A recent directive of the Kerala High Court to strictly implement the rules on drug storage conditions has created confusion among the drug dealers as well as the drug control officials in Kerala, especially on the extent to which the rules could be enforced.

The Drug Controller has called a meeting of the top brass of the Kerala Drug Control Department officials and the traders association in the state - All Kerala Chemists and Druggists Association (AKCDA), on June 25 to discuss the issue and evolve practical solutions in strengthening the drug storage system, in the backdrop of the court directive.

Last week, a single bench of the High Court, while disposing a writ petition on the storage condition of Oxytoxin, had directed the officials to cancel the license of retail outlets if they fail to provide thick walled wooden shelves with wooden shutters to store drugs, as per the rules. Most of the retail outlets have wooden shelves with glass shutters kept very close to walls, violating the rules prescribed for storage conditions. The drug controller was bound to follow and implement the rules, and hence should strictly enforce it, the court had observed.

Speaking to Pharmabiz, A Mohan, president of AKCDA noted that the department was sanctioning licenses for retail outlets only after satisfied with the facilities set up by the retailers. Hence, the question of canceling the licenses was a point of contention.

He also noted that the Drug Control Department mandates all medical shops to have at least 50 cubic feet of either wooden boxes or Ultra Violet (UV) coated sun film sheets for glass shutters for storing certain drugs that could lose potency when exposed to heat beyond prescribed levels. Further, drugs that need to be kept in cold and cool conditions were kept only in refrigerators, which most of the medical shops have.

With numerous brands and drugs around, it would be practically impossible for the pharmacists to locate a drug demanded by the consumer, when enclosed in wooden boxes. Further, it was practically impossible to maintain the rules on drug storage condition during transportation of drugs, especially for small firms, noted Mohan.

When contacted, top-level Drug Control Department officials said they had pointed out the practical factors that hinder strict enforcement of drug storage conditions as per the rules to the court during the hearings. With the court directive, the department was bound to bring in a few necessary changes in storage conditions. "It could be like asking the retailers to provide a separate wooden box to maintain the drugs. We understand the practical difficulties involved, and will try to reach at some practical solutions," said M P George, assistant drugs controller, Kerala.

Mohan also said the trade was also looking forward to the meeting called by the DC, and would decide on future course of action depending on the outcome of the meeting.