In yet another case of non-compliance, Maharashtra Food and Drug Administration (FDA) has directed hospital pharmacy based in Hingadghat of Wardha district in Maharashtra to shut shop as it was being run without a pharmacist thus endangering patient safety.
Meanwhile, Maharashtra FDA vigilance team in Nagpur seized orthopedic implants worth Rs. 11 lakh from Chandan Nagar based firm for illegal stocking and supplies.
Maharashtra FDA recently made a massive crackdown on government-run hospital pharmacies across the state and found some of the hospital pharmacies were operated in the absence of registered pharmacist without maintaining proper records and found that drugs were also not stored as per label requirements.
Hospital pharmacies in the past were inspected at Aurangabad, Nashik, Pune, Kalyan, Amravati and Bhiwandi.
Based on the inspections at a hospital at Nagpur, FDA found that drugs were not stored as per label requirements, proper sanitary condition were not followed and medicines were stored on floor. Another drug store at ESIS Hospital, Nagpur, which distributed medicines to 16 dispensaries on loan basis during shortage of drugs did not have proper storage facilities and inspection revealed further that selling price as per rate contract of the same drug from same manufacturer varied from dispensary to dispensary.
Following raids and inspections, a total of 14 samples were drawn for testing and analysis to be reported for compliance purpose and further action.
As per Drugs and Cosmetics Act 1940 and Rules there under, Schedule K (5-A), drugs supplied by a hospital should follow the conditions that dispensing and supply of drugs shall be carried out by or under the supervision of a registered pharmacist. Drugs shall be stored under proper storage conditions.
Drugs shall be purchased from a manufacturer or a dealer licensed under these rules or received as transferred stocks from hospital stores for distribution. Records of such purchases or receipt shall also be maintained.
Maharashtra FDA intelligence branch observed that most of drugs stores in government and semi government hospitals violated the said section of the Act.
Inspections done at hospital pharmacy of Chatrapati Shivaji Maharaj Hospital, Thane revealed that medicines were not stored properly as per product label claim. Products with temperature below 20 to 25 degree Centigrade were stored at room temperature. Boxes of medicines were kept on floor. Premise was found dusty and register of stock return of expired drugs to manufacturer was not available.