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LICENSING HOSPITAL STORES
P A Francis | Wednesday, September 8, 2010, 08:00 Hrs  [IST]

An avoidable tussle is on between some of the medical practitioners belonging to Qualified Private Medical Practitioners Association of Kerala and the state Drug Control Dept there over licensing of private hospital pharmacies. It has begun ever since the verdict by the Kerala High Court on this matter last March. The Court had made it very clear that pharmacies in hospitals should obtain trade licenses for selling drugs as in case of any other pharmacies operating in the state. The state apex court verdict is an affirmation of the state government order issued to the private hospitals in this connection two decades ago. The state government order was then challenged in the High Court but lost and petitioners moved Supreme Court and it directed the state HC hear the case again. And the new verdict again upheld the state government stand. As per the provisions of the Drugs & Cosmetics Act, a drug licence is required to run a pharmacy store whether it is owned by an establishment or an individual. Now, the Drug Control Dept of the state already started acting on the rule following the HC order. The department had already issued an ultimatum to all private hospitals to take licenses before the end of July and asked the wholesalers and distributors not to supply medicines after July 31 to private hospital pharmacies which did not obtain drug licences. It has suspended the operations of some medical stores attached to private hospitals which have been ignoring the order.


Even when the department’s action is on against private hospital pharmacies, some members of the QPMPA are arguing that they are entitled to sell drugs without a drug licence. These members are quoting the clauses of Rule 65 of the Drugs & Cosmetics Rules which according to them make clear 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 them, this rule allows the registered medical practitioners to keep and dispense medicines to their patients without licence. Whatever may be the interpretation of the rule, selling of medicines to patients or public need to be under licence and control of regulatory authorities. That is what is happening in all other states and Union territories in the country today. It is not the job of medical practitioners to sell drugs in medical stores or in their clinics. That is what pharmacists are expected to do under section 42 of the Pharmacy Act. And there cannot be an exemption to this rule in one state just because some medical practitioners are opposed to obtaining a trade licence for pharmacies in hospitals. If there is still any lack of clarity or confusion in this regard to medical profession, that needs to be addressed urgently by the office of DCGI.

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