Special Provisions Relating to Biological and other Special Products

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Chapter: Forensic Pharmacy : The Drugs and Cosmetics Act (DCA) 1940 and Rules 1945

These products cannot be sold unless they have been sealed in previously sterilized containers made up of glass or other suitable materials approved by the Licensing Authority.


Special Provisions Relating to Biological and other Special Products

These products cannot be sold unless they have been sealed in previously sterilized containers made up of glass or other suitable materials approved by the Licensing Authority. This is not necessary if the substance is to be terminally sterilized.

In multiple dose containers, sufficient proportion of antiseptic! preservative is to be added. This is not applicable to penicillin suspensions. Test for sterility for surgical ligatures and sutures should be carried out as per Schedule F.

Special provisions of Biological products can be covered under the following.

1. Test for sterility

2. Test for freedom from abnormal toxicity

3. Test for pyrogens

4. Approval oftesting institutions for biological products.

Test for sterility, abnormal toxicity and pyrogens are carried out as per procedures described in Indian Pharmacopoeia.

Following biological and other products shall be tested for freedom from living aerobic or anaerobic micro-organisms.

(a) Sera and solution of sera proteins

(b) Bacterial vaccines and antirabis vaccine

(c) Preparation of posterior pituitary lobe

(d) Toxins, antigens, and their mixtures and immunisation or diagnostic products

(e) Preparation of insulin

(f) Any other parenteral preparation

(g) Any preparation from culture of pathogenic organism to be administered orally which must be steriled.

Procedure for sterility test (some requirements):-

(i) Preparation: Not less than 0.1 % volume of batch for a batch which is less than 10 litres; 10ml if, volume is more than 10 litres.

(ii) Containers: Not less than 1% of total number of containers if the batch is of more than 1000 containers; and a minimum of 10 container, if the total number is less than 100.

(iii) Medium for aerobic micro-organism: It consists of either meet extract with addition of 1% peptone or equivalent medium.

(iv) Medium for anaerobic micro-organism: It consists of nutrient broth similar to use in testing aerobic micro-organism with addition of heat coagulated musle, sufficient to occupy a depth of not less than I cm at the bottom of the tube.

For manufacturing of Schedules C, C (l) and X, the particulars of production, quantity of Schedule X drugs used for manufacturing and quantity of manufactured drugs are required to be maintained by the licensee.

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