A confusion centered round the meaning of a clause in the Drugs and Cosmetics Rules is creating controversial interpretations and causes rivalry between the drugs control department and the private hospital managements in Kerala for the last 24 years.

The controversy is about one clause in item five of schedule K of the D&C Rules which mandates a registered medical practitioner to dispense medicines to his/her patients without a trade licence from the state drugs control department.

It is high time the office of the DCGI intervened and clarified the clause in the D & C Rules because due to the lack of clarity in the meaning, a legal tussle is going on between the enforcement authorities and the hospitals led by their association Qualified Private Medical Practitioners Association (QPMPA).

The QPMPA, which has undertaken the issue for legal fight, argues that under Schedule K of Drugs and Cosmetics Rules, 1945, the registered medical practitioners (RMPs) are exempted from taking license from the DC department for stocking and dispensing of drugs to their own patients. Whereas, the state drugs control authorities are of the opinion that a single doctor can keep medicines and dispense them to his/her patients, but he is not authorised to set up a pharmacy in his hospital or hospital premises and sell medicines to the patients across the counter. The RMP can stock and dispense the drugs in his cabin, but a separate pharmacy does not come under his control.

The issue had come up before the High Court in Kerala 24 years ago and its verdict came in favour of the drugs control department. Later, the hospital management’s body approached the Supreme Court, but it redirected the case to the High Court for more clarification. At last, seeking clarity on the part of the clause, the QPMPA wrote a letter to the office of the president of India, which directed the drugs controller general of India (DCGI) to sort out the matter and go for amendment  if required. But so far no discussion has been held in this matter in any platform.

Even today, the national secretary of QPMPA, Dr Kishore Kumar, advises all the private hospital managements that hospitals run by a single medical practitioner does not need licence for their pharmacy as they are exempted from drug licence and are authorized to procure, stock and dispense medicines.  So it is the duty of the  national regulator to clarify the clause and clear the confusion.