Strongly opposing the move of the Kerala Pharmacy Council to go on with inspections in all the medical shops and hospital pharmacies to regulate pharmacy practice, the All Kerala Chemists and Druggists Association (AKCDA) has decided to take up the issue with the national organisation putting one demand that the terms ‘pharmacy’ and ‘medical store’ should be distinguished and defined separately.

The association will hold their scheduled protest in front of the Council office in the state capital on July 29 and continue the protest with a day’s strike of medical shops if the inspection of the Council is not halted.

The traders argue that the licence granted to them by the drugs control department is for sale of medicines, and not for ‘dispensing’. It is clearly written in the licence that ‘no dispensing of medicine’ should be carried out in the drug stores. So, the pharmacy council has no legal right to inspect the medical stores licensed under Drugs & Cosmetics Act, and Rules, because no dispensing of medicines is taking place at medical stores. What is happening at the medical shops is sale of tested and company packed medicines to the customers, commented A N Mohan, president of AKCDA.

According to him, dispensing is held only in pharmacies which are hospital centred and managed by qualified pharmacists under the supervision of medical practitioners. Pharmacy is the place where medicines are compounded or mixed or dispensed to the patients. The pharmacy council can introduce their practice regulations in the hospital pharmacies and hold inspections there. The medical stores are not the places for their inspections. They should be inspected by the state drugs control officials.

He tried to define medical stores as the places/centres licensed to stock and sell medicines to the customers. Sale of medicines cannot be termed as dispensing. So, the term, ‘dispensing’ cannot be acknowledged or accepted, and it should be deleted from the purview of drugs sales. Medical stores are not pharmacies, which are shops that carry out medicine business under a licence holder who need not be a pharmacist. The pharmacy should be centred with in the premises of a healthcare establishment, whereas the medical store should operate outside of hospitals and clinics.

Mohan said, in the next executive committee meeting of the All India Organisation of Chemists and Druggists (AIOCD), slated for September 12 in Bilaspur in Chattisgarh, this issue will be discussed for the sake of the traders community in the country. The association will not allow pharmacy council to implement their practice regulations in the medicine retail shops. The regulations should be withdrawn, he added.

“Medical shops are licensed under D&C Act 1940 and Rules 1945, much prior to the Pharmacy Act 1948. They are supposed to stock and sell medicines, having licenses in Form 20 and 21. The Rule mandates presence of a pharmacist and sale of Schedule H and X drugs should be made against the prescription of a registered medical practitioner. Any condition/regulation overruling the D&C Act and Rules, in our opinion, is unconstitutional. So, such regulations should be revoked. Let the council regulate and inspect the hospital pharmacies, instead of taking law into their hands,” the president of AKCDA told Pharmabiz.

Meanwhile the consensus meeting called by the Kerala drugs controller, B Hariprasad, to sort out the issues between traders and pharmacy council has failed and the members of AKCDA staged a walk out from the meeting hall. They raised the slogan, ‘stop inspection raj by pharmacy council’ and decided to escalate the issue in the national level. The members of the trade body said the Pharmacy Practice Regulations should be withdrawn from the country.

When contacted the president of Kerala Pharmacy Council, B. Rajan, said the inspection will continue to safeguard the profession of pharmacy practice in the state. But, if any harassment by pharmacy inspectors is reported from anywhere, action will be initiated.