A serious regulatory issue has emerged in Kerala over carrying out inspections of medical stores by the pharmacy inspectors there. Inspections of medical shops by the pharmacy inspectors are being conducted now in the state after notification of Pharmacy Practice Regulations 2015 by the Union government in January last. These Regulations are aimed at enhancing the status and practice of pharmacy profession in the country. Kerala is perhaps the only state in India which has got pharmacy inspectors in all the 14 districts. As per the Pharmacy Act, State Pharmacy Councils are empowered under Section 26 A to appoint inspectors with the sanction of the respective state governments and pharmacy inspectors are expected to report the offences by the medical stores to the State Pharmacy Council. All Kerala Chemists and Druggists Association (AKCDA) representing the pharmaceutical trade in the state, is strongly opposing the inspections by the pharmacy inspectors on the ground that the trade licence is granted to the members by the state drug control department for sale of medicines and not for ‘dispensing’. And no dispensing is taking place at medical stores now. Therefore, the pharmacy inspectors have no right to inspect the medical stores licensed under Drugs & Cosmetics Act and Rules. What is happening at the medical shops is sale of tested and company packed medicines to the customers, the traders say.
Although the word dispensing is defined in Pharmacy Practice Regulations, its meaning still can be disputed by the trade to their advantage. But the objective of the new regulation is the patient safety and welfare and regular inspections of a medical store by a pharmacy inspector is intended for that only. It may be true that such a regulatory intervention has not been there earlier and it is causing some inconvenience to the trading community now. For this, trade is also responsible to some extent as some of their members have been breaking rules here and there. The main issue of concern in a medical store is the sale of medicines to the patients or to their agents with a professional guidance. In India, in a large number of 7.5 lakh medical shops this is not happening as qualified pharmacist is not present in the premises. As most state pharmacy councils have not yet appointed pharmacy inspectors, enforcement of Section 42 of Pharmacy Act is also being carried out by the drug inspectors of the respective states. But, in states where adequate number of pharmacy inspectors are available, inspections relating to all pharmacy practices should be entrusted with them and not with the drug inspectors. Pharmacy Council of India has to act now by directing the state pharmacy councils to appoint sufficient number of pharmacy inspectors in all the states for the purpose.