manual on management of drugs

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6. Quality failure of registration samples attributed to manufacturing defect/failure If there is a quality failure, the application will be recommended for rejection by the DESC and the manufacturer will not be allowed to reapply for registration for the same product for a period of 12 months from the date of communicating the decision to the applicant. In the case of local manufacturers, the DRA will take a decision after inspecting the factory and testing samples collected by the DRA 7. The following decisions were taken on “withholds” Whenever there is a complaint, the Head of the Institution should initiate immediate action to withhold the batch and inform D/NDQAL with copies to D/MT&S and D/MSD. NDQAL will immediately investigate and analyse samples of the withheld batches and inform the D/MSD. D/MSD will give instructions to the Heads of Institutions on the actions to be followed. With regard to the private sector, (SPC or private market) recall procedures according to WHO GMP Guidelines will be followed. When quality failures are detected by the NDQAL, the D/MSD should immediately inform all respective PDHSS, RDHSS and Head of Institutions of all decisions to withhold items by fax followed by a hard copy. On receipt of this information, the PDHSS, RDHSS and Head of Institutions should immediately take actions to withhold the items and to send more samples for testing within 2 weeks of the letter sent by the D/MSD. If such samples are not available, that information should be intimated to the D/NDQAL, D/MSD and D/MT&S. 8. Recovery of cost In cases of quality failures, it is the responsibility of the SPC either to reimburse the cost or to replace the stocks with drugs of acceptable quality. 9. Destruction of substandard drugs The PDHSS, RDHSS and Head of Institutions are responsible for destroying stocks according to the WHO guidelines after receiving circulars for withdrawals from the D/MSD. 87
10. Recalls initiated by manufacturers When a manufacturer initiates the recall of a product available for sale, the reason for the recall should be intimated to the D/NDQAL, D/MSD and D/MT&S,. The D/MT&S and D/NDQAL should carry out complete investigations as to the reason for withdrawal by the manufacturer. 11. Tender samples Until further improvements are made to the NDQAL, samples will be selected on a random basis from each consignment of DHS supplies and tested. A quality certificate of the bulk drug (active ingredient) incorporated into the product should be sent along with each consignment. The SPC should send samples of all quality failed registered drugs submitted for tenders to the D/NDQAL. 88
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MANUAL ON MANAGEMENT OF DRUGS SECON
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MESSAGE BY THE SECRETARY/ MINISTRY
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ACKNOWLEDGEMENT It is a great pleas
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Dr. J. M. J. Munasinghe Dr. K. C. L
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ABBREVIATIONS AD CP CDD CDDA D(F) D
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CONTENTS Message by the Hon. Minist
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X Form for Drug sample for quality
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CHAPTER 1 INTRODUCTION 1.Ensuring a
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3.The expenditure on drugs has been
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of poisons, opium, and dangerous dr
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(Medical Technology & Supplies) No
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c) NDQAL for quality assurance of d
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Deputy Director General (Finance) D
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(d) The Institutional Drug Therapeu
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CHAPTER 4 ESTIMATION OF ANNUAL REQU
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Step 2 Identify the stock available
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In the case of institutions under t
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oard appointed by him and a report
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Head of the Institution may add any
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ii. Injections costing Rs. 25.00 or
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42. Delivery schedules are planned
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CHAPTER 6 CARE IN PRESCRIBING DRUGS
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CHAPTER 7 DISTRIBUTION AND LOGISTIC
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the institution. Records of the inv
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RMSD or institutional stores, the o
Page 52 and 53: CHAPTER 8 QUALITY ASSURANCE OF DRUG
Page 54 and 55: ioavailability. Further, in apprais
Page 56 and 57: x. Details of any preservative adde
Page 58 and 59: To request institutions to inform t
Page 60 and 61: CHAPTER 9 STORAGE OF DRUGS. 1. Prop
Page 62 and 63: xi. Storage of vaccine in the refri
Page 64 and 65: CHAPTER 10 MONITORING OF CONSUMPTIO
Page 66 and 67: ii. VEN analysis ( See annexure XV
Page 68 and 69: 9. Monitoring of quality of drugs;
Page 70 and 71: alance as per ledger, actual balanc
Page 72 and 73: 1.3 In case of institutions coming
Page 74 and 75: Ampoules should be crushed and buri
Page 76 and 77: ANNEXURE I1: Main functions of Medi
Page 78 and 79: I - Annual stock holding cost as a
Page 80 and 81: Anti Rabies cell culture vaccine. (
Page 82 and 83: unobservable (animal dead, killed,
Page 84 and 85: on D0, D3, D7, D14 & D30. 6.1.2 For
Page 86 and 87: All patients who receive rabies PET
Page 88 and 89: Monthly return for vaccine consumpt
Page 90 and 91: Death in the house / outside a Medi
Page 92 and 93: 2.2 In case of major exposures: 2.2
Page 94 and 95: ANNEXURE - V MyNo……/…../….
Page 96 and 97: Advertisement Screening Unit Unit o
Page 98 and 99: ANNEXURE VIII (To be amended To: My
Page 100 and 101: ANNEXURE X ……………………
Page 105 and 106: ANNEXURE XIII Lot Card SR No……
Page 107 and 108: ANNEXURE XV VEN Analysis This analy
Page 109: Sample Guidelines for VEN Category
Page 112 and 113: Unsatisfactory clinical response, a
Page 114 and 115: Local Agents of supplier (on reques
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manual on management of drugs

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