A committee appointed to investigate the detection of glass particles and other substances in phials of certain injections and in bottles of saline recently in government hospitals, recommended that the Health Ministry withdraw sixteen types of drugs manufactured by ‘Belco Pharma’ of India for two years. The Manufacturer should also take steps to reimburse the cost of the withdrawn injections and other drugs, the committee recommended.

Health Ministry sources said yesterday (17) that the committee headed by the Head of the Cosmetic and Drug Devices Authority (CDDA) Dr. Hemantha Beneragama had recommended that the Recall Committee be informed of the withdrawal.

The panel advised the Ministry to warn all manufacturing companies that they would be black-listed if their drugs were found to be substandard.

The committee warned that new drug registration applications would not be accepted until a good medical product (GMP) inspection was carried out. A team nominated by the Health Ministry was to be sent for GMP inspection with the cost borne by the manufacturer.

The local agent had stated that he would get in touch with the manufacturer about the GMP inspection and inform the CDDA. The drugs and injections which are to be withdrawn are:

1) Ampicillin sodium for Injection BP 250mg

2) Ampicillin sodium for Injection BP 500mg

3) Atropine sulphate Injection BP0.6mg/ml

4) Cefotaxime sodium Injection USP 1g

5) Ceftazidime for Injection USP 1g

6) Ceftazidime for Injection USP 1g

7) Cefuroxime for Injection USP 750mg

8) Cloxacillin sodium for Injection BP 250mg

9) Dexamethasone sodium phosphate Injection USP 4mg/ml

10) Gentamiein Injection 80mg/2ml

11) Hydrocortisone sodium succinate Injection 100mg

12) Lignocaine 2% + Adrenaline 1:100,000 Injection BP

13) Lignocaine Hydrochloride 2% Injection

14) Metoelopramide Injection BP 10mg/2ml

15) Morphine Sulphate Injection BP 15mg/1ml

16) Neostigmine Injection 2.5mg/ml

17) Pethidine Injection BP 50mg/ml

18) Pethidine Injection BP 75mg/1.5ml