The Kerala High Court has directed the state drug controller not to proceed with prosecution of companies for violating storage conditions of Oxytocin injection until the contradiction on rules elaborated in the Indian pharmacopea and Drugs and Cosmetics Act, 1945 were sorted out.
The single bench of Justice C.N.Ramachandran Nair, while disposing off a writ petition filed by TTK Healthcare, Chennai challenging the DC's move to initiate legal action against the company for labeling Oxytocin injection as 'store in a cool place' instead of 'store in a cold place', felt there were contradictions in the rules (Indian drug pharmacopoeia) and act (Schedule B of the Drugs and Cosmetics Act, 1945) related to storage of this medicine. Because of this, and since the accused companies were ready to follow the specified rules, the government need not proceed with the prosecution process, opined the court.
However, the court refrained from pronouncing a declaration or verdict as demanded by the petitioner, according to sources.
The Kerala Drug Control Department initiated prosecution against four companies last year, including Inga Laboratories, Mumbai, Astra Zeneca and TTK Healthcare citing that they were violating the storage condition on Oxytocin, mentioned in the Schedule B of the Drugs and Cosmetics Act, 1945. The officials maintained that the drug should be stored in refrigerators, with a temperature below 8 degree, as per the definition of cold condition in the act. Cool definition is between 10 to 25 degree and hence the retail stores were keeping the drug outside refrigerators. This could cause to lose the efficacy of the drug, maintained the Drug Control Department.
The companies challenged the move in the court, citing they were manufacturing drugs as per the conditions prescribed in the Indian pharmacopoeia, and hence should not be branded as offenders. The pharmacopoeia says only 'cool condition' for storing Oxytocin, a drug often prescribed by gynecologists for uterine contraction to reduce pain during birth.
A top level drug control official in Kerala said the Drug Controller General of India (DCGI) had issued a circular on the storage issue of Oxytocin a few years ago, directing the states to maintain cold condition for storage. However, the official added he was not sure about the exact content of the circular, as it was issued many years ago.