not to implement the provisions in the new order until September, this year. Our executing committee meeting will decide what needs to be done, including the option of approaching the High Court" A Mohan, president of AKCDA told Pharmabiz.
Meanwhile, the Kerala Drug Control department is also exploring the possibilities to approach the high court with a revision petition to re-look the directives ordered by the single bench as per its order O.P.No.10793 of 2002 (1). "We understand the practical difficulties of the shops in implementing the order. But with the court directive, we are forced to immediately implement the same. We are also exploring the possibilities of filing a revision petition," said a top brass of drug control office in Kerala.
As per a circular dated 24/06/2004, the DC directed the traders that suitable false ceiling using thermocol, wood or other bad conductor of heat should be provided in medical shops situated in single storied R.C.C. buildings. Further, the DC banned use of asbestos for ceiling or partitioning in medical shops.
Drugs requiring cold storage (2 to 8 degree C) should alone be stored inside refrigerators without freezers, and the refrigerator should work 24 hours a day. For storing drugs in cool place (below 25 degree C), thick walled wooden shelves with wooden shutters have to be provided. There should be a minimum of 150 cubic feet storage space in retail shops. Wooden shelves fixed on walls exposed to direct sun light or excessive heat should be provided with wooden paneling on the walls.
Further, the DC directed that drugs should not be stored on open racks, shelves or on counters made of glass. Drugs having no special storage directions on the labels, cosmetics and Ayurvedic drugs can only be stored and exhibited in racks or on glass shelves. All capsules, dry syrups and ointments should be kept in wooden shelves only. Directions given by the manufacturers on the labels about storage should be strictly followed.
Wholesale dealers should provide wooden platforms for keeping drugs in the original unopened secondary packing of the manufacturers (cartons or other boxes). All drugs taken out of cartons should be stored in wooden shelves with wooden shutters. Drugs like I.V. fluids in plastic containers shall be stored in rooms protected from rodents and insects. Manufacturers and dealers should ensure proper storage conditions while transporting drugs, said the DC circular.
The DC also said the new storage conditions are also applicable for hospital clinics and nursing homes where drugs are stored and distributed, and defaulters will have to face penalty like cancellation of licenses. The DC also mentioned that the provisions are applicable to fresh licenses since 1/07/2004 and in case of existing licenses from 01/01/2005.
The single bench of the High Court, while disposing a writ petition on the storage condition of Oxytoxin, said on the basis of report made available to it, the present practice of storing drugs in shelves with full glass shutters is likely to affect the quality of drugs adversely. Such drugs should be stored in thick walled wooden shelves with wooden shutters to prevent exposure to warm condition. The court directed the officials to cancel the license of retail outlets if they violate the norms. The drug controller is bound to follow and implement the rules, and hence should strictly enforce it, the court had observed.