The Kerala branch of the Qualified Private Medical Practitioners Association (QPMPA) may approach the division bench of the state High Court against the state drugs control administration's move to enforce licensing of private hospital pharmacies as per the Section 18 c of the Drugs & Cosmetics Act.

The issue has taken a new turn also with a tussle brewing up between the private medical practitioners and the drug control authorities of the state.

The drug control department has already started acting on the rule following the high court verdict of 25/03/2010 mandating all pharmacies attached to private hospitals, either for dispensing or for stocking drugs, to obtain licences from the drugs control department.

Last month the department had given an ultimatum to all private hospitals to take licences before the end of the month, and later asked the wholesalers and distributors not to supply medicines after July 31 to private hospital pharmacies who did not obtain drug licences. Although some hospitals approached the licensing authorities for the license, those who are going by the advice of QPMPA have so far not applied for or shown any interest in taking licences, according to DCA sources.

Meanwhile, the drug inspectors across the state are regularly inspecting the pharmacies and penal actions are being taken. Last week, the department has suspended operations of two hospital pharmacies at Vadakara in Kozhikodu, where 250 licenses were issued to hospitals in August this year, said K E Mohan, ADC of Kozhikodu region. Even when the department is taking stringent actions, the members of the QPMPA are sticking to their stand arguing that they are entitled to dispense the drugs without licence.

Dr K Kishore Kumar, secretary of the state branch of QPMPA, says that the doctors community are exempted from drug licence under section 5 of Schedule K of the D&C Act, and it is a constitutional right enjoyed by them for the last 70 years. He said the drug authorities have misinterpreted Section 5 A in Schedule K to impose drug licence on all hospitals and there by to bring the hospitals under their control.

According to him the drug authorities have not bothered to read all the clauses of Rule 65 under which the conditions for licences are given. Dr Kishore, who is fighting the case for the last 20 years, said under the clauses of Rule 65, it is clearly mentioned that the conditions for drug licences are not applicable to a hospital, medical, educational or research institution or a registered medical practitioner for the purpose of supply to his patients. According to him, this means that the registered medical practitioners can keep and dispense medicines to his patients without licence. Section 5 of Schedule K gives exemption and Rule 65 (5) (1), (1) (a) & (b) do not demand a licence by the doctors to supply medicines to their patients.

As per D&C Act, the registered medical practitioners should purchase the drugs from a licensed dealer. The act says that 'retail sale' means a sale whether to a hospital, or dispensary, or a medical, educational or research institute or to any other person other than a sale by way of wholesale dealing. So the QPMPA argues that a licensed drug dealer can sell his drugs to a hospital or to a dispensary irrespective of the fact that it is privately owned or government controlled.

The HC order of March 25 was for implementing a two decades old government directive which wanted all the private hospitals in the Kerala to obtain drug licences for their pharmacies working with them.

Against this directive, twenty years ago, the state branch of the IMA and the Qualified Private Medical Practitioners Association had approached the High Court. The court then had favoured the directive of the Government. Further the medical practitioners groups filed a suit in the Supreme Court, but the apex court had asked the HC to hear the case once again. Accordingly, HC held that it was mandatory for the hospital pharmacies to get licenses from the concerned authority. In fact, the court was reiterating its earlier stand on the issue.

When the QPMPA lost the case, the drugs control department initiated steps to implement the HC order. It has given specified time to the hospitals to apply for licences. Even the government of Kerala has made some relaxations in the rules by giving exemption from taking license to doctor couples if they are jointly running a hospital.

When the case was in the court, the State Pharmacy Council also joined along with the drugs control department to fight against the medical practitioners' move, to implement section 42 of the Pharmacy Council Act which mandates the presence of a qualified pharmacist in every pharmacy. The council hoped that it would give job opportunities for the unemployed pharmacists in Kerala.

Dr Kishore Kumar said since they are registered medical practitioners, they would not appoint any registered pharmacist in their hospitals as the doctors themselves have the right to dispense medicines to their patients.