The Kerala High Court directed the state drug controller to strictly implement the rules related to storage condition of drugs in wholesale and retail outlets, including mandatory wooden box shelves to prevent heat exposure on drugs and air-conditioning if necessary.

The single bench of Justice C N Ramachandran Nair, while disposing a writ petition filed by TTK Healthcare challenging the prosecution initiated by the drug control department on the storage condition for Oxytoxin, observed that the department should cancel the license of retail outlets if they fail to provide thick walled wooden shelves with wooden shutters to store drugs.

The court observed that 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, felt the court.

M P George, the Assistant Drug Controller, who submitted before the court on behalf of the department during the hearings, had said many retail outlets were not fully implementing the rule of installing thick walled wooden shelves with wooden shutters for storing drugs to prevent heat exposure. Exposure of drugs to heat beyond prescribed levels could cause to affect its potency. The officials were lenient considering the practical difficulties of the pharmacists in identifying the drugs. However, the department mandates to have at least a wooden box of 50 cubic feet to store drugs, for issuing license for retail outlets.

When the court had enquired why the department was not insisting on air-conditioning, the official maintained only more than 5 percent of the drugs stored in the medical shops required mandatory refrigeration as per the rules, considering the temperature of the region which never goes beyond 30 to 32 degree, normally.

Most of the companies, which make life saving drugs, maintain quality-packaging norms, good enough to withstand normal temperature. The department insists on mandatory refrigeration in retail outlets for storing drugs prescribed to be stored in the 'cold condition' as per the rules. Kerala has made it mandatory to have wholesale storing facilities fully air-conditioned, and for practical reasons, the same have not been implemented for retail outlets, the official told the court.

When contacted, top-level drug control officials in Kerala said they were yet to receive a copy of the judgment.