The Maharashtra Food and Drug Administration (FDA) made a massive crackdown on government-run hospital pharmacies across Maharashtra and found that drugs were not stored as per label requirements. Following inspections, in all 14 samples were drawn for testing and analysis to be reported for compliance purpose and further action.

Hospital pharmacies were inspected at Nagpur, Aurangabad, Thane, Nashik, Pune, Kalyan, Amravati and Bhiwandi. It was also found that some of the hospital pharmacies were operated in the absence of registered pharmacist and without proper records.

As per Drugs and Cosmetics Act 1940 and Rules thereunder, Schedule K (5-A), drugs supplied by a hospital or dispensary maintained or supported by government or local bodies granted should follow the conditions that the 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 there rules or received as transferred stocks from hospital stores for distribution. Records of such purchases or receipt shall 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.

Based on the inspections at Isolation of Hospital at Nagpur, following discrepancies were observed like drugs were not stored as per label requirements, proper sanitary condition were not followed and medicines were stored on floor. Another drug store inspected was Central Medicines Stores at ESIS Hospital, Nagpur, where it was found that medicines were distributed to 16 dispensaries on loan basis during shortage of drugs. Some of the medicines boxes were stored on floor and selling price/ rates as per rate contract of the same drug from same manufacturer varied from dispensary to dispensary.
 
Inspection done at drug store at Government Cancer Hospital, Aurangabad, it was found that there were no sanctioned posts of pharmacists, dispensing of medicines was done by a deputed pharmacist and cold storage facility to store medicines was also not provided. Drugs batch number and expiry date were not maintained in stock distribution record details.

Inspections done at Central Medical Store at Chatrapati Shivaji Maharaj Hospital, Thane, it was found 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. Enough pellets or proper racks were not provided. Difference in stock was found for one product on verification with physical stock. Premise was found dusty. Register of stock return of expired drugs to manufacturer was not available.

Inspection at drugs store at Rural Hospital, Nashik found that medicine boxes were kept on floor, proper racks were not provided. Medicines were not stored at temperature as per label instructions. Refrigerator was not provided for storage medicines. Schedule X medicines were not stored separately with proper status label. Purchase and distribution record was not updated since 8 September 2016 and there was a mismatch of available stock with records.

On inspection of drug store at Rukhmini Bai KDMC hospital, Kalyan, drugs were distributed to 11 dispensaries and in a drug store at Smt Late Indira Gandhi District Hospital in Bhiwandi, discrepancies like record of dispensed medicines like batch number, manufacturing date, expiry date, patients details not being maintained were found.

Inspections at drug store at Civil Surgeon Hospital, Akola revealed that there was no cleanliness, purchase/ distribution of drugs mismatched, pellets and racks not provided for storage of drugs and storage conditions were not followed as per label requirements.