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As per Indian Drug and Cosmetic Act 1945 is an Act of the Parliament of India which contains provisions for classification of drugs under given schedules and there are guidelines for the storage, sale, display and prescription of each schedule.


Schedule A Drugs

Gives the specimens of prescribed forms necessary for obtaining licenses, permits, certificates, intimations and so on.

FORM 2A- Certificate of test or analysis from the Pharmacopoeia! Laboratory for Indian Medicine or Government Analyst

FORMS 3-7- (Omitted)

FORM 8 -Application for license to import drugs (excluding those specified in Schedule X) to the Drugs and Cosmetics Rules, 1945

FORM 8A - Application for license to import drugs specified in Schedule X to the Drugs and
Cosmetics Rules, 1945

FORM9- Form of undertaking to accompany an application for an import licence

FORM 46- Permission/Approval for manufacture of new drug formulation

There are in total up to 50 forms.



Schedule B Drugs

This Schedule includes fees for test or analysis by the Central Drug Laboratory or the Government Analyst.

1. Fees for test and assay of Drugs requiring use of animals - Eg :- Adrenocorticotrophic hormone assay- 1000 Rs

2. Microbiological tests and assays - Eg:- Microbiological assay of vitamins - 300 Rs

3. Identification tests - Eg:- Electrophoresis - Polyacrylamide Gel- 300 Rs

4. Physical tests- Optical rotation, Specific gravity, Viscosity, Solubility, pH, Refractive index, Solubility, Absorbancy, Disintegration and dissolution test. Fees for Sera and Vaccine, Cosmetics, Homoeopathic medicines, etc. are also included in Schedule B.

Schedule B(1) : Fees for the test or analysis by the Pharmacopoeia/ Laboratory for Indian Medicine (PLIM) or the Government analyst - Eg:- Determination of lethal does LD 50 to 10 on mice - 2500 Rupees



Schedule C Drugs

Includes biological and special products such as Sera Vaccines, Antigens,Toxin, Antitoxin, Insulin, Bacteriophages, solution of serum proteins intended for injection, etc.


Schedule C1 : includes Other Special products such as Digitalis Preparations, fish liver oil, ergot preparations, Liver extract, vitamins,hormones, etc. Labelled with the words-- 'Caution: It is dangerous to take this preparation except under medical supervision. Prohibition of import of these products after expiry of potency.



Schedule D Drugs - '

Provides extent and conditions of exemption regarding import of drugs.

1. Class of drugs which are substances not intended for medicinal use

Exempted according to provisions of Chapter Ill of this Act and Rules, thereunder subject to the condition. If the substance is imported in bulk, the importer should certify that the substance is imported for non-medicinal uses. If imported otherwise than in bulk, each container should bear a label indicating that the substance is not intended for medicinal use or is intended for some purposes other than medicinal use.

E.g. Skimmed milk, powdered milk fortified with vitamins, Lactose, cereal products, oats, ginger, pepper, cummins, etc. come under this class of drugs.

2. Drugs and cosmetics imported for manufacture and export:-

Exempted under the provisions of Chapter Ill of the Act and rules, provided:-

They are covered under an import licence, import registration and import through notified port of entry. Subject to the conditions that these drugs and cosmetics shall not be diverted for sale in the country.

Schedule DI : Contains Information and undertaking required to be submitted by the manufacturer or his authorized agent with the Application Form for a Registration Certificate.

The details required are:

1. Particulars of the manufacturer and manufacturing premises

2. Particulars of the manufactured drugs to be registered under Registration
Certificate

3. Undertaking to declare that manufacturer should comply with all the conditions imposed on the Registration Certificate.

Schedule D11 : Here, the information is required to be submitted by the manufacturer for registration of a bulk drug/formulation/special product for its import into India.

The details required are:

- General like name, regulatory status of drug, etc.

- Chemical and pharmaceutical information of drugs.

- Biological and biopharmaceutical information

- Pharmacological and toxicological information of Drugs.

- Clinical documentation

- Labeling and packing information of drug

- Specified information required for special products.



Schedule E Drugs

Schedule E- Omitted as per GOI Notification No.G.S.R. 462(E) dt 22-6-1982.

Schedule E (I) : List of poisonous substances under the Ayurvedic (including Siddha) and Unani Systems of Medicine:

Ayurvedic System:

■ Drugs of Vegetable origin :- Bhang, Dhatura, Jaiphala, etc

■ Drugs of Animal origin :- Snake Poison

■ Drugs of Mineral origin :- Hartala (arsenic), Parada (mercury), etc.

The container of a medicine for internal use should be labelled conspicuously with the words 'Caution: To be taken under medical supervision' both in English and Hindi language.



Schedule F Drugs

It includes requirements for the Functioning and operation of a blood bank and/ or for preparation of blood components.

General :- Blood bank location, infrastructure requirements, Staff and equipment s required, etc.

Minimum requirement for grant of license to procure blood components from whole human blood.

F (I) :- Give details of the standards of bacterial vaccines, antisera and diagnostic antigens made from any microorganism pathogenic to man or other animals.

F (II):- Standards for Surgical Dressings that include bandage cloth, absorbent gauze, rolled bandage,etc

F (Ill):- Standards For Umbilical Tapes like umbilical polyester tape, cotton tape, etc.



Schedule FF Drugs


It lays down Standards for Ophthalmic preparations.


Part-A. Ophthalmic Solutions and suspensions.

1. sterile when dispensed

2. contain suitable substances to prevent the growth of micro-organisms

3. free from foreign matter & in bottles made of either neutral glass or soda glass

Label Contains:•

The statement 'Use the solution within one month after opening the container'.

The words 'NOT FOR INJECTION'.

WARNING:- " Do not touch the dropper tip or other dispensing tip to any surface since this may contaminate solutions".


Part B: Ophthalmic Ointments

1. Sterile when dispensed

2. Free from foreign matter

3. Label contains:- "Warning :- lf irritation persists or increases discontinue the use and consult physicians

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